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 (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.