Comment

Document Sample
Comment Powered By Docstoc
					                                    Inhaled insulin for the treatment of diabetes (types 1 and 2)

                                       Table of Comments from the web site on the first ACD


Web          Section             Comment                                                    Response
comment
NHS          Appraisal           I Strongly support this approach. Current evidence of      Comment noted.
Profession   Committee’s         effectiveness/cost effectiveness not sufficient for any
al 1         preliminary         other policy at present.
             recommendations

NHS          Clinical need and   Good summary                                               Comment noted.
Profession   practice
al 1
NHS          The technology      Good summary                                               Comment noted.
Profession
al 1
NHS          Evidence and        Extremely comprehensive and clearly linked to              Comment noted.
Profession   interpretation      objective evidence base.
al 1
NHS          Appraisal           I am delighted that the committee has taken this           Comment noted.
Profession   Committee’s         cautionary step. Insulin is only one aspect of diabetes
al 2         preliminary         care. Those of us working in diabetes realise that
             recommendations     therapy is just one aspect of care and is only effective
                                 if adequate support and training programmes are in
                                 place to teach self management skills.
NHS          Clinical need and   In my 30 years experience with people with diabetes,       In view of the concerns raised by NHS professionals and people
Profession   practice            true needle phobia is extremely rare. Few people           diabetes, the committee is now recommending inhaled insulin for
al 2                             would chose to inject themselves, but learn to do so       people who are unable to start insulin therapy or intensification of
                                 when the need is identified. Most fears around insulin     insulin therapy because of severe problems with injection sites fo
                                 involve the correct dosing and being certain that the      example as a consequence of lipohypertrophy.
                                    "gadget" works. Education programmes for the health
                                    professionals and the person with diabetes have
                                    addressed ways of overcoming all the issues. The one
                                    place that I feel inhaled insulin would be useful is for
                                    those people with lipohypertrophy at injection sites or,
                                    as with one of my case load, subcutaneous tissue of
                                    abnormal absorbency.
NHS          The technology         Having seen the inhalers, they are quite large, and far    Comment noted.
Profession                          from discrete. People may need to carry two for
al 2                                dosage titration. This will add to amount of equipment
                                    being carried for diabetes management
NHS          Evidence and           No psychological studies to discover actual phobias or     Comment noted.
Profession   interpretation         assess levels of concern with injections. Sub
al 2                                Cutaneous insulin can be initiated quickly, no delay
                                    with lung assessment etc. No evidence of structured
                                    education programmes being used with initiation of
                                    inhaled insulin.
NHS          Proposed               More work needs to be done to identify the numbers of      The Committee has subsequently recommended that a prospecti
Profession   recommendations        people who would benefit i.e. true phobia,                 observational study to assess the effectiveness of inhaled insulin
al 2         for further research   lipohypertrohpy etc                                        amongst people with proven injection phobia or lipohypertrophy s
                                                                                               be undertaken and the use of inhaled insulin is part of a prospect
                                                                                               observational study of all specialist use requiring the collection of
                                                                                               on individual patient outcomes.


NHS          Preliminary views      If inhaled insulin was to be recommended; More             Comment noted.
Profession   on the resource        training required for nursing/medical staff to learn
al 2         impact for the NHS     about dosing and titration Clear criteria required for
                                    suitable patients - more education sessions to inform
                                    them of their role in managing this resource
                                    Psychological assessment Lung function studies
NHS          Proposals for          Clinical Studies would allow for the relatively few        Comment noted.
Profession   implementation and   people identified as suitable, to be assessed fully.
al 2         audit                However, is the number of suitable people ever going
                                  to be large enough to warrant the increased cost?
NHS          Related guidance     The present guidance available clearly advises on            Comment noted.
Profession                        early interventions to improve diabetes/glyaemic
al 2                              control and emphasises the need to provide structured
                                  education and support for people with diabetes, at
                                  diagnosis and ongoing through life. If programmes are
                                  in place throughout primary and secondary care, there
                                  would only be a very small number of people who
                                  could not achieve acceptable diabetes control.
NHS          Proposed date for    If suitable clinical studies report sooner, a review         Guidance is reviewed when new evidence on the clinical and cos
Profession   review of guidance   before 2009 would be helpful to Diabetes care Teams          effectiveness of the technology in question emerges.
al 2                              in all settings.
NHS          Appraisal            There are a small number of patients who have                In view of the concerns raised by NHS professionals and people
Profession   Committee’s          genuine psychological and physical (in the context of        diabetes, the committee is now recommending inhaled insulin for
al 3         preliminary          severe lipohypertrophy & lipodystrophy) difficulties with    people who are unable to start insulin therapy or intensification of
             recommendations      insulin administration. It is already difficult to justify   insulin therapy because of a proven injection phobia or severe
                                  alternatives to subcutaneous insulin injection with the      problems with injection sites for example as a consequence of
                                  NICE guidelines for the use of CSII. These                   lipohypertrophy.
                                  recommendations will again take away a viable
                                  treatment option for this very small number of patients.
NHS          Clinical need and    In my practice, I would not be recommending                  Although individual choice is important for the NHS and its users,
Profession   practice             widespread change to inhaled insulin. Patients may           should not have the consequence of promoting the use of interve
al 3                              demand it however, in line with the importance of            that are not clinically and/or cost effective” (Social Value Judgem
                                  patient choice in diabetes, although the size of the         Principles for the development of NICE guidance; principle 5)
                                  inhaler device and the difficulties with dose adjustment
                                  would mean that for most it would be inappropriate.          In view of the concerns raised by NHS professionals and people
                                  However, for a small number of patients with                 diabetes, the committee is now recommending inhaled insulin for
                                  difficulties with injections, severe lipodystrophy or        people who are unable to start insulin therapy or intensification of
                                  severe lipohypertrophy, I would like to consider using       insulin therapy because of a proven injection phobia or severe
                                  inhaled insulin.                                             problems with injection sites for example as a consequence of
                                                                                                  lipohypertrophy.
NHS          The technology         Inhaled insulin does seem to cause a small drop in            Comment noted.
Profession                          FEV1, so I would perform spirometry before
al 3                                commencing inhaled insulin, and then afterwards as
                                    per the manufacturers" instructions. The size of the
                                    insulin inhalation device will preclude many patients
                                    from choosing inhaled insulin.
NHS          Evidence and           I agree that this new treatment should not be widely          In view of the concerns raised by NHS professionals and people
Profession   interpretation         used, and I feel that most patients on seeing and using       diabetes, the committee is now recommending inhaled insulin for
al 3                                the inhaler device would find it more inconvenient than       people who are unable to start insulin therapy or intensification of
                                    subcutaneous insulin injections. However, for a small         insulin therapy because of a proven injection phobia or severe
                                    number of patients (<1% of all diabetic patients on           problems with injection sites for example as a consequence of
                                    insulin), with true psychological aversion to insulin         lipohypertrophy.
                                    therapy, or with severe lipodystrophy or
                                    lipohyerptrophy, inhaled insulin would be another
                                    modality of treatment that could be tried, so I would not
                                    support a blanket recommendation for the insulin not
                                    to be used.
NHS          Proposed               It will take some time to get results from such               Comment noted.
Profession   recommendations        research, thus making inhaled insulin not available on
al 3         for further research   the NHS for many years in all likelihood.
             Proposals for          Inhaled insulin should be offered to the small number         In view of the concerns raised by NHS professionals and people
             implementation and     of patients (<1% of all diabetic patients on insulin), with   diabetes, the committee is now recommending inhaled insulin for
             audit                  true psychological aversion to insulin therapy, or with       people who are unable to start insulin therapy or intensification of
                                    severe lipodystrophy or lipohyerptrophy, so that              insulin therapy because of a proven injection phobia or severe
                                    benefits or otherwise could be audited.                       problems with injection sites for example as a consequence of
                                                                                                  lipohypertrophy.

                                                                                                  The Committee has also recommended a prospective observatio
                                                                                                  registry study to evaluate the effectiveness of inhaled insulin in th
                                                                                                  population.
NHS          Proposed date for      Should be reviewed much earlier, September 2007.              Guidance is reviewed when new evidence on the clinical and cos
Profession   review of guidance                                                                 effectiveness of the technology in question emerges.
al 3
Patient 1    Appraisal            To reject simply on cost is not acceptable for people         For both legal and bioethical reasons those undertaking technolo
             Committee’s          with type 1 injections where there mental and long            appraisals and developing clinical guidelines must take account o
             preliminary          term well being should be taken into account                  economic considerations” (Social Value Judgements - Principles
             recommendations                                                                    development of NICE guidance; principle 5)

                                                                                                The Committee does not consider the affordability of new technol
                                                                                                but rather their cost effectiveness in terms of how its advice may
                                                                                                the more efficient use of available healthcare resources (NICE Gu
                                                                                                the Methods of Technology Appraisal, paragraphs 6.2.6.1 – 6.2.6

Patient 1    Clinical need and    I have diabetes type 1 for over 25 years and am now           In view of the concerns raised by NHS professionals and people
             practice             having increased problems with insulin resistance and         diabetes, the committee is now recommending inhaled insulin for
                                  having to increase the amounts of insulin I inject. I do      people who are unable to start insulin therapy or intensification of
                                  not ""fear"" injections, however the number of                insulin therapy because of severe problems with injection sites fo
                                  injections (six per day) has increased the amount of          example as a consequence of lipohypertrophy.
                                  pain has increased as I now suffer as my legs,
                                  abdomen and arms are now suffering from hypotrophy
                                  (forgive my spelling) hardening. This has not been
                                  helped by the new ""pens"" which tend to inject under
                                  pressure (I am thinking of Lantus pens by Aventis) and
                                  to a lesser degree the novo pen which are not
                                  developed for large amounts of insulin thus requiring a
                                  split in dosage - hence 6 injections (3 long acting and 3
                                  short) In the past it was easier to find alternative sites
                                  to inject but with the frequency increasing this has
                                  become harder to do. I do object to be ""labelled"" a
                                  whinge regarding pain - this is not the case. I have
                                  never refused to inject but would welcome an
                                  alternative method to receive insulin which whilst not
                                  alleviating all injections may at least potentially lead to
                              a reduction in the number of injections. This section
                              should be reviewed
Patient 2   Appraisal         Although I suffer from diabetes, I am glad to read           Comment noted.
            Committee’s       NICE"s recommendations, and believe they are
            preliminary       correct. Resources need to be marshalled effectively,
            recommendations   and (excepting those who are needle-phobic) I believe
                              that the injecting insulin is relatively un-painful,
                              straightforward and simple. I would hate to think of
                              people with life-threatening conditions who were
                              unable to benefit from treatment because of limited
                              money caused by the fact that the country’s diabetic
                              population were given access to what is effectively a
                              life-style enhancer. In some cases, I see a case for
                              improved quality of life, but I don’t think the difference
                              between a tiny needle and an inhaler (with which one
                              actually has to think more carefully about technique
                              etc), sufficient to warrant the extra cost. I can see that
                              for those who are needle phobic there is an advantage
                              to inhalers, but I feel that they should be treated for
                              their condition (i.e. with therapy) rather than simply
                              trying to avoid any needles.
            Appraisal         My 24 year old son was diagnosed as having type 1 at         The Committee considered evidence from patient groups and too
Carer 1     Committee’s       the age of 3 years. In all this time there has been no       into account when making its recommendations. Patient experts w
            preliminary       significant change in the treatment regime for a type 1.     were currently injecting insulin were present at the Committee me
            recommendations   It involves injections (up to 6 a day) and finger pricking
                              to test blood sugar levels). The development of insulin      Although individual choice is important for the NHS and its users,
                              in an inhaled form is the first significant change in        should not have the consequence of promoting the use of interve
                              treatment. I know that there have been smaller               that are not clinically and/or cost effective” (Social Value Judgem
                              improvements such as meter readers which provide             Principles for the development of NICE guidance; principle 5)
                              more accurate sugar readings and the recording of
                              readings. The speedy production of HBA1 results and          In view of the concerns raised by NHS professionals and people
                              probably, in our case, the development of Insulatard         diabetes, the committee is now recommending inhaled insulin for
                              which made a huge impact on the number of night             people who are unable to start insulin therapy or intensification of
                              hypos that my son experienced over a period of 15           insulin therapy because of severe problems with injection sites fo
                              years. As welcome as these developments are, they           example as a consequence of lipohypertrophy.
                              pale next to the possibility of NOT HAVING TO
                              INJECT except at night. We are frankly amazed at the        It also needs to be noted that inhaled insulin has a marketing
                              comment that most injection users do not mind               authorisation only for adults with diabetes.
                              injecting; I am inclined to think that this has become
                              such a part of their life that have forgotten what life
                              might be like without it. This perspective does not take
                              into consideration the damage that can be caused to
                              injection sites by repeated injecting. I urge you to
                              overturn your recommendation.
Carer 1   Clinical need and   The issue of cleanliness is a problem. Public toilets are   Although individual choice is important for the NHS and its users,
          practice            very often far from clean enough to put anything down       should not have the consequence of promoting the use of interve
                              on surfaces. Fortunately my son has a rather defiant        that are not clinically and/or cost effective” (Social Value Judgem
                              attitude to injecting and whilst he would take              Principles for the development of NICE guidance; principle 5)
                              advantage of a discrete location - if it is not available
                              then he will inject wherever he can. When he goes to        In view of the concerns raised by NHS professionals and people
                              music events he has to make public the fact that he         diabetes, the committee is now recommending inhaled insulin for
                              has needles about his person in case anyone                 people who are unable to start insulin therapy or intensification of
                              misinterprets his actions when injecting. Needle site       insulin therapy because of severe problems with injection sites fo
                              problems are almost an inevitable consequence of            example as a consequence of lipohypertrophy.
                              long term injecting.
Carer 1   The technology      What is the cost for injecting so that we can make a        See ACD sections 4.2.6-4.2.13.
                              comparison?
Carer1    Evidence and        Please do not rely totally on cost effectiveness. Quality   For both legal and bioethical reasons those undertaking technolo
          interpretation      of life is of paramount importance.                         appraisals and developing clinical guidelines must take account o
                                                                                          economic considerations” (Social Value Judgements - Principles
                                                                                          development of NICE guidance; principle 5)

                                                                                          The Committee does not consider the affordability of new technol
                                                                                          but rather their cost effectiveness in terms of how its advice may
                                                                                              the more efficient use of available healthcare resources (NICE Gu
                                                                                              the Methods of Technology Appraisal, paragraphs 6.2.6.1 – 6.2.6

Partner to   Clinical need and   The points in Clinical need and practice.7 cannot be
patient 1    practice            emphasised enough. My wife in type 1 and has been            Comment noted.
                                 injecting for years, the regular injection sites can get
                                 very painful, and injecting in public is a no-no. People
                                 give all kinds of funny looks, which makes what is a
                                 painful administration even worse.
Partner to   Evidence and        "The experts advised the Committee that using                The Committee considered evidence from patient groups and too
patient 1    interpretation      injected insulin is not usually a concern for the majority   into account when making its recommendations. Patient experts w
                                 of people with diabetes, given the availability of patient   were currently injecting insulin were present at the Committee me
                                 support and education, modern small needle types and         The committee also discussed the issue of diabetic complications
                                 insulin pens." - Who are these experts? Do they
                                 actually listen to their patients? This statement does       For both legal and bioethical reasons those undertaking technolo
                                 not constitute valid research and should not be              appraisals and developing clinical guidelines must take account o
                                 submitted for consideration. Most diabetes sufferers do      economic considerations” (Social Value Judgements - Principles
                                 not have "a concern" with injections as there has been       development of NICE guidance; principle 5)
                                 no alternative. Now there is, and this will improve the
                                 quality of life for diabetics and should help control of     The Committee does not consider the affordability of new technol
                                 the disease which inevitably will reduce the                 but rather their cost effectiveness in terms of how its advice may
                                 complications that the disease brings in later life          the more efficient use of available healthcare resources (NICE Gu
                                 (consequently reducing expenditure in the long term). I      the Methods of Technology Appraisal, paragraphs 6.2.6.1 – 6.2.6
                                 appreciate the long term in not a consideration when it
                                 comes to government spending.

NHS          Appraisal           As a borderline type 1/2 diabetic 48 year old who has        Comment noted.
Profession   Committee’s         to inject 4 times a day I find it very intrusive at having
al 4         preliminary         to do so, whilst my last injection is a long term insulin
             recommendations     and accept I will have to continue with this, as there is
                                 an option to avoid this intrusion I very much would like
                                 to do so.
NHS          Clinical need and      As I have said above I inject 4 times a day, the sites I   In view of the concerns raised by NHS professionals and people
Profession   practice               use the tissue is becoming harder and making it more       diabetes, the committee is now recommending inhaled insulin for
al 4                                difficult for the insulin to be absorbed into my body      people who are unable to start insulin therapy or intensification of
                                    thus not working effectively enough causing the control    insulin therapy because of severe problems with injection sites, fo
                                    problems.                                                  example as a consequence of lipohypertrophy.

NHS          The technology         The technology has come in leaps and bounds and will       For both legal and bioethical reasons those undertaking technolo
Profession                          make effective control easier; the costs alone should      appraisals and developing clinical guidelines must take account o
al 4                                not be a factor.                                           economic considerations” (Social Value Judgements - Principles
                                                                                               development of NICE guidance; principle 5)

                                                                                               The Committee does not consider the affordability of new technol
                                                                                               but rather their cost effectiveness in terms of how its advice may
                                                                                               the more efficient use of available healthcare resources (NICE Gu
                                                                                               the Methods of Technology Appraisal, paragraphs 6.2.6.1 – 6.2.6

NHS          Evidence and           The committee should look to widen the trial or            NICE can only provide guidance on the use of technologies within
Profession   interpretation         preferably licence the product for the reasons above.      licensed indications. Licences are granted by the MHRA or the EM
al 4

             Proposed               My diabetes is not poorly controlled but my tests          In view of the concerns raised by NHS professionals and people
NHS          recommendations        should a vast range of reading as the insulin cannot be    diabetes, the committee is now recommending inhaled insulin for
Profession   for further research   absorbed as the tissue in my injection sites has           people who are unable to start insulin therapy or intensification of
al 4                                hardened                                                   insulin therapy because of severe problems with injection sites fo
                                                                                               example as a consequence of lipohypertrophy.


NHS          Preliminary views      Cost alone should not be the only issue for not            For both legal and bioethical reasons those undertaking technolo
Profession   on the resource        granting a licence, patient care should be the only        appraisals and developing clinical guidelines must take account o
al 4         impact for the NHS     issue.                                                     economic considerations” (Social Value Judgements - Principles
                                                                                               development of NICE guidance; principle 5).
                                                                                              The Committee does not consider the affordability of new technol
                                                                                              but rather their cost effectiveness in terms of how its advice may
                                                                                              the more efficient use of available healthcare resources (NICE Gu
                                                                                              the Methods of Technology Appraisal, paragraphs 6.2.6.1 – 6.2.6

NHS          Proposals for        Grossly unfair on us sufferers.                             Although individual choice is important for the NHS and its users,
Profession   implementation and                                                               should not have the consequence of promoting the use of interve
al 4         audit                                                                            that are not clinically and/or cost effective” (Social Value Judgem
                                                                                              Principles for the development of NICE guidance; principle 5)

NHS          Proposed date for    This date is too far ahead, if the committee still intend   Guidance is reviewed when new evidence on the clinical and cos
Profession   review of guidance   to put us suffers through the hardship of having to         effectiveness of the technology in question emerges.
al 4                              inject, they should review this at the latest in April
                                  2007.
Patient 3    Discussion           As a diabetic for 25 years now, I can only suggest that     The Committee considered evidence from patient groups and too
                                  you ask patients about injections rather than clinicians.   into account when making its recommendations. Patient experts w
                                  As there has been no alternative to injections (until       were currently injecting insulin were present at the Committee me
                                  recently anyway) diabetics like myself "put up with"
                                  injections. Now an alternative is becoming available I      Although individual choice is important for the NHS and its users,
                                  would like to strongly urge you to consider allowing this   should not have the consequence of promoting the use of interve
                                  as an available treatment option. For 25 years I have       that are not clinically and/or cost effective” (Social Value Judgem
                                  wanted to escape the pain of injections, to find a better   Principles for the development of NICE guidance; principle 5)
                                  mechanism for the uptake of the insulin I take. Please,
                                  allow this treatment option to become available.
Patient 3    Recommendations      You use the phrase "quality of life" here - please          The Committee discussed the evidence on quality of life with inje
                                  consider the quality of life of a person dependant on       and inhaled insulin in detail. See ACD sections 4.3.8, 4.3.9, 4.3.1
                                  painful, multiple injections. These have to be carried
                                  out in sometimes unsanitary places for the                  In view of the concerns raised by NHS professionals and people
                                  convenience of other members of the public who do           diabetes, the committee is now recommending inhaled insulin for
                                  not wish to see a person injecting in restaurants for       people who are unable to start insulin therapy or intensification of
                                  instance. Where is the quality of life here for people?     insulin therapy because of severe problems with injection sites fo
                                  Also, different parts of the body absorb insulin            example as a consequence of lipohypertrophy.
                                   differently; to gain the required control risks repeated
                                   use of the same site for repeated blood glucose
                                   results. This destroys the tone of the muscle and skin
                                   in that area.
Patient 3   Clinical need and      After 25 years as a type 1 diabetic, I know many other     The Committee considered evidence from patient groups and too
            practice               diabetics. Not one of the diabetics I know who is taking   into account when making its recommendations. Patient experts w
                                   injections is happy with the method. We all of us put up   were currently injecting insulin were present at the Committee me
                                   with the treatment mechanism as it’s the only one
                                   available to us. Or perhaps the panel believe that
                                   diabetics should suffer the indignity of the pain and
                                   blood spots as an embarrassing external indicator of
                                   our condition?
Patient 3   The technology         This is an interesting cost breakdown. So nice to see      The Committee decision was based on a detailed economic analy
                                   the cost of a human beings happiness expressed as a        which took into account of all relevant costs, including the long-te
                                   simple number. The costs here however do not               complications resulting of poor glycaemic control.
                                   attempt to take into account the cost of treatment for
                                   people who have poor control and who in later life will
                                   have diabetic complications as a result of this poor
                                   control. Here we have the promise of a treatment
                                   mechanism that could reduce the risks. The cost
                                   savings will be large if realised I believe, the cost in
                                   terms of quality of life are incalculable however.
Patient 3   Evidence and           The idea that those patients with a real phobia of         Although individual choice is important for the NHS and its users,
            interpretation         needles and injections could be offered the inhaled        should not have the consequence of promoting the use of interve
                                   insulin is to be applauded, however this should not be     that are not clinically and/or cost effective” (Social Value Judgem
                                   a limiting factor. The inference from the figures          Principles for the development of NICE guidance; principle 5)
                                   supports the views of diabetics that injections are not
                                   our first choice options and that most of us will
                                   welcome a chance to move away from them.
Patient 3   Proposed               I myself would be very happy to take an active part in     Comment noted.
            recommendations        any trials of the inhaled insulin
            for further research
Patient 3   Proposed date for      I would like to urge an earlier date, August 2007.           Guidance is reviewed when new evidence on the clinical and cos
            review of guidance                                                                  effectiveness of the technology in question emerges.

Clinical    Recommendations        See comments below. This advice will be used by PCT          In view of the concerns raised by NHS professionals and people
academic                           to effectively prevent any patient from receiving,           diabetes, the committee is now recommending inhaled insulin for
                                   however strong the case. Would the committee                 people who are unable to start insulin therapy or intensification of
                                   consider inserting an additional caveat while we are         insulin therapy because of a proven injection phobia or severe
                                   waiting for the suggested studies on quality of life etc     problems with injection sites for example as a consequence of
                                   along the lines of ""except where extreme and unusual        lipohypertrophy.
                                   problems with injection sites exist (e.g. a clinically
                                   defined needle phobia or severe resistant
                                   lipohypertrophy of injection sites)?
Clinical    Clinical need and      Frank needle phobia is indeed rare but a far greater         In view of the concerns raised by NHS professionals and people
academic    practice               problem is that of lipohypertrophy affecting injection       diabetes, the committee is now recommending inhaled insulin for
                                   sites. The small number of patients who I had initially      people who are unable to start insulin therapy or intensification of
                                   earmarked as being possible candidates for inhaled           insulin therapy because of a proven injection phobia or severe
                                   insulin are those with injection site lipohypertrophy        problems with injection sites for example as a consequence of
                                   which has been resistant to standard attempts to rest        lipohypertrophy.
                                   sites and rotate away from problem areas (all clinics
                                   will have such patients), with the aim of being able to
                                   offload at least some of the injections for at least a
                                   period of time. The other option for these folk is insulin
                                   pump therapy- twice as expensive as inhaled insulin
                                   therapy and probably not as effective given that it still
                                   involves subcutaneous delivery of the offending growth
                                   factor!!
Clinical    Proposed               Lipohypertrophy (as per my comments above)-                  The Committee has recommended a prospective observational s
academic    recommendations        perhaps in comparison to pump Rx                             assess the effectiveness of inhaled insulin amongst people with p
            for further research                                                                needle phobia or lipohypertrophy.
Clinical    Preliminary views      Also suspect that even if was widely available, that not     Comment noted.
academic    on the resource        many would take up when they discover how large
            impact for the NHS     inhaler is and how inflexible for those on small doses
                                of insulin.
Patient 4   Clinical need and   Your description of the means of controlling type 1           The Committee considered evidence from patient groups and too
            practice            diabetes (2.4) is a statement of fantasy put about by         into account when making its recommendations. Patient experts w
                                largely ill informed so called diabetic "specialists". It     were currently injecting insulin were present at the Committee me
                                would be better to talk to diabetics rather than the UK
                                medical profession who are largely ignorant of what           In view of the concerns raised by NHS professionals and people
                                constitutes living with diabetes. The same could be           diabetes, the committee is now recommending inhaled insulin for
                                said of point 2.7 and the pejorative use of the word          people who are unable to start insulin therapy or intensification of
                                "some". Anyone who injects themselves will tell that          insulin therapy because of a proven injection phobia or severe
                                over a period of twenty to thirty years the use of            problems with injection sites for example as a consequence of
                                needles damages the skin (regardless of how often             lipohypertrophy.
                                you rotate sites) and leads to what the American
                                diabetic specialists (a deserved title) describe as
                                Diabetic burnout. This dangerous condition leads to
                                long-term complications all of which are extremely
                                expensive to treat.
Patient 4   Evidence and        Do not rely too heavily on HbA1c blood sugar readings         Although individual choice is important for the NHS and its users,
            interpretation      they are, as any type 1 diabetic will tell, heavily           should not have the consequence of promoting the use of interve
                                influenced by blood sugar levels three days prior to the      that are not clinically and/or cost effective” (Social Value Judgem
                                test. Point 4.3.8 is frankly silly. No one, no one in their   Principles for the development of NICE guidance; principle 5)
                                right mind and no doctor in their right mind would
                                suggest injections as a course of treatment,                  For both legal and bioethical reasons those undertaking technolo
                                particularly if their is an inhaled alternative. Anyone       appraisals and developing clinical guidelines must take account o
                                who does injections would understand that. I was              economic considerations” (Social Value Judgements - Principles
                                surprised that in point 4.3.12 that you mentioned             development of NICE guidance; principle 5).
                                clinical effectiveness. From you own writing and
                                objective correlatives (re-read points 4.1.13 and points      The Committee does not consider the affordability of new technol
                                4.1.14) over provided and tested evidence this is             but rather their cost effectiveness in terms of how its advice may
                                clearly a financial decision not one based on patient         the more efficient use of available healthcare resources (NICE Gu
                                welfare.                                                      the Methods of Technology Appraisal, paragraphs 6.2.6.1 – 6.2.6

Patient 4   Proposed            Glad to see no more time and money is going to be             Comment noted.
            recommendations        wasted doing more research.
            for further research
Patient 4   Proposed date for      Interesting to see that there was not a single diabetic      The Committee considered evidence from patient groups and too
            review of guidance     on this committee, and only one Doctor involved in           into account when making its recommendations. Patient experts w
                                   diabetes. So in conclusion it would appear that the          were currently injecting insulin were present at the Committee me
                                   very analytical basis of your own research and
                                   evaluation of this drug is flawed. Only one person on
                                   this committee was in any way qualified to make a
                                   medical assessment of the impact of this drug on
                                   diabetes care in the UK. Well done, more wasted
                                   public resources. You should stick to making decisions
                                   on life threatening conditions like breast cancer, oh
                                   wait.
Patient 5   Appraisal              It is my firm belief that Inhaled insulin should be one of   The Committee considered evidence from patient groups and too
            Committee’s            the recommended treatments for type 1 or type 2              into account when making its recommendations. Patient experts w
            preliminary            diabetes mellitus. A further consultation with a wider       were currently injecting insulin were present at the Committee me
            recommendations        variety of diabetic patients and their carers should be
                                   undertaken before reaching a definitive decision.
Patient 5   Clinical need and      Clinical studies are of course completely necessary. It      Although individual choice is important for the NHS and its users,
            practice               may be that not all patients would benefit or be able to     should not have the consequence of promoting the use of interve
                                   inhale insulin. However, compared with injecting             that are not clinically and/or cost effective” (Social Value Judgem
                                   insulin several times a day the inhaled option should        Principles for the development of NICE guidance; principle 5)
                                   be allowed to compliment patients diabetes regimens if
                                   the patient so desire. Many type 2 diabetics are not yet     The committee is now recommending inhaled insulin for people w
                                   injecting insulin, but may be in the future. The thought     are unable to start insulin therapy or intensification of insulin thera
                                   of daily injections too many is quite traumatic. This        because of a proven injection phobia or severe problems with inje
                                   recommendation does not appear to be considering             sites for example as a consequence of lipohypertrophy.
                                   the future clinical need of these patients. A further
                                   consultation with a wider variety of diabetic patients
                                   and their carers should be undertaken before reaching
                                   a definitive decision.
Patient 5   The technology         It is clear that the technology may not be suitable for      Although individual choice is important for the NHS and its users,
                                   all; this does not mean that it is unsuitable for all. Once   should not have the consequence of promoting the use of interve
                                   all the risks have been explained to the patient the          that are not clinically and/or cost effective” (Social Value Judgem
                                   patient should have the choice. As with most                  Principles for the development of NICE guidance; principle 5)
                                   technologies the greater the use the cheaper the cost.
Patient 5   Evidence and           The social implications of diabetes appears to have           Comment noted.
            interpretation         been neglected in this study. Inhaled diabetic
                                   medication would be more socially acceptable than
                                   injections. Many diabetics are forced by social
                                   pressures to inject privately as if there is something
                                   sinister about receiving ones medication in public.
                                   Other social consideration such as the need for
                                   removal of clothing and the practicalities of not being
                                   able to do so, may inhibit or delay the administration of
                                   injected medication. This would not even be a
                                   consideration with an inhaler. Of the estimated 2
                                   million diabetics (this figure is likely to be more) a
                                   study on 0.11% is not a fair representation of the
                                   diabetic population, or a realistic sized study group.
Patient 5   Proposed               All diabetes management carries the risk of severe            Comment noted.
            recommendations        hypoglycaemic events. General research should be
            for further research   undertaken as a matter of course in this area. Further
                                   trials should be carried out that will either confirm or
                                   contradict the statistic that there is a general greater
                                   satisfaction with the inhaled insulin. A larger a more
                                   representative study should be undertaken. The
                                   personal and social needs of the diabetic patient and
                                   their carers should also be further considered and
                                   researched.
Patient 5   Preliminary views      Diabetes has a lot of associated medical risks and            Comment noted.
            on the resource        complications. The resource impact on the NHS would
            impact for the NHS     be reduced if diabetes were to be controlled
                                   effectively. All diabetics should be given more
                                  information with special emphasis on nave diabetics.
Patient 5    Proposals for        It is my belief the implementation of this guidance            Comment noted.
             implementation and   should be delayed whilst further more expansive
             audit                studies are carried out.
Patient 5    Proposed date for    I believe that April 2009 is too far away and that this        Guidance is reviewed when new evidence on the clinical and cos
             review of guidance   technology should be reviewed in April 2007.                   effectiveness of the technology in question emerges.

NHS          Evidence and         As health care clinicians we rarely know from first            In view of the concerns raised by NHS professionals and people
Profession   interpretation       seeing a patient who has an aversion to insulin                diabetes, the committee is now recommending inhaled insulin for
al 5                              injections but this becomes apparent over time whilst          people who are unable to start insulin therapy or intensification of
                                  working with the person to achieve good glycaemic              insulin therapy because of a proven injection phobia or severe
                                  control. I feel that inhaled insulin (just like insulin pump   problems with injection sites for example as a consequence of
                                  therapy) would not be first choice but would be used to        lipohypertrophy.
                                  help tighten glycaemic control in those people who are
                                  unable to tighten control on s/c insulin because of their
                                  aversion
Patient 6    Appraisal            Al diabetic’s blood sugars are to a certain extent             The Committee discussed the evidence on quality of life with inje
             Committee’s          uncontrolled; otherwise they would not be diabetics.           and inhaled insulin in detail. See ACD sections 4.3.8, 4.3.9, 4.3.1
             preliminary          Diabetics put up with their current regime as there has
             recommendations      never been an alternative, This inhaler would improve
                                  quality of life.
Patient 6    Clinical need and    I suffer from all of the above and have 26 years of            Comment noted.
             practice             being a type one diabetic.
Patient 6    The technology       Cost should not be a factor and the contraindications          For both legal and bioethical reasons those undertaking technolo
                                  of injected insulin including poor absorption in a site        appraisals and developing clinical guidelines must take account o
                                  that through no fault of the patient inevitably becomes        economic considerations” (Social Value Judgements - Principles
                                  over used should merit the consideration of an insulin         development of NICE guidance; principle 5).
                                  inhaler.
                                                                                                 The Committee does not consider the affordability of new technol
                                                                                                 but rather their cost effectiveness in terms of how its advice may
                                                                                                 the more efficient use of available healthcare resources (NICE Gu
                                                                                                 the Methods of Technology Appraisal, paragraphs 6.2.6.1 – 6.2.6
                                                                                             In view of the concerns raised by NHS professionals and people
                                                                                             diabetes, the committee is now recommending inhaled insulin for
                                                                                             people who are unable to start insulin therapy or intensification of
                                                                                             insulin therapy because of a proven injection phobia or severe
                                                                                             problems with injection sites for example as a consequence of
                                                                                             lipohypertrophy.

Patient 6   Evidence and           In my experience most diabetic clinics last               Comment noted.
            interpretation         approximately 10 minutes, once a year. I applaud
                                   anyone who could give an accurate patient portrayal
                                   under these circumstances
Patient 6   Proposed               Give every diabetic a fair chance to research and try     Although individual choice is important for the NHS and its users,
            recommendations        this treatment. Don’t penalise or take away the choice    should not have the consequence of promoting the use of interve
            for further research   from ""controlled"" diabetics                             that are not clinically and/or cost effective” (Social Value Judgem
                                                                                             Principles for the development of NICE guidance; principle 5)

Patient 6   Preliminary views      Again it should be a matter of choice not cost. Not all   Although individual choice is important for the NHS and its users,
            on the resource        diabetics will want to go on to the inhaled regime,       should not have the consequence of promoting the use of interve
            impact for the NHS     mainly pensioners some of whom don’t even use an          that are not clinically and/or cost effective” (Social Value Judgem
                                   insulin pen. For those of us who do want to try an        Principles for the development of NICE guidance; principle 5)
                                   alternative, this should be made readily available
                                                                                             For both legal and bioethical reasons those undertaking technolo
                                                                                             appraisals and developing clinical guidelines must take account o
                                                                                             economic considerations” (Social Value Judgements - Principles
                                                                                             development of NICE guidance; principle 5).

                                                                                             The Committee does not consider the affordability of new technol
                                                                                             but rather their cost effectiveness in terms of how its advice may
                                                                                             the more efficient use of available healthcare resources (NICE Gu
                                                                                             the Methods of Technology Appraisal, paragraphs 6.2.6.1 – 6.2.6
Patient 6    Proposals for          All diabetics should be questioned to give their views     The Committee considered evidence from patient groups and too
             implementation and     via their consultations to give a better picture and a     into account when making its recommendations. Patient experts w
             audit                  more realistic demograph.                                  were currently injecting insulin were present at the Committee me
                                                                                               The public is invited to comment and contribute via the Institutes
                                                                                               website, once an ACD is issued.


Patient 6    Related guidance       try asking a real life diabetic for their views and        The Committee considered evidence from patient groups and too
                                    guidance                                                   into account when making its recommendations. Patient experts w
                                                                                               were currently injecting insulin were present at the Committee me


Patient 6    Proposed date for      Why 2009 when trials already indicate that the             Guidance is reviewed when new evidence on the clinical and cos
             review of guidance     treatment could be operative now. I would be very          effectiveness of the technology in question emerges.
                                    surprised if there are any diabetics on the team.
NHS          Appraisal              This seems an extreme recommendation; whilst I             In view of the concerns raised by NHS professionals and people
Profession   Committee’s            would agree with a limited and cautious introduction of    diabetes, the committee is now recommending inhaled insulin for
al 6         preliminary            this medication there are some groups of patients          people who are unable to start insulin therapy or intensification of
             recommendations        particularly with needle phobia in whom the inhaled        insulin therapy because of a proven injection phobia or severe
                                    insulin would be a major step forward.                     problems with injection sites for example as a consequence of
                                                                                               lipohypertrophy.

NHS          Evidence and           I am concerned about possible long term pulmonary          Comment noted.
Profession   interpretation         problems and feel we need considerably more
al 6                                evidence before any widespread usage.
NHS          Proposed               As above: the effects on the lungs need further            Comment noted.
Profession   recommendations        independent research
al 6         for further research
NHS          Appraisal              These studies should particularly focus on injection       In view of the concerns raised by NHS professionals and people
Profession   Committee’s            phobic patients. Identifying such patients with            diabetes, the committee is now recommending inhaled insulin for
al 7         preliminary            reasonable confidence is crucial to the wise use of this   people who are unable to start insulin therapy or intensification of
             recommendations        technology. I believe that they are few in number.         insulin therapy because of a proven injection phobia or severe
                                    Hence I support the emphasis on measuring                  problems with injection sites for example as a consequence of
                                    RELEVANT outcome measures to evaluate quality of           lipohypertrophy.
                                    life.
NHS          Clinical need and      No special comments. This is a reasonable summary          Comment noted.
Profession   practice               of the current state of affairs.
al 7

NHS          The technology         The lack of evidence and resulting uncertainty of long     Comment noted.
Profession                          term effects on the lung is noted. It is of course
al 7                                inevitable for a new technology: one can’t wait 10
                                    years. But it does provide grounds for caution if a
                                    growth factor like insulin is to be given in significant
                                    dose on to the bronchial mucosa and alveoli.
NHS          Evidence and           This is an excellent summary and I agree with its          Comment noted.
Profession   interpretation         conclusions. It is hard to deny that there is a small
al 7                                number of patients who would truly benefit, but the
                                    continuing uncertainties argue caution. The
                                    demonstrated benefits appear small and the quality of
                                    life measures are, of course, in trials in which
                                    recruitment selects patients who might have a pre-
                                    existing preference for this mode of administration.
                                    There is a case for special comment on the likely risks
                                    of inhaled insulin when driving in view of the reported
                                    hypoglycaemia risk.
NHS          Proposed               Agree                                                      Comment noted.
Profession   recommendations
al 7         for further research

NHS          Preliminary views      The potential costs could be substantial. Enthusiasts      Comment noted.
Profession   on the resource        will wish to try the new technology and patients will be
al 7         impact for the NHS     eager to request it - as many have done already after
                                    newspaper articles.
NHS          Proposals for        Agree                                                        Comment noted.
Profession   implementation and
al 7         audit

NHS          Proposed date for    Understand this is currently draft guidance only.            Comment noted.
Profession   review of guidance
al 7

Patient 7    Clinical need and    My own experience of a basal/bolus regime (Eli Lilley        Although individual choice is important for the NHS and its users,
             practice             Lantus/Lispro) is that the Lantus (long term) injection is   should not have the consequence of promoting the use of interve
                                  easy to manage and not inconvenient, however the             that are not clinically and/or cost effective” (Social Value Judgem
                                  Lispro injections cause significant problems. I inject 3     Principles for the development of NICE guidance; principle 5)
                                  to 6 (sometimes maybe up to about 10) times per day,
                                  small does (4, 6 or 8 units) in response to blood            In view of the concerns raised by NHS professionals and people
                                  glucose measurements. I can’t use an insulin pump            diabetes, the committee is now recommending inhaled insulin for
                                  because I have an extremely active life - anything           people who are unable to start insulin therapy or intensification of
                                  attached to my body will get damaged. I use a pen with       insulin therapy because of a proven injection phobia or severe
                                  an attached needle (I don’t detach it because of the         problems with injection sites for example as a consequence of
                                  time and inconvenience of obtaining 100 needles a            lipohypertrophy.
                                  month). The main result is that my injection sites are
                                  limited - I don’t want to get undressed for every
                                  injection. While my situation is maybe relatively
                                  unusual I find the same problems with injections in
                                  restaurants. (A diabetic using this regime must inject
                                  every time food is consumed.) In the past I have
                                  injected in restaurant (and pub) toilets - I gave up
                                  doing this years ago because of the extreme hygiene
                                  problems! The problems of undressing in a restaurant
                                  restrict me to abdominal injection sites. Even with
                                  modern (very narrow gauge) needles this has led to
                                  the expected problems.
Patient 7    The technology       My concerns with the technology (in no particular            Comment noted.
                             order) are: 1) Reliability of delivery of small doses (4-8
                             units). 20% accuracy is more than enough on my
                             regime because I do very frequent blood tests. 2) Long
                             term effects - I’ve injected myself for over 30 years, the
                             realistic time scale of inhaler use for a type 1 diabetic
                             is at least 60 years. 3) Absence of any special storage
                             or carriage requirements (e.g. requiring a refrigerator
                             would prevent my own use of such a device.) This
                             report seems to fail to provide a detailed analysis of
                             how the device might accommodate lifestyles of
                             different diabetics. For example someone who has a
                             religious or cultural requirement to wear particular
                             clothing may find such a device usable, or unusable,
                             where injection is not/is. (Notice that it is possible to
                             inject insulin through clothing!)
Patient 7   Evidence and     4.3.5 is the most significant point here. Direct             The Committee considered evidence from patient groups and too
            interpretation   comparison of glargine (e.g. Lantus) + lispro against        into account when making its recommendations. Patient experts w
                             glargine + inhaler (Exubera is classed as "rapid acting"     were currently injecting insulin were present at the Committee me
                             - I assume this is equivalent to lispro, described as
                             "short acting" here) is essential. I find it amazing that    In view of the concerns raised by NHS professionals and people
                             the studies in 4.1.1 omitted this comparison. The            diabetes, the committee is now recommending inhaled insulin for
                             expert statement in 4.3.2 is extremely misleading -          people who are unable to start insulin therapy or intensification of
                             ""using injected insulin is not usually a concern for the    insulin therapy because of a proven injection phobia or severe
                             majority of people with diabetes"" - the issue here is       problems with injection sites for example as a consequence of
                             not those people for whom injection is *not* a concern.      lipohypertrophy.
                             The statement implies that the expert opinion
                             discounts the requirements of the people, perhaps a
                             minority, for whom this is a concern. The subsequent
                             text in 4.3.2 and the whole of 4.3.3 seem to
                             concentrate on people with needle phobia and the
                             driving license interaction (which is a serious problem I
                             encountered in the UK). The committee fails to realise,
                                    or maybe acknowledge, that there are very real
                                    physical reasons why a person on a "standard"
                                    glargine/lispro injection regime may significantly
                                    benefit from a glargine/inhaler regime. These arise if
                                    (and only if) the lispro injections can be replaced one-
                                    for-one with inhaler use.
Patient 7    Proposed               There is a real need to find alternatives to frequent      Although individual choice is important for the NHS and its users,
             recommendations        lispro injection. Alternatives cannot be regarded as       should not have the consequence of promoting the use of interve
             for further research   replacements. The relative merits of lispro pen, insulin   that are not clinically and/or cost effective” (Social Value Judgem
                                    pump and inhaler vary from diabetic to diabetic and        Principles for the development of NICE guidance; principle 5)
                                    from time to time for an individual diabetic. An
                                    individual may need to use an inhaler in public but
                                    prefer injection in private. Someone with a physically
                                    demanding job might use a pump at weekends and
                                    injection or inhaler while working. Individuals *do*
                                    forego treatment options to avoid inconvenient
                                    injections (and blood tests). I will skip both injection
                                    and food to allow me to work. Taking off protective
                                    clothing and getting to a location which is hygienic
                                    where blood test and insulin apparatus can be safely
                                    stored is an enormous overhead. The risks of
                                    hypoglycaemia are sufficiently serious in a demanding
                                    environment that I favour high blood sugars while
                                    working. Inhalers do not provide a solution - nothing
                                    does - but inhalers are a potential tool in a solution.
NHS          Appraisal              In contrast to many of my colleagues I would agree         Comment noted.
Profession   Committee’s            with this statement. Only a small minority of patients
al 8         preliminary            with extreme needle phobia might potentially benefit
             recommendations        from inhaled insulin. Secondly so far studies have only
                                    analysed equipotency of inhaled insulin, but have not
                                    been able to show superiority of inhaled insulin over
                                    injection of insulin. No studies have compared inhaled
                                 insulin therapy with insulin analogues or insulin pump
                                 therapy.
NHS          Clinical need and   In the light of DCCT patients with type 1 diabetes are      Comment noted.
Profession   practice            encouraged to aim for HbA1C of less than 7% (6.5%
al 8                             ADA) which so far has only been achievable with a
                                 basal bolus regimen or insulin pump therapy. No study
                                 so far has shown that inhaled insulin therapy is able to
                                 achieve this aim in a significant proportion of patients
                                 with type 1 diabetes. I see no indication for using
                                 inhaled insulin therapy in patients with type 2 diabetes.
                                 Current practice is either adding a long acting insulin
                                 analogue or starting patients on a biphasic insulin
                                 regimen while continuing with
                                 metformin/sulphonylurea.
NHS          The technology      Long term data on the safety on inhaled insulin therapy     Comment noted.
Profession                       are lacking and I would be concerned starting young
al 8                             patients with type 1 diabetes (>18 years old) on long-
                                 term inhaled insulin therapy. One also needs to take
                                 into account the cost of monitoring lung function tests
                                 in patients on inhaled insulin therapy.
NHS          Evidence and        I fully agree with the conclusion drawn.                    Comment noted.
Profession   interpretation
al 8
Patient 8    Evidence and        I am concerned that no mention is made of the               In view of the concerns raised by NHS professionals and people
             interpretation      complications that can be caused by high frequency          diabetes, the committee is now recommending inhaled insulin for
                                 insulin injections. In particular tenderness and other      people who are unable to start insulin therapy or intensification of
                                 effects on injection sites and also erratic and             insulin therapy because of a proven injection phobia or severe
                                 unpredictable insulin absorption that can occur on          problems with injection sites for example as a consequence of
                                 regularly used injection sites. Furthermore the             lipohypertrophy.
                                 correlation of weight difference is not made with
                                 general health of both type 1 and type 2 diabetics.         The committee was aware of differences in weight change with In
                                 Both of these points are pertinent to this assessment       insulin compared to subcutaneous insulin.
                                 and while the issue of injection site complications may
                                 be too lengthy to examine, speculation is made about
                                 potential detrimental behaviour of inhaled insulin (lung
                                 problems) but potential benefits are omitted. This
                                 seems to me to be partial.
Patient 8   Proposed date for    This is far too long. In particular if the cost of the       Guidance is reviewed when new evidence on the clinical and cos
            review of guidance   product is (inflation adjusted) reduced then this is         effectiveness of the technology in question emerges.
                                 extremely important that review occurs quickly
                                 considering the lack of established negative effects
                                 outside that of cost, and the high ratings of satisfaction
                                 among patients. I would have thought a maximum of
                                 18 months would be acceptable.
Patient 9   Appraisal            I have been an insulin dependent diabetic for 33 years.      For both legal and bioethical reasons those undertaking technolo
            Committee’s          Why do NICE refuse such a groundbreaking fantastic           appraisals and developing clinical guidelines must take account o
            preliminary          treatment purely on the grounds of cost! Who ever            economic considerations” (Social Value Judgements - Principles
            recommendations      makes these pathetically stupid decisions should try         development of NICE guidance; principle 5)
                                 injecting themselves 5 times a day! Your comments
                                 would be appreciated especially as our friends in the        The Committee does not consider the affordability of new technol
                                 EU understand the needs and lives of their patients          but rather their cost effectiveness in terms of how its advice may
                                 and citizens.                                                the more efficient use of available healthcare resources (NICE Gu
                                                                                              the Methods of Technology Appraisal, paragraphs 6.2.6.1 – 6.2.6

Patient 9   The technology       This will save money in the long run due to the              The Committee decision was based on a detailed economic analy
                                 reduced costs of syringe manufacturing and disposal.         which took into account of all related costs.
                                 The lesser disposal / incineration will help the
                                 environment and save tax payers money.
Patient 9   Evidence and         You try injecting 5 times a day for 33 years. Cost is        For both legal and bioethical reasons those undertaking technolo
            interpretation       irrelevant when it comes to pain and discomfort.             appraisals and developing clinical guidelines must take account o
                                                                                              economic considerations” (Social Value Judgements - Principles
                                                                                              development of NICE guidance; principle 5)

                                                                                              The Committee does not consider the affordability of new technol
                                                                                               but rather their cost effectiveness in terms of how its advice may
                                                                                               the more efficient use of available healthcare resources (NICE Gu
                                                                                               the Methods of Technology Appraisal, paragraphs 6.2.6.1 – 6.2.6

                                                                                               The Committee discussed the evidence on quality of life with inje
                                                                                               and inhaled insulin in detail. See ACD sections 4.3.8, 4.3.9, 4.3.1

Patient 9    Proposed               I would be happy to be involved in research to improve     Comment noted.
             recommendations        the lives of diabetics. I am very active and do a lot of
             for further research   sport.
Patient 9    Proposed date for      That’s in approximately 5,500 injections time!             Guidance is reviewed when new evidence on the clinical and cos
             review of guidance                                                                effectiveness of the technology in question emerges.

Patient 10   Appraisal              Why the disparity between us & the USA together with       NICE has been requested by the Department of Health to carry o
             Committee’s            parts of Europe in adopted this inhaler system.            appraisal of inhaled insulin. The Appraisal Committee at NICE is
             preliminary                                                                       required to make decisions on the basis of clinical and cost
             recommendations                                                                   effectiveness and to base it’s decisions on the use of the technolo
                                                                                               within the UK NHS.
Patient 10   Clinical need and      One particular need for the Inhaled insulin delivery       In view of the concerns raised by NHS professionals and people
             practice               system as outlined in 2.7 is for those who have had        diabetes, the committee is now recommending inhaled insulin for
                                    type 1 diabetes for an extended period of time & who       people who are unable to start insulin therapy or intensification of
                                    are "running out" of suitable injection sites. Pumps are   insulin therapy because of a proven injection phobia or severe
                                    not always suitable in some types of occupation & are      problems with injection sites for example as a consequence of
                                    surely a more expensive option.                            lipohypertrophy. The committee also agreed that inhaled insulin
                                                                                               be cost effective in these populations.


Patient 10   Section 3              To what extent is Exubera's performance affected by        This question is outside the remit for this Appraisal.
                                    temperature.
Patient 10   Section 4              A study undertaken on a much larger group would not        In view of the concerns raised by NHS professionals and people
                                    seem to be an unreasonable step to take - providing it     diabetes, the committee is now recommending inhaled insulin for
                                 encompassed diabetics with uncontrolled to well                  people who are unable to start insulin therapy or intensification of
                                 controlled blood sugar levels. Unfortunately you can             insulin therapy because of a proven injection phobia or severe
                                 never put a price on a patients quality of life.                 problems with injection sites for example as a consequence of
                                                                                                  lipohypertrophy. The committee agreed that inhaled insulin would
                                                                                                  cost effective in these populations.
                                                                                                  The Committee is also recommending further data collection in pa
                                                                                                  who are eligible to receive inhaled insulin.

Patient 10   Section 5           The suggested scope of the recommendations &                     See above.
                                 further research is not wide enough.
Patient 10   Section 6           The cost of diabetic complications however.....                  Comment unclear
Carer 2      Appraisal           If you only include people who have ""uncontrolled""             Although individual choice is important for the NHS and its users,
             Committee’s         diabetes in the studies, how will you be able to assess          should not have the consequence of promoting the use of interve
             preliminary         the effect on quality of life for the majority of patients,      that are not clinically and/or cost effective” (Social Value Judgem
             recommendations     who may only experience occasional periods of                    Principles for the development of NICE guidance; principle 5)
                                 uncontrolled blood sugar levels. Are you saying that it
                                 is only worth improving the quality of life for those who
                                 are in the worst possible situation?
Carer 2      Clinical need and   Has Nice got any statistics which illustrate how many            The information was submitted by Diabetes UK and can be acces
             practice            people report problems/lack of satisfaction with                 via their website.
                                 multiple injections? ""Some"" is rather vague.
Carer 2      The technology      Is this estimate of cost really realistic? It is unlikely that   The Committees appraisal was based on the licensed indication,
                                 many children, smokers, the elderly or asthmatic would           therefore excluded children, smokers and people with asthma. Th
                                 be prescribed this treatment so it is hardly likely to be a      Committee decision was based on a detailed economic analysis w
                                 big cost to the pHs. Also, it may be combined with               took into account of all relevant costs.
                                 injection therapy and the amount needed to be inhaled            The Committee does not consider the affordability of new technol
                                 may be much less than expected by Nice.                          that is cost to the PCTs, but rather their cost effectiveness in term
                                                                                                  how its advice may enable the more efficient use of available
                                                                                                  healthcare resources (NICE Guide to the Methods of Technology
                                                                                                  Appraisal, paragraphs 6.2.6.1 – 6.2.6.3).
Carer 2      Evidence and        The committee heard from ""patient experts"" who                 The Committee considered evidence from patient groups and too
             interpretation      reported that most diabetes patients had few problems            into account when making its recommendations. Patient experts w
                                 with injections but it is unclear who these experts are     were currently injecting insulin were present at the Committee me
                                 or where they get their survey results from. For
                                 instance, responses to a Diabetes UK website survey         Although individual choice is important for the NHS and its users,
                                 may only come from people who are conscientious             should not have the consequence of promoting the use of interve
                                 and used to controlling their symptoms with injections -    that are not clinically and/or cost effective” (Social Value Judgem
                                 rather than from newly diagnosed patients who may be        Principles for the development of NICE guidance; principle 5)
                                 desperate to find another, less invasive way, of coming
                                 to terms with and treating their condition. Most people     It also needs to be noted that inhaled insulin has a marketing
                                 get used to their treatment and are reluctant to change     authorisation only for adults with diabetes.
                                 it as it is part of their daily routine. This is true for
                                 people who use a highly inefficient two injections a day
                                 system as well as those who opt for multiple (and often
                                 more effective) injection system. So they may be stuck
                                 in the ways - and the ways may be bad ones! Also, set
                                 against this is the fact that all the surveys carried out
                                 with people who inhaled insulin showed a marked
                                 increase in satisfaction and control over their condition
                                 - proof that this is a valuable alternative for many
                                 patients. Try asking a 13 year old teenager who has to
                                 inject himself six times a day if he would prefer twice?
Carer 2   Proposed               This research seems very sensible. Perhaps it would         The Committee is also recommending further data collection in pa
          recommendations        be worthwhile, as quality of life is also being             who are eligible to receive inhaled insulin.
          for further research   considered, moving away from simply looking at
                                 medical research and consulting patient
                                 representatives, to paying for a large scale ""opinion
                                 poll"" from a reputable firm like MORI or YOUgov - for
                                 both type 1 and type 2 patients, asking for their
                                 opinions of multiple injection therapy v inhaler and less
                                 injections. Pump therapy could be included in the
                                 survey.
Carer 2   Preliminary views      The committee is correct to consider cost, but only         Although individual choice is important for the NHS and its users,
          on the resource        paying for things when ""other treatment fails"" misses     should not have the consequence of promoting the use of interve
             impact for the NHS   the point for many of these new treatments. They are      that are not clinically and/or cost effective” (Social Value Judgem
                                  more likely to be used well by patients who can control   Principles for the development of NICE guidance; principle 5)
                                  their condition, but have a severe form and would
                                  welcome an easier life after years of inconvenience.
                                  Pumps, for instance, might also be of great benefit to
                                  parents of babies who are most at risk of long term
                                  complications if their levels go high. With a pump,
                                  parents can control and adapt the treatment more
                                  effectively. Then, in adolescence, the child may be
                                  best placed to go to injection therapy which gives them
                                  freedom from a machine and a greater sense of
                                  distance from their diabetes.
Carer 2      Proposals for        Those who will benefit most will be type 1 diabetics,     The Committee decision was based on a detailed economic analy
             implementation and   who make up the smallest group with the disease.          which took into account of all relevant costs.
             audit                Surely this will limit the cost? However, I understand
                                  cost must be a consideration. Please remember that        Although individual choice is important for the NHS and its users,
                                  most diabetics manage with injections simply because      should not have the consequence of promoting the use of interve
                                  they have no choice - many are yearning for a bit more    that are not clinically and/or cost effective” (Social Value Judgem
                                  choice in future!                                         Principles for the development of NICE guidance; principle 5)

Carer 2      Proposed date for    An earlier date would be better as we seem to be on       Guidance is reviewed when new evidence on the clinical and cos
             review of guidance   the brink of lots of breakthroughs with diabetes and it   effectiveness of the technology in question emerges.
                                  would be a shame to hold up anything which might be       .
                                  developed in a broader way to help the majority of
                                  people.
Patient 11   Appraisal            As a patient with diabetes I would ask that inhaled       Comment noted.
             Committee’s          insulin is available to all patients
             preliminary
             recommendations
Patient 11   Clinical need and    As a patient who has to work hard on controlling my       Although individual choice is important for the NHS and its users,
             practice             blood sugar I have heard that inhaler makes it easier     should not have the consequence of promoting the use of interve
                                  as I am more likely to remember it and me able to         that are not clinically and/or cost effective” (Social Value Judgem
                               carry it around with me. I would prefer to use an           Principles for the development of NICE guidance; principle 5)
                               inhaler. It would also prevent damage caused by
                               repeated use of injection sites                             In view of the concerns raised by NHS professionals and people
                                                                                           diabetes, the committee is now recommending inhaled insulin for
                                                                                           people who are unable to start insulin therapy or intensification of
                                                                                           insulin therapy because of a proven injection phobia or severe
                                                                                           problems with injection sites for example as a consequence of
                                                                                           lipohypertrophy.

Patient 12   Appraisal         Obviously you and your co-workers do not understand         For both legal and bioethical reasons those undertaking technolo
             Committee’s       the great disappointment that will be felt by millions of   appraisals and developing clinical guidelines must take account o
             preliminary       diabetic sufferers and their families after your short-     economic considerations” (Social Value Judgements - Principles
             Appraisal         sighted decision to restrict their choice of how to         development of NICE guidance; principle 5)
             Committee’s       manage their insulin purely on the basis of cost alone!
             preliminary       Rather than spending billions of taxpayers money on         The Committee does not consider the affordability of new technol
             recommendations   outdated treatments, perhaps this country could use         but rather their cost effectiveness in terms of how its advice may
                               some foresight for once and allow this treatment to         the more efficient use of available healthcare resources (NICE Gu
                               ease the suffering of people with diabetes. Or even         the Methods of Technology Appraisal, paragraphs 6.2.6.1 – 6.2.6
                               actively fund/support Islet Cell Transplantation
                               Research (including stem cell research), which could
                               eventually cure Diabetes in the near future and
                               therefore save the NHS billions year on year!
Member of    Appraisal         Inhalation of medication would substantially improve        The Committee discussed the evidence on quality of life with inje
the public   Committee’s       the quality of life of people suffering diabetes. NICE      and inhaled insulin in detail. See ACD sections 4.3.8, 4.3.9, 4.3.1
             preliminary       should support the provision of this method as a real
             recommendations   alternative to injections for all people who suffer         Although individual choice is important for the NHS and its users,
                               diabetes and find injections painful, embarrassing or       should not have the consequence of promoting the use of interve
                               seriously inconvenient.                                     that are not clinically and/or cost effective” (Social Value Judgem
                                                                                           Principles for the development of NICE guidance; principle 5)

Carer 3      Appraisal         with approval granted in Europe and the use what is         For both legal and bioethical reasons those undertaking technolo
             Committee’s       the rationale for such a statement? the benefit to          appraisals and developing clinical guidelines must take account o
          preliminary            quality of life is clear to all and no amount of wasted        economic considerations” (Social Value Judgements - Principles
          recommendations        rhetoric can disguise the fact that these statements are       development of NICE guidance; principle 5)
                                 driven from a budget constraint it will be an interesting
                                 position if uk citizens can travel to Europe and receive       The Committee does not consider the affordability of new techno
                                 this medication but the uk will not make it available.         but rather their cost effectiveness in terms of how its advice may
                                                                                                the more efficient use of available healthcare resources (NICE Gu
                                                                                                the Methods of Technology Appraisal, paragraphs 6.2.6.1 – 6.2.6


Carer 3   Clinical need and      the statement from your spokeswoman that the                   The Committee considered evidence from patient groups and too
          practice               majority of insulin dependant sufferer do not mind             into account when making its recommendations. Patient experts w
                                 injections is ridiculous....................... The clinical   were currently injecting insulin were present at the Committee me
                                 experts we asked advised us that using injected insulin
                                 is not usually a concern for the majority of people with
                                 diabetes Andrea Sutcliffe, of NICEs try asking the
                                 individuals who give children injections or the injected
                                 patients what they think. clinical advisors do not suffer
Carer 3   The technology         the technology has been proven and given clinical              The Committee is not requesting more technological information.
                                 approval by usa and Europe. explain why nice need
                                 more technological information
Carer 3   Evidence and           seems the quality of life argument wins through. how           The Committee discussed the evidence on quality of life with inje
          interpretation         on earth can you not support such a technological              and inhaled insulin in detail. See ACD sections 4.3.8, 4.3.9, 4.3.1
                                 breakthrough in times passed people had amputations
                                 w/o anaesthetic. today we offer pain reducing
                                 therapies. this has a cost..............
Carer 3   Proposed               this recommendation to study more is a waste of funds          Comment noted.
          recommendations        that could be used to provide the new treatments
          for further research
Carer 3   Preliminary views      I await with great interest                                    Comment noted.
          on the resource
          impact for the NHS
Carer 3   Proposals for          an open ended story.........again, lets study more and         Comment noted.
             implementation and   let people suffer.
             audit
Carer 3      Related guidance     how on earth can you stand for clinical excellence            Although individual choice is important for the NHS and its users,
                                  when you do not support this clear benefit?                   should not have the consequence of promoting the use of interve
                                  disappointment is insufficient to express my disgust          that are not clinically and/or cost effective” (Social Value Judgem
                                  perhaps you would like to tell my son that he is ok with      Principles for the development of NICE guidance; principle 5)
                                  injections in the uk but if he lived elsewhere he would
                                  not need to have them during the day?
Carer 3      Proposed date for    thereby putting off the decision and the cost for 3           Guidance is reviewed when new evidence on the clinical and cos
             review of guidance   years. then what? how many of the committee are               effectiveness of the technology in question emerges.
                                  diabetics and suffer multiple daily injections? pls
                                  advise their qualifications to judge quality of life issues
                                  for millions of sufferers.
Patient 13   Appraisal            I have been a diabetic for the last 34 years, since I was     It needs to be noted that inhaled insulin has a marketing authoris
             Committee’s          4 I had to learn to inject myself once a day until I          only for adults with diabetes.
             preliminary          reached 13 when I had to inject myself twice a day, I
             recommendations      now inject myself with insulin 4 times a day which I          The committee is now recommending inhaled insulin for people w
                                  have done since I was 17 using the Nova Pen, which            are unable to start insulin therapy or intensification of insulin thera
                                  even though means more injections gives me greater            because of a proven injection phobia or severe problems with inje
                                  freedom of set mealtimes. I have longed for the day           sites for example as a consequence of lipohypertrophy.
                                  when I wouldn’t have to stick a needle into my body,
                                  having to alternate between locations so as not to            Although individual choice is important for the NHS and its users,
                                  cause lumps and swellings (all to no avail). I have had       should not have the consequence of promoting the use of interve
                                  to have liposuction (on the NHS) to try and relieve           that are not clinically and/or cost effective” (Social Value Judgem
                                  these unsightly injection sites but they have returned.       Principles for the development of NICE guidance; principle 5)
                                  Yes we would still have to use needles to do blood
                                  tests but how can you realistically compare a simple
                                  finger prick test to injecting and pumping insulin into
                                  your body. My daughter was recently diagnosed as
                                  diabetic and again whilst not complaining about having
                                  to inject I think this is because until now there has
                                  been no alternative. My daughter and I would love to
                                    simply be able to inhale our medicine rather than inject
Patient 13   Clinical need and      Whilst some people may experience the points raised            The Committee considered evidence from patient groups and too
             practice               in 2.7 Some will willingly inject as there has been no         into account when making its recommendations. Patient experts w
                                    realistic alternative until now. The development of the        were currently injecting insulin were present at the Committee me
                                    inhaler has shown that it can work as well as injections
                                    in some people. It would be excellent to have the              Although individual choice is important for the NHS and its users,
                                    choice. It is all very well for clinicians and practitioners   should not have the consequence of promoting the use of interve
                                    to say what they believe but they are not the people           that are not clinically and/or cost effective” (Social Value Judgem
                                    who have to live everyday with the disease and its             Principles for the development of NICE guidance; principle 5)
                                    practicalities
Patient 13   The technology         The cost of different insulin’s varies e.g. porcine and        The committee decision was based on a detailed economic analy
                                    analogue insulin’s, the production of needles and pens         which took into account of all relevant costs mentioned.
                                    then the safe disposing of them all adds to the overall
                                    cost of diabetic medication. Also has the overall cost
                                    taken into consideration all the expense that poorly
                                    controlled blood sugars and the complications that can
                                    occur over long periods of time no matter how well
                                    controlled a person is, can actually cost the NHS
Patient 13   Evidence and           If those who took part in the trail commented upon a           The committee is now recommending inhaled insulin for people w
             interpretation         improvement on their blood sugar controls and an               are unable to start insulin therapy or intensification of insulin thera
                                    improvement in their quality of life why can these             because of a proven injection phobia or severe problems with inje
                                    benefits not be passed onto other diabetics                    sites for example as a consequence of lipohypertrophy.
Patient 13   Proposed               Widen the research so those with well and poor                 The Committee discussed the evidence on quality of life with inje
             recommendations        controlled blood sugars are included to gain a more            and inhaled insulin in detail. See ACD sections 4.3.8, 4.3.9, 4.3.1
             for further research   balanced opinion. Look at the wider issues rather than
                                    just control e.g. quality of life, personal preference         In view of the concerns raised by NHS professionals and people
                                                                                                   diabetes, the committee is now recommending inhaled insulin for
                                                                                                   people who are unable to start insulin therapy or intensification of
                                                                                                   insulin therapy because of a proven injection phobia or severe
                                                                                                   problems with injection sites for example as a consequence of
                                                                                                   lipohypertrophy.
Patient 13   Proposed date for    If a wider sector is able to use the insulin April 2009 is     Guidance is reviewed when new evidence on the clinical and cos
             review of guidance   just about acceptable. But an interim review should be         effectiveness of the technology in question emerges.
                                  made in 18 months time
Carer 4      Appraisal            Would NICE Like to take into account the fact that the         Comment noted.
             Committee’s          number of people with Type 1 or Type 2 Diabetes
             preliminary          "whose blood sugar levels are uncontrolled with their
             recommendations      current diabetes regimen" is over 85% of these people.
                                  Are they all hence to be included in these clinical
                                  studies? Will these people be entitled to compensation
                                  for loss of limb, vision, kidneys, or loss of life 20-30
                                  years prematurely? Will NICE allocate enough funding
                                  for this as from now onwards?
Carer 4      Clinical need and    NICE has in the past delayed the availability of novel         Comment noted.
             practice             therapies or delivery methods of these therapies to
                                  people living with Type 1 or type 2 Diabetes. We all
                                  remember how NICE attempted to erect barriers to the
                                  availability of insulin Lantus and restrict its use to a
                                  certain group of people with diabetes. Yet, it soon
                                  became evident how unjustified on clinical and
                                  economic grounds this policy was and the floodgates
                                  were overturned by the tidal wave - and NICE could
                                  not justify its false economy denial of this first real life
                                  saving insulin, which for the first time enabled, for
                                  example, our little daughter to achieve some kind of
                                  quality of life. Are you seriously going to repeat this
                                  short term "economy drive" again and deny many
                                  people with both types of diabetes a means of getting
                                  this life line drug which could make a difference to their
                                  glycaemic control and overall quality of life? Shame on
                                  you. NICE insists on repeating as guidelines the
                                  outdated recommended HbA1c level as from 6.5 -
                                  7.5%. Again, we know and many other countries have
                            already adopted the recommendation of control to goal
                            of LESS THAN 6.5%.
Carer 4   The technology    Have the Appraisal Committee calculated the cost per
                            annum or per month of a person with diabetes
                            requiring renal dialysis, needing Income Support after        The Committee decision was based on a detailed economic analy
                            having become unable to continue in employment                which took into account of all relevant costs mentioned.
                            when hooked to the dialysis machine 3 days per
                            week? Please calculate theses costs and compare               The Committee considered that inhaled insulin was highly unlikel
                            with this minimal cost of 1102 - what a disgrace that         cost effective and as such did not feel that its use should be
                            your mathematical approximation even does not give            recommended for routine use. However, the committee is now
                            you an instant answer!                                        recommending inhaled insulin for people who are unable to start
                                                                                          therapy or intensification of insulin therapy because of a proven
                                                                                          injection phobia or severe problems with injection sites for examp
                                                                                          a consequence of lipohypertrophy..

Carer 4   Evidence and      Please consider yourself as an individual person in the       Although individual choice is important for the NHS and its users,
          interpretation    position where you would face insulin start as 2-4            should not have the consequence of promoting the use of interve
                            injections per day. Just try and reconsider your flippant     that are not clinically and/or cost effective” (Social Value Judgem
                            words about the utility and benefit of being able to use      Principles for the development of NICE guidance; principle 5)
                            an inhaler rather than needle every day and to suffer
                            less weight gain, less physical pain and inconvenience
                            compared with pen =needle method!
Carer 5   Appraisal         My observations as a parent of a young adult are that         It needs to be noted that inhaled insulin has a marketing authoris
          Committee’s       using an inhaler as an alternative to fast acting             only for adults with diabetes.
          preliminary       injections before each meal, which are recommended
          recommendations   for dealing with the topsy turvey world of a student,         Although individual choice is important for the NHS and its users,
                            would increase compliance and would lead to better            should not have the consequence of promoting the use of interve
                            health later in life. This should, ultimately reduce health   that are not clinically and/or cost effective” (Social Value Judgem
                            costs. It would also enable more dignity for young            Principles for the development of NICE guidance; principle 5)
                            people. My daughter does not like to inject in public
                            e.g. in the pub or a restaurant - and has to go to the
                            toilets for privacy. She experiences a feeling of
                                    exclusion as a result. Inhaling, she feels, is more
                                    acceptable and I know she would be more compliant
                                    with this treatment.
Carer 5      Clinical need and      My daughter is on the common management strategy             See comment above.
             practice               and as stated above does not always comply due to
                                    her dislike of injecting in very public places. She also
                                    gets very irritated by needing to be different from her
                                    peers. She states her compliance would be better with
                                    an inhaler
Carer 5      The technology         I agree there would need to be restrictions on               The committee is now recommending inhaled insulin for people w
                                    prescription but where there are no contraindications        are unable to start insulin therapy or intensification of insulin thera
                                    and where it would increase compliance surely it would       because of a proven injection phobia or severe problems with inje
                                    be cost effective in the long term - in terms of a better    sites for example as a consequence of lipohypertrophy..
                                    health outcome.

Carer 5      Evidence and           Successive government documents expound the                  Although individual choice is important for the NHS and its users,
             interpretation         benefits of choice. If there is a reported improvement       should not have the consequence of promoting the use of interve
                                    in quality of life and satisfaction with the regime surely   that are not clinically and/or cost effective” (Social Value Judgem
                                    this should be taken seriously.                              Principles for the development of NICE guidance; principle 5)


Carer 5      Proposed               I would certainly support further research but feel this     Comment noted.
             recommendations        should not deny use, where appropriate, now.
             for further research
Carer 5      Proposals for          I agree that any further studies should include quality      Comment noted.
             implementation and     of life and choice. In my experience improvements in
             audit                  theses areas significantly improve compliance.
Patient 14   Appraisal              I understand that the cost of the treatment will limit the   It needs to be noted that inhaled insulin has a marketing authoris
             Committee’s            availability of the inhaler. There has always been a         only for adults with diabetes.
             preliminary            certain amount of stigma attached to diabetes
             recommendations        especially for younger patients so surely the benefits of
                                    such treatment would be of enormous benefit to
                                  children. I know from experience what it meant to me
                                  having daily injections, the testing and the not very
                                  discreet regime. Had an inhaler been available to me
                                  whilst at school it would have been valued very highly
                                  and so I hope that the cost will not be an issue.
NHS          Preliminary views    compared to the limited benefit and even shakier            Comments noted.
Profession   on the resource      evidence base for recommending ACE inhibitors to
al 9         impact for the NHS   type diabetics with micralbuminuria or the evidence
                                  poor trend in forcing all diabetics to take statins then
                                  this seems a genuine patient focused advance
Patient 15   General              I inject 4 times a day and am always getting bruised so     Comment noted.
                                  I am interested in an alternative
Patient 16   Appraisal            Why are these studies limited to people whose               Although individual choice is important for the NHS and its users,
             Committee’s          diabetes is uncontrolled with current regimen? Inhaled      should not have the consequence of promoting the use of interve
             preliminary          insulin will also benefit those whose diabetes is           that are not clinically and/or cost effective” (Social Value Judgem
             recommendations      controlled at the moment with injected insulin. People      Principles for the development of NICE guidance; principle 5)
                                  should have the choice.
Patient 16   The technology       The estimated cost of 3 per day is a small price to pay     The committee decision was based on a detailed economic analy
                                  for a new therapy. As has been proved in the past,          which took into account of all relevant costs, but the Committee c
                                  these costs can be negotiated downwards particularly        take into consideration future, currently unknown price decrease.
                                  when competition kicks in.
Patient 16   Evidence and         didn’t understand the RCT information - plain English       The Committee does not consider the affordability, that is the cos
             interpretation       please. 4.3.2 needles are not used for day to day           new technologies only, but rather their cost effectiveness in terms
                                  glucose testing. A small lancet is used to prick the skin   how its advice may enable the more efficient use of available
                                  - a lot different to a needle. 4.3.4 Patients will learn    healthcare resources (NICE Guide to the Methods of Technology
                                  how to control dosage of inhaled insulin like they learn    Appraisal, paragraphs 6.2.6.1 – 6.2.6.3).
                                  to control the dose of injected insulin. Inhaled Insulin
                                  will save some lives and make living with diabetes          For both legal and bioethical reasons those undertaking technolo
                                  more tolerable for thousands. It should not be banned       appraisals and developing clinical guidelines must take account o
                                  solely on the basis of cost. Less than 3 a day extra        economic considerations” (Social Value Judgements - Principles
                                  over injected insulin is NOT excessive.                     development of NICE guidance; principle 5)
NHS          Appraisal              The restriction of inhaled insulin to a ""clinical trial use   In view of the concerns raised by NHS professionals and people
Profession   Committee’s            only"" is not sensible. In addition to trials, specialist      diabetes, the committee is now recommending inhaled insulin for
al 10        preliminary            clinicians (i.e. secondary care diabetologists) should         people who are unable to start insulin therapy or intensification of
             recommendations        be at liberty to prescribe, all be it judiciously. There are   insulin therapy because of a proven injection phobia or severe
                                    a few rare circumstances where its use would be                problems with injection sites for example as a consequence of
                                    appropriate and clinicians need to develop expertise in        lipohypertrophy.
                                    the use of inhaled insulin. If necessary on a ""named
                                    pt"" basis
NHS          The technology         Not all cases would need 3 times daily inhaled pre             Comments noted.
Profession                          prandial insulin - its use could be envisage as: 1. once
al 10                               daily treatment (in addition to basal bolus therapy) to
                                    take with a meal in an environment not conducive to
                                    injecting. 2. Short term use whilst awaiting resolution of
                                    lipohypertrophy. 3. As a palliative care measure
NHS          Proposed               NICE will yet again get adverse publicity if limiting          Comments noted.
Profession   recommendations        inhaled insulin’s use to trials alone, especially if the
al 10        for further research   public perceive this decision to be based purely on            Guidance is reviewed when new evidence on the clinical and cos
                                    cost (how the tabloid press are ""selling"" the story).        effectiveness of the technology in question emerges.
                                    Why not allow the specialist clinicians to use the
                                    professional acumen that the government says it
                                    believes us to have? I fully agree that the use of
                                    inhaled insulin should be both restricted and monitored
                                    - (personally I cannot believe that there will not be long
                                    term alveolar consequences) A review date of 2009
                                    however is not realistic - it need to be sooner
                                    (remember the glitazones?)
Patient 17   Clinical need and      I am Type 2, trying to conceive, and have been on              Comment noted.
             practice               injected insulin since December. I actively dislike
                                    having to inject, but do it because I have to and have
                                    no choice. I have days when I cannot bring myself to
                                    inject, because of the pain and my husband does it for
                                    me. I currently inject at least 5 times a day, as well as
                              having to do finger pricks for blood testing and feel like
                              a pin cushion. I dislike having to inject in public,
                              although I work in healthcare, and find that I am
                              developing greater sensitivity to pain in my usual
                              injection sites. I would be over the moon if I could use
                              an alternative, which was pain-free and more socially
                              acceptable to use in public. I am lucky because I know
                              that my insulin use should be temporary. I strongly
                              believe that all people with diabetes should be able to
                              access treatment which is pain-free and convenient,
                              especially if they face the prospect of having to use the
                              treatment day in and day out for the rest of their lives.
Carer 6   Appraisal           Why is it not recommended for use in Type 1                    In view of the concerns raised by NHS professionals and people
          Committee’s         diabetics?                                                     diabetes, the committee is now recommending inhaled insulin for
          preliminary                                                                        people who are unable to start insulin therapy or intensification of
          recommendations                                                                    insulin therapy because of a proven injection phobia or severe
                                                                                             problems with injection sites for example as a consequence of
                                                                                             lipohypertrophy. This refers to type 1 and type 2 diabetes.
Carer 6   Clinical need and   So much in maintaining insulin levels is psychological.        It needs to be noted that inhaled insulin has a marketing authoris
          practice            My son has 4 injections a day and puts off injecting           only for adults with diabetes.
                              because it will hurt and he bleeds. Also the skin
                              becomes lumpy if the insulin is not injected correctly.
                              Inhaled insulin would take away the fear factor and let
                              patients in hale without the psychological barrier of
                              knowing ""if I do this it will hurt, therefore I am going to
                              put this off for as long as possible""
Carer 6   The technology      So as with everything else in the NHS it comes down            The Committee does not consider the affordability, that is cost alo
                              to cost again??? Not thought or care for the patient?          of new technologies but rather their cost effectiveness in terms of
                                                                                             its advice may enable the more efficient use of available healthca
                                                                                             resources (NICE Guide to the Methods of Technology Appraisal,
                                                                                             paragraphs 6.2.6.1 – 6.2.6.3).
Carer 6      Evidence and         I do not think this is fair. The decision has been based    For both legal and bioethical reasons those undertaking technolo
             interpretation       on cost - yet again, and not on clinical or psychological   appraisals and developing clinical guidelines must take account o
                                  need. This decision needs to be revisited.                  economic considerations” (Social Value Judgements - Principles
                                                                                              development of NICE guidance; principle 5)

Carer 6      Preliminary views    By spending a little more now on the inhaled insulin
             on the resource      you will be allowing diabetics to practise better insulin   The committee decision was based on a detailed economic analy
             impact for the NHS   control, thus saving thousands of s later in life when      which took into account of all relevant costs mentioned.
                                  the NHS will have to treat the outcome of poor insulin
                                  control - we all know the ramifications of this. It is
                                  short-sighted and lacking in long-term economic
                                  sense.
Carer 6      Proposals for        There is a need to get comments from carers, parents        The Committee considered evidence from patient groups and too
             implementation and   and diabetics - how will you get this feedback              into account when making its recommendations. Patient experts w
             audit                                                                            were currently injecting insulin were present at the Committee me
                                                                                              All members of the public are entitled to comment on the prelimin
                                                                                              recommendations via the Institutes website.

Carer 6      Proposed date for    Too far in the future for diabetics many of whom will       Guidance is reviewed when new evidence on the clinical and cos
             review of guidance   have died before then or at least suffered very poor        effectiveness of the technology in question emerges.
                                  quality of life.
Patient 18   Appraisal            it is all well and good but what about the people who       In view of the concerns raised by NHS professionals and people
             Committee’s          have a real fear of needles                                 diabetes, the committee is now recommending inhaled insulin for
             preliminary                                                                      people who are unable to start insulin therapy or intensification of
             recommendations                                                                  insulin therapy because of a proven injection phobia or severe
                                                                                              problems with injection sites for example as a consequence of
                                                                                              lipohypertrophy.

Patient 18   The technology       they did the same to us about syringes they gave them       Comment noted.
                                  to drug users free first to do they not like people who
                                  suffer from this illness
NHS          Appraisal            Many patients with Type 2 DM are poorly controlled          In view of the concerns raised by NHS professionals and people
Profession   Committee’s          because they fear insulin injections and go on to             diabetes, the committee is now recommending inhaled insulin for
al 11        preliminary          develop complications. This may have been delayed or          people who are unable to start insulin therapy or intensification of
             recommendations      prevented if oral or inhaled insulin preparations were        insulin therapy because of a proven injection phobia or severe
                                  available. Many patients with Type 1 DM omit regular          problems with injection sites for example as a consequence of
                                  injections and many more have technical difficulties.         lipohypertrophy.
                                  While I support the need for the further studies
                                  suggested, the introduction of inhaled insulin should
                                  not be delayed as field studies are likely to produce
                                  more rapid results.
NHS          Preliminary views    Preventing or delaying the complications of DM is a           The committee decision was based on a detailed economic analy
Profession   on the resource      cheaper as well as a better option for the NHS                which took into account of all relevant costs mentioned, for exam
al 11        impact for the NHS                                                                 costs of long term complications.

NHS          Proposed date for    A delay of 3 years is unlikely to succeed and I feel is       Guidance is reviewed when new evidence on the clinical and cos
Profession   review of guidance   unacceptable                                                  effectiveness of the technology in question emerges.
al 11
Patient 19   General              Is use of Inhaled Insulin likely to lead to mortality         This appraisals included all of the following outcomes: Mortality,
                                  benefits? As I understand it in Type 2s use of insulin        Frequency and severity of symptomatic hypoglycaemic episodes,
                                  has lead to little/or no increase in mortality (Not true in   Incidence of diabetic emergences, such as diabetic ketoacidosis,
                                  TYPE1s). Higher insulin levels has been shown in              requiring hospitalisation, Frequency of occlusive vascular events
                                  some patients to increase incidence of Heart Failure          microvascular complications, Health-related quality of life ,Advers
                                                                                                effects of treatment, Measures of glycaemic control ,Adverse cha
                                                                                                in body mass index

Patient 19   Evidence and         As a Type 1 diabetic and PCT Pharmaceutical adviser,          In view of the concerns raised by NHS professionals and people
             interpretation       presently using short acting Lispro three times daily         diabetes, the committee is now recommending inhaled insulin for
                                  and Glargine once daily, I see no advantage in using          people who are unable to start insulin therapy or intensification of
                                  Exubera when balanced against the potentially longer          insulin therapy because of a proven injection phobia or severe
                                  term adverse effects that Exubera may have e.g. on            problems with injection sites for example as a consequence of
                                  lung function. Only patient group where I consider that       lipohypertrophy.
                                  benefits may outweigh risks is if patient has fat
                                  hypertrophy at majority of injection sites, leading to
                                    difficulty in injecting and irregular uptake of insulin from
                                    these sites.
Patient 20   Appraisal              Rubbish - if you think that at the start without an open       Comment noted.
             Committee’s            mind you are obviously going to be critical of the
             preliminary            technology from the start - you are like my parents -
             recommendations        you have to accept new technology and roll with the
                                    times - don’t get stuck in the past.
Patient 20   Clinical need and      It would make life a hell of a lot easier taking an            Although individual choice is important for the NHS and its users,
             practice               inhaled insulin in public or even sitting next to my           should not have the consequence of promoting the use of interve
                                    friends while eating. I would much prefer one injection        that are not clinically and/or cost effective” (Social Value Judgem
                                    to four - I am not a pincushion, and hate needles as           Principles for the development of NICE guidance; principle 5)
                                    much as the next person, even though they have been
                                    part of my life for the past 14 years
Patient 20   The technology         So what - you are cutting off enough                           The Committee does not consider the affordability, that is cost on
                                    nurses/doctors/entire clinic/hospitals to be able to           new technologies but rather their cost effectiveness in terms of ho
                                    afford inhaled insulin for every diabetic in England. I        advice may enable the more efficient use of available healthcare
                                    would also mention that most diabetics, due to regular         resources (NICE Guide to the Methods of Technology Appraisal,
                                    health checks, do not smoke in order to avoid                  paragraphs 6.2.6.1 – 6.2.6.3).
                                    complications, according to doctors on the NHS who
                                    recommend that they do not smoke.
Patient 20   Evidence and           According to what you have shown in your evidence              Comment noted.
             interpretation         and analysis, it is perfectly safe etc. and works fine for
                                    insulin dependants’ So what’s the problem - afraid you
                                    might get more bad publicity - even though you’ll be
                                    buying something that will work, and will be one of the
                                    best things for diabetics since recombinant DNA
Patient 20   Proposed               If you feel that this will not help those who do not           Comment noted
             recommendations        comply with treatment regimes, then it makes no
             for further research   difference - they don’t comply now and still cost money
                                    - that’s their problem, not every other diabetics"- so
                                    you are preventing change for good because some
                                    idiots are not doing their injections. That’s like
                                  penalising a class full of children because one kid
                                  annoyed the teacher - that’s hardly fair.
Patient 20   Preliminary views    As mentioned above, you’ll have a lot of available         Comments noted. See above responses.
             on the resource      funds now you’ve laid off so many staff - what’s the
             impact for the NHS   problem with putting that money to good use????
Patient 20   Proposals for        Of course it’s not used for people who have diabetes,      Comment noted. See above responses.
             implementation and   because you won’t allow it. If you let them review their
             audit                policies and had done this in advance, you could be on
                                  your way to providing better health care - what you are
                                  all about. Stop making excuses.
Patient 20   Proposed date for    Get reviewing and accept the thing - if this country       Comment noted. See above responses.
             review of guidance   cares so much about the welfare of its people, and it is
                                  being shown that "normal" people are now having
                                  problems with diabetics injecting in public, then
                                  perhaps the NHS should consider appeasing the
                                  public. If this is the best year ever for the NHS, the
                                  next one’s going to be even better if this sort of thing
                                  continues.
Patient 21   Appraisal            have been a type 1 diabetic for just under 2 and a half    In view of the concerns raised by NHS professionals and people
             Committee’s          years. I am 34 years of age. my stomach is swollen         diabetes, the committee is now recommending inhaled insulin for
             preliminary          and badly bruised by the injections I take (4 on a good    people who are unable to start insulin therapy or intensification of
             recommendations      day). insulin is not absorbed the same way in other        insulin therapy because of a proven injection phobia or severe
                                  areas of my body. I am trying my best to handle a          problems with injection sites for example as a consequence of
                                  difficult long term health condition and think the nhs     lipohypertrophy.
                                  should help.
Patient 21   Clinical need and    some days are good and others not so. I check my           Comments noted.
             practice             blood regularly and for e.g. when on the tube I find out
                                  I am high I want to take an injection. besides being
                                  stared at by other passengers it is not very pleasant
                                  and quite awkward getting ones stomach out in the
                                  tube that is swollen with bruises to inject. my body is
                                  becoming something I detest.
Patient 21   The technology         using an average weight is an unfair way of looking at        In view of the concerns raised by NHS professionals and people
                                    this cost. type 1 and type 2 are different diseases and       diabetes, the committee is now recommending inhaled insulin for
                                    should be considered as such. also you are comparing          people who are unable to start insulin therapy or intensification of
                                    the short term cost as apposed to the long term costs if      insulin therapy because of a proven injection phobia or severe
                                    my body continues to decline. our main concern now            problems with injection sites for example as a consequence of
                                    should be stable and normal blood sugar.                      lipohypertrophy.

Patient 21   Evidence and           my HBA1c is 5.5. I try to be as controlled as possible.       Although individual choice is important for the NHS and its users,
             interpretation         however the inability to take injections easily quite         should not have the consequence of promoting the use of interve
                                    often means I will inject too much, for e.g. at a cocktail    that are not clinically and/or cost effective” (Social Value Judgem
                                    party or a restaurant. I spend a lot of time low, or low      Principles for the development of NICE guidance; principle 5)
                                    borderline as a result. the ability to take injections
                                    easily will have a great impact on my daily life, and
                                    freedom of choice not to mention health benefits and
                                    body love. I think it is an idea to at least let us try new
                                    medicines as they come out, as apposed to reject
                                    them. an improvement in our standard of living will
                                    have a vast change in my outlook and wellbeing.
Patient 21   Proposed               happy to be part of a clinical study to help gain this        Comment noted
             recommendations        information for you. as I was not a type 1 diabetic at
             for further research   the time I do not know, was the same system of
                                    analyst used when the pump came out? (apparently
                                    another very good method of control not offered by the
                                    nhs).
Patient 21   Proposals for          happy to volunteer. as explained previously I think it        Comment noted
             implementation and     would greatly change my outlook. since becoming a
             audit                  type 1 and living in this ever eating/starving/injecting
                                    cycle I have put on over a stone in weight, developed a
                                    swollen leather-like stomach covered in bruising and
                                    injection marks. my bottom/thigh does not respond to
                                    insulin in the same way and I would just like it to be
                                    easier and less painful and traumatic to control. do you
                                  know what it is like having to think before you inject -
                                  where shall I sacrifice now?
Patient 21   Proposed date for    let us not let technology and the improved treatment of    Comment noted
             review of guidance   a very serious and hard to deal with medical condition
                                  run away from us, and ignore all the new and better
                                  ways of controlling the disease. NICE please think,
                                  and consider important our standard of life. we didn’t
                                  ask for this to happen, have done nothing wrong and
                                  would appreciate some help in making things easier.
Carer 7      Appraisal            I have read through the whole report. My general           It needs to be noted that inhaled insulin has a marketing authoris
             Committee’s          opinion is that you should be putting the feelings of      only for adults with diabetes.
             preliminary          diabetic people before your cost effective concerns.
             recommendations      Unless you live with a young diabetic child, you are not
                                  qualified to understand the mental problems that
                                  children experience with having to be "different" and
                                  inject themselves countless times a day. Believe me,
                                  any child would rather inhale from a device (no matter
                                  how cumbersome) than feel/dread pain and shame by
                                  injecting. If you want to consider cost, then consider
                                  the cost to the NHS for the child psychologists and
                                  future mental health care that my child has needed
                                  and will surely need in the future. The thought that he
                                  will be denied help to cope with this condition purely
                                  down to cost is disgusting. No doubt, like most
                                  innovative ideas, the USA will make this available and
                                  I will have to buy from abroad. The government should
                                  remember, the thousands of children that they are
                                  refusing to help will be the voters of the future.
NHS          Clinical need and    Clinical need and practice.3 states that the key goal in
Profession   practice             management of diabetes is the normalisation of blood       Comments noted.
al 12                             glucose. Analysis of the impact of various therapeutic
                                  interventions on the life expectancy of people with
                                 diabetes shows that the intervention which brings most
                                 benefit is stopping smoking, the intervention with the
                                 second highest benefit is control of blood pressure,
                                 then comes cholesterol lowering, Metformin and
                                 Aspirin, and lastly is control of blood glucose. This
                                 analysis has been made by the National Prescribing
                                 Centre. Would it not therefore be better to state that
                                 the main goal in the management of diabetes is to
                                 prevent the cardiovascular problems that are the main
                                 cause of morbidity and mortality and that one of the
                                 measures used to achieve this aim is the control of
                                 blood glucose?
Patient 22     General           I hope NICE will allow my physician to prescribe this     In view of the concerns raised by NHS professionals and people
                                 Inhaled Insulin treatment for patient like me who have    diabetes, the committee is now recommending inhaled insulin for
                                 phobia about needle/injection. Every time I think of      people who are unable to start insulin therapy or intensification of
                                 injection/needle and thought of needle going in my        insulin therapy because of a proven injection phobia or severe
                                 body my blood pressure goes up very high(I am happy       problems with injection sites for example as a consequence of
                                 for you to check my GP&Hospital record) which is          lipohypertrophy.
                                 more life threatening. I do have regular check up also
                                 do regular exercise I am 56years of age I do not want
                                 any complication as I get old. I sincerely hope NICE
                                 will allow me to have this treatment. Thank you
Member of      Appraisal         This recommendation suggests that NICE believes           The Committee does not consider the affordability, that is costs a
the public 2   Committee’s       that the current research base for inhaled insulin is     of new technologies but rather their cost effectiveness in terms of
               preliminary       inadequate and yet the product has been granted a         its advice may enable the more efficient use of available healthca
               recommendations   licence by European and UK licensing authorities          resources (NICE Guide to the Methods of Technology Appraisal,
                                 which require a robust demonstration of clinical          paragraphs 6.2.6.1 – 6.2.6.3).
                                 efficacy and safety. Clinical effectiveness and patient
                                 preference are undisputed - the argument is clearly       For both legal and bioethical reasons those undertaking technolo
                                 about cost.                                               appraisals and developing clinical guidelines must take account o
                                                                                           economic considerations” (Social Value Judgements - Principles
                                                                                           development of NICE guidance; principle 5)
Member of      The technology         This technology is a breakthrough which has taken            Although individual choice is important for the NHS and its users,
the public 2                          many years, much investment and dedication on the            should not have the consequence of promoting the use of interve
                                      part of scientists and engineers. We should be               that are not clinically and/or cost effective” (Social Value Judgem
                                      celebrating the success of the partner companies in          Principles for the development of NICE guidance; principle 5)
                                      achieving this milestone, not stifling progress and
                                      further development by denying clinicians and patients
                                      real world experience of what inhaled insulin can
                                      achieve.
Member of      Proposed               Properly conducted clinical trials take years to             See comment above.
the public 2   recommendations        complete, as the Committee well knows. This drug has
               for further research   been granted a licence on the basis of properly
                                      conducted clinical research and should be made
                                      available to clinicians for use in appropriate patients to
                                      be decided by clinicians in consultation with their
                                      patients.
Member of      Appraisal              What is quality of life to someone with Diabetes?            The Committee discussed the evidence on quality of life with inje
the public 3   Committee’s            [please see my other comments with actual examples           and inhaled insulin in detail. See ACD sections 4.3.8, 4.3.9, 4.3.1
               preliminary            below]. Do we always have quality of life information
               recommendations        on drugs and treatments before they are approved and
                                      paid for? This is the most significant advance in the
                                      treatment of diabetes (blood glucose) for a very long
                                      time - why deny it as an option to people with
                                      Diabetes.
Member of      Clinical need and      know someone who has had diabetes for 30 years.              Comment noted
the public 3   practice               During that time he estimates he has injected himself
                                      42,000 times! Whilst many are pain free, some are not
                                      and he would do anything to avoid any more pain than
                                      necessary. Despite "good" HbA1c control (7.5 last
                                      time), it’s not enough for him as he has signs of
                                      nephropathy, neuropath and retinopathy. So, he
                                      probably needs more insulin but doesn’t want to alter
                                    his established (and reasonable) lifestyle and doesn’t
                                    want to inject any more than the 4-5 times a day he
                                    does at present. He saw inhaled insulin as a way for
                                    him to take more / more frequent insulin without
                                    increasing the number of injections.
Member of      The technology       What is 1102 per year in the cost of managing              The committee decision was based on a detailed economic analy
the public 3                        diabetes over a person with diabetes" lifetime? And        which took into account of all relevant costs mentioned.
                                    how much more than the cost of injections? Maybe
                                    inhaled insulin will encourage smokers who have
                                    diabetes to stop smoking? As for side effects, my
                                    friend / colleague endures many symptoms with
                                    diabetes......side effects need to be placed in context.
Member of      Evidence and         If inhaled insulin would be suitable for even some         The Committee has concluded that inhaled insulin is not cost-effe
the public 3   interpretation       people with diabetes, then why not let them have it?       in general use. However, the committee is now recommending in
                                    Also, my friend’s mum struggled with tablets for her       insulin for people who are unable to start insulin therapy or
                                    diabetes for many years (more than both 2 and 4            intensification of insulin therapy because of a proven injection pho
                                    years!) before going onto insulin, so comparisons used     severe problems with injection sites for example as a consequenc
                                    to make the assessment need to reflect what happens        lipohypertrophy
                                    in real life, not academic life
Member of      Proposals for        would urge you to review your proposal for the sake of     See comment above.
the public 3   implementation and   all people with diabetes and their families.
               audit
Member of      Related guidance     In light of above, surely anything that helps achieve      Comment noted
the public 3                        better blood sugar management for people with
                                    diabetes and achieves the recommended targets set,
                                    has to be a good thing?
Member of      Proposed date for    If you don’t change your position on this guidance, I      Guidance is reviewed when new evidence on the clinical and cos
the public 3   review of guidance   would urge you to review this guidance as soon as the      effectiveness of the technology in question emerges.
                                    other data you need is provided by the manufacturer.
                                    Then, as least, it an be made available to people with
                                    diabetes at the earliest opportunity.
Patient 23     Appraisal            Not to recommend inhaled insulin outside of clinical       Although individual choice is important for the NHS and its users,
             Committee’s         trials is contradictory to the ethos of patient choice and    should not have the consequence of promoting the use of interve
             preliminary         a patient centred NHS. In consideration of the balance        that are not clinically and/or cost effective” (Social Value Judgem
             recommendations     of evidence the benefit to the patients must take             Principles for the development of NICE guidance; principle 5)
                                 priority over the cost efficacy debate.
                                                                                               The Committee does not consider the affordability, that is cost alo
                                                                                               new technologies but rather their cost effectiveness in terms of ho
                                                                                               advice may enable the more efficient use of available healthcare
                                                                                               resources (NICE Guide to the Methods of Technology Appraisal,
                                                                                               paragraphs 6.2.6.1 – 6.2.6.3).

Patient 23   Clinical need and   agree fully with the needs identified above and find it       See comment above.
             practice            perverse that the document on one hand recognises
                                 importance of patient preference, local experience and
                                 problems with injections, and then ignores this in
                                 consideration of inhaled insulin.
Patient 23   The technology      This is evidently a device that will not suit all diabetics   The committee decision was based on a detailed economic analy
                                 but will prove a god send to many others who will find        which took into account of all relevant costs.
                                 control of glucose and prevention of terrifying
                                 complications more achievable, saving the NHS 10"s
                                 of 1,000"s of pounds.
Patient 23   Evidence and        4.3.1 how many resources are spent on complications           The Committee considered evidence from patient groups and too
             interpretation      of uncontrolled diabetes? 4.3.2 -a life time of facing        into account when making its recommendations. Patient experts w
                                 injections day in day out, often painful. I question who      were currently injecting insulin were present at the Committee me
                                 your "experts" are, the experts on this issue are the
                                 patients. 1000s of patients do not broach the subject of
                                 this psychological distress because they know there is
                                 no point. Insulin has to be injected -what else can be
                                 done -until now!! And you feel it’s appropriate to not
                                 recommend it availability!!! 4.3.5 How can a clinical
                                 trial compare to current therapy? The current therapies
                                 were not widely adopted or available when these trials
                                 were started. The same is true of UKPDS and every
                                    other trial. 4.3.8 On what expert basis do you impose
                                    your opinions on what patients would consider
                                    "discreet" -how dare you assume you speak for the
                                    patients 4.3.9 On what clinical evidence do you base
                                    your adjustments to 0.04? Were your assumptions
                                    based on inhaler data in asthma? How would the
                                    treatment of asthma be seen if ventolin was to be
                                    injected every time you got wheezy? 4.3.12. You may
                                    be "uncertain”, I suggest you leave the clinical
                                    decisions to the doctors and nurses who deal with the
                                    patients every day.
Patient 23   Proposed               What happens in 5-6 yrs time when these trials report         Comment noted
             recommendations        and clinical practice is different? No doubt you will
             for further research   demand fresh trial to compare against the new
                                    regimes? This guidance shows that those reporting to
                                    the committee lack the degree of knowledge and
                                    experience in diabetes to be able to make a reasoned
                                    submission. Two key indicators are: (1) The comment
                                    regarding "blinding" studies for patient preference data
                                    -how on earth do you suggest a 6"" inhaler in your
                                    mouth is disguised to look like a syringe in your leg?
                                    (2) ""Dosages were not always clear in the trial data"" -
                                    the daily dose today will be different to tomorrow and
                                    that will be different to the next day -that is how insulin
                                    is used, how can those writing these reports make
                                    such fundamentally flawed statements unless they
                                    have NO relevant experience of the treatment of
                                    diabetes.
NHS          Appraisal              When looking at cost effectiveness the whole life cost        It needs to be noted that inhaled insulin has a marketing authoris
Profession   Committee’s            to the NHS of poorly controlled diabetes should be            only for adults with diabetes.
al 13        preliminary            taken into account. Often barriers to control in young
             recommendations        people are the stigmas attached to injecting in front of
                                  peers and this leads to poor control
NHS          Clinical need and    Again lack of control in teenagers is often down to        Please see comment above.
Profession   practice             stigma. Also the injection sites available often become
al 13                             lumpy leading to poor effectiveness of injected insulin.
NHS          The technology       I am not a doctor so feel unable to comment on the         The committee decision was based on a detailed economic analy
Profession                        technical side although research on other web sites        which took into account of all relevant costs.
al 13                             indicates side effects are no worse than other drugs.
                                  The cost seems small compared to the cost of treating
                                  long term side effects of diabetes and the social and
                                  individual costs not to mention the cost to the economy
                                  of potential premature economic inactivity.
                                  Unfortunately calculations often seem to only look at
                                  the short term costs
NHS          Evidence and         It would be useful if NICE engaged views of diabetic       The Committee considered evidence from nursing organisations
Profession   interpretation       nurses on the practical problems associated with           took these into account when making its recommendations.
al 13                             injected insulin and ask them whether a mixed
                                  economy of injected and inhaled insulin would benefit
                                  patients under their care
NHS          Preliminary views    Should look at whole life costings                         The committee decision was based on a detailed economic analy
Profession   on the resource                                                                 which took into account of all relevant costs, including long-term
al 13        impact for the NHS                                                              complications in diabetes.
NHS          Proposed date for    It would be interesting to know the cost to the NHS of     Please see comment above.
Profession   review of guidance   guidance review in 2009 in terms of delaying
al 13                             potentially cost saving treatments. I assume an impact
                                  assessment is carried out when setting review dates
Patient 24   General              From what I have read it would appear that the             Comment noted.
                                  inhalation equipment is much more bulky to carry           A discussion of specific contraindications is outside the remit of th
                                  about and as an insulin injector would not like to         appraisal.
                                  change the method. What if one gets a cough or cold
                                  or what happens if circulation is poor?
Patient 24   Appraisal            Most type 1 diabetics cannot live without insulin so       For both legal and bioethical reasons those undertaking technolo
             Committee’s          cost effectiveness should not come into it.                appraisals and developing clinical guidelines must take account o
             preliminary                                                                     economic considerations” (Social Value Judgements - Principles
             recommendations                                                                 development of NICE guidance; principle 5)

Patient 24   Clinical need and      Injecting insulin in public cannot be any worse than     Comment noted
             practice               using a large inhaler. Injections are a small price to
                                    pay for living.
Patient 24   The technology         In cases where inhalers are used, once again - cost      For both legal and bioethical reasons those undertaking technolo
                                    effectiveness should not come into it.                   appraisals and developing clinical guidelines must take account o
                                                                                             economic considerations” (Social Value Judgements - Principles
                                                                                             development of NICE guidance; principle 5)

Patient 24   Evidence and           have read all of the above and agree that in some        In view of the concerns raised by NHS professionals and people
             interpretation         cases inhalation would be the best BUT I STILL THINK     diabetes, the committee is now recommending inhaled insulin for
                                    YOU ARE WRONG IN CONSIDERING COST WHEN                   people who are unable to start insulin therapy or intensification of
                                    IT COMES TO SAVING LIVES.                                insulin therapy because of a proven injection phobia or severe
                                                                                             problems with injection sites for example as a consequence of
                                                                                             lipohypertrophy.

Patient 24   Proposed               Diabetes is a very tricky disorder and so many things    Comment noted
             recommendations        can affect balance. In fact anything can upset the
             for further research   blood sugar balance and a great deal more research is
                                    needed.
Patient 24   Preliminary views      Do you cost the treatment for AIDS? A self inflicted     Comment noted
             on the resource        disease.
             impact for the NHS
Carer 8      General                would like to read the document as my son has Type 1     It needs to be noted that inhaled insulin has a marketing authoris
                                    diabetes and suffers every day when injecting himself    only for adults with diabetes.
                                    with insulin, he is 12yrs old and became a diabetic
                                    2yrs ago. I read that the cost of this new treatment
                                    would be 1 thousand 1 hundred pounds a year. I would
                                    like to know how much it costs for him to have 4
                                    injections a day with needles and disposing of the
                                 sharps box.
Carer 8      Appraisal           My son is nearly 12yrs old and has Type 1 diabetes             Please see comment above.
             Committee’s         and symptoms of type 2 diabetes; he also suffers with
             preliminary         hypothyroidism for which he takes tablets. I have to
             recommendations     battle every day to get his injections done, he needs
                                 four a day, his sugar levels are not stable after two
                                 years of injections. He has lumps appearing where he
                                 injects himself; being overweight it is difficult for him to
                                 change sites for his injection.
Carer 8      The technology      My son is on 70 units a day sometimes more when his            Please see comment above.
                                 sugar levels are high. The cost of this seems to me
                                 much higher than 1.100 pounds.
NHS          preliminary         This recommendation is very limiting. Patients are             Although individual choice is important for the NHS and its users,
Profession   Appraisal           demanding inhaled insulin now. They know it is                 should not have the consequence of promoting the use of interve
al 14        Committee’s         available and to limit it in this way is extremely unfair.     that are not clinically and/or cost effective” (Social Value Judgem
             preliminary         There are risks associated with all forms of                   Principles for the development of NICE guidance; principle 5)
             recommendations     medications; patient should be given the chance to
                                 make informed choices about their own treatment
                                 regimes. Many, many people with diabetes only barely
                                 tolerate the misery of daily multiple injections, to
                                 further delay an alternative to this is cruel. This
                                 recommendation will also delay HCP"s from gaining
                                 clinical experiences with this medication.
NHS          Clinical need and   Your own recommendations for the treatment of type 2           The Committee does not consider the affordability of new technol
Profession   practice            diabetes states that "local experience, patient                but rather their cost effectiveness in terms of how its advice may
al 14                            preference and relative costs should inform the choice         the more efficient use of available healthcare resources (NICE Gu
                                 of insulin type and regimen" how can we gain local             the Methods of Technology Appraisal, paragraphs 6.2.6.1 – 6.2.6
                                 experience if inhaled insulin is not available, how can
                                 the patients express a preference if inhaled insulin is
                                 not available? Cost effectiveness can be shown to a
                                 certain effect by clinical trials but not in the large
                                 number of patients that it could if the inhaled insulin
                                 was more widely available.
NHS          The technology      What is the difference between this and sub-cutaneous        For explanation of the technology please see Section 3 of the AC
Profession                       insulin?
al 14
Patient 25   General             I think one should consider the effect of inhaled insulin    In view of the concerns raised by NHS professionals and patients
                                 on long term type 1 diabetes 20yrs+. Some of us are          committee is now recommending inhaled insulin for people who a
                                 experiencing lipodystrophy due to the long term effect       unable to start insulin therapy or intensification of insulin therapy
                                 of multiple daily injections. It’s not the needles which     because of severe problems with injection sites for example as a
                                 cause lipodystrophy but the passage of insulin through       consequence of lipohypertrophy.
                                 the subcutaneous tissue. Insulin pumpers also
                                 experience skin and tissue problems. I strongly believe
                                 that it can offer some degree of relief for such patients.
Patient 26   General             The thought of reduced injections and the difficulties in    Although individual choice is important for the NHS and its users,
                                 find sites would make this a much better option. For         should not have the consequence of promoting the use of interve
                                 my one injection per day must be better for my body          that are not clinically and/or cost effective” (Social Value Judgem
                                 than four. This should be readily available to all           Principles for the development of NICE guidance; principle 5)
                                 suitable diabetics now.

Patient 26   Appraisal           By reducing the number of injections and that the            The Committee discussed the evidence on quality of life with inje
             Committee’s         inhaler can be used more openly than injections there        and inhaled insulin in detail. See ACD sections 4.3.8, 4.3.9, 4.3.1
             preliminary         would be a great improvement in quality of life
             recommendations
Patient 26   Clinical need and   For type 1 the inhaler would be a much better option.        In view of the concerns raised by NHS professionals and patients
             practice            Less skin damage as injections reduced. Also easier to       committee is now recommending inhaled insulin for people who a
                                 use in public. Also the inhaler may be cleaner as many       unable to start insulin therapy or intensification of insulin therapy
                                 of the places where one goes to have an injection are        because of severe problems with injection sites for example as a
                                 not always too sanitary. Where possible we should            consequence of lipohypertrophy.
                                 move away from injections to less invasive options.
                                                                                              Although individual choice is important for the NHS and its users,
                                                                                              should not have the consequence of promoting the use of interve
                                                                                              that are not clinically and/or cost effective” (Social Value Judgem
                                                                                              Principles for the development of NICE guidance; principle 5)
Patient 26   The technology      Whilst cost must be a concern, so should quality of life    The committee decision was based on a detailed economic analy
                                 and care. The amount of wasted product when priming         which took into account of all relevant costs.
                                 the injection system would possibly be reduced. In my
                                 case four injections per day, is four needles, four
                                 priming’s
Patient 27   General             I have been an insulin controlled diabetic for 48 years,    Although individual choice is important for the NHS and its users,
                                 and after all this time I still do not like needles. on     should not have the consequence of promoting the use of interve
                                 reading about this inhaled insulin treatment I and I        that are not clinically and/or cost effective” (Social Value Judgem
                                 suppose a lot more diabetics like myself thought that       Principles for the development of NICE guidance; principle 5)
                                 we could cut down on our daily injections unless you
                                 have regular daily injections you would not fully
                                 understand how we feel it is possible this treatment
                                 could and probably would give diabetics like myself a
                                 better life style please give this breakthrough for
                                 people like myself your full attention
Patient 28   General             I have taken insulin of many different types for 30-40      Comment noted.
                                 years. I think this NICE proposed decision on the use
                                 of inhaled insulin is absolutely correct.
Patient 28   Appraisal           I think this is very sensible and the correct approach to   Comment noted
             Committee’s         a new formulation of a drug. Which seems to have no
             preliminary         clear benefits.
             recommendations
Patient 28   Clinical need and   Compared to the needles we used to use 20-40 years          Comment noted
             practice            ago, when it is true some people did find it difficult to
                                 cope with injections to start with, now a days it is very
                                 rare to find patients that have difficulty starting
                                 injections. A lot of the fear of injections is induced by
                                 health care professionals, "hyping it up". It does not
                                 come from the average patient themselves. Some
                                 people do have a fear of going on to insulin, but this is
                                    more commonly because of the potential difficulties
                                    with driving, work etc. Not the actual injections.
Patient 28   The technology         Inhaled insulin is not worth the money.                     Comment noted
Patient 28   Evidence and           I entirely agree with NICE                                  Comment noted
             interpretation
Patient 28   Proposed               Very sensible recommendations, I agree fully.               Comment noted
             recommendations
             for further research
Patient 28   Preliminary views      There can only be a tiny use for it on the NHS              Comment noted
             on the resource
             impact for the NHS
Carer 9      Clinical need and      My son was diagnosed with type 1 diabetes when he           Comment noted.
             practice               was 15. He has been injecting twice a day since then -
                                    he is now 23. Russell is very slim and, consequently,
                                    experiences pain and bruising on a regular basis - this
                                    is despite using the thinnest needles available. As you
                                    can imagine he was very excited to hear of the inhaled
                                    insulin which would make a considerable difference to
                                    his quality of life.
Carer 9      The technology         It would be a great pity for my son and fellow sufferers    “The Committee does not consider the affordability, that is cost al
                                    should this breakthrough be limited through reasons of      of new technologies but rather their cost effectiveness in terms of
                                    cost.                                                       its advice may enable the more efficient use of available healthca
                                                                                                resources (NICE Guide to the Methods of Technology Appraisal,
                                                                                                paragraphs 6.2.6.1 – 6.2.6.3).

                                                                                                It needs to be noted that inhaled insulin has a marketing authoris
                                                                                                only for adults with diabetes.

Carer 9      Proposed date for      Which means that my son and others like him will have       Guidance is reviewed when new evidence on the clinical and cos
             review of guidance     to suffer unnecessarily for at least another three years!   effectiveness of the technology in question emerges.

Carer 10     Appraisal              I welcome the Committee’s preliminary                       Comment noted
             Committee’s       recommendations and urge them to continue their
             preliminary       detailed and exhaustive review of the proposed
             recommendations   treatment. Personally, I see the proposed introduction
                               of inhaled insulin as no more than a marketing
                               exercise by Pfizer to increase market share. I
                               understand that Diabetes UK is coordinating a reply.
                               You should be aware that Diabetes UK, although
                               claiming to be the "charity for people with diabetes"
                               has a very strong Health Care Professional Section
                               that overwhelms the influence of those living with
                               diabetes. You should also be aware that there seems
                               to be a strong connection between members of the
                               Diabetes UK Health Care Professional Section and
                               Pfizer. This is evidence by Diabetes UK Research
                               funding the preliminary trial that lead to the CARDS
                               trial, with the full trial being funded by Pfizer and
                               others, which lead to the vastly increased use of
                               statins by people with diabetes. I suggest that any
                               reply to you from Diabetes UK is significantly more
                               influenced by the Health Care Professional Section
                               than the lay; inhaled insulin is certainly not an issue
                               that is at the top of the lay agenda so far as I am
                               aware.
NHS          Appraisal         While I am pleased that national guidelines are being      Although individual choice is important for the NHS and its users,
Profession   Committee’s       produced I am concerned that such an exclusive             should not have the consequence of promoting the use of interve
al 15        preliminary       statement will make life difficult for us in practice.     that are not clinically and/or cost effective” (Social Value Judgem
             recommendations   Patients expectations have been built up and various       Principles for the development of NICE guidance; principle 5)
                               lead clinicians seem to be promoting its possible use
                               through patient choice. The company have been
                               advertising in journals (supposedly as opportunities for
                               training) for many months and must be aware that
                               many HCPs have diabetes.
NHS          Clinical need and      We are aware that a number of people with diabetes           Comment noted
Profession   practice               do not achieve good control as they miss injections.
al 15                               They may be more compliant with inhaled insulin
                                    reducing risks of complications in the longer term.
NHS          The technology         would agree that potential side effects are of concern,      In view of the concerns raised by NHS professionals and people
Profession                          also that costs are greater than for subcutaneous            diabetes , the committee is now recommending inhaled insulin fo
al 15                               insulin, but believe that we should be concentrating on      people who are unable to start insulin therapy or intensification of
                                    identifying groups that may benefit.                         insulin therapy because of severe problems with injection sites fo
                                                                                                 example as a consequence of lipohypertrophy.

NHS          Evidence and           The Committee was persuaded that inhaled insulin             Comment noted
Profession   interpretation         could be cost effective in people with diabetes who
al 15                               experience a true and severe fear of insulin injections
                                    and who refuse to accept injected insulin therapy
                                    despite a high risk of complications. - Our PCT is
                                    considering allowing us to use inhaled insulin for a
                                    small number of people so identified - but this will bring
                                    in value judgements and may encourage others to
                                    become "needle phobic" in order to achieve their
                                    desired goal.
NHS          Proposed               re 5.3 - great if their control can be improved with         Comment noted
Profession   recommendations        inhaled insulin but then are we rewarding those who
al 15        for further research   do not always follow medical recommendations at the
                                    expense of those who do but would prefer this form of
                                    treatment? Individual patients do not always interested
                                    in the overview re NHS cost effectiveness.
NHS          Proposals for          If there is to be a further period of study how could this   Comment noted
Profession   implementation and     message be delivered to patients in a balanced way
al 15        audit                  while at the same time there are stories in the
                                    newspapers about this newest breakthrough and
                                    clinicians are being heavily targeted with info letting
                                    them know that the inhaled insulin is available and
                                   they should be training in use of the device.
Member of      Evidence and        I feel that the Appraisal Committee’s conclusions are        In view of the concerns raised by NHS professionals and people
the public 4   interpretation      absurd. I fully acknowledge the need to consider cost        diabetes, the committee is now recommending inhaled insulin for
                                   effectiveness and the Committee acknowledges that            people who are unable to start insulin therapy or intensification of
                                   Exubera ""can be cost effective in patients who              insulin therapy because of severe problems with injection sites fo
                                   experience a true and severe fear of insulin                 example as a consequence of lipohypertrophy.
                                   injections."" The debate should therefore be about how
                                   to identify these patients. To recommend that Exubera
                                   should not be used on any patients is clearly
                                   unreasonable and driven entirely by short term cost
                                   concerns. A new technology such as this will doubtless
                                   improve and reduce in cost over time and true
                                   innovation should be rewarded and encouraged.
                                   Exubera must therefore be supported for ""some
                                   patients"", identified by clinicians now, not ""no
                                   patients"" as is suggested in this absurd
                                   recommendation.
NHS            Appraisal           Many people with diabetes have fears and unhelpful           Please see comment above
Profession     Committee’s         beliefs around injectable treatments. These constitute
al 16          preliminary         significant barriers to improving long term outcomes for
               recommendations     people with diabetes and their families. Inhaled
                                   insulin’s offer a new way to increase insulin uptake
                                   among specific groups of people who, for a variety of
                                   reasons, would defer insulin therapy
NHS            Clinical need and   It is not only that people experience problems with          The Committee has discussed these issues. See ACD sections 4
Profession     practice            injections but that some have an absolute objection to       4.3.3.
al 16                              them per se. Health beliefs, employment situations,
                                   association with failure, site problems, social
                                   associations and stigma all play a part in lowering self
                                   esteem among injection users
NHS            The technology      It is a real step forward in helping people with diabetes.   For both legal and bioethical reasons those undertaking technolo
Profession                         the NICE guidance is so disappointing - it seems only        appraisals and developing clinical guidelines must take account o
al 16                               to be based solely on cost effectiveness arguments         economic considerations” (Social Value Judgements - Principles
                                                                                               development of NICE guidance; principle 5)

NHS          Evidence and           To make a novel delivery product (that has been            Comment noted
Profession   interpretation         licensed for use in Type 1 and 2 diabetes) broadly
al 16                               unavailable because cost effectiveness studies have
                                    not been completed seems ethically questionable.
                                    Whilst there is clearly a need for ongoing studies I
                                    know for certain that specific groups of patients in my
                                    practice and in the unit will develop complications at a
                                    rate that might be slowed if inhaled insulin’s were
                                    available now. In all likelihood, because of unknown
                                    factors in relation to long term lung function, we would
                                    be very cautious in our initial use of inhaled insulin.
                                    Initial use will probably be confined to those for whom
                                    injectable forms of insulin are absolutely unacceptable
NHS          Proposed               Yes, there is a need for ongoing research into             Comment noted
Profession   recommendations        concordance and cost effectiveness but it is
al 16        for further research   unsupportable, in my view, to deny specific groups of
                                    people with diabetes the opportunity to at least explore
                                    the inhaled option
NHS          Preliminary views      Important but the primacy of cost considerations need      Comment noted
Profession   on the resource        to be made explicit to the public. I suspect people with
al 16        impact for the NHS     diabetes and professionals looking after them would
                                    expect an overseeing body to appropriately balance
                                    the needs of individuals with the corporate good
NHS          Proposed date for      This is far too long. We are already being asked why       Guidance is reviewed when new evidence on the clinical and cos
Profession   review of guidance     this insulin is not available - perhaps rightly so         effectiveness of the technology in question emerges.
al 16
NHS          Appraisal              If there is an alternative to the trauma of having to      The Committee does not consider the affordability, that is cost alo
Profession   Committee’s            inject at least 4 times per day and the attendant          new technologies but rather their cost effectiveness in terms of ho
al 17        preliminary            suffering that this places on the patient, then cost       advice may enable the more efficient use of available healthcare
             recommendations        should NOT be a factor in the decision to seek a more       resources (NICE Guide to the Methods of Technology Appraisal,
                                    comfortable option. I am a Type 1 diabetic and have         paragraphs 6.2.6.1 – 6.2.6.3).
                                    continued problems in maintaining control and decent
                                    life style.
NHS          Clinical need and      Continued use of injections has a detrimental affect to     Please see comment above.
Profession   practice               the lifestyle of the patient and can and does lead to
al 17                               problems in trying to maintain reasonable control.
                                    Anything that can help and ease the problems must be
                                    sought and encouraged. COST should not be a factor.
NHS          The technology         As stated earlier, COST should not be a factor. If it       Please see comment above.
Profession                          only costs 1102 per year to potentially improve a
al 17                               patients control, this is CHEAP compared to the cost of
                                    having to constantly refer to the Medical profession for
                                    help.
NHS          Evidence and           You should leave the final decision whether it is           Although individual choice is important for the NHS and its users,
Profession   interpretation         beneficial or not to the patient’s Doctor and medical       should not have the consequence of promoting the use of interve
al 17                               advisors, and not to the findings of a report or            that are not clinically and/or cost effective” (Social Value Judgem
                                    evaluation by those who do not have direct dealings         Principles for the development of NICE guidance; principle 5)
                                    with diabetes or suffer the disease directly. If is
                                    irresponsible to take the stance on concluding the
                                    COST is a driver.
NHS          Proposed               I cannot comment on Type 2 control with inhaled             The committee is now recommending inhaled insulin for people w
Profession   recommendations        insulin as I am Type 1 (but was Type 2 previously, but      are unable to start insulin therapy or intensification of insulin thera
al 17        for further research   treatment was not effective until insulin was               because of a proven injection phobia or severe problems with inje
                                    considered). However, you should make this treatment        sites for example as a consequence of lipohypertrophy.
                                    readily available to Type 1 sufferers with no strings
                                    attached.
NHS          Preliminary views      What benefit to the well being of the patient will your     The Committee discussed the evidence on quality of life with inje
Profession   on the resource        cost template have?????????                                 and inhaled insulin in detail. See ACD sections 4.3.8, 4.3.9, 4.3.1
al 17        impact for the NHS
NHS          Proposals for          You cannot place a cost value on the quality of life of a   The NICE Guide to the Methods of Technology Appraisal explain
Profession   implementation and     patient. To do so is a serious infringement of a patients   costs per quality-adjusted life years are derived. (Available from U
al 17        audit                human rights                                                 http://www.nice.org.uk/page.aspx?o=201974).

NHS          Related guidance     How many of the above guidance actually involved             The Committee considered evidence from patient groups and too
Profession                        patient feedback??????????                                   into account when making its recommendations. Patient experts w
al 17                                                                                          were currently injecting insulin were present at the Committee me
                                                                                               As part of the NICE process, the committee is provided with copie
                                                                                               all the responses posted on the website before the final appraisal
                                                                                               decision meeting.

NHS          Proposed date for    FAR TOO LATE. Act now and help the sufferer, not             Guidance is reviewed when new evidence on the clinical and cos
Profession   review of guidance   the Government’s purse!                                      effectiveness of the technology in question emerges.
al 17
Patient 29   Appraisal            This is a disappointing recommendation. I feel that          Although individual choice is important for the NHS and its users,
             Committee’s          inhaled insulin would mean a dramatic improvement            should not have the consequence of promoting the use of interve
             preliminary          on quality of life. (especially for Type 1 diabetes where    that are not clinically and/or cost effective” (Social Value Judgem
             recommendations      there is no treatment other than injecting insulin.) It is   Principles for the development of NICE guidance; principle 5)
                                  unpleasant to inject for many reasons and inhaled
                                  insulin would encourage better compliance.
Patient 29   Clinical need and    Addition to 2.7 some unsightly bruising. Also in             Comment noted
             practice             addition to a dislike to injecting in public, there is a
                                  much greater factor of public dislike of diabetics
                                  injecting in public/ in front of others. Pain, dislike of
                                  needles and problems of finding injection sites
                                  (especially in those will less body fat) are all relevant
                                  problems.
Patient 29   The technology       Technology sounds more user friendly than injected           Comment noted
                                  insulin and with fewer problems.
Patient 29   Evidence and         I feel that inhaled insulin should also be offered to        Although individual choice is important for the NHS and its users,
             interpretation       people who find it difficult to inject when at work or who   should not have the consequence of promoting the use of interve
                                  have lifestyles where they are out in public much of the     that are not clinically and/or cost effective” (Social Value Judgem
                                  time where injecting can be difficult. It is argued that     Principles for the development of NICE guidance; principle 5)
                                  the inhaler is less discreet to use than an insulin pen,
                                    but it would seem to be more acceptable in public than
                                    the sight of needles and easier to use on the move.
                                    You could use this devise when in crowds/ around lots
                                    of people etc which is difficult with a insulin pen.
Patient 29   Proposed               feel that individual patients in consultation with their         Although individual choice is important for the NHS and its users,
             recommendations        doctor and given relevant advice would be better                 should not have the consequence of promoting the use of interve
             for further research   placed to decide what the best course of action would            that are not clinically and/or cost effective” (Social Value Judgem
                                    be for them given their lifestyle, preferences and need.         Principles for the development of NICE guidance; principle 5)
                                    Inhaled insulin should not be offered only to those who
                                    are non compliant, but also to those who are compliant
                                    but find their current treatment difficult. I don’t think this
                                    proposal takes this into account.
Patient 29   Proposed date for      This should be reconsidered sooner, 2009 is a long               Guidance is reviewed when new evidence on the clinical and cos
             review of guidance     time for patients to wait for the potentially better way to      effectiveness of the technology in question emerges.
                                    administer insulin
Patient 30   General                As an insulin dependent diabetic I understand that               Comment noted
                                    taking the correct doses of the drug is very important in
                                    treatment and maintaining good blood sugar level
                                    control. I am also however an asthmatic and I regularly
                                    use an inhaler, where the level of dose is not at all as
                                    required to be so exact. In fact in this respect the
                                    dosing of asthma drugs, even using the best form of
                                    inhalation technique, can not be exactly measured. My
                                    general concern with inhaled insulin is the very real
                                    possibility that it would be a less accurate a method of
                                    administering the drug than currently exists in the form
                                    of injection. Understandably taking a drug by inhalation
                                    instead of injection is an attractive proposition for those
                                    who do not like using needles, but I do worry that this
                                    consideration is being made to the detriment of
                                    effectiveness of future treatment.
Patient 30   Clinical need and      2.7 As a diabetic I find that it is not I who dislikes           Comment noted
             practice               injecting in public - it is in fact other people who (very
                                    rarely) dislike me doing it in front of them and I always
                                    ask if people mind. Pain is not an issue with the form
                                    of micro fine needles used for insulin except in very
                                    rare circumstances. Testing blood sugar is a far more
                                    painful process and will still have to take place with
                                    inhaled insulin. I’m not sure the benefit can necessarily
                                    be winning sold using this explanation.
Patient 30   The technology         It would be useful to have the average cost of injected      The cost of injected insulin depends on the regimen used. The
                                    insulin here as a comparison                                 Assessment Report (page 84) shows scenarios for annual insulin
                                                                                                 regimen costs of between £476 and £755.
Patient 30   Proposed               would suspect that this is more connected to patients        Comment noted
             recommendations        not being properly educated into the seriousness of
             for further research   their condition. If nursing and support staff were more
                                    readily available and check up appointments more
                                    regular then common sense would suggest that
                                    uncontrolled figures would drop. A hospital that has
                                    more than two clinics a week, where Doctors are able
                                    to spend longer with each patient, and cover details
                                    more thoroughly would obviously produce better
                                    results.
Patient 30   Proposed date for      The effect of this technology should be seen on              Guidance is reviewed when new evidence on the clinical and cos
             review of guidance     patients immediately and therefore the review should         effectiveness of the technology in question emerges.
                                    be ongoing, with a date set for a final report and
                                    recommendation. I would suggest 18 months.
NHS          Appraisal              Use of inhaled insulin should be considered in selected      In view of the concerns raised by NHS professionals and people
Profession   Committee’s            patients who have been finding injections difficult to       diabetes, the committee is now recommending inhaled insulin for
al 18        preliminary            manage                                                       people who are unable to start insulin therapy or intensification of
             recommendations                                                                     insulin therapy because of severe problems with injection sites fo
                                                                                                 example as a consequence of lipohypertrophy.

NHS          Clinical need and      Patient choice should be considered when prescribing         Although individual choice is important for the NHS and its users,
Profession   practice             insulin and mode of delivery. Not everybody finds            should not have the consequence of promoting the use of interve
al 18                             injections convenient in places of work, while many          that are not clinically and/or cost effective” (Social Value Judgem
                                  may be ready to consider basal bolus if available in the     Principles for the development of NICE guidance; principle 5)
                                  inhaled form
NHS          The technology       definitely a costly drug and pulmonary side effects are      Comment noted
Profession                        a worry. Patient selection criteria should be stringent.
al 18
NHS          Preliminary views    costly but newer technology. Careful patient selection       Comment noted
Profession   on the resource      necessary.
al 18        impact for the NHS
NHS          Evidence and         Evidence and interpretation.3.5 is crucial as the            In view of the concerns raised by NHS professionals and people
Profession   interpretation       majority of patients who are placed on insulin use           diabetes, the committee is now recommending inhaled insulin for
al 19                             insulin analogues and therefore any evaluation not           people who are unable to start insulin therapy or intensification of
                                  comparable to current standard care is unlikely to be        insulin therapy because of severe problems with injection sites fo
                                  accurate. Evidence and interpretation.3.1.2 - it is          example as a consequence of lipohypertrophy.
                                  certainly possible using psychological testing and
                                  clinical experience of an individual patient by a
                                  diabetologist to identify the very small group of patients
                                  with true needle phobia. I believe that it would be
                                  morally and professionally wrong to withhold a
                                  potentially life-saving treatment from such individuals
                                  on the basis that trials have not been specifically done
                                  (unlikely to ever happen as the numbers are so small)
                                  and there is no standard way of identifying them -
                                  surely there should be room for individual patient
                                  assessment and use in this unique group?
NHS          Proposals for        think that it should be available for the minority of        Please see comment above.
Profession   implementation and   patients who have been identified by a consultant
al 19        audit                diabetologist, perhaps after psychological testing, to
                                  have true needle phobia if the resultant lack of use of
                                  insulin would lead to an high risk of complications and
                                  reduced life expectancy
Patient 31   Appraisal           Quality of life issues may be harder to quantify, but are   The Committee discussed the evidence on quality of life with inje
             Committee’s         extremely important. Diabetes is for life, 365 days a       and inhaled insulin in detail. See ACD sections 4.3.8, 4.3.9, 4.3.1
             preliminary         year.
             recommendations
Patient 31   Clinical need and   The patients referred to in 2.7 may be in the minority      In view of the concerns raised by NHS professionals and people
             practice            but their quality of life is just as important as other     diabetes, the committee is now recommending inhaled insulin for
                                 patients. The issues mentioned may lead to patients         people who are unable to start insulin therapy or intensification of
                                 omitting their insulin injections, especially around        insulin therapy because of severe problems with injection sites fo
                                 adolescence, leading to life-threatening (and               example as a consequence of lipohypertrophy.
                                 expensive) complications. A friend of mine has
                                 avoided attending GP/diabetic clinic for over a year
                                 because they have suggested putting her on insulin
                                 and she has a strong aversion to needles. She is
                                 putting herself at great risk of complications and
                                 receiving no follow-up at all. Non-compliance with
                                 insulin for these reasons can worsen perceptions of
                                 diabetes in the wider public, e.g. a person reported as
                                 blind at age 25 due to diabetes, whereas in fact poor
                                 compliance with insulin throughout teenage years was
                                 a major factor.
Patient 31   The technology      What price quality of life and patient choice?              The NICE Guide to the Methods of Technology Appraisal explain
                                                                                             costs per quality-adjusted life years are derived. (Available from U
                                                                                             http://www.nice.org.uk/page.aspx?o=201974).
                                                                                             Patient choice and preference is taken into account if it translates
                                                                                             measurable change in quality of life.

Patient 31   Evidence and        One wonders what NICE"s views would have been if            Comment noted
             interpretation      the same evidence had been presented in the 1970s
                                 regarding the disposable syringes, insulin pens and
                                 home blood glucose monitoring equipment that
                                 diabetics now enjoy. With the greatest respect, NICE-
                                  style reliance on retrospective evidence of improved
                                  clinical outcomes and cost-effectiveness (no evidence
                                  so few people use it - few people using it so little
                                  evidence) could have resulted in diabetics still using
                                  the Ames chemistry set for urine-only testing, unwieldy
                                  glass syringes and huge boil-in-a-saucepan needles of
                                  the 1970s. And no patient choice.
Patient 31   Proposals for        Individuals vary. Not all cases of diabetes respond to         Although individual choice is important for the NHS and its users,
             implementation and   treatment in the expected way (e.g. some insulin’s do          should not have the consequence of promoting the use of interve
             audit                not suit some diabetics); therefore patients need to           that are not clinically and/or cost effective” (Social Value Judgem
                                  have a choice of options. Just as we still need animal         Principles for the development of NICE guidance; principle 5)
                                  insulin’s, inhaled insulin should be available for
                                  patients who wish to try it. Even if inhaled insulin
                                  doesn’t work for a particular patient, they should be
                                  able to try it and know that their treatment regimen is
                                  the most suitable one for THEM.
Patient 32   General              I am a 52 year old insulin dependent diabetic                  Although individual choice is important for the NHS and its users,
                                  diagnosed 9 years ago. My condition is not related to          should not have the consequence of promoting the use of interve
                                  obesity. Initially prescribed tablets, I now have to inject    that are not clinically and/or cost effective” (Social Value Judgem
                                  twice a day. Injecting is inconvenient and sometimes           Principles for the development of NICE guidance; principle 5)
                                  unpleasant. If I visit a restaurant I am forced to inject in
                                  the toilet; a cubicle is not always available. Travelling
                                  abroad brings its own problems; carrying                       In view of the concerns raised by NHS professionals and people
                                  pens/syringes invites security concerns. I am deeply           diabetes, the committee is now recommending inhaled insulin for
                                  disappointed that NICE may be recommending that the            people who are unable to start insulin therapy or intensification of
                                  inhaled version of insulin may not be made available at        insulin therapy because of severe problems with injection sites fo
                                  comparatively little extra cost; It would make my              example as a consequence of lipohypertrophy.
                                  condition so much easier to bear. I also have an insulin
                                  dependent son (Alexander) who was diagnosed at the
                                  age of 7 yrs. He is now 23. Alex states how
                                  psychologically it affected him, to inject himself at 7 yrs
                                  of age. It was also painful at times. Alex agrees with all
                                 my former points but wishes to emphasize the lack of
                                 independence when he needs to ask myself or his
                                 mother to hold his arm to inject, as he needs to rotate
                                 injection sites in arms and legs. The provision of
                                 inhaled insulin would make a tremendous difference to
                                 our lives and we implore you to recognise this and
                                 make inhaled insulin available to people of all ages.
Patient 32   Appraisal           The costs appear to be relatively small; an extra 500
             Committee’s         pa considering the benefits and improvement in              In view of the concerns raised by NHS professionals and people
             preliminary         diabetics quality of life, if inhaled insulin were an       diabetes, the committee is now recommending inhaled insulin for
             recommendations     option. Injecting is unpleasant and often inconvenient      people who are unable to start insulin therapy or intensification of
                                 and increases the stigma of having the disease.             insulin therapy because of severe problems with injection sites fo
                                 Children are terrified, especially at first, and the        example as a consequence of lipohypertrophy.
                                 psychological impact can last a lifetime. I also think
                                 that many older people will be deterred from switching
                                 to injectable insulin when their condition worsens and
                                 become seriously ill or dying. There was a case in the
                                 `Express & Star` last week where a 35 yr old man died
                                 from complications as he hated injecting, according to
                                 his mother. In the 21st century, to deny diabetics the
                                 possibility of receiving an inhaled form of insulin as
                                 opposed to injecting it is unacceptable and cruel.
Patient 32   Clinical need and   There is still a need to inject up to 4 times a day. As     Comment noted
             practice            there is no choice except death, people get on with it,
                                 unless you have the condition yourself or live with
                                 people who do, it is difficult to emphasize the impact of
                                 an injecting regime.
Patient 32   The technology      The annual costs need to be balanced with the present       Comments noted. The committee decision was based on a detail
                                 cost of injectable insulin. The Times newspaper quoted      economic analysis which took into account of all relevant costs.
                                 an extra 500 pa - a small amount considering the
                                 benefits. Many younger diabetics do not smoke and           In view of the concerns raised by NHS professionals and people
                                 may be willing to inhale insulin. Presumably lung           diabetes, the committee is now recommending inhaled insulin for
                                    damage will have been investigated in the medical             people who are unable to start insulin therapy or intensification of
                                    trials. Injecting insulin in the long term can also present   insulin therapy because of severe problems with injection sites fo
                                    risks including infected injection sites that may not heal    example as a consequence of lipohypertrophy.
                                    well. A diabetic may well decide to control his blood
                                    sugars more efficiently if he needed to inhale insulin
                                    more frequently rather than inject.
Patient 32   Evidence and           It appears that overall, the patients who trialled the        Comment noted
             interpretation         inhaled form of insulin were convinced of the benefits it
                                    gave them. The reduction in the risks of a
                                    hypoglycaemic reaction also appear to be reduced.
Patient 32   Proposed               The time for action is now. Very little has changed in        Comment noted
             recommendations        the treatment of diabetes since the 1920`s. A great
             for further research   deal of money and effort has gone into developing
                                    these drugs and we should receive the benefits now.
Patient 32   Preliminary views      The resource impact appears to be beneficial to               Comment noted
             on the resource        provide inhaled insulin.
             impact for the NHS
Patient 32   Proposals for          No doubt improvements will continue if some diabetics         In view of the concerns raised by NHS professionals and people
             implementation and     can receive inhaled insulin.                                  diabetes, the committee is now recommending inhaled insulin for
             audit                                                                                people who are unable to start insulin therapy or intensification of
                                                                                                  insulin therapy because of severe problems with injection sites fo
                                                                                                  example as a consequence of lipohypertrophy.

Patient 32   Proposed date for      This is far too late. We need action now.                     Guidance is reviewed when new evidence on the clinical and cos
             review of guidance                                                                   effectiveness of the technology in question emerges.

NHS          Recommendations        agree with the exception for patients who are unable to       In view of the concerns raised by NHS professionals and people
Profession                          give insulin via injection. At discretion of consultant       diabetes, the committee is now recommending inhaled insulin for
al 20                                                                                             people who are unable to start insulin therapy or intensification of
                                                                                                  insulin therapy because of severe problems with injection sites fo
                                                                                                  example as a consequence of lipohypertrophy.
NHS            Clinical need and      agree. It is only a small minority who have difficulty       Please see comment above
Profession     practice               with injections once fully explained and adequately
al 20                                 taught
NHS            The technology         agree                                                        Comment noted
Profession
al 20
NHS            Evidence and           Whilst accepting that there is no evidence but given         In view of the concerns raised by NHS professionals and people
Profession     interpretation         availability it is inappropriate to deny its use in the      diabetes, the committee is now recommending inhaled insulin for
al 20                                 small number of patients who are unable to use sc            people who are unable to start insulin therapy or intensification of
                                      insulin. They should be able to use this preparation on      insulin therapy because of severe problems with injection sites fo
                                      a named patient basis, at the decision of a consultant       example as a consequence of lipohypertrophy.
                                      and as a part of a national study/data collection. I
                                      agree that in the absence of clear benefit, greater cost
                                      and safety concerns it should not be routinely available
NHS            Proposed               agree                                                        Comment noted
Profession     recommendations
al 20          for further research
Member of      Recommendations        This is a shame as it takes away patient choice as well      Although individual choice is important for the NHS and its users,
the public 4                          as the Clinicians choice and frowns upon innovation.         should not have the consequence of promoting the use of interve
                                                                                                   that are not clinically and/or cost effective” (Social Value Judgem
                                                                                                   Principles for the development of NICE guidance; principle 5)

Member of      Clinical need and      it is unfair to take away patient choice. People with        Please see comment above.
the public 4   practice               type 1 Diabetes have to have insulin to survive, these
                                      people could have been injecting for 30 years at least
                                      and their sites of injection often break down, this is a
                                      great alternative for Bolus insulin so they can give sites
                                      a rest
Member of      The technology         type 2 Diabetes is on the up as we know this is usually      Comments noted.
the public 4                          diagnosed when the damage is done, what’s more
                                      important Costs or Life
Member of      Evidence and           As mentioned Life is more important than costs, what         The Committee decision was based on a detailed economic analy
the public 4   interpretation         about the costs of patients being admitted due to type      which took into account the cost of complications, including long t
                                      2 complications as they are not controlled and are          complications resulting from diabetes.
                                      reluctant to take their insulin Injections
Member of      Proposed               Research should be ongoing while this innovative new        Comment noted.
the public 4   recommendations        devise should be allowed to be used to helps save
               for further research   patients lives who are reluctant to take extra insulin or
                                      start insulin because of the fear of injections
Member of      Preliminary views      this will be useful but surely people should still have     Although individual choice is important for the NHS and its users,
the public 4   on the resource        the opportunity to be given the chance to use exubera       should not have the consequence of promoting the use of interve
               impact for the NHS                                                                 that are not clinically and/or cost effective” (Social Value Judgem
                                                                                                  Principles for the development of NICE guidance; principle 5)

Member of      Proposals for          why wait their are people out there lined up and ready      The committee is now recommending inhaled insulin for people w
the public 4   implementation and     to use exubera, audit people while they are using it in     are unable to start insulin therapy or intensification of insulin thera
               audit                  a real life situation                                       because of severe problems with injection sites for example as a
                                                                                                  consequence of lipohypertrophy.
Member of      Related guidance       I think the proposed guidance is wrong and only takes       The Committee does not consider the affordability, that is the cos
the public 4                          into account the cost of the product and not the            new technologies but rather their cost effectiveness in terms of ho
                                      patients needs and the clinicians needs.Pharma              advice may enable the more efficient use of available healthcare
                                      companies are developing new drugs and delivery             resources (NICE Guide to the Methods of Technology Appraisal,
                                      systems all the time to improve the health of the nation    paragraphs 6.2.6.1 – 6.2.6.3).
                                      why can nice not take this on board.
Member of      Proposed date for      Why leave it this long when their are people dying from     Guidance is reviewed when new evidence on the clinical and cos
the public 4   review of guidance     diabetes when they need not die. Take account of            effectiveness of the technology in question emerges.
                                      what’s been said and think again.
Patient 33     Appraisal              This is a shame as it takes away patient choice as well     Although individual choice is important for the NHS and its users,
               Committee’s            as the Clinicians choice and frowns upon innovation.        should not have the consequence of promoting the use of interve
               preliminary                                                                        that are not clinically and/or cost effective” (Social Value Judgem
               recommendations                                                                    Principles for the development of NICE guidance; principle 5)

Patient 33     Clinical need and      it is unfair to take away patient choice. People with       In view of the concerns raised by NHS professionals and people
               practice               type 1 Diabetes have to have insulin to survive, these      diabetes, the committee is now recommending inhaled insulin for
                                    people could have been injecting for 30 years at least       people who are unable to start insulin therapy or intensification of
                                    and their sites of injection often break down, this is a     insulin therapy because of severe problems with injection sites fo
                                    great alternative for Bolus insulin so they can give sites   example as a consequence of lipohypertrophy.
                                    a rest
Patient 33   The technology         type 2 Diabetes is on the up as we know this is usually      Comments noted.
                                    diagnosed when the damage is done, whats more
                                    important Costs or Life.

Patient 33   Evidence and           As mentioned Life is more important than costs, what         The Committee decision was based on a detailed economic anal
             interpretation         about the costs of patients being admitted due to type       which took into account the cost of complications, including long t
                                    2 complications as they are not controlled and are           complications resulting from diabetes.
                                    reluctant to take their insulin Injections
Patient 33   Proposed               Research should be ongoing while this innovative new         Comment noted
             recommendations        devise should be allowed to be used to helps save
             for further research   patients lives who are reluctant to take extra insulin or
                                    start insulin because of the fear of injections
Patient 33   Preliminary views      this will be useful but surely people should still have      Although individual choice is important for the NHS and its users,
             on the resource        the opportunity to be given the chance to use exubera        should not have the consequence of promoting the use of interve
             impact for the NHS                                                                  that are not clinically and/or cost effective” (Social Value Judgem
                                                                                                 Principles for the development of NICE guidance; principle 5)

Patient 33   Proposals for          why wait their are people out there lined up and ready       The committee is now recommending inhaled insulin for people w
             implementation and     to use exubera, audit people while they are using it in      are unable to start insulin therapy or intensification of insulin thera
             audit                  a real life situation                                        because of severe problems with injection sites for example as a
                                                                                                 consequence of lipohypertrophy.
Patient 33   Related guidance       I think the proposed guidance is wrong and only takes        The Committee does not consider the affordability, that is the cos
                                    into account the cost of the product and not the             new technologies but rather their cost effectiveness in terms of ho
                                    patients needs and the clinicians needs.Pharma               advice may enable the more efficient use of available healthcare
                                    companies are developing new drugs and delivery              resources (NICE Guide to the Methods of Technology Appraisal,
                                    systems all the time to improve the health of the nation     paragraphs 6.2.6.1 – 6.2.6.3).
                                    why can nice not take this on board.
Patient 33   Proposed date for      Why leave it this long when there are people dying           Guidance is reviewed when new evidence on the clinical and cos
             review of guidance   from diabetes when they need not die. Take account of       effectiveness of the technology in question emerges.
                                  whets been said and think again.
NHS          Appraisal            An outrageous decision that will set us behind the rest     In view of the concerns raised by NHS professionals and people
Profession   Committee’s          of the Western world in terms of diabetes care. We          diabetes, the committee is now recommending inhaled insulin for
al 21        preliminary          have needle phobic brittle diabetic patients with           people who are unable to start insulin therapy or intensification of
             recommendations      recurrent admissions with hyperglycaemia - the              insulin therapy because of severe problems with injection sites fo
                                  personal cost to them and financial cost to the NHS         example as a consequence of lipohypertrophy.
                                  enormous - how short sighted is this draft guidance.

Patient 34   General              I think it is scandalous that a maximum cost of 500 per     The committee decision was based on a detailed economic analy
                                  year should stop the production of inhaled insulin in       which took into account all relevant costs.
                                  the UK. Surely the costs involved in treating the
                                  problems associated with diabetes are higher and if
                                  the problems are lessened by using this technology
                                  that it will save the country money in the long run (and
                                  save many people a lot of pain and suffering)
Patient 34   Preliminary views    Having seen a report on the costs involved for inhaled      The Committee does not consider the affordability, that is costs a
             on the resource      insulin on BBC news a short while ago, I think it is        of new technologies but rather their cost effectiveness in terms of
             impact for the NHS   scandalous that a maximum cost of 500 per patient per       its advice may enable the more efficient use of available healthca
                                  year should stop the production of inhaled insulin in       resources (NICE Guide to the Methods of Technology Appraisal,
                                  the UK. Surely the costs involved in treating the           paragraphs 6.2.6.1 – 6.2.6.3).
                                  problems associated with diabetes are higher and if
                                  the problems are lessened by using this technology
                                  that it will save the country money in the long run (and
                                  save many people a lot of pain and suffering
Patient 35   Appraisal            Speaking personally as a Type 1 diabetic who needs          Comment noted.
             Committee’s          to inject up to 4 times a day it would make a huge
             preliminary          difference to me if I was simply able to inhale insulin,
             recommendations      even if I had to use an injection for my final injection
                                  each night. I am not surprised that your clinical experts
                                  said that their patients did not find injections a
                                  problem. We don’t it keeps us alive but it is
                                 unpleasant, slightly painful and undignified. Each
                                 diabetic will have their own particular take on it but
                                 here are a few of the reasons why an inhaler would be
                                 so much better: Privacy: trying to find an appropriate
                                 place (usually lavatory) for injections during the
                                 working day or when out at night Dignity: blood spots
                                 on your shirt don’t look great and cant always be
                                 avoided Hygiene: there are many workplace, pub and
                                 restaurant lavatories that aren’t entirely suitable for
                                 attempting a clean injection Scarring many years of
                                 injections eventually produce lumps, bumps and
                                 discoloured scars no matter how often you change
                                 injection sites All the above would be completely
                                 sorted by simply having to take an inhaler out,
                                 assemble it, taking a puff and getting on with life.
Patient 35   Clinical need and   Comment on 2.7: My issue is not a problem with                 Although individual choice is important for the NHS and its users,
             practice            insulin injections, but that for the reasons stated in my      should not have the consequence of promoting the use of interve
                                 comment on the preliminary findings, an inhaler would          that are not clinically and/or cost effective” (Social Value Judgem
                                 improve my quality of life. To put it another way, if          Principles for the development of NICE guidance; principle 5)
                                 asthmatics had a choice of injection or inhaler then
                                 which would they choose and which would be most
                                 likely to encourage them to be compliant with their
                                 care plan?
Patient 35   Evidence and        4.3.2 - I am not convinced that the experts truly              The Committee considered evidence from patient groups and too
             interpretation      reflected patients" viewpoint. Injections are intrusive        into account when making its recommendations. Patient experts w
                                 and can be painful no matter how habitual they are             were currently injecting insulin were present at the Committee me
                                 and these concerns, in my experience, will not be
                                 reported to clinicians as they are simply part of diabetic
                                 life, with no alternative available. 4.3.8 It’s hard to work
                                 out how the smallest injection pen could be more
                                 discreet than an inhaler. There is a huge difference
                                 between being able to assemble even an ungainly
                               device in public, then puff on it, compared to having to
                               push a small needle into exposed flesh in the stomach
                               or thigh. The injection requires privacy.
Patient 36   Evidence and      Comment on ""The experts advised the Committee                 Comment noted.
             interpretation    that using injected insulin is not usually a concern for
                               the majority of people with diabetes, given the
                               availability of patient support and education, modern
                               small needle types and insulin pens"" How many of
                               your ""experts"" have been injecting themselves daily
                               for 30 years to come up with a dismissive comment
                               like this? I hope that I have another 40 or so years to
                               go, and am fed up with finding 4 injection sites a day,
                               more so during the daytime, when at the office or on
                               site with my job (company managing director), having
                               to find places to carry out my injections. Do you know
                               what it is like to use stinking, filthy public toilets or to
                               be confronted by people who think you are a junkie if
                               you try to inject in public. Using inhaled insulin would
                               be a fantastic opportunity to be able to take insulin on
                               the spot, anywhere. Instead of delaying injections to
                               find a suitable opportunity of privacy. Inhalable insulin
                               would allow me to tighten my control significantly in
                               this regard, something I currently cannot do with
                               insulin pens during the daytime. (Type 1 diabetic
                               diagnosed 10/73)
Patient 37   Appraisal         I have lived with type 1 diabetes for the past 15 years.       Comment noted
             Committee’s       During this time it has been well controlled and I have
             preliminary       never had to be admitted to hospital due to lack of
             recommendations   control. Whilst I accept that some people have poor
                               control due to no fault of their own, there are people
                               whose lack of control is simply their own fault (I have
                               met several of these people). Trials should be looking
                                    at helping and improving the lives of people with
                                    diabetes who do their best to keep control of the
                                    disease.
Patient 37   Clinical need and      No diabetic has to inject in public - there are always       Comment noted
             practice               alternatives!
Patient 37   The technology         According to this report, the people who tested the          Comment noted.
                                    inhaled insulin preferred this treatment method and
                                    ""All reported that overall quality of life and subscales
                                    showed more favourable improvement among people
                                    taking inhaled insulin..."" (4.1.14) As I mentioned
                                    previously, some people who are uncontrolled on their
                                    present regimen are in this position due to their own
                                    fault. They should not be the ones who benefit first
                                    from any new treatments that improve quality of life or
                                    are more preferable! I too, dislike injections (are there
                                    many people who are pleased to have to have daily
                                    insulin injections?) and have problems with injection
                                    sites (probably some kind of reaction, but changing
                                    insulin’s and taking antihistamines has not solved the
                                    problem), but I have not missed an injection. Perhaps
                                    if I stopped doing my injections (therefore losing
                                    control of my diabetes) because of my dislike and the
                                    discomfort they give me, I too would be able to
                                    participate in a trial for a treatment method that I would
                                    prefer and find much easier and then perhaps even
                                    find that I would be higher up the list for this new
                                    treatment when it became available!
Patient 38   Proposed               People who do not comply with current treatment              Comment noted
             recommendations        regimes are not the only people with diabetes who
             for further research   dislike the disease and the resulting treatments.
                                    Priority should be given to those people who have
                                    demonstrated that they can follow a treatment regime.
                                  What is there to say that those who do not comply with
                                  their treatment at the moment will comply with their
                                  treatment in the future - will they get fed up of having
                                  to inhale insulin?
Patient 38   Preliminary views    In the long term, if people are more willing to comply to     The committee decision was based on a detailed economic analy
             on the resource      this treatment then there will be fewer diabetes related      which took into account of all relevant costs, including long-term
             impact for the NHS   complications, therefore saving money for the NHS. If         complications related to diabetes.
                                  a treatment can provide people with a much better
                                  quality of life, cost, to a certain extent should not be an
                                  issue. It would also be very embarrassing if this
                                  country fell behind the times with regards to diabetes
                                  treatment because it was simply trying to save a few
                                  pounds.
Patient 39   Appraisal            Once again treatment is limited firstly on the basis of       Although individual choice is important for the NHS and its users,
             Committee’s          cost, and secondly to those who have difficulty               should not have the consequence of promoting the use of interve
             preliminary          controlling their blood sugar levels. The same thing          that are not clinically and/or cost effective” (Social Value Judgem
             recommendations      happened with insulin pumps. My blood sugar levels            Principles for the development of NICE guidance; principle 5)
                                  are generally very well controlled but I and others like
                                  me are penalised because of this. Why? The simple
                                  fact is that inhaled insulin would drastically improve my
                                  quality of life and my body would no longer resemble a
                                  pin cushion as it wouldn’t constantly have needles
                                  stuck into it. This treatment should be available to all
                                  insulin dependent diabetics.
Patient 40   Appraisal            What about people like me who have a phobia of                In view of the concerns raised by NHS professionals and people
             Committee’s          needles and experience problems injecting insulin on a        diabetes, the committee is now recommending inhaled insulin for
             preliminary          daily basis? A comment by Andrea Sutcliffe on the             people who are unable to start insulin therapy or intensification of
             recommendations      BBC News website says that usually people with                insulin therapy because of severe problems with injection sites fo
                                  diabetes don’t have problems with injecting insulin           example as a consequence of lipohypertrophy.
                                  when needed, so the cost of putting the inhaler on the
                                  NHS would be too high. This is not a good enough
                                  explanation for me. I would appreciate your comments
                                    on whether people who do have a problem injecting
                                    insulin will be considered
NHS          Evidence and           Due to the result supporting inhaled insulin as             In view of the concerns raised by NHS professionals and people
Profession   interpretation         comparable to soluble Sub cit insulin I feel it should be   diabetes, the committee is now recommending inhaled insulin for
al 22                               available for intensification of treatment in patients in   people who are unable to start insulin therapy or intensification of
                                    whom all other options have been fully explored.            insulin therapy because of severe problems with injection sites fo
                                                                                                example as a consequence of lipohypertrophy.

NHS          Proposed               Assume by comply this means don’t take current              The Committee has revised their recommendations. In view of the
Profession   recommendations        regimen prescribed. this needs further clarification.       concerns raised by NHS professionals and people with diabetes,
al 22        for further research   Who’s going to do this research? where will the             committee is now recommending inhaled insulin for people who a
                                    funding come from?                                          unable to start insulin therapy or intensification of insulin therapy
                                                                                                because of severe problems with injection sites for example as a
                                                                                                consequence of lipohypertrophy. Outcome data in these patients
                                                                                                advised to be collected.

NHS          Proposed date for      3 years seems along time before this reviewed feel 2        Guidance is reviewed when new evidence on the clinical and cos
Profession   review of guidance     years more appropriate it is likely a lot of new evidence   effectiveness of the technology in question emerges.
al 22                               will become available over the next 2 years/
Carer 11     General                Having witnessed the trauma of injections over many         Comment noted
                                    years (29) of my daughter
NHS          Appraisal              Supported -the Committee’s assessment of the                Comment noted
Profession   Committee’s            evidence presented is fair and reasonable.
al 23        preliminary
             recommendations
NHS          Clinical need and      .6 Control of CV risk factors and use of metformin,         Comment noted
Profession   practice               rather than tight blood glucose control per se, are the
al 23                               key interventions in these patients in terms of
                                    reduction in morbidity and mortality. (UKPDS). 2.7 The
                                    appraisal committee considered and addressed this
                                    point.
NHS          The technology         3.2 The inhaler device is relatively large and requires     Comment noted
Profession                          replacement of the firing mechanism every 14 days.
al 23                               Some patients may require a large number of capsules
                                    (firings) per dose, which would be time consuming and
                                    unwieldy. 3.3 Once started, insulin will be required life-
                                    long. The majority of studies were of relatively short
                                    duration. The SmPC states that 2 700 have used
                                    inhaled insulin in trials, of whom 1975 have been
                                    engaged in trials of greater than 6 months duration,
                                    and only 745 in trials of longer than 2 years. Both the
                                    number of patients and the duration of studies are
                                    such to give concern as to whether all adverse effects
                                    have been identified. 3.4 Patients need to be re-titrated
                                    to an appropriate dose, with the risk of loss of control,
                                    including hypoglycaemia. The costs quoted are 3-4
                                    times the costs for subcut insulin.
NHS          Evidence and           The comments of the appraisal committee are valid            Comment noted
Profession   interpretation         and appropriate. 4.3.11 An alternative needle-free
al 23                               device is currently available. However as noted, blood
                                    glucose monitoring is still required.
NHS          Proposed               Agreed                                                       Comment noted
Profession   recommendations
al 23        for further research
NHS          Preliminary views      Based on data provided by the manufacturer the               Comment noted.
Profession   on the resource        widespread use of inhaled insulin would present a
al 23        impact for the NHS     significant financial burden to the NHS. There will be
                                    enormous patient demand for this product, with huge
                                    prescribing costs. However, there will be additional
                                    hidden costs in terms of re-titration of doses and the
                                    need for spirometry
NHS          Proposed date for      Supported                                                    Comment noted.
Profession   review of guidance
al 23
NHS            Appraisal              Should be available for some clinical practice within         In view of the concerns raised by NHS professionals and people
Profession     Committee’s            NHS and not just within studies. A total block to clinical    diabetes, the committee is now recommending inhaled insulin for
al 23          preliminary            use is not in the best interest of patients, clinicians, or   people who are unable to start insulin therapy or intensification of
               recommendations        the clinical standing of the NHS within the wider             insulin therapy because of severe problems with injection sites fo
                                      international diabetes community, and it should be            example as a consequence of lipohypertrophy.
                                      possible to define limited groups of patients for clinical
                                      use in NHS
NHS            Clinical need and      This is a new technology and the true clinical place will     Comment noted.
Profession     practice               only be found from clinical experience
al 23
NHS            The technology         Although more costly than routine/conventional insulin        Comment noted.
Profession                            which has been in clinical use for 80 years, it
al 23                                 compares well with treatments in other disease areas
NHS            Evidence and           Clearly further trials are needed and several are in          Comment noted.
Profession     interpretation         progress
al 23
NHS            Proposed               Again, several of these issues will only be resolved          Comment noted.
Profession     recommendations        when used in clinical practice. If not used in the NHS
al 23          for further research   the experience will come from other countries, and the
                                      private sector in UK
Member of      Appraisal              If patients are not controlled with injected insulin, what    In view of the concerns raised by NHS professionals and people
the public 5   Committee’s            other options are available whether it is in clinical         diabetes, the committee is now recommending inhaled insulin for
               preliminary            studies or not. Patients may need other options and           people who are unable to start insulin therapy or intensification of
               recommendations        choice to aid compliance and lifestyle, yet another cost      insulin therapy because of severe problems with injection sites fo
                                      driven decision which is a disgrace taking decision           example as a consequence of lipohypertrophy.
                                      making away from clinicians with the clinical expertise
                                      to assess patients individually
Member of      Clinical need and      2.5 NICE states that insulin regimen should be tailored       Although individual choice is important for the NHS and its users,
the public 5   practice               to meet the needs of the patient yet that NICE have           should not have the consequence of promoting the use of interve
                                      taken that decision to tailor appropriate use of inhaled      that are not clinically and/or cost effective” (Social Value Judgem
                                      insulin from clinicians and choice from patients 2.6          Principles for the development of NICE guidance; principle 5)
                                      Patient preference may prefer choice with a
                                    combination of injections and Inhaled insulin to avoid
                                    no. of painful injections and injecting in public
Member of      The technology       Exubera should be made available for uncontrolled          Please see above comment.
the public 5                        patients with type 1 & type 2
Member of      Evidence and         Evidence suggests that it works patient choice quality     The Committee discussed the evidence on quality of life with inje
the public 5   interpretation       of life and preference seems to have been ignored          and inhaled insulin in detail. See ACD sections 4.3.8, 4.3.9, 4.3.1
                                    Decision based on cost how does this compare to
                                    insulin pumps?                                             An economic evaluation of inhaled insulin compared to insulin pu
                                                                                               currently unavailable.

Member of      Preliminary views    Costs of managing complication s in Diabetes is            The committee decision was based on a detailed economic analy
the public 5   on the resource      escalating the NHS should be investing in preventing       which took into account of all relevant costs, including long-term
               impact for the NHS   patients developing complications instead of managing      complications related to diabetes.
                                    the long term conditions
Member of      Proposed date for    Very disappointing for patients                            Comment noted.
the public 5   review of guidance
Patient 41     General              I am addressing this letter to you in the hope, that you   In view of the concerns raised by NHS professionals and people
                                    will reconsider your decision to postpone the              diabetes, the committee is now recommending inhaled insulin for
                                    availability of inhaled insulin to NHS patients. I have    people who are unable to start insulin therapy or intensification of
                                    been a diabetic patient for over 20 years, being on        insulin therapy because of severe problems with injection sites fo
                                    insulin for last 15 years. Since four years ago I          example as a consequence of lipohypertrophy. The committee al
                                    developed an intense generalised pruritis which was        agreed that inhaled insulin would be cost effective in these popula
                                    eventually found to be due to allergy to meta cresols
                                    and phenols used as preservatives in all injectable        There is currently no evidence that pruritis symptoms are reduced
                                    insulin preparations available to NHS patients. I have     inhaled insulin compared to subcutaneous insulin.
                                    been desensitised but haven’t received any benefit
                                    from the procedure, as I still have to continue using
                                    insulin. I suffer from intense pruritis, constant
                                    rhinorrhoea and lipodystrophy in that the
                                    subcutaneous tissue has mostly withered away. I have
                                    to take insulin in small doses at frequent intervals and
                                    take high doses of antihistamines which do not help
                       much. When pruritis becomes intolerable I take a two
                       week course of prednisolone. This, I have to do at
                       frequent intervals and gives relief for a few weeks. The
                       consultant physician whom I see about this allergy is
                       considering prescribing immuno suppressant drugs,
                       which I asked him to withhold until I try inhaled insulin
                       which do not carry the allergenic preservatives.
                       Importing this drug from United States is expensive
                       and inconvenient, on a long term basis. I need this
                       drug not as a luxury or for convenience but to improve
                       quality of life and survival. I would therefore be
                       grateful, if you would make inhaled insulin available, to
                       those many patients with special problems and needs,
                       as soon as possible until a final decision is made by
                       the Appraisal group.

Patient 42   General   I have just read with great excitement about Exubera          The committee is now recommending inhaled insulin for people w
                       the insulin inhaler which is about to be launched in the      are unable to start insulin therapy or intensification of insulin thera
                       UK. I have suffered from Diabetes 2, and have already         because of severe problems with injection sites for example as a
                       tried a range of oral medications. I was diagnosed with       consequence of lipohypertrophy.
                       diabetes 2 approx two years ago.
                       Of course my consultant and GP doctor check my
                       blood ect about once every three months.
                       …my consultant is a very good and kind man and so is
                       his nurse. I cringe at the thought of insulin injections. I
                       was offered Glargine but the action of the insulin itself
                       nearly made me sick!
                       Have you any idea at all please, if and when the insulin
                       spray will be available in the UK.
                       I have been advised strongly to try the Glargine
                       injections and persevere with it if possible.
                       To make matters worse I am suffering a nervous
breakdown as a result of my husband’s recent death. I
get very panicky about needles. I hope you can re-
assure me.

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:27
posted:2/1/2012
language:English
pages:82