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									                                         Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses
                                                                             7 June – 5 July 2004

         Organisation              Section                                 Comments                                                           Response
 Addenbrooke's NHS              Section       The Scope indicates that ‘The guideline will offer best practice     We are not seeking to cover the management of complicating
 Trust                          4.1           advice on the care of people who have a clinical diagnosis of        factors in any detail. The primary focus of the remit and
                                              anaemia associated with chronic kidney disease’, and specifies       Scope is on anaemia management in CKD.
                                              which groups will and will not be covered. In several of the
                                              groups that the Scope does not intend to cover there will be
                                              patients where chronic kidney disease may be a contributory
                                              factor, but not the sole factor in causing anaemia. Examples
                                              would be patients with myeloma (haematological disease) or
                                              vascultiis (inflammatory disease), where there may be impaired
                                              renal function as a consequence of the primary disease. It
                                              would be helpful to clarify whether such patients would be
                                              included in the Scope.
 Addenbrooke's NHS              Section       It would be helpful to make this more explicit, so that guidelines   Thank you. The remit we have been given is to develop a
 Trust                          4.2           are prepared for the specific role of primary, secondary and         single guideline and not individual sector delivery.
                                              tertiary care.
 Addenbrooke's NHS              Section       The provision of guidelines on the management of nutritional         These issues will be covered but only as they relate to
 Trust                          4.3.c         status, dialysis adequacy and hyperparathyroidism is to be           anaemia management in CKD.
                                              welcomed, but these are major tasks, each of which could
                                              warrant a NICE guideline in its own right.
 Aintree Hospitals NHS                                                                                             This organisation was approached but did not respond.
 Trust
 Aksys Healthcare Ltd           4.3           We consider the following two factors as important additions         Thank you but this is a guideline and not a technology
                                Clinical      that must be included in this technology assessment. Whilst          assessment.
                                Managem       neither of the two factors serve as first line approaches in
                                ent           anaemia management, they have important influences on its
                                              management and clinical outcomes:
 Aksys Healthcare Ltd           4.3.c         DIALYSIS FREQUENCY                                                   Thank you, noted.
                                              Evidence will be submitted showing that more frequent dialysis
                                              leads to better removal of uraemic toxins, higher haematocrit
                                              and haemoglobin levels and a lowered need for Erythropoeitin
                                              Stimulating Agents (ESA).
 Aksys Healthcare Ltd           4.3.c         ULTRAPURE DIALYSATE                                                  Thank you, noted.
                                              Evidence will be submitted showing that ultrapure dialysate
                                              leads to reduced endotoxin levels that are associated with the
                                              inflammatory response and ESA resistance.
 Amgen UK Ltd                                 Amgen considers the draft Scope to be well considered, and           Thank you.
                                              wishes to make no comment.

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                                         Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses
                                                                             7 June – 5 July 2004
         Organisation              Section                                Comments                                                           Response


 Anaemia Nurse                   4.1.1        Population: There should be links with the Diabetes NSF with
 Specialist Association                       regard to the problem with Diabetes & anaemia. It would be          We will use the stages 1–5 in the guideline (but not in the
 (ANSA)                                       appropriate to develop guidelines that could overlap with these     scope) as a more accurate method of defining CKD.
                                              two disease areas.
                                               A clear definition is needed for CKD related to level of kidney
                                              function.
 Anaemia Nurse                  4.1.1         Transplantation should not be restricted to directly following      Thank you. When the transplant is failing this is
 Specialist Association                       surgery. It should include all patients who have a transplant as    encompassed under the category of pre dialysis.
 (ANSA)                                       they can become anaemic and require treatment, which is             We confirm that the Scope includes failing transplant.
                                              essential to prevent any cardiovascular complications. Clear        Those who have well functioning transplants may not have
                                              parameters regarding transplantation need to be agreed.             anaemia; hence we would not need to expand to encompass
                                                                                                                  the whole of the transplant period.
 Anaemia Nurse                  4.1.2         Groups’ not covered- haematological disease, Myeloma and            The Scope of the guideline pertains to anaemia caused by
 Specialist Association                       CKD are closely linked. Whilst the primary cause of anaemia is      CKD. Hence we are only seeking to exclude the treatment of
 (ANSA)                                       myeloma, there are patients with ESRD & myeloma who are on          malignancy where it is the primary cause of anaemia.
                                              dialysis.                                                           The guideline will only deal with the treatment of renal
                                              It is possible to carry out erythropoietin predication tests for    contribution to anaemia in myeloma.
                                              patients who have haematological disorders to see if they would
                                              respond to treatment and to check erythropoietin levels.
                                              Perhaps it would be appropriate to have a more in depth
                                              screening process for this type of patient.
 Anaemia Nurse                  4.1.2         Anaemia caused by acute/chronic inflammatory states requires        Re infections/chronic inflammation – we agree that dialysis
 Specialist Association                       clarification. It needs to be disease specific as many Vasculitis   patients are subject to infection. However, it is anaemia that
 (ANSA)                                       patients have renal disease.                                        is the focus of the guideline and hence it is the impact of
                                                                                                                  infection on anaemia. This will be included in the Scope when
                                                                                                                  considering management of, and factors, which have an
                                                                                                                  impact on anaemia in renal disease under section 4.3c.
 Anaemia Nurse                  4.1.2         Children should be included, as they will become the adults with    We accept that this is a valid point and hence the Scope and
 Specialist Association                       renal failure. There is a great deal of evidence to prove the       guideline will include children.
 (ANSA)                                       benefits of treating anaemia early and preventing cardiovascular
                                              complications. Children should not be denied access to
                                              treatment, which may happen if they are not included in the
                                              guidelines.
 Anaemia Nurse                  4.2           Healthcare setting is unclear as to how, where and by whom the      Thank -you. We need a firm evidence-base for healthcare
 Specialist Association                       care will given. In the UK the majority of renal units use the      setting issues. Published evidence that these factors are
 (ANSA)                                       expertise of nurses to run their anaemia management                 important can then be considered. It would be extremely
                                              programmes. This proves to be efficient and cost effective and      helpful if you could please submit any references directly
                                              beneficial to the patient. This role has been promoted nationally   pertaining to this that you would wish the developers to
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                                         Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses
                                                                             7 June – 5 July 2004
         Organisation              Section                                 Comments                                                             Response
                                              and internationally by the Anaemia Nurse Specialist Association       consider during the stakeholder evidence submission stage.
                                              and has resulted in nurses in Europe adopting a similar role.
                                              Prior to such posts anaemia management was fragmented and
                                              uncontrolled. To manage anaemia across primary, secondary &
                                              tertiary care will require close monitoring, but it must be clear
                                              who will be responsible and accountable for the patient’s
                                              treatment.
                                              Renal Nurses play a key role in the management of anaemia in
                                              patients with CKD and EKD and this should not be overlooked
                                              when deciding where and who should manage these patients
                                              across health care settings.
 Anaemia Nurse                  4.3           Diagnostic evaluation differs depending on which criteria are         Thank you. We agree.
 Specialist Association                       used, often dependent on the tests that the pathology labs are
 (ANSA)                                       capable of carrying out. A decision needs to be made as to
                                              which tests are most relevant, evidence based and available.
 Anaemia Nurse                  4.3           Target levels – should not say target levels but criteria for point   Thank you, we will delete ‘target’ and insert ‘threshold’.
 Specialist Association                       of referral, A target is an aim not a starting point.
 (ANSA)
 Anaemia Nurse                  4.3           Management factors – should they be the same for CKD and              Thank you, yes, they will be the same whether EKD means
 Specialist Association                       EKD.                                                                  early or established KD by you in this context.
 (ANSA)
 Anaemia Nurse                                Nutritional status – an agreed marker is needed here such as          We are referring to the use of conventional haematinics here
 Specialist Association                       albumin when considering haematinics.                                 (for example ferritin and B12). The context of ‘haematinics’ as
 (ANSA)                                                                                                             a term only is made reference to in Scope.
 Anaemia Nurse                  4.3           Dialysis adequacy should have recommendations regarding               Thank you but this is not a guideline about dialysis. It is
 Specialist Association                       water quality, dialysers, vascular access, time and frequency of      anaemia that is the focus of the guideline and hence it is the
 (ANSA)                                       treatment.                                                            impact of these on the anaemia. This will be included in the
                                                                                                                    Scope when considering management of, and factors, which
                                                                                                                    have an impact on anaemia in renal disease under section
                                                                                                                    4.3c.
 Anaemia Nurse                  4.3           Transplantation should be included here as some of the immuno         Thank you but this is not a guideline on transplantation.
 Specialist Association                       suppressant therapy can cause anaemia due to the effect of the
 (ANSA)                                       bone marrow.
 Anaemia Nurse                  4.3           Assessment & Optimisation of Hb etc. should make                      Thank you, the evidence-base will be considered here.
 Specialist Association                       recommendations for targets and upper/lower parameters of Hb
 (ANSA)                                       , iron status,
                                              Should discuss type of drug therapy recommended.
                                              There are current issues with use of iron dextran and is use has
                                              been questioned by the new European Best Practice Guidelines
National Institute for Clinical Excellence
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                                         Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses
                                                                             7 June – 5 July 2004
         Organisation              Section                                Comments                                                           Response
                                              for anaemia management.
 Anaemia Nurse                  4.3           Monitoring treatment should include management of non-               Thank you, the evidence-base will be considered here.
 Specialist Association                       response to treatment. Also should address who manages this
 (ANSA)                                       group of patients, how often and where.
 Anaemia Nurse                  4.3           Funding has not been included but it is an area of concern as        Funding generally lies outside of the remit.
 Specialist Association                       postcode prescribing does exist especially for patients not          We need a firm evidence-base for healthcare setting issues..
 (ANSA)                                       receiving dialysis and inequity of funding results in poor service   Published evidence that these factors are important can then
                                              provision and is detrimental to the patient. Patients who are        be considered. It would be extremely helpful if you could
                                              denied treatment are compromised and should not be put at risk       please submit any references directly pertaining to this that
                                              due to lack of resources and funding.                                you would wish the developers to consider during the
                                                                                                                   stakeholder evidence submission stage.

                                                                                                                   If there is indeed a published evidence-base relevant to these
                                                                                                                   factors we will be able to consider this.
 Anaemia Nurse                  General       Overall the document is very positive and addresses the key          We will strive to include the evidence base as far as we can
 Specialist Association                       issues. Concerns regarding evidence are such that several of         but there has to be an agreed date cut off point. The
 (ANSA)                                       the studies being carried out in patients with CKD and anaemia       published guideline will be reviewed at a 2-year period in
                                              will not have been completed when these guidelines are being         order to decide whether an update of the evidence is
                                              devised. Evidence from these studies could well have an              required.
                                              influence on future practice.
 Anaemia Nurse                  General       The renal registry may not be a true picture of anaemia              Thank you.
 Specialist Association                       management across the country as many units are not able to
 (ANSA)                                       submit data due to software incompatibility. Most units
                                              undertake regional audits and it may be pertinent to collect data
                                              from units which cannot submit to the registry by other means.
 Anglesey Local Health                                                                                             This organisation was approached but did not respond.
 Board
 Association of Renal           4.1.1 a)      The population should include patients with stages 1-V CKD as        Thank you we agree and will use the stages 1–5 in the
 Industries                     & title       defined in the KDOQI guidelines and adopted by the UK renal          guideline (but not in the Scope).
                                              community. This a more accurate method of defining CKD.
 Association of Renal           4.1.1b        Transplant patients should be considered CKD patients and            Thank you we agree and will use the stages 1–5 in the
 Industries                                   staged and managed appropriately not just directly after             guideline (but not in the Scope).
                                              transplant surgery.                                                  When the transplant is failing this is encompassed under the
                                                                                                                   category of pre dialysis.
                                                                                                                   We confirm that the Scope includes failing transplant.
                                                                                                                   Those who have well functioning transplants may not have
                                                                                                                   anaemia; hence we would not need to expand to encompass
                                                                                                                   the whole of the transplant period.
 Association of Renal           4.1.2         Chronic inflammatory disease could be caused by non                  Re infections/chronic inflammation – we agree that dialysis
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                                         Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses
                                                                             7 June – 5 July 2004
         Organisation              Section                                  Comments                                                              Response
 Industries                                   biocompatible dialysis solutions and membranes or the                   patients are subject to infection. However, it is anaemia that
                                              materials in which they are packed, catheters and infection.            is the focus of the guideline and hence it is the impact of
                                              Water quality and protein-energy malnutrition can also be               infection on anaemia. This will be included in the Scope when
                                              contributing factors inflammation.                                      considering management of, and factors, which have an
                                              It may not be appropriate to exclude all patients with                  impact on anaemia in renal disease under section 4.3c.
                                              haematological disease or malignancy if their primary cause of          The Scope of the guideline pertains to anaemia caused by
                                              anaemia is renal failure.                                               CKD. Hence we are only seeking to exclude the treatment of
                                                                                                                      malignancy where it is the primary cause of anaemia.
 Association of Renal           4.1.2b        Is the exclusion of children appropriate as this is a small but         We accept that this is a valid point and hence the Scope and
 Industries                                   important treatment group who would benefit from good                   guideline will include children.
                                              anaemia management.
 Association of Renal           4.3 a         In vitro diagnostics should include test which monitor nutritional      Thank you for your suggestion. We will consider the evidence
 Industries                                   status prealbumin, Vit B12, and folate. Markers of infection and        base.
                                              inflammation, CRP, cytokines such as TNFα, interleukin-6.
                                              Differential tests diagnosis of anaemia, ESR, & fibrinogen. Iron
                                              status, total iron binding capacity (TIBC) transferring and ferritin.
 Association of Renal           4.3 b         Account should be taken of normal ranges for different patient          Thank you.
 Industries                                   groups, male/female, young/old. A “one size fits all may not be
                                              appropriate. It may be more relevant to have targets which
                                              state that Hb levels should not fall below a certain level for a
                                              patient group which should help to minimise the consequences
                                              of chronic anaemia such as LVH etc. Preventing chronic
                                              anaemia in the CKD population is probably more effective than
                                              trying to build patients back up to a certain HB level.
 Association of Renal           4.3 c         Nutritional status should take account of both protein/energy           Thank you. This is not specific to anaemia management. This
 Industries                                   malnutrition and the use of phosphate binders. The type of              is considered to be part of the general management of CKD
                                              binder needs to be considered and the affect each has on the            not anaemia.
                                              patient. Particular note of the use of aluminium based binders
                                              and the potential effect on bone marrow and the development of
                                              microcytic anaemia needs to be taken and its use limited to the
                                              absolute minimum and carefully monitored.
 Association of Renal           4.3 c         hPTH the importance of the early intervention of dietary                Thank you. This is not specific to anaemia management. This
 Industries                                   management and the use of phosphate binders, vitamin D                  is considered to be part of the general management of CKD
                                              analogues and other interventions as they become available, to          not anaemia.
                                              reduce the risk of parathyroid hyperplasia at an early stage.
 Association of Renal           4.3 c         As well as dialysis adequacy the quality of dialysis should be          It is anaemia that is the focus of the guideline and hence it is
 Industries                                   considered, biocompatible membranes and solutions, strategies           the impact of infection on anaemia. This will be included in
                                              for minimising infection from access sites and water quality.           the Scope when considering management of, and factors,
                                                                                                                      which have an impact on anaemia in renal disease under
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                                         Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses
                                                                             7 June – 5 July 2004
         Organisation              Section                                Comments                                                            Response
                                                                                                                   section 4.3c.
 Association of Renal           3b            RRT patient numbers. Need to use data from the 2003 registry         When the Scope was written, recently published update
 Industries                                   data giving figures for 2002. Estimate for England and Wales         figures were not available. 2003 figures will have now been
                                              32,500 patients with 46% transplanted patients.                      used to update the Scope.
 Association of Renal           3d            Update information from the 2003 renal registry document.            Thank you – noted.
 Industries                                   Effective use of IV iron and EPO should be considered in stages
                                              1-1V.
 Association of Renal           Overall       The Scope is quite wide ranging and does go beyond the               Thank you.
 Industries                     comment       narrow remit of EPO therapy which is to be commended.
                                              However note does need to be taken of the confounding factors
                                              which may work against efficient and effective anaemia
                                              management.
 Association of the                                                                                                This organisation was approached but did not respond.
 British Pharmaceuticals
 Industry,(ABPI)
 Barking, Havering &                                                                                               This organisation was approached but did not respond.
 Redbridge NHS Trust
 Barts and The London                         This is a very important topic in renal medicine. Proper             The question about the selection of the topic lies outside the
 NHS Trust                                    management of anaemia and the introduction of erythropoeisis         consultation on the development of the Scope.
                                              stimulating agents (ESA) and intravenous iron therapy has            NICE are referred topics from the Department of Health via a
                                              revolutionised the quality of life of these patients.                topic selection process. Details of the process can be found
                                                                                                                   at
                                              However, I am interested as the why this topic has been              http://www.dh.gov.uk/Consultations/ClosedConsultations/Clo
                                              commissioned as there are already several generally accepted         sedConsultationsArticle/fs/en?CONTENT_ID=4016963&chk=
                                              detailed guidelines published on this subject. For the NICE          7lPThG
                                              guidelines to be helpful the Scope needs to be reviewed. It
                                              needs to consider the practicalities of administration and funding
                                              of such programs. The European and K/DOQI guidelines are             Service delivery models and funding are generally outside the
                                              clear in the targets that we should be aiming for, how best we       Scope of a NICE clinical guideline.
                                              achieve them, but do not look at the UK specific issues of
                                              delivery. For the perspective of a renal physician, the biggest
                                              issue is the funding and prescribing of ESA. Many units are
                                              faced with extremely complicated arrangements in order to
                                              ensure that patients are receiving the appropriate products at
                                              the right doses in a timely fashion. This is because we are
                                              having to negotiate with primary care continuously. This leads to
                                              both clinical and staff inefficiencies. The end result is patients
                                              suffering.
                                              This Scope should therefore also examine the most efficient
National Institute for Clinical Excellence
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                                          Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses
                                                                              7 June – 5 July 2004
         Organisation              Section                                  Comments                                                              Response
                                               way to run and fund a anaemia program.
 Bedfordshire &                                                                                                        This organisation was approached but did not respond.
 Hertfordshire NHS
 Strategic Health
 Authority
 Birmingham Heartlands          General        The term established renal failure (used interchangably with end        Thank you. This will be reflected within the staging terms that
 & Solihull NHS Trust                          stage renal failure) is confusing. The term established renal           we will use.
                                               failure doesn't define the degree of renal failure and there is
                                               considerable potential for readers to confuse this with the term        We will use the stages 1–5 in the guideline (but not in the
                                               chronic kidney disease (CKD). End stage renal failure does              Scope).
                                               define the degree of renal failure clearly and should be the
                                               preferred term.
 Birmingham Heartlands          4.1.1          Patients with a failing renal transplant are a particular sub group     We confirm that we include patients with poorly functioning
 & Solihull NHS Trust                          of CKD (pre-dialysis) who may have significant anaemia. For             transplants within 4.1.1. of the Scope and that they will be
                                               completeness it would be helpful in the Scope to acknowledge            included in the guideline.
                                               this sub group which represents an overlap between CKD, pre-
                                               dialysis and renal replacement therapy (transplant).
 Birmingham Heartlands          4.3 c)         The guideline should include recommendations about the type             Thank you.
 & Solihull NHS Trust                          of vascular access to be used in haemodialysis patients. This
                                               should be a native AV fistula whenever possible. Temporary
                                               vascular access use (i.e. catheters) is associated with a lower
                                               haemoglobin concentration, probably due to the fact that
                                               dialysis adequacy is worse and infection rates, and hence
                                               erythropoetin resistance, are greater with catheters.
                                               [References: Patient characteristics associated with hemoglobin
                                               concentrations: the DOPPS. Pisoni RL, Prutz KG, Canaud B et
                                               al. J Am Soc Nephrol 2003; 14: 265A.
                                               Erythropoietin therapy and associated haemodialysis patient
                                               characteristics: DOPPS results. Pisoni RL, Young EW Gillespe
                                               BW et al. J Am Soc Nephrol 2003; 14: 267A.]
 Birmingham Heartlands          4.3 c)         The optimal management of anaemia in CKD should minimise                Thank you. This is already covered by the Scope.
 & Solihull NHS Trust                          the use of blood transfusion. The importance of this cannot be
                                               over emphasised given the restricted supply of blood products,
                                               their expense and the amount of blood products administered in
                                               renal units. It would be helpful to include in the Scope -
                                               guidelines on best practice in relation to blood transfusion in this
                                               patient group.
                                                                                                                  th
 British Association for        4.1.2 b        Following on from the Stakeholder meeting held on Monday 28             We accept that this is a valid point and hence the Scope and
 Paediatric Nephrology                         June, we wish to reiterate our view that under 16 year olds             guideline will include children.
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                                         Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses
                                                                             7 June – 5 July 2004
         Organisation              Section                                  Comments                                                             Response
 And                                          should be included within the Scope of this guideline.
 Royal College of                                  1. The remit from the Department of Health was to
 Paediatrics & Child                                   “develop a guideline ………… for ………. people with
 Health                                                poor renal function.” It is therefore discriminatory
                                                       against children to exclude them simply on account of
                                                       their age.
                                                   2. The underlying causes and the underlying principles for
                                                       the treatment of renal anaemia in children are
                                                       essentially the same as they are in adults. It is
                                                       therefore logical to include children within the remit of
                                                       the guidelines.
                                                   3. We understand that there is a concern that there would
                                                       be inadequate resources to cope with the additional
                                                       work required to include children within the guidelines.
                                                       In comparison to the adult literature on erythropoietin
                                                       there is only a very small body of evidence specifically
                                                       relating to children. It is therefore unlikely that this will
                                                       make a material difference to the amount of evidence
                                                       that needs reviewing. There would however be a need
                                                       for considering the children separately because of the
                                                       differences in target haemoglobin levels and drug
                                                       dosing.
                                                   4. There are in the United Kingdom some 800 children
                                                       with end stage renal failure and a considerably greater
                                                       number of children with chronic renal failure (pre-
                                                       dialysis). These guidelines will therefore potentially
                                                       benefit a large number of children and young people.
                                              We are concerned for the plight of children with chronic,
                                              uncommon diseases. These children tend to be excluded from
                                              chronic disease initiatives (e.g. National Service Frameworks,
                                              Clinical Guidelines) but also excluded from Paediatric initiatives
                                              because they are a small group of children in comparison to
                                              those with common childhood disorders. The anaemia
                                              guidelines are a great opportunity to ensure that children and
                                              young people receive the same high quality management as
                                              their adult counterparts.
 British Association for        4.1.2 b)      The BAPN wishes the guideline to include children & young                We accept that this is a valid point and hence the Scope and
 Paediatric Nephrology                        people under 16 yrs. Reasons for inclusion:                              guideline will include children.
                                              1. Under 16’s with CKD fulfil the inclusion criteria in section

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                                         Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses
                                                                             7 June – 5 July 2004
         Organisation              Section                                 Comments                                                             Response
                                                  4.1.1
                                              2. The anaemia in under 16s due to CKD has essentially the
                                                  same causation and impact as in adults
                                              3. Under 16s are included in the renal NSF.
                                              4. Under 16s with CKD will be disadvantaged in comparison to
                                                  adults if not included.
                                              5. Whilst the evidence base for management is not as well
                                                  documented for children, this is in itself a strong reason for
                                                  developing a guideline.
 British Dietetic               General       When does a patient become predialysis. As there is a shift of         Thank you we agree and will use the stages 1–5 in the
 Association                                  emphasis from hospital Nephrology (in centre) to community /           guideline (but not in the Scope).
                                              primary care Nephrology (out of centre) what about the many
                                              patients that are classed as General Nephrology being
                                              managed in the primary care that are anaemic and may benefit
                                              from therapy.
 British Dietetic                             People directly after transplant – suggest this may need to be         Thank you. When the transplant is failing this is
 Association                                  expanded to encompass the whole of the transplant period               encompassed under the category of pre dialysis.
                                              particularly failing transplant.                                       We confirm that the Scope includes failing transplant.
                                                                                                                     Those who have well functioning transplants may not have
                                                                                                                     anaemia; hence we would not need to expand to encompass
                                                                                                                     the whole of the transplant period.
 British Dietetic                             More consideration needed about whether to include paediatrics         We accept that this is a valid point and hence the Scope and
 Association                                  or not. As far as I am aware paediatrics tend to remain in             guideline will include children. This has been changed in the
                                              paediatrics up until 18yrs or full time secondary education.           Scope.
 British Dietetic                             Address the aspect of patient education. It won’t matter what          Patient education is a generic issue across all guidelines. We
 Association                                  gold standard of therapy you come up with if patients are not          will look specifically for literature pertaining to anaemia in
                                              educated appropriately then the effectiveness of the treatment is      CKD for example self-management / management plans.
                                              lost.
 British Dietetic                             ? Address compliance issues.                                           This is a generic issue across all guidelines. It has been
 Association                                                                                                         recognised that this needs to be addressed in a separate
                                                                                                                     guideline dedicated to concordance issues.
 British Dietetic                             ? Look at measurements of improved therapy on QOL issues for           QoL outcome measures will be addressed in the evidence
 Association                                  patients.                                                              base.
 British Dietetic               Comments      Whole heartedly agree that nutritional status of an individual will    Thank you.
 Association                    on            have an impact on anaemia but evidence will be limited.
                                Nutrition

 British Dietetic                             Nutritional status affects anaemia but this is also true if reversed   Thank you, noted.
 Association                                  i.e. anaemia will affect nutritional status.
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                                         Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses
                                                                             7 June – 5 July 2004
         Organisation              Section                                 Comments                                                             Response
 British Dietetic                              Limited evidence about the micronutrient nutritional status of our   Thank you. There is limited evidence on micronutrient
 Association                                   patients most evidence concentrates on macro nutrients –             nutritional status (e.g. carnatine). We will be led by the
                                               protein / calorie.                                                   evidence base.
 British Dietetic                              Limited evidence generally.                                          Thank you.
 Association
 British Dietetic                              Not sure whether by increasing the iron, B12 and folate content      Thank you, noted.
 Association                                   of the diet will improve serum levels and ultimately anaemia
                                               management.
 British Dietetic                              Also not sure whether by improving general nutritional status        Thank you, noted.
 Association                                   this will impact on anaemia management, similarly whether
                                               improving anaemia management results in an improvement in
                                               anaemia.
 British Geriatrics             4.1            Whilst there has been no specific exclusion of older people with     Thank you. We are not excluding the elderly.
 Society                        Population     chronic kidney disease (CKD) it should be noted and possibly
                                               mentioned in the Scope that older people should be included.
                                4.11           CKD is a disease of older people increasing from 1,900 people
                                Groups         per million age 50-59 years to 17,000 people per million age 70-
                                that will be   79 years. Most of these older patients are at stages 3 and 4
                                covered        CKD and are not on dialysis.
 British Geriatrics             4.2            It is worth noting that many patients with CKD are under the         Thank you. This is already covered by the Scope in section
 Society                        Healthcare     care of secondary care physicians who are not renal physicians.      4.2.
                                setting        The care of patients with anaemia caused by CKD under other
                                               hospital teams should not be included.
 British Geriatrics             4.3            4.3a Detection and diagnosis of anaemia in CKD- CKD in older         We agree.
 Society                        Clinical       people has been missed on many occasions due to the use of
                                managem        serum creatinine as a marker of glomerular filtration rate (GFR).
                                ent            This will be improved with the use of calculated clearances such
                                               as the MDRD and the Cockcroft and Gault equation. The Scope
                                               should take this into account.
 British National                                                                                                   This organisation was approached but did not respond.
 Formulary (BNF)
 British Psychological                                                                                              This organisation was approached but did not respond.
 Society, The
 British Renal                                                                                                      This organisation was approached but did not respond.
 Association, The
 British Renal Society          General        Excellent document : focussed , deliverable, clear and hopefully     Thank you.
                                               will complement Renal NSF.
 British Renal Society          Section 3      There is clear agreement by clinicians on “optimal management        Thank you.
                                d              renal anaemia. The variations in different regions is rather due
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                                         Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses
                                                                             7 June – 5 July 2004
         Organisation              Section                                Comments                                                           Response
                                              to differences in funding and commissioning arrangements.
 British Renal Society                        We welcome an evidence based guideline, however we hope             Thank you.
                                              that UK experience will be looked at even if the publications of
                                              single centres are not from large RCTs provided such
                                              experience is multidisciplinary. We hope to supply a list of some
                                              of the abstracts on anaemia management presented in the past
                                              at our symposia.
 British Renal Society          Section       Predialysis CKD hopefully does not only refer to advanced CKD       We will use the stages 1–5 in the guideline (but not in the
                                4.1.1         (GFR <20), one particular group of patients of concern are          Scope).
                                              diabetics who may develop anaemia requiring treatment at
                                              earlier stages of CKD.
 British Renal Society          Section       I would concur with the exclusion criteria .The evidence for        Thank you.
                                4.1.2         most of the conditions excluded is patchy , otherwise the
                                              guideline will be full of Class C evidence, however we would
                                              hope that at the time of guideline review in the future
                                              consideration would be given to these groups depending on
                                              evidence available.
 British Renal Society          Section       The guideline should include when treatment will be withdrawn       Thank you the evidence base will be considered
                                4.3 c         in refractory/resistant anaemia when there is lack of response to
                                              erythropoiesis stimulating agents.
 CHI                                                                                                              This organisation was approached but did not respond.
 Cochrane Renal Group,                                                                                            This organisation was approached but did not respond.
 NHMRC Centre for
 Clinical Research
 Excellence, University
 of Sydney, Australia
 and Dept of Emergency
 & Organ
 Transplantation,
 University of Bari, Italy
 Conwy and                                                                                                        This organisation was approached but did not respond.
 Denbighshire NHS
 Trust
 Countess of Chester                                                                                              This organisation was approached but did not respond.
 Hospital NHS
 Foundation Trust
 Department of Health                         The Department of Health has no comments on the draft Scope         Thank you.
                                              of the anaemia management in chronic kidney disease
                                              appraisal.
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                                          Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses
                                                                              7 June – 5 July 2004
         Organisation              Section                                 Comments                                                         Response
 Department of Health -                                                                                           This organisation was approached but did not respond.
 Publication of the
 National Service
 Framework for Renal
 Services, Part One:
 Dialysis and
 Transplantation
 (Gateway reference
 1611)
 Diabetes UK                    General        Diabetes is the most common cause of kidney failure in the         People with diabetes are included within the evidence base
                                and            westernised world affecting as many as 40% of patients on          (and hence this is not excluded when searching the
                                4.1.1          dialysis. In the UK this figure is estimated at 15% of dialysis    literature). However, people with diabetes will not be
                                               patients also having diabetes. However, it is also accepted that   considered as a separate subgroup as this is outside of the
                                               the prevalence of diabetes is notably undiagnosed in patients      Scope.
                                               with kidney failure.
                                               Because of this, we strongly feel that people with diabetes
                                               should be considered as a separate subgroup within this
                                               guidance.
 Diabetes UK                    4.3.c          Erythropoietin deficiency is probably more common in patients      People with diabetes are included within the evidence base
                                               with diabetes, although the precise reason for this is unclear.    (and hence this is not excluded when searching the
                                               This again raises the need for a separate subgroup within this     literature). However, people with diabetes will not be
                                               guidance for people with diabetes.                                 considered as a separate subgroup as this is outside of the
                                                                                                                  Scope.
 East Kent Hospitals                                                                                              This organisation was approached but did not respond.
 NHS Trust
 Genzyme Products Ltd           4.1.1 a)       The population should specify that the guidelines will include     Thank you we agree and will use the stages 1–5 in the
                                               patients with Chronic Kidney Failure Stages 1-5 and specific       guideline (but not in the Scope).
                                               criteria for determining these stages 1-5 CKD (according to UK
                                               practice guidelines, European Best Practice Guidelines, and
                                               Kidney Disease Outcomes Quality Initiative/KDOQI).
 Genzyme Products Ltd           4.3. a)        The Scope recommends that anaemia due to haematological            Thank you. Regarding the last sentence – this will be covered
                                               malignancy, acute and chronic inflammatory disorders and HIV       in guideline but it is premature to include detail here.
                                               should not be covered. The problem is that the cause of
                                               anaemia in ESRD due to these conditions will be difficult to
                                               distinguish from anaemia due to the anaemia caused by these
                                               conditions themselves. The clinical question raised is the
                                               process of distinguishing between the causes of anaemia in
                                               ESRD – how will the guideline propose to diagnose causes of
                                               anaemia in ESRD?
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                                          Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses
                                                                              7 June – 5 July 2004
         Organisation              Section                                 Comments                                                           Response
 Genzyme Products Ltd           4.3.           A separate section on factors related to resistance to anaemia      Thank you, this is addressed in maintaining threshold levels
                                General        therapy should be added as this can be quite complex.               under section 4.3.b of the Scope.
 Genzyme Products Ltd           4.3.           Clarification on measuring certain outcomes in anaemia, i.e.,       The evidence base will be considered.
                                General        evidence on mortality, morbidity and quality of life (also likely
                                               included).
 Genzyme Products Ltd           4.3. c)        The guideline should address the clinical question raised           Thank you, noted.
                                               regarding management of factors which have an impact on
                                               anaemia in renal disease as relates to bone and mineral
                                               metabolism. These include treatment of factors such as
                                               hyperparathyroidism and hyperphosphatemia in which the
                                               choice of treatment can impact the severity of anaemia and the
                                               resistance or success of anaemia treatment such as
                                               erythropoietin and Vitamin D efficacy. Phosphate binders such
                                               as aluminium-based binders and related toxicity have been
                                               shown to have an impact on bone marrow health, erythropoietin
                                               efficacy, and progression of anaemia. Control of
                                               hyperparathyroidism with different binders is likely to have
                                               different impacts on anaemia levels.
 Genzyme Products Ltd           4.3. c)        The terminology on ‘optimization of hemoglobin’ and ‘targets’       Thank you. Please see Scope for amended text 4.3.c. The
                                               should be clarified as a more accurate description would be         word ‘target’ will be deleted and amended to ‘threshold’.
                                               ‘improvement and maintenance of haemoglobin within a defined
                                               range’.
 Genzyme Products Ltd           4.3. c)        Inflammation as a factor related to the management of anaemia       Thank you, noted.
                                               should be addressed, as relates to levels of C-reactive protein
                                               (CRP), a marker of inflammation. The presence of inflammation
                                               has been associated with increased resistance to erythropoietin
                                               treatment; therefore reducing the levels of inflammation would
                                               be favourable for the management of anaemia. Management of
                                               hyperohosphatemia with different binders is likely to have
                                               different impacts on inflammation and anaemia.
 Gloucestershire                                                                                                   This organisation was approached but did not respond.
 Hospitals NHS Trust
 Guys & St Thomas               4.1.1          The use of the term pre-dialysis CKD should not restrict the        Yes, we agree with your comment. We will consider them if
 NHS Trust                                     guideline to those patients known to renal services and being       the anaemia is due to CKD.
                                               considered/prepared for dialysis. The guideline should cover all
                                               patients with CKD irrespective of the stage of CKD, and whether
                                               or not they are under renal or other services (diabetic clinic,
                                               primary care).
 Guys & St Thomas               4.1.1          Patients soon after transplant and those with longer standing       Thank you. When the transplant is failing this is
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                                           Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses
                                                                               7 June – 5 July 2004
         Organisation              Section                                  Comments                                                          Response
 NHS Trust                                      patients with impaired graft function and anaemia should be          encompassed under the category of pre dialysis.
                                                considered separately.                                               We confirm that the Scope includes failing transplant.
                                                                                                                     Those who have well functioning transplants may not have
                                                                                                                     anaemia; hence we would not need to expand to encompass
                                                                                                                     the whole of the transplant period.
 Guys & St Thomas               4.1.2 a)        This should be worded as to avoid interpretation that pts with       Thank you, noted.
 NHS Trust                                      CKD causing anaemia who have one of these co-morbid states           The guideline specifically deals with anaemia caused by
                                                should be treated in a different fashion.                            chronic kidney disease. Patients with these co-morbidies
                                                Patients with co-morbid conditions contributing to both anaemia      have other causes of anaemia and are therefore being
                                                and renal failure should not be covered by these exclusions.         excluded.
 Guys & St Thomas               4.3 b)          This might be more accurately an Hb range in which treatment         Thank you – noted.
 NHS Trust                                      for anaemia should be commenced, and a level below which Hb
                                                should not be allowed to fall. Careful consideration needs to be
                                                given as to whether minimal acceptable levels or desirable
                                                targets are stated, and whether these targets apply to individual
                                                patients or to cohorts.
 Guys & St Thomas               4.3 b)          It should be considered whether an overall target range for Hb       Thank you.
 NHS Trust                                      level should be given, or whether different target ranges are
                                                desirable in different conditions (heart disease, diabetes, young
                                                patients).
 Guys & St Thomas               4.3.c)          Recommendations on iron use should include recommendations           Thank you – we will consider the evidence base.
 NHS Trust                                      that the best measures of iron stores and iron availability be
                                                readily available.
 Guys & St Thomas               4.3 c)          An indication as to the use of blood transfusions should be          Thank you. This is already covered by the Scope.
 NHS Trust                                      considered, as there is likely to be greater restrictions on blood
                                                stocks in the next few years and tighter controls on blood
                                                transfusions generally. It should be made clear that blood
                                                transfusions are not to be used to maintain Hb in target range.
 Guys & St Thomas               4.3 c)          It may be desirable to give guidance on those patients who           Thank you – the evidence base will be considered.
 NHS Trust                                      exhibit resistance to treatment, in terms of their identification,
                                                investigation and management.
 Hammersmith Hospitals               4.3        The guideline should be as explicit as possible about the actions    Yes, we agree and acknowledge this.
 NHS Trust                                      that needs to be undertaken to optimise anaemia, prior to
                                                instituting EPO therapy. (Not just Ix required).
 Hammersmith Hospitals               4.3        What maintenance targets of Hb should be aimed at and how            Thank you – noted.
 NHS Trust                                      specific co-morbidities may influence that target.
 Hammersmith Hospitals               4.3        Defining which conditions/patients should be excluded from           Thank you, the evidence-base will be considered here.
 NHS Trust                                      requirement to reach anaemia targets (ie those in whom this
                                                would result in significant iron overload).
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                                           Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses
                                                                               7 June – 5 July 2004
         Organisation              Section                                   Comments                                                           Response
 Hammersmith Hospitals               4.3        Comments on type and route of therapy.                                Thank you – noted.
 NHS Trust
 Hammersmith Hospitals               4.3        Guidelines on the assessment of complications of EPO therapy          Thank you – noted.
 NHS Trust                                      – recommendations for BP monitoring.
 Hammersmith Hospitals               4.3        Management of poor responders.                                        Thank you – the evidence base will be considered.
 NHS Trust
 Hammersmith Hospitals               4.3        Actions to be taken if Hb overshoots desired target range Hb.         Thank you. This will be considered.
 NHS Trust
 International Myeloma                                                                                                This organisation was approached but did not respond.
 Foundation (UK)
 Kidney Alliance, The                                                                                                 This organisation was approached but did not respond.
 King's College Hospital                                                                                              This organisation was approached but did not respond.
 NHS Trust
 Long Term Medical                                                                                                    This organisation was approached but did not respond.
 Conditions Alliance
 Media Innovations              General         1. Existing Guidelines for Renal Anaemia:                             Thank you – noted.
 Limited                        comments        National and international guidelines (Renal Association,
                                :               European Renal Association, Dialysis Outcomes Quality
                                                Initiative (DOQI), and other national bodies) are available for the
                                                management of renal anaemia covering much of the population
                                                suggested in the NICE scoping document.
                                                1.1 These have typically been through several versions already.
                                                1.2 They concentrate in particular on the ‘targets’ for
                                                haemoglobin (and iron) to be achieved in individual patients.
                                                1.3 They have reviewed the extensive literature on the use of
                                                Epoetins and Iron therapy, as well as contingent clinical factors
                                                as outlined in the NICE scoping document.
                                                1.4 They too attempt to provide ‘recommendations for good
                                                practice that are based on the best available evidence of clinical
                                                (but not cost) effectiveness’ [2a].
                                                1.5 Despite these efforts, clinical studies (ESAM, DOPPS) and
                                                Registry data show systematic underachievement in managed
                                                renal anaemia in Europe and there is ‘wide variation in practice’.
 Media Innovations                              2. Aspirations for Guidelines:                                        Thank you, noted.
 Limited                                        Whether or not there is ‘lack of agreement on the optimal
                                                management’ rather depends on the definition of ‘optimal’, but
                                                certainly processes are varied and depend on a range of
                                                principles of staffing and clinical methods [2d].
                                                2.1 Whether ‘an evidence based guideline would improve the
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                                         Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses
                                                                             7 June – 5 July 2004
         Organisation              Section                                 Comments                                                      Response
                                              standards of care across renal units’ remains to be seen, since
                                              that has not occurred necessarily as a consequence of the
                                              existing work.
                                              2.2 There has been an annual improvement in both pre-dialysis
                                              and dialysis related Haemoglobin outcomes as documented by
                                              the UK Renal Registry (UKRR) that probably represents an
                                              intuitive effect of improving clinical practice on the part of renal
                                              units generally.
                                              2.3 Unfortunately, great and sophisticated effort, however
                                              transparent, is no guarantee that any subsequent guideline will
                                              be effective in improving clinical outcomes and costs.
                                              2.4a By contrast, a guideline statement is likely to beneficially
                                              influence ‘appropriate commissioning of cost-effective
                                              treatments’ in this area, in part because it is apparent that lack
                                              of investment in Epoetin has occurred regionally in England,
                                              with consequences for Haemoglobin outcomes. The extent and
                                              specificity of the relation between funding and performance
                                              have not been clearly described, the UKRR finding it hard to
                                              compile Epoetin doses, in particular, from clinical databases.
                                              2.4b It is worth emphasising that the cost-effectiveness of
                                              Epoetin is especially dependent on the pricing of the agents,
                                              with recent competition creating discounts of up to 50% in some
                                              areas. Improvements in clinical practice are unlikely to
                                              challenge that scale of cost reduction.
 Media Innovations                            3. Characteristics of current guidelines:                              Thank you, noted.
 Limited                                      Existing guidelines are imperfect. They often incorporate an
                                              element of yardstick or clinical performance measure, without
                                              acknowledging that is the case (for example, in the past, 85%
                                              compliance with a guideline statement as a criterion of
                                              performance).
                                              3.1 Alternatively, in recent versions, they appear to abrogate
                                              the responsibility for any yardstick whatsoever.
                                              3.2 Even more mischievously, they tend to create ‘pseudo-
                                              algorithms’ for management from the literature of clinical
                                              efficacy, typically untested in general populations for practical
                                              effect. This is demonstrably misleading in the case of European
                                              guidelines for the control of high Se Ferritin levels, for example.
                                              3.4 Lastly, despite the fact that unit performance must be
                                              represented by summary statistics, the guideline documents

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                                         Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses
                                                                             7 June – 5 July 2004
         Organisation              Section                                Comments                                                     Response
                                              rehearse individual patient management exhaustively but give
                                              little or no guidance on how to manage a patient population to
                                              achieve desirable outcomes overall.
                                              3.5 Little work has been done in this area, general distributions
                                              being simply compiled from the sum of individual clinical
                                              encounters.
 Media Innovations                             4. Necessary features of anaemia outcomes:
 Limited                                      As indicated in UKRR Reports (www.renalreg.com), the
                                              currently achievable haemoglobin and iron outcomes to give
                                              any desired unit profile can be precisely known (Rose-Day
                                              plots).
                                              4.1 The clinical technology to allow their definition on a
                                              predictable and consistent basis is not practised except in a few
                                              northern UK renal units.
                                              4.2 The evidence that this is feasible has been ignored by
                                              recent European guideline authors.
                                               4.3 This may have been in part because literature search
                                              techniques are incomplete for the supporting experimental
                                              papers. This is reflected in their absence in the Cochrane renal
                                              database and will be repeated unless especial care is taken in
                                              the NICE searches for supporting evidence.
                                              4.4 There is also a strong undercurrent of cultural antipathy for
                                              the management of patient sets or groups for optimal
                                              management, rather than individuals, even though this may be
                                              beneficial overall.
                                              Part of this in Europe and the US can be related to the financing
                                              of medical care in different Health Care Systems.
 Media Innovations                            5. The necessary Guideline:                                          Thank you, noted.
 Limited                                      The issue then resolves into the need for a guideline that does
                                              not simply repeat the aspirational ‘target’ values for individuals
                                              that are unachievable, except systematically, at unit level, but
                                              goes some way to explain how predictable, consistent and cost
                                              effective results may be brought about through appropriate
                                              clinical processes.
                                              5.1 The ‘optimal’ clinical outcomes from any given spend on
                                              Epoetin and Iron are unlikely to be achieved from unsystematic,
                                              piecemeal clinical management.
                                              5.2 An effective system also has clinical benefit, since any
                                              anaemic patients stand out from the adequately managed
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                                         Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses
                                                                             7 June – 5 July 2004
         Organisation              Section                                 Comments                                                            Response
                                              population as ‘non-responders’ and are revealed as in need of
                                              clinical attention.
                                              5.3 In addition, the facilitation of recurrent audit of anaemia
                                              management is an important part of clinical and cost-
                                              effectiveness.
 Media Innovations                            6. The advantage of the NICE:                                          Thank you, noted.
 Limited                                      It is easier to frame an ideal guideline than produce it, of course,
                                              but there are possibilities that have not been considered by
                                              previous authors in this area that fit well with the NICE remit.
                                              6.1 The focus of the NICE on the clinical technologies required
                                              to manage patient sets coincides with available, mature work in
                                              renal anaemia on the benefit of managing renal unit cohorts to
                                              achieve predictable haemoglobin and iron outcomes at the
                                              individual level.
                                              6.2 By these means a platform of unit achievement can be
                                              reliably achieved, with individual modulation if believed
                                              necessary.
                                              6.3 Further evidence will be presented to demonstrate these
                                              assertions in the later part of this exercise by the Media
                                              Innovations Group of the University of Leeds.
 Media Innovations                            Specific Comments by section:                                          PRCA – This will be considered when addressing EPO and
 Limited                        4.1            Population                                                            route of administration.
                                4.1.2         These categories presumably exclude Primary Red Cell Aplasia
                                              (PRCA-EPO), the consequence of developing neutralising                 Re infections/chronic inflammation – we agree that dialysis
                                              antibodies to epoetins.                                                patients are subject to infection. However, it is anaemia that
                                              Dialysis patients are subject to frequent infections and any           is the focus of the guideline and hence it is the impact of
                                              management system will need to address/make provision for              infection on anaemia. This will be included in the Scope when
                                              the response to acute infection/inflammation in that setting.          considering management of, and factors, which have an
                                              Haemodialysis patients, in particular, are considered by many to       impact on anaemia in renal disease under section 4.3c.
                                              express a chronic inflammation as a background to their illness,
                                              modified perhaps by the conditions of dialysis, so that some
                                              inflammatory component will need to be addressed, if not
                                              Primary inflammatory diseases.
 Media Innovations              4.2            Healthcare setting                                                    Thank you. We need a firm evidence-base for healthcare
 Limited                                      The NHS care of chronic illness is in a state of flux and is likely    setting issues. Published evidence that these factors are
                                              to change over the next few years. It will be important to keep        important can then be considered. It would be extremely
                                              open the potential for commentary on management in all three           helpful if you could please submit any references directly
                                              settings, including by nurses and nurse practitioners/’anaemia         pertaining to this that you would wish the developers to
                                              co-ordinators’.                                                        consider during the stakeholder evidence submission stage.
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                                         Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses
                                                                             7 June – 5 July 2004
         Organisation              Section                                Comments                                                           Response
                                              The home delivery of epoetin by the companies or their              If there is indeed a published evidence-base relevant to these
                                              associates and the effect on VAT charges of different               factors we will be able to consider this. Health Economic cost
                                              prescribing mechanisms will also need to be considered.             effective evidence will also be taken into account.
 Media Innovations              4.3           Clinical management                                                 Thank you
 Limited                                      [a] Guidance on the investigation of potential blood loss would          a. This is outside of the remit and Scope.
                                              be of interest since haemodialysis patients often show evidence
                                              of persistent minor bowel losses that can be misconstrued as
                                              requiring expensive imaging for diagnosis.

                                              [b] The use of ‘target’ here appears to be an error, since              b. Yes we agree, this has been amended.
                                              threshold would be more apposite. There has been much
                                              confusion in clinical intervention in the terminology of aims,
                                              goals and targets that have been clarified in the field of renal
                                              anaemia, at least. This has been shown to have an important
                                              bearing on the principles of management.

                                              [c] Mention should be made of the dialytic features that                c.   It is anaemia that is the focus of the guideline and
                                              influence renal anaemia as well as dialysis adequacy, which                  hence it is the impact of these on the anaemia. This
                                              would include water treatment, chloramines, dialysis frequency               will be included in the Scope when considering
                                              and, possibly, dialyser type.                                                management of, and factors, which have an impact
                                                                                                                           on anaemia in renal disease under section 4.3c.
                                              The meaning of the ‘optimisation of haemoglobin (and iron
                                              stores)’ will need to be considered precisely; for individuals or
                                              unit cohorts, over time, variability etc.? What exactly would be
                                              ‘optimised’?
                                                                                                                      d. Opportunity costs – we need a firm evidence-base for
                                              The opportunity costs of clinical time and effort should also be            this to be considered. Published evidence that these
                                              considered since this is demonstrable, sometimes expressed in               factors are important can then be considered. It
                                              the employment of a separate nurse/pharmacist co-ordinator.                 would be extremely helpful if you could please submit
                                              This has also been prompted by the need to undertake                        any references directly pertaining to this that you
                                              administrative functions in order to run the epoetin contract or            would wish the developers to consider during the
                                              undertake the multiple liaisons required to make ‘shared care’              stakeholder evidence submission stage. A health
                                              effective in a locality.                                                    economist will guide us.
 Medicines and                                                                                                    This organisation was approached but did not respond.
 Healthcare Products
 Regulatory Agency
 (MHRA)
 Mid Essex Hospitals            4.1.2a        Clarification is required on anaemia as a result of chronic/acute   Re infections/chronic inflammation – we agree that dialysis
 NHS Trust                                    inflammatory disease states – we presume pts on RRT who             patients are subject to infection. However, it is anaemia that
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                                         Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses
                                                                             7 June – 5 July 2004
         Organisation              Section                                 Comments                                                             Response
                                              have episodes of sepsis will be covered from their diagnosis of         is the focus of the guideline and hence it is the impact of
                                              CKD and not excluded because of their inflammatory state. In            infection on anaemia. This will be included in the Scope when
                                              addition, if a CKD who doesn’t have anaemia per se but suffers          considering management of, and factors, which have an
                                              it as a result of sepsis – will they be covered?                        impact on anaemia in renal disease under section 4.3c.
 Mid Essex Hospitals            4.1.2b        We believe that children should be included in the Scope as             We accept that this is a valid point and hence the Scope and
 NHS Trust                                    they are treated with the same drugs in the same way and                guideline will include children.
                                              progress on to adults with CKD. The long-term effects of
                                              anaemia are well documented and guidelines are needed to
                                              treat the children effectively in order that they don’t become
                                              adults with CKD with significant LVH which could have been
                                              prevented by effective, consistent treatment guidelines.
 National Kidney                Section 2b    You use the phrase – “ Where a Framework has been                       Thank you – we will use the stages 1–5 in the guideline (but
 Federation (NFK)                             published”. The Renal NSF has only been part published – part           not in the Scope).
                                              two is still awaited. It is essential that guidelines encompass the
                                              advice expected in Part two of the NSF. Part two will deal with
                                              early detection and prevention of renal disease and that means
                                              that the vast majority of patients will be contained in the part two
                                              area. If part two of the NSF is not published in time for the
                                              guidelines then it is vital that the guidelines cover potential renal
                                              patients not yet receiving renal replacement therapy, either pre
                                              dialysis or earlier. The advancement of renal disease is now
                                              classified in groups from one to five. The guidelines must cover
                                              all five categories whether they are in the care of GP’s or renal
                                              units.
 National Kidney                Section 3b    Please check again the figure 45,000 as the national Kidney             The figures quoted were obtained from the NSF. This is part
 Federation (NFK)                             Federation is expecting the current ( 2004 ) numbers of ESRF            of the background of the Scope and not part of the evidence
                                              patients (37,500) to rise to between 60,000 and75,000 in ten            base for the guideline. The latest published evidence has
                                              years time.                                                             been used in the guideline.
 National Kidney                Section 3d    An evidence based guideline will only improve standards of care         NICE guidelines are not compulsory. However, once the
 Federation (NFK)                             across renal units if the guidelines can be “enforced” at               development and validation phases of the guideline is
                                              commissioning level. The numbers of renal patients are                  complete the work will be available on our website, and
                                              deemed so low, as to be ignored by commissioners unless there           proactively disseminated within the NHS.
                                              is to be an element of compulsion.
 National Kidney                Section       Population – see my first comment.                                      Thank you.
 Federation (NFK)               4.1
 National Kidney                Section       Haemoglobin target levels. If, for example, it is desired to            Thank you.
 Federation (NFK)               4.3b          achieve a certain standard i.e, 11g/dl then to result in an
                                              average of 11g/dl the target must of mathematical necessity be
                                              pitched higher than the average required. In other words the
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                                         Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses
                                                                             7 June – 5 July 2004
         Organisation              Section                                Comments                                                           Response
                                              target must be 12 or 13 g/dl to allow the average of 11g/dl to be
                                              achieved. An average is exactly that – a middle position. It
                                              would be no good setting a target of 11g/dl if you wanted to
                                              achieve an average standard across patients of 11g/dl.
 National Kidney                General       Renal patients require relief from Anaemia and it does not          Thank you
 Federation (NFK)                             matter to them whether this relief is achieved by the Use of Iron
                                              supplement or Erythropoietin or a combination of both. Patients
                                              would support a cost effective solution that enabled more
                                              patients to obtain relief from anaemia, however they would not
                                              support a reduction in the amount of Erythropoitin prescribed
                                              purely for cost cutting reasons – the control of Anaemia is an
                                              important quality of life issue to all renal patients.
 National Kidney                general       The view of The National Kidney Research Fund is that it is well    Thank you.
 Research Fund, The                           put together, and complete, and all the stated objectives are
                                              sensible.

                                              We do not have any specific criticisms.

                                              Benchmarks are the more recent guidelines and
                                              recommendations for the target haemoglobin level for
                                              successful treatment, derived from European Best Practice, and
                                              from K-DOQI. When new Renal Association guidelines emerge
                                              these will need to be taken into account as well.
 National Public Health           General     Content with Scope.                                                 Thank you.
 Service - Wales
 Nebo a/s                       COMMEN        Relevance of dividing the patient groups in regard to the           Thank you, we agree and will use the stages 1–5 in the
                                T ONE,        level of kidney function:                                           guideline (this was not felt to be necessary in the Scope).
                                Part 4.1.1.
                                b             The guidelines issue the following groups:                          With regard to GFR as a tool we agree that this would be a
                                                  Pre-dialysis CKD also known as pre renal replacement           useful development. However it is currently beyond the remit
                                                     therapy and pre end stage renal disease                      and Scope.
                                                  People with established renal failure receiving renal
                                                     replacement therapy
                                                  People with established renal failure receiving
                                                     conservative management
                                                  People directly after transplant surgery

                                              We agree on the relevance of differentiating between different
                                              patient groups in regard to the level of kidney function, since
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                                         Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses
                                                                             7 June – 5 July 2004
         Organisation              Section                               Comments                                                           Response
                                              both the prognosis and in many cases the treatment will vary
                                              depending on the type of patient. We although recommend that
                                              each group is made more specific by using for example the
                                              DOQI criteria for degree of renal function.

                                              We agree with the overall term pre-dialysis as this would aid in
                                              the early identification, diagnosis and subsequent management
                                              of patients.
                                              The terminology is very important in the context of increasing
                                              the focus on early detection and intervention thereby delaying
                                              the need for renal replacement therapy.

                                              We consider it important to use haemoglobin in combination
                                              with GFR as a tool to identify pre-dialysis patients in general
                                              practice as early as possible. Earlier diagnosis and treatment
                                              improve prognosis and patients’ choice regarding renal
                                              replacement therapy.
 Nebo a/s                       COMMEN        Relevance of dividing the patient groups in regard to the          We confirm that the wording ‘renal replacement therapy’ will
                                T TWO,        type of renal replacement therapy:                                 include both peritoneal dialysis and haemodialysis.
                                Part 4.1.1.
                                b             The terminology “renal replacement therapy”, should be made
                                              more explicit to define the two options of renal replacement
                                              therapy i.e. CAPD and haemodialysis (as the treatment
                                              strategies in these two groups often will vary).
 Nebo a/s                       COMMEN        This statement is not very clear in regard to the use of the       The word ‘target’ will be deleted and amended with
                                T THREE,      wording “target”, we recommend a statement such as; “A             ‘threshold’.
                                4.3 b)        threshold for the haemoglobin concentration below which
                                              treatment of anaemia should be initiated.”
 Nebo a/s                       COMMEN        Erythropoiesis should replace haemoglobin so that the phrase       See amended wording in the Scope.
                                T FOUR,       will be; “Assessment and optimization of erythropoiesis,
                                4.3 c)        including iron supplements (iron stores) and erythropoiesis
                                              stimulating agents.”
 Nebo a/s                       COMMEN        Always should replace normal in the following sentence;            Thank you for your comment. This phrase is part of our
                                T     FIVE,   “Note that guidelines recommendations will always fall within      standard wording for scopes.
                                4.3 c)        licensed indication in UK; exceptionally and only where clearly    There are occasions where evidence has supported the
                                              supported by evidence and where no license alternative is          recommendations outside of the license. Exceptionally, and
                                              available use outside license indication may be recommended.”      when this occurs it would be made explicit within the
                                                                                                                 guideline so that practitioners are aware of it. .
 Nebo a/s                       GENERAL       Having attended the stakeholder meeting June 28, we were           Thank you. The patient representation will be appropriate for
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                                         Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses
                                                                             7 June – 5 July 2004
         Organisation              Section                                 Comments                                                            Response
                                              somewhat concerned that the discussion in relation to patient          the guideline. We take note of your helpful comments.
                                              representation focused on the participation of two haemodialysis
                                              patients. We consider it more appropriate that patients reflect
                                              the different management stages/options, especially predialysis,
                                              as this group of patients that has the greatest Scope to
                                              influence their choice and clinical/economical outcome.
 NHS Modernisation                                                                                                   This organisation was approached but did not respond.
 Agency, The
 NHS Quality                                                                                                         This organisation was approached but did not respond.
 Improvement Scotland
 North Sheffield PCT            4.3           The guideline should be explicit as to what the expected               Explicit outcomes will be considered from the evidence base.
                                              benefits of anaemia treatment (for each of the four groups of
                                              patients) would be. In particular, is it expected to be on
                                              improvement in quality of life alone, or is it also expected to lead
                                              to a reduction in mortality.
 Ortho Biotech                  4.1.2         There may be difficulties entirely excluding anaemia associated        Thank you. We look forward to what the HTA says.
                                              with haematological disease from the guideline. For instance,
                                              the technology appraisal on erythropoietins for chemotherapy
                                              related anaemia will report by the end of 2005 – the renal
                                              guideline will need to consider the recommendation in this
                                              guidance to ensure equity of funding and access to EPO for
                                              renal and haematology patient groups.
 Ortho Biotech                  4.3.c         It would be useful for the guideline to consider making                Thank you, the evidence base will be considered.
                                              recommendations concerning route of administration for
                                              erythropoiesis stimulating agents (intravenous and
                                              subcutaneous).
 Ortho Biotech                  4.4           Although stated by NICE to be outside its remit (stakeholder           Thank you for your comment. It is outside the scope of this
                                                                   th
                                              meeting on June 28 ), this particular guideline would benefit          guideline to prescribe commissioning mechanisms to the
                                              from considering recommendations concerning the most                   NHS.
                                              appropriate mechanism for commissioning recommended
                                              interventions for anaemia management in patients with CKD.
                                              Otherwise, there is a real danger of non-uniform implementation
                                              of the guidance, leading to postcode prescribing of agents such
                                              as erythopoiesis stimulating agents.
 Plymouth Hospitals                                                                                                  This organisation was approached but did not respond.
 NHS Trust
 Princess Alexandra                                                                                                  This organisation was approached but did not respond.
 Hospital NHS Trust
 Qualipharm (UK) Ltd            General/Ti    As discussed at the meeting classifying CKD in stages I – V as         Thank you – we agree and will use the stages 1–5 in the
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                                           Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses
                                                                               7 June – 5 July 2004
         Organisation                 Section                               Comments                                                            Response
                                tle             per KDOQI encouraging assessment of renal function by GFR            guideline (but not in the Scope).
                                                /CCr estimation.
 Qualipharm (UK) Ltd            2 b) final      Important fact is that only module I & II (Part 1) of renal NSF is   Thank you. We will endeavour to work closely with the NSF
                                sentence        available. The vital aspect of ‘Pre Dialysis’ treatment and          team.
                                                module 3 may not be published until 2005 or even 2006.
 Qualipharm (UK) Ltd            3 b)            The number of patients is likely to rise rapidly and these are the   Thank you – noted.
                                                tip of the iceberg. Early diagnosis and treatment may have
                                                significant benefits on population health and in the long term
                                                reduce burden on NHS.
 Qualipharm (UK) Ltd            3 d)            Renal Registry Report for 2003 looking at 2002 data is now           Thank you – the Scope will be updated.
                                                available. This demonstrates very clearly where units are
                                                performing well. It could also prove useful looking at Hbs before
                                                dialysis and relationship with mortality.
 Qualipharm (UK) Ltd            4.1.1 b)        ‘directly after transplant’ is too narrow. I agree with X who        Thank you – we agree.
                                final           mentioned that other patients with some degree of renal
                                sentence        impairment would re-enter as Stage I – V CKD as confirmed by
                                                GFR evaluation.
 Qualipharm (UK) Ltd            4.1.2 a)        Exclusion of certain patients must be more clearly defined.          The Scope of the guideline pertains to anaemia caused by
                                                Many patients may have a complex anaemia whereby renal               CKD. Hence we are only seeking to exclude the treatment of
                                                failure is a major contributory factor. This may exclude such        malignancy where it is the primary cause of anaemia.
                                                patients as Myeloma’s from treatment which could improve QOL         The guideline will only deal with the treatment of renal
                                                significantly and future renal function being restored.              contribution to anaemia in myeloma.
 Qualipharm (UK) Ltd            4.3 b)          ‘Targets for Haemoglobin’. I agree with comments at the              We will consider the evidence base for the correct Hb target
                                                meeting that this area needs careful consideration. If target        level.
                                                means patients should have a Hb > 11g/dl appropriate
                                                treatment should be initiated once their Hb is below this figure.
                                                Also if all patients are to have Hbs above 11g/dl recommended,
                                                then consideration should be paid to population dynamics and
                                                statistics in order to fully achieve this. It can be done cost
                                                effectively too.
                                                It was revealing to find out at the meeting that the initial Remit
                                                which quoted a Hb of > 11g/dl , an internationally accepted
                                                standard, is not fixed. This has important implications;
                                                Does this mean that stakeholder contributions will have to
                                                provide supportive evidence to demonstrate that keeping Hbs >
                                                11g/dl is worthwhile as well as providing clinical publications
                                                which outline the interventions and their cost effectiveness in
                                                order to achieve this level.
 Qualipharm (UK) Ltd            Appendix        Hopefully full consideration and appropriate comment will be         Thank you – the guideline can only consider products with a
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                                         Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses
                                                                             7 June – 5 July 2004
         Organisation              Section                                Comments                                                         Response
                                              given to any future innovative product developments and/or the      current evidence base.
                                              availability of ‘bio-similar’ products.
                                              Virtually all current evidence and guidelines have assessed the
                                              use of oral iron salts which have been proven to be of limited
                                              use for patients already on ESAs. Their traditional side effects
                                              also contribute to poor compliance and uraemic patients do not
                                              benefit much either. An effective oral iron formulation which can
                                              overcome the current limitations of oral iron salts could have a
                                              major impact on the ability to treat more patients earlier. This
                                              would allow more patients to benefit from earlier effective
                                              treatment in the primary care environment. This approach will
                                              reduce the need for IV Iron therapy and the associated costs of
                                              travel to hospital, medical staff time etc. Falling Hbs have been
                                              shown to contribute to the progression of the renal disease.
                                              The license patent protection for Epoetins is running out soon,
                                              which could allow for the introduction of bio-similar products.
                                              This could impact on the cost of treating individual patients and
                                              provide an opportunity to treat more patients earlier in the
                                              course of their disease for the same cost.
 Renal Association                                                                                                This organisation was approached but did not respond.
 Renal Nutrition Group,                                                                                           This organisation was approached but did not respond.
 British Dietetic
 Association
 Richmond &                                                                                                       This organisation was approached but did not respond.
 Twickenham PCT
 Roche Products Limited         General,in    Roche welcomes the fact that the original remit and consequent      Thank you.
                                cluding       Scope covers the broad management of anaemia in chronic
                                guidance      kidney disease (CKD) and not just anaemia in renal failure.
                                title
                                              Guidance on the management of anaemia in renal failure only
                                              would have been less useful because the inclusion of early CKD
                                              addresses an area in which there is a greater unmet clinical
                                              need and also greater variation in clinical practice. This
                                              approach is also supported by the fact that the forthcoming NSF
                                              for CKD will complement the current NSF for renal failure.
                                              Roche recommends that both areas will be given equal attention
                                              in the guideline. It may also be useful to investigate during the
                                              development of the guideline the impact of other co-morbidities
                                              such as cardiac risk on CKD patients.
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                                         Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses
                                                                             7 June – 5 July 2004
         Organisation              Section                                Comments                                                           Response
 Roche Products Limited         General       Roche suggests that the terminology for classifying different        Thank you – we agree and will use the stages 1–5 in the
                                              renal health states be reviewed.                                     guideline (but not in the Scope).

                                              This is because the current descriptions may be inappropriate;
                                              CKD (‘irreversible and progressive’), established renal failure /
                                              end stage renal failure (‘progressed to RRT’, ‘irreversible, long-
                                              term’), and pre-dialysis CKD are all mentioned, but only
                                              effectively delineate two groups. Roche recommends that GFR-
                                              based staging definitions should be used in addition or instead,
                                              as this would allow a more accurate classification of early CKD
                                              severity.
                                              The most widely used system is the K-DOQI scale.
 Roche Products Limited         General       Roche would like to seek further guidance regarding the              All evidence should be submitted in the normal way. Please
                                              economic evaluation of therapies within NICE clinical guidelines.    see attached link to Guidelines process manual on the NICE
                                              This includes an identification of the requirements for cost         website –
                                              effectiveness analysis of treatments (e.g. which costs,              http://www.nice.org.uk/page.aspx?o=114268 .
                                              outcomes, time horizons, etc., should be included) for economic
                                              submissions within clinical guidelines, and are there any other
                                              differences compared to technology assessments that need to
                                              be considered?
 Roche Products Limited         4.1.1a        Roche would like to seek clarity on the population groups that       The guideline addresses people with anaemia secondary to
                                4.3a          will be covered.                                                     CKD and therefore cannot include people until they have
                                                                                                                   been identified.
                                              4.1.1a presently identifies people ‘who have a clinical diagnosis’
                                              of anaemia, but does not include people with undiagnosed             The Scope does not include screening populations.
                                              anaemia in CKD. However, 4.3a includes ‘Detection and
                                              diagnosis’ of anaemia.

                                              The definitions need to be made more explicit regarding
                                              undiagnosed groups within the guideline.
 Roche Products Limited         4.3a          Roche recommends that the guideline also covers the detection        The Scope does not include screening populations.
                                              and diagnosis of CKD itself (independent / prior to detection and
                                              diagnosis of related anaemia).                                       The Scope pertains to anaemia in CKD not CKD as the
                                                                                                                   primary disease.
                                              This is because early CKD (e.g. at stages 3 / 4) is presently
                                              underdiagnosed which will result in a consequent
                                              underdiagnosis of related anaemia.

                                              Further related issues, such as which healthcare professionals
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                                                                                  Page 26 of 45
                                         Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses
                                                                             7 June – 5 July 2004
         Organisation              Section                                Comments                                                            Response
                                              (e.g. GPs/ diabetologists, rather than nephrologists?) could
                                              identify such patients and how GFR (rather than creatinine
                                              testing?) should be incorporated.
 Roche Products Limited         4.2           Roche welcomes the fact that the Healthcare Setting section           Thank you. We need a firm evidence-base for healthcare
                                4.3c          covers the full range of healthcare professionals who may be          setting issues. Published evidence that these factors are
                                              involved in this disease area.                                        important can then be considered. It would be extremely
                                                                                                                    helpful if you could please submit any references directly
                                              Roche hopes that this approach will also be applied to section        pertaining to this that you would wish the developers to
                                              4.3c, and in particular, the use of r-HuEPOs for haemoglobin          consider during the stakeholder evidence submission stage.
                                              management (such as epoetin-beta (NeoRecormon).                 We
                                              suggest that this section should provide guidance on which            If there is indeed a published evidence-base relevant to these
                                              groups of healthcare staff might best deliver these therapies.        factors we will be able to consider this.
                                              This is because the current paradigm largely limits prescribing
                                              of
                                              r-HuEPOs to nephrology specialists (due to a historical
                                              emphasis on treatment of renal failure). However, it is
                                              anticipated that earlier treatment of CKD will increasingly involve
                                              other healthcare staff (such as GPs and diabetologists).

                                              In addition, ‘delivery’ may involve both initiation and
                                              maintenance of therapy – guidance on who should best manage
                                              each phase would be useful.
 Roche Products Limited         4.3 c         As discussed at the Stakeholders Meeting on 28.6.04, Roche            Thank you.
                                              would also like to reiterate that the available r-HuEPO products
                                              differ significantly (e.g.; in optimal route of administration and    Consideration of separate products will only be made if there
                                              dosing requirements) and this should be evaluated during the          is a strong evidence base for doing so.
                                              development of the clinical guideline
                                                                                                                    Only licensed products will be considered.
                                              We would also therefore suggest that provision be made to
                                              allow assessment of these products separately (as well as from
                                              a ‘class’ perspective) within any clinical and cost effectiveness
                                              analysis.

                                              Roche would also like to point out that clinical development is
                                              presently underway of a new treatment agent CERA which is
                                              expected to be launched in 2007. It may be possible to include
                                              some data relating to CERA during the development of the
                                              clinical guideline and we would like to discuss this further with
                                              the guideline developers.
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                                         Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses
                                                                             7 June – 5 July 2004
         Organisation              Section                                 Comments                                                              Response
 Roche Products Limited         4.3 c         Roche would like to clarify what is meant by ‘optimisation’, in        The evidence base will be considered.
                                              relation to haemoglobin.

                                              This term was used helpfully in the remit, and appeared to refer
                                              to optimal haemoglobin from a clinical effectiveness perspective
                                              (e.g. European and K-DOQI standards), towards which an
                                              assessment of cost effective interventions would be geared.
                                              This perspective is less clear in the Scope for the guideline.

                                              Will haemoglobin treatment targets be defined a priori, or will
                                              this treatment outcome standard be part of what the guideline
                                              decides based on economic assessments?
 Royal College of               General       Very little of this Scope relates directly to anaesthesia and          Thank you.
 Anaesthetists                                critical care but there are important points to make from this
                                              perspective.
                                              A recent review was published on-line by The Critical Care
                                              Forum on 14 June at http://ccforum.com/supplements/8/S2.
 Royal College of               3d            Most patients with CRF have adapted physiologically to their           Thank you for the references.
 Anaesthetists                                anaemia and, as long as circulating blood volume is maintained,
                                              will cope reasonably well with anaesthesia and surgery.
                                              In patients who are anaemic and unable or unwilling to receive
                                              blood before or during surgery, rEPO can usefully raise the
                                              haemoglobin level.
                                              Milligan LJ. Anaesthesia and critical care of Jehovah's
                                              Witnesses. Continuing Education in Anaesthesia Critical Care
                                              and Pain 2004; 4:35-39.
 Royal College of               4.1.2         Although the Scope does not cover anaemia caused by acute              The remit and Scope do not include the critically ill. Multiple
 Anaesthetists                                inflammatory disease I think it is worth mentioning the unique         organ failure is not related to the remit of CKD.
                                              circumstances of the anaemia seen in critically ill patients.
 Royal College of               4.3a          Some of the anaemia seen in ICUs could be ameliorated by               Thank you – the guideline relates specifically to anaemia in
 Anaesthetists                                careful attention to blood sampling practices.                         CKD and not to other causes.
                                              Napolitano LM. Scope of the problem: epidemiology of anemia
                                              and use of blood transfusions in critical care. Critical Care
                                              2004; 8(Suppl 2):S1-S8.
 Royal College of               4.3b          In general, critically ill patients do not gain a survival advantage   Thank you.
 Anaesthetists                                from a transfusion trigger above 70 g/L haemoglobin.
                                              Hebert PC. A multi-center, randomized, controlled clinical trial of
                                              transfusion requirements in critical care. NEJM 1999; 340:409-
                                              17.
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                                         Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses
                                                                             7 June – 5 July 2004
         Organisation              Section                                  Comments                                                             Response
 Royal College of               4.3b          There is some debate as to whether patients with active cardiac          Thank you.
 Anaesthetists                                disease benefit from a higher transfusion trigger.
                                              Freudenberger RS. Is there an optimal haemoglobin level in the
                                              cardiac intensive care unit? Curr Opin Crit Care 2003; 9:356-6.
 Royal College of               4.3b          It is unlikely that a fixed transfusion trigger will apply to patients   Thank you.
 Anaesthetists                                with active cardiac disease.
                                              Fakhry SM. How low is too low? Cardiac risks with anemia.
                                              Critical Care 2004; 8(Suppl 2):S11-S14.
 Royal College of               4.3c          In critically ill patients with elevated cytokines EPO levels may        Thank you.
 Anaesthetists                                be high initially and fall later. The anaemia seen in the critically
                                              ill does not seem to be predominantly due to abnormally low
                                              levels of EPO but rather to a failure of its effect.
                                              Pharmacological doses of rEPO may be necessary to stimulate
                                              erythropoesis.
                                              Elliot JM. Erythropoietin mimics the acute phase response in
                                              critical illness Critical Care 2003, 7:R35-R40.
 Royal College of                                                                                                      Thank you for the evidence submission.
 Anaesthetists


 Royal College of                                                                                                      This organisation was approached but did not respond.
 General Practitioners
 Royal College of               General       This is a straightforward document and is clearly primarily about        Thank you.
 Nursing (RCN)                                the investigation and non-transfusion management of patients
                                              with chronic renal disease.
 Royal College of               General       It is surprising there is no mention of blood transfusion as an          Thank you. This is not excluded.
 Nursing (RCN)                                option for the management of anaemia even if it is then
                                              excluded from the Scope of this exercise.
 Royal College of               General       Primary health care management of Anaemia is a major                     Thank you.
 Nursing (RCN)                                challenge and the NICE guidelines must reflect the existing
                                              evidence as outlined within the recently published NSF Renal
                                              Service (2004).
 Royal College of               4.1.2. [b]    Concerns that children have been excluded from these draft               We accept that this is a valid point and hence the Scope and
 Nursing (RCN)                                guidelines. Whilst children represent a relatively small                 guideline will include children.
                                              population in comparison to the adult population it is essential
                                              that their needs are not excluded from this important guideline.
 Royal College of               General       The specific needs of the older patient with renal failure needs         Thank-you. Older patients are included. Care will be
 Nursing (RCN)                                to be much more explicit in the guidelines as these patients with        addressed but not who will provide such care.
                                              renal anaemia may not be managed by a Nephrologist.
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                                         Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses
                                                                             7 June – 5 July 2004
         Organisation              Section                                 Comments                                                              Response
 Royal College of               General       What about funding of anaemia management drug therapies?               The guideline developers are not asked to consider funding
 Nursing (RCN)                                How will the guidelines reflect this? This is particularly important   but rather the cost effectiveness of treatment options.
                                              when the treatment between primary and secondary care is
                                              taken into consideration, which could lead to local inequalities in
                                              terms of clinical management & services provided.
 Royal College of                             What about patients who are not being referred to a                    Thank you – we agree and will use the stages 1–5 in the
 Nursing (RCN)                                Nephrologist? Is the term predialysis too broad? And therefore it      Guideline (but not in the Scope).
                                              might be best if this is considered as Chronic Kidney Disease
                                              stages 1 – 5. The staging of treatment for renal anaemia maybe
                                              an issue the guidelines need to reflect.
 Royal College of               4.1.2         What about dialysis sepsis induced dialysis anaemia? This              Re infections/chronic inflammation – we agree that dialysis
 Nursing (RCN)                                needs further clarification as the draft guidelines indicates that     patients are subject to infection. However, it is anaemia that
                                              anaemia caused by acute and chronic inflammatory disease               is the focus of the guideline and hence it is the impact of
                                              states is to be excluded.                                              infection on anaemia. This will be included in the Scope when
                                                                                                                     considering management of, and factors, which have an
                                                                                                                     impact on anaemia in renal disease under section 4.3c.
 Royal College of               Clinical      What about the actual ergonomics of clinical management &              Thank you. This is outside of the remit and Scope of the
 Nursing (RCN)                  managem       delivery? Questions such as by who and how; this will highlight        guideline.
                                ent 4.3       important manpower issues which could impact upon the
                                              successful implementation of the guidelines. Whilst there will be
                                              issues related to local delivery this needs to be considered more
                                              in the development of these guidelines.
 Royal College of               4.3 a         Detection of Chronic Kidney Disease: consideration should be           We agree that this would be a useful development. However
 Nursing (RCN)                                given to other markers identified, as Creatinine Clearance is not      it is currently beyond the remit and Scope.
                                              a particularly good marker. What about consideration of GFR
                                              reporting system. I understand in France the GFR is also
                                              reported at the same time as the Creatinine Clearance
 Royal College of                             What about the administration of products in primary care i.e.         Thank you. We have noted this and accept that this is a good
 Nursing (RCN)                                Iron particularly this will be an issue for patients who do not wish   point for the future.
                                              to travel long distance to hospital when it could be administered      Administration of products and sector will be considered in
                                              in the primary care setting?                                           relation to the evidence base.
 Royal College of                             What about the development of a diagnostic pathway between             Thank you.
 Nursing (RCN)                                primary and secondary care. Could this be considered within the        We have noted this point, however it is outside the current
                                              draft guidelines?                                                      remit of AMCKD guideline.
                                                                                                                     The diagnosis and management of anaemia in CKD including
                                                                                                                     referral where appropriate will be considered.
 Royal College of                             What about routes and timing of administration? Will guidelines        Yes this will be addressed.
 Nursing (RCN)                                reflect patient preferences?
 Royal College of                             Consideration needs to be made regarding service                       Thank you. This is outside of the remit of the guideline as it
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                                          Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses
                                                                              7 June – 5 July 2004
         Organisation              Section                                 Comments                                                               Response
 Nursing (RCN)                                 configurations and the development of these guidelines needs          pertains to commissioning.
                                               to be balanced against agreed priorities.
 Royal College of               4.1.2b         The Royal College of Paediatrics and Child Health would wish          We accept that this is a valid point and hence the Scope and
 Paediatrics and Child                         to see the Guideline extended to include children under 16            guideline will include children.
 Health                                        years of age. Whilst the number of studies performed in this
                                               field involving paediatric patients is smaller that the number
                                               involving adults, particularly with reference to high quality RCTs,
                                               a number of studies do exist and it would be appropriate for
                                               these to be used in preparation of the Guideline.
 Royal College of               4.1.2.b        100 new cases of end stage renal disease occur in UK children         We accept that this is a valid point and hence the Scope and
 Paediatrics and Child                         annually. Why not include children in the guideline? On what          guideline will include children.
 Health (2)                                    grounds are children to be excluded?
 Royal College of               General        The Scope should include consideration of the most effective          Thank you. This is outside of our current remit and Scope.
 Pathologists                                  way of prescribing erythropoietin (Epo) - GP v. hospital and the
                                               allocation of resources to prescribers.
 Royal College of               Section 4.     The Scope should make specific comment about anaemia in               The Scope of the guideline pertains to anaemia caused by
 Pathologists                   Population     patients with haematological disease AND chronic kidney               CKD. Hence we are only seeking to exclude the treatment of
                                               disease, where patients may still benefit from the use of Epo. A      malignancy where it is the primary cause of anaemia.
                                               special case is myeloma, where renal impairment and anaemia
                                               at presentation are common. The UK myeloma guidelines                 The guideline will only deal with the treatment of renal
                                               recommend the use of Epo in anaemic myeloma patients.                 contribution to anaemia in myeloma.
 Royal College of               General        National and international guidelines are already available for       Thank you – noted.
 Physicians of London           comments       the management of renal anaemia. However despite extensive
                                :              literature review on most of the topics outlined in the scoping
                                               document they focus on desired outcomes and not the means
                                               by which to achieve these desired outcomes, nor are they
                                               focused on cost effectiveness. The DOPPS and ESAM studies
                                               demonstrate geographical differences in outcome and the UK
                                               Renal Registry additionally demonstrates consistent differences
                                               in performance between units across time (in the era of de-
                                               anonymised data). As part of the audit loop and in addition to
                                               the benchmarking the Registry provides, exploration of
                                               differences in funding and / or practice (the means by which
                                               they achieve these outcomes) between units across the UK
                                               could provide a way to improve outcomes generally.
 Royal College of                              Changes that could be made at a political level following             Service delivery models and funding is generally outside the
 Physicians of London                          recommendations from NICE, to create a level playing field in         Scope of a NICE clinical guideline.
                                               funding for EPT across the NHS might provide the opportunity
                                               for the greatest improvement in outcome for patients.
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         Organisation              Section                                 Comments                                                             Response
                                              Differences in EPT funding generate different difficulties in the
                                              management of this patient population. EPT may be funded,
                                              partially funded, not funded, funded via hospital based health
                                              care providers or via general practice (whilst treatment is
                                              managed almost uniformly by the hospital based nephrologist /
                                              anaemia co-ordinator).
 Royal College of                             Recent developments relating to Primary Red Cell Aplasia               PRCA is an important issue that will be dealt with under the
 Physicians of London                         appears to have created a more competitive market and lower            effectiveness of EPOs.
                                              costs. The upcoming end of the licence for erythropoietin
                                              requires guidance on the use of generic products particularly in
                                              the light of the development of PRCA relating to subcutaneous
                                              administration of erythropoietin-alpha, but also on the potential
                                              for large potential cost savings in using generic EPT.
 Royal College of                             The guidelines must add value over and above the national and          Thank you.
 Physicians of London                         international guidelines that already exist. The areas that appear
                                              to have been overlooked in these previous documents are cost
                                              effectiveness and the guidance on how to produce a
                                              predictable, sustainable and prescribed outcome for renal
                                              anaemia across renal units.
 Royal College of                             Specific Comments by section:                                          Thank you.
 Physicians of London           4.1           Population                                                             When the transplant is failing this is encompassed under the
                                4.1.1         The immediate post transplant period is often associated with          category of pre dialysis.
                                              anaemia and requirements for post-operative blood transfusion,         We confirm that the Scope includes failing transplant.
                                              and it has been observed that the greater the degree of                Those who have well functioning transplants may not have
                                              anaemia preoperatively, the greater the risk of requiring              anaemia; hence we would not need to expand to encompass
                                              transfusion. However, the guideline should include all patients        the whole of the transplant period.
                                              with a renal transplant (not necessarily just ‘directly after          Regarding transplant patients with adequately functioning
                                              transplant surgery’). Chronic failure of renal transplants also        grafts and anaemia, we note your points and these will be
                                              produces the anaemia of erythropoietin deficiency as for native        addressed.
                                              chronic renal insufficiency. Thus transplant patients with             We are also mindful of considering the treatment of anaemia
                                              adequately functioning grafts can develop anaemia secondary            caused by kidney disease and not that necessarily caused by
                                              to erythropoeitin deficiency, functional iron deficiency, chronic      the treatment.
                                              inflammation (i.e. rejection), infection or other causes as for pre-   Your last point is noted, thank you.
                                              dialysis / dialysis patients. In addition transplant patients are on
                                              immunosuppressive agents that can suppress marrow function
                                              (i.e. azathioprine).
                                              There is no current consensus as to when it is appropriate to
                                              discontinue erythropoietic therapies, but it is most usual to
                                              discontinue therapy at the time of transplantation. Some
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                                                                             7 June – 5 July 2004
         Organisation              Section                                Comments                                                            Response
                                              transplants have delayed graft function but erythropoietic
                                              therapy is still discontinued.
 Royal College of                             Diagnosis and recommended management of Erythropoietin               We agree this is an important issue, which will be dealt with
 Physicians of London                         Associated Primary Red Cell Aplasia should be discussed.             under the effectiveness of EPOs.
 Royal College of                             These categories         presumably exclude Primary Red Cell         We agree this is an important issue, which will be dealt with
 Physicians of London           4.1.2         Aplasia (PRCA-EPO), the consequence of developing                    under the effectiveness of EPOs.
                                              neutralising antibodies to epoetins.
 Royal College of                             Dialysis patients are frequently subject to chronic inflammation     Re infections/chronic inflammation – we agree that dialysis
 Physicians of London                         and / or acute infections and exclusion of these patients from       patients are subject to infection. However, it is anaemia that
                                              the guidelines will reduce the value of the subsequent advice to     is the focus of the guideline and hence it is the impact of
                                              the clinical nephrologist.                                           infection on anaemia. This will be included in the Scope when
                                                                                                                   considering management of, and factors, which have an
                                                                                                                   impact on anaemia in renal disease under section 4.3c.
 Royal College of                             Patients with renal failure and a malignancy should not              The Scope of the guideline pertains to anaemia caused by
 Physicians of London                         necessarily be excluded from management of renal anaemia.            CKD. Hence we are only seeking to exclude the treatment of
                                                                                                                   malignancy where it is the primary cause of anaemia.
 Royal College of               4.2           Healthcare setting                                                   Thank you, noted.
 Physicians of London                         The current legal loophole of VAT reimbursement on home
                                              administered erythropoietic therapy (EPT) needs analysis as
                                              any cost benefit in VAT rebait may be lost in reduced
                                              compliance in selfadministered compared to hospital based
                                              patients (nurse administered).
 Royal College of               4.3           Clinical management                                                  Thank you for suggesting these questions.
 Physicians of London                         [a] Intravenous iron:
                                              Does intravenous iron have a place in the treatment of renal
                                              anaemia prior to commencement of EPT in CKD.
                                              Is there any benefit (improvement in Hb or reduction in EPT
                                              dose) gained in administering intravenous iron to haemodialysis
                                              patients with a ferritin greater than 500ng/ml
                                              What is the most cost effective range for ferritin in
                                              haemodialysis patients on EPT?
                                              What is the most cost effective range for ferritin in peritoneal
                                              dialysis patients?
                                              What is the most cost effective range for ferritin in pre-dialysis
                                              patients?
 Royal College of                             The Revised European Best Practice Guideline minimum                 Thank you, we will look at the evidence-base for target Hb as
 Physicians of London                         standard for Hb is that all patients have a Hb > 11g/dl? Is this     part of Scope.
                                              European standard compatible with avoiding Hb values > 14g/dl
                                              as recommended in the same new European guidelines? The
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         Organisation              Section                                 Comments                                                              Response
                                               DOQI guideline of 11-12g/dl (even with use a 3 month averaged
                                               mean) is not a achievable outcome in a dialysis patient
                                               population so is not necessarily a more useful (or realistic)
                                               benchmark than the UK minimum standard.
 Royal College of                              [b]      On what evidence of improved cost effectiveness              Thank you. This is dependent upon the current evidence-
 Physicians of London                          should NICE move to a recommendation other than that of the           base. We will also be taking health economic advice on this.
                                               previous Renal Association and Royal College of Physicians
                                               (UK minimum standards document) of 85% > 10g/dl? This prior
                                               recommendation also provides a practical benchmark against
                                               which unit performance can be measured.
 Royal College of                              The use of a threshold or trigger Hb value that should initiate       Thank you.
 Physicians of London                          work-up and then initiation of EPT would be useful than a
                                               ‘target’. Intervention values for Hb requiring subsequent
                                               changes in EPT dose necessary to achieve the desired
                                               outcome distribution for the treated population would be of more
                                               practical value than a target.
 Royal College of                              [c] Guidance on the cost benefit to choice of dialyser                Thank you. These will be looked at in so far as they impact
 Physicians of London                          membrane, route of EPT administration, use of ultrapure water         on anaemia management only.
                                               (for haemodialysis) or any given type of peritoneal dialysis fluid
                                               (biocompatibilty), achievement of higher dialysis dose and
                                               provision of prompt and definitive vascular access should be
                                               given.
 Royal College of                              The ‘optimisation of haemoglobin (and iron stores)’ needs             Thank you. We will be led by the evidence-base and health
 Physicians of London                          detailed clarification for each patient population (pre-, haemo, or   economic input.
                                               peritoneal-dialysis) in terms of cost benefit as explored above in
                                               4.3[a].
 Royal College of                              Would uniform central (hospital) funding for all EPT improve the      We agree with this statement and consider it a valid point,
 Physicians of London                          Hb outcome for patients and remove the problem of post-code           however the guideline cannot consider commissioning
                                               differences in outcome for this expensive therapy(see general         issues, as it is not within the remit of Scope. This is a service
                                               comments).                                                            delivery issue, which we are not allowed to address under the
                                                                                                                     current commission.
 Royal College of               4.1            Whilst there has been no specific exclusion of older people with      Thank you. We are not excluding the elderly.
 Physicians/British             Population     chronic kidney disease (CKD) it should be noted and possibly
 Geriatrics Society                            mentioned in the Scope that older people should be included.
                                4.11           CKD is a disease of older people increasing from 1,900 people
                                Groups         per million age 50-59 years to 17,000 people per million age 70-
                                that will be   79 years. Most of these older patients are at stages 3 and 4
                                covered        CKD and are not on dialysis.
 Royal College of               4.3            4.3a Detection and diagnosis of anaemia in CKD- CKD in older          We agree.
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                                                                             7 June – 5 July 2004
         Organisation              Section                                 Comments                                                              Response
 Physicians/British             Clinical      people has been missed on many occasions due to the use of
 Geriatrics Society             managem       serum creatinine as a marker of glomerular filtration rate (GFR).
                                ent           This will be improved with the use of calculated clearances such
                                              as the MDRD and the Cockcroft and Gault equation. The Scope
                                              should take this into account.
 Royal Pharmaceutical                         This is to advise that the Royal Pharmaceutical Society of Great      Thank you.
 Society of Great Britain                     Britain will not be submitting comments on the above
                                              consultation.
 Scottish Intercollegiate                                                                                           This organisation was approached but did not respond.
 Guidelines Network
 (SIGN)
 Sheffield Teaching             4.1           The focus should be on the Hb which requires treatment and not        We agree the aim is to correct anaemia associated with CKD.
 Hospitals NHS Trust                          be determined by a particular population such as dialysis status.
                                              There is, of course, a problem with identification of people with     The Scope of the guideline pertains to anaemia caused by
                                              chronic kidney disease (CKD) within the population - and thus         CKD. Hence we are only seeking to exclude the treatment of
                                              those who would benefit from this form of anaemia                     malignancy where it is the primary cause of anaemia.
                                              management. Currently many such patients do not get referred,
                                              or are referred late.                                                 Children – we accept that this is a valid point and hence the
                                              There is some ambiguity of groups which will be covered - thus        Scope and guideline will include children.
                                              in 4.1.2 many renal patients have haematological problems (eg
                                              myeloma) or malignancy or chronic inflammation (eg
                                              rheumatoid arthritis).
                                              Since numbers of children who are affected are small they do
                                              not need to be the subject of this guideline - which is about
                                              delivering optimal anaemia management to a large population of
                                              patients cost effectively. Children can be dealt with on an
                                              individual basis - costs are not so important because of the
                                              smaller numbers.
 Sheffield Teaching             4.1           Part 'a' is sufficient, but part 'b', whilst attempting to clarify,   Thank you.
 Hospitals NHS Trust                          actually confuses matters. An example of this is the statement        We agree with your point but it is difficult to define. Potentially
                                              "people directly after transplant surgery". How long after surgery    this is until, or if, stable transplant function is achieved.
                                              is "directly" and why not anybody who has a transplant and has        As the Scope and guideline pertains to anaemia
                                              anaemia. Some transplants function for years at a level which         management in CKD we are referring to renal transplant. We
                                              equates with moderate renal failure, but not severe enough to         have amended the wording accordingly.
                                              warrant RRT. At what point does a failing transplant warrant
                                              intervention for anaemia? Finally, whilst it may appear pedantic,
                                              does the SCOPE document mean renal transplant or any
                                              transplant?
 Sheffield Teaching             4.2           The guidelines should not miss the opportunity of delivering          Thank you. The guideline pertains primarily to anaemia
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                                                                             7 June – 5 July 2004
         Organisation              Section                                Comments                                                          Response
 Hospitals NHS Trust                          renal care in the primary care setting - eg GP based intravenous    management in CKD (not the delivery of renal care in the
                                              iron clinics.                                                       primary care setting).

                                                                                                                  We need a firm evidence-base for healthcare setting issues.
                                                                                                                  Published evidence that these factors are important can then
                                                                                                                  be considered. It would be extremely helpful if you could
                                                                                                                  please submit any references directly pertaining to this that
                                                                                                                  you would wish the developers to consider during the
                                                                                                                  stakeholder evidence submission stage.
                                                                                                                  If there is indeed a published evidence-base relevant to these
                                                                                                                  factors we will be able to consider this.
 Sheffield Teaching             4.2           It states that people who have haematological or malignant          The Scope of the guideline pertains to anaemia caused by
 Hospitals NHS Trust                          disease will not be covered as CKD is not the principal cause of    CKD. Hence we are only seeking to exclude the treatment of
                                              anaemia. Patients such as those with myeloma can go on to           malignancy where it is the primary cause of anaemia.
                                              require renal replacement therapy. Anaemia in this cohort is        The guideline will only deal with the treatment of renal
                                              usually quite severe and as a result would suggest that they will   contribution to anaemia in myeloma.
                                              become a disadvantaged group as their main source of care           The publication of this guideline should not disadvantage
                                              moves from the haemotologists to the nephrologists, as each         patients who require clinical care from both the haematologist
                                              will claim the other should be providing the anaemia therapy.       and nephrologist. Local arrangements should be in place to
                                                                                                                  address these issues.
                                              A proportion of those with CKD may require little or no             Re infections/chronic inflammation – we agree that dialysis
                                              intervention for their anaemia, however from time to time they      patients are subject to infection. However, it is anaemia that
                                              may have inflammatory episodes which will impact on their           is the focus of the guideline and hence it is the impact of
                                              anaemia. The Scope document at present excludes this group.         infection on anaemia. This will be included in the Scope when
                                              Finally, being pedantic again, it has been suggested in many        considering management of, and factors, which have an
                                              texts that CKD itself is an inflammatory condition, thus            impact on anaemia in renal disease under section 4.3c.
                                              precluding anyone with CKD from the remit of the SCOPE              We note your final sentence and thank you for making us
                                              document.                                                           aware of this.
 Sheffield Teaching             4.3           The ergonomics of anemia management are very important and          We agree. Health Economic advice will be taken and we will
 Hospitals NHS Trust                          should be considered for review. It is of paramount important to    be guided by the evidence-base.
                                              ensure cost-effective use of expensive products, avoidance of
                                              waste, optimization of compliance, and to build in quality
                                              assurance and audit to support this. For example if Hb is
                                              permitted to over-shoot the target range, or if drug doses are
                                              missed, this results in un-necessary expense.
 Sheffield Teaching             General       I feel the SCOPE should not only look at what are the best          Thank you. Commissioning questions regarding the allocation
 Hospitals NHS Trust                          interventions, but also the most effective means of delivering      of resources are currently outside of the Scope.
                                              those interventions. Huge sums of money are wasted each year
                                              due to compliance issues and ineffective monitoring of the
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                                                                             7 June – 5 July 2004
         Organisation              Section                                Comments                                                         Response
                                              treatment given. I suggest that what may appear on paper to be
                                              most efficacious, in actual practice is compromised due to
                                              limitations of having real people involved in the implementation.
                                              Therefore the intervention most easily implemented and
                                              adhered to may actually be superior to that which initially
                                              appears most cost effective.
 Shire Pharmaceuticals          General       We strongly support this Scope.                                     Thank you.
 Limited
                                                                                              th
 Shire Pharmaceuticals          4.3 c)        A specific item could usefully be added to the 4 stab point:        We are not sure of your meaning here. Please provide us
 Limited                                      ‘..including agents which promote erythrocyte stability.’           with further information.
 Society of District                                                                                              This organisation was approached but did not respond.
 General Hospital
 Nephrologists
 South Manchester                 General     I just have a few general comments on the subject above:            We have been specifically asked to consider only anaemia in
 University Hospital NHS                      - As you are aware we are obliged to implement the Department       CKD and anything else is outside of the Scope. We confirm
 Trust                                        of Health Better Blood Transfusion 2 which is aimed at              that children are included and that blood transfusion is
                                              encouraging alternatives to allogeneic blood transfusion. Being     included. The evidence base will be considered.
                                              a Haematologist and a member of the Hospital Transfusion
                                              Team I have this urge to see that the NICE Guidance gives
                                              more support for the use of Erythropoietin in both Renal and
                                              other anaemias where the product might be of value.
                                              - I did not get it clearly why children under 16 years are not
                                              included (may be they have another group dealing with them)?
                                              Otherwise this is this group you would want to restrict use of
                                              blood. -Another reason why I am in favour of giving
                                              Erythropoietin to patients with non-renal diseases with severe
                                              anaemia is in one case whwn there might be overlap with
                                              kidney disease and because of the fact that in some case when
                                              you have achieved a reasonable level of Haemoglobin when a
                                              patient is not symptomatic (eg: 100g/l) the patient could be
                                              observed off therapy. Furthermore, there is improvement in the
                                              performance status/quality of life when people are on
                                              erythropoietin even earlier before there has been a significant
                                              rise in haemoglobin level. -Very soon the cost of blood will
                                              exceed the cost of using alternatives to blood transfusion when
                                              you put together the cost of blood collection and processing,
                                              patient time and hospital costs. Of course, in most cases
                                              patients who require blood transfusion would need a minimum
                                              of 2 units of blood at a given time and we have cases where
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                                                                             7 June – 5 July 2004
         Organisation              Section                                 Comments                                                            Response
                                              patients come in weekly or worse still twice weekly for blood
                                              transfusion. -The Pharmaceutical Companies are keen to offer
                                              help with regard to patient monitoring such as assy of
                                              erythropoetin and offering the agent free for a limited trial period
                                              which I think should be encouraged since in that way more
                                              needy patients would be offered treatment. As more usage of
                                              erythropoietin goes up the cost of patient care in these
                                              categories will fall, I should think so.
 Syner-Med (PP) Ltd             “general” /   Suggestion to amend to include “Anaemia management in                   Thank you – we agree and will use the stages 1–5 in the
                                Title         people with chronic kidney disease (CKD) as per K DOQI staging          guideline (but not in the Scope).
                                              I to IV and transplants”. REASON – KDOQI staging :
                                              (1) provides precise definition of the degree of renal failure
                                              being referred to, and reduces ambiguity
                                              (2) follows most up to date convention
                                              (3) Estimates of CCr/GFR are more reliable measures of renal
                                              function and moves away from less reliable measures such as
                                              serum Creatinine which is commonly used outside Nephrology.
 Syner-Med (PP) Ltd             2 b) last     Specify for the purpose of clarity                                      Thank you. We will be working closely with the NSF team.
                                sentence       “part one of the NSF including module 1 (renal replacement
                                              therapy) and module 2 (Transplantation) was published in
                                              January 2004. Part 3 covering Module 3 (predialysis) and
                                              module 4 (conservative management / alternative strategies) will
                                              probably not be published until 2005.”
 Syner-Med (PP) Ltd             3 b)          Point of fact                                                           Thank you – noted.
                                              The number of patients with CKD is set to grow quite
                                              dramatically in the next 10 years and the number of predialysis
                                              patients will be greater than the figure stated. See NHANES data
                                              for the USA. The data given re. England only included patients
                                              on dialysis and post Tx. Many more patients will be anaemic with
                                              CKD stages I-V and not be on dialysis or have had a Tx. The
                                              numbers quoted here fail to address the vast number of patients
                                              with all stages of CKD who may never be referred to a
                                              Nephrologist but may be anaemic and should be treated.
 Syner-Med (PP) Ltd             3 d)          The UK Renal Registry document referred to is for 2002. The             Thank you – the Scope will be updated.
                                              2004 document is now available and comments may need
                                              updating in light of more up to date information. The graph used
                                              by X in his presentation on Monday is especially worthy of note.
                                              This showed clearly that although Hb outcomes have improved
                                              the Hb in incident patients lags far behind prevalent patients. It is
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                                                                             7 June – 5 July 2004
         Organisation              Section                                 Comments                                                             Response
                                              during the CKD stages I-IV that much of the damage due to
                                              anaemia takes place, damage that cannot be reversed by
                                              treated on dialysis.
 Syner-Med (PP) Ltd             3 d)          Whilst not questioning the restriction on the availability of ESA’s    Thank you – noted.
                                second        30-50% of CKD patients stages I-IV have been shown to
                                sentence      respond to Intra Venous Iron supplementation alone. There are
                                              other therapeutic options which are more cost effective and
                                              should be considered for inclusion prior to ESA therapy.
                                              References: Jenkins K, poster Brit Renal Soc, May 2004.
                                              Silverberg DS Kidney Int. Vol 55 Suppl 69, S79-S85.
 Syner-Med (PP) Ltd             4.1.1 b)      “….people directly after transplant surgery”                           Thank you, yes we agree, we have deleted the word
                                last          Suggest deleting the word “directly” because transplant patients       ‘directly’. When the transplant is failing this is encompassed
                                sentence      need their anaemia managing throughout their life. They need           under the category of pre dialysis.
                                              their anaemia managing post operatively, but as their transplant       We confirm that the Scope includes failing transplant.
                                              eventually fails they need more intensive management once              Those who have well functioning transplants may not have
                                              again. Its important not to imply that anaemia management has          anaemia; hence we would not need to expand to encompass
                                              been completed after the post operative phase.                         the whole of the transplant period.
 Syner-Med (PP) Ltd             4.1.2 a)      Whilst fully accepting the need to exclude non-renal anaemia if is     The Scope of the guideline pertains to anaemia caused by
                                              important to consider the that, due in part to the age of CKD          CKD. Hence we are only seeking to exclude the treatment of
                                              patients it is likely they will suffer from a number of co-morbid      malignancy where it is the primary cause of anaemia.
                                              conditions. In the light of this it is important not to exclude
                                              patients where more than CKD alone is contributing to the
                                              anaemia. An example could be a patient with Myeloma who may            The guideline will only deal with the treatment of renal
                                              well be anaemic and CKD is the major contributor to the                contribution to anaemia in myeloma.
                                              anaemia. By excluding haematological malignancy one would
                                              exclude a large proportion of myeloma patients who are usually
                                              managed by haematologists and are often not referred to
                                              Nephrology departments until end stage (i.e CKD stage V).
 Syner-Med (PP) Ltd             4.3 b)        “Criteria for the target levels of haemoglobin concentration for       The word ‘target’ will be deleted and amended to ‘threshold’.
                                              initiating the treatment of anaemia”
                                               It is unclear what this means precisely. If the target is 11g/dl,
                                              then surely anyone below this value goes onto treatment. If it is
                                              being suggested that there is a value below which the
                                              haemoglobin level has to fall before treatment can be initiated
                                              e.g. 10g/dl this is not optimum treatment. It can be argued that
                                              any one with a falling haemoglobin level should go onto therapy
                                              as this is sub optimal for this individual. However, using 11g/dl as
                                              a threshold is not unreasonable as this is also the target end
                                              point. Allowing the haemoglobin level to fall further than
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                                                                             7 June – 5 July 2004
         Organisation              Section                                Comments                                                           Response
                                              necessary will result in further disease progression and should
                                              not be recommended.
 Syner-Med (PP) Ltd             Appendix      The example give of achieving the accepted international             Thank you.
                                              standards (K-DOQI and EBPG II) of 11g/dl is still a level of Hb
                                              well below the normal. Hb varies between individuals and this
                                              should be taken into account. A male with an Hb of 17g/dl when
                                              healthy would feel the consequences of a fall to 14g/dl. The
                                              whole issue of what outcome is desired is one that will need
                                              careful examination. Part of the problem in renal patients is that
                                              the Hb is allowed to fall, often to levels well below 10g/dl (see
                                              European Survey of Anaemia Management). Having fallen to
                                              such low level the body adapts. If the Hb has been at a low level
                                              for a long period pushing the Hb too high may have a negative
                                              effect. The ideal could be not to allow the patients Hb to fall in
                                              the first place.
                                              The question may be rather than asking what Hb level to move a
                                              patient to, ask the question of what is the minimum level of Hb
                                              that should be tolerated.
                                              Recent work in patients with CHF has shown that anaemia is
                                              associated with significantly worse outcomes. Most CHF patients
                                              have a degree of CKD and many have anaemia. Likewise many
                                              CKD patients will have either LVH or overt CHD in part
                                              associated with their anaemia. The view in cardiology is that a
                                              level Hb of <13g/dl is associated with poorer outcomes in CHF.
                                              Some would find it strange that a CKD sharing many of the same
                                              problems is often treated to achieve a lower Hb.
 Syner-Med (PP) Ltd             Overall       The Scope covers many of the issues but it may benefit form          Thank you. These will be looked at in so far as they impact
                                Comment       being more specific in what is to be included. Examples would        on anaemia management only.
                                              include, water quality, dialyser membrane compatibility, etc. At
                                              the stakeholder meeting comments were made re. the exclusion         In relation to children we note your helpful comments.
                                              of children which will be a concern of anyone involved in            Children will now be included due to the weight of
                                              paediatrics. Not all the treatments used in children are licensed    stakeholder comments. We will be mindful of the unlicensed
                                              for use and it may be difficult to offer guidelines on the use of    treatments.
                                              unlicensed treatments.
 The Royal Society of                                                                                              This organisation was approached but did not respond.
 Medicine
 UK Anaemia                      Title        1. Does the title imply that patients in KDOQI stages I-V who            1. Yes it does as long as CKD.
                                                 develop anaemia will all be treated if anaemia develops
                                                 regardless of stage?
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                                                                             7 June – 5 July 2004
         Organisation              Section                                Comments                                                           Response


                                              2. Will all treatments of anaemia be included eg iron deficiency,        2. Yes.
                                                 and will the recognition and treatment of iron deficiency be
                                                 recommended prior to the initiation of ESA therapy
                                                 especially as there may be a huge cost saving.
 UK Anaemia                     2 a)          1. Will this guideline supersede any part of the renal NSF in        We will be working closely with the NSF team so that the
                                                 any way                                                           clinical guideline and the NSF are complementary.

                                2 b)          1. How will NICE support the NSF if the NICE guideline               As both NSF and guidelines are in development at the
                                              recommendation is different. Could the NICE guideline effectively    moment we are unable to be more specific at this stage.
                                              delay diagnosis and treatment.

                                              2. There is a significant time delay before Module 3 & 4 are in
                                                  the public arena, how will the NICE guideline affect pre-
                                                  dialysis and palliative care patients.
 UK Anaemia                     3 a)          1. ESR or CKD etc may not always end with the patient                Points a to d will be included under conservative
                                              receiving dialysis,                                                  management in the Scope.
                                               a) the patient may die from other co-morbid disease
                                               b) the patient may choose palliative care,                              3b (1) – This is background information – thank you for
                                               c) with proactive care the progression of CKD may be so far             these statements.
                                              delayed that dialysis will never become a reality.
                                               d) should anaemia be treatment when it is first evident patients        3c - When the Scope was written, recently published
                                              may not compound CKD with heart failure. 70% of ALL patient              update figures were not available. 2003 figures have
                                              commencing dialysis have significant left ventricular hypertrophy.       now been used to update the Scope.

                                              Does this imply that these patients with be omitted from the
                                              guidelines.

                                3 b)          1. If you concentrate on people with CKD as their primary
                                              diagnosis then the estimation may be correct, however with the
                                              growing incidence of diseases such as diabetes and heart
                                              disease and their impact on renal function the estimate is grossly
                                              inaccurate.

                                              2. There is no estimate of the % of patients with such diseases
                                              who are not diagnosed. It is pertinent to consider the USA
                                              experience and NHANES.

                                              1. PLEASE NOTE THAT YOU REFER TO THE RENAL
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                                         Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses
                                                                             7 June – 5 July 2004
         Organisation              Section                                 Comments                                                           Response
                                3 c)          REGISTRY 2002 NOT 2004.

                                              2. There is failure to treat patients approaching dialysis early and
                                              commence dialysis before the patient becomes symptomatic.

                                              3. Patients commencing HD lose residual renal function at a
                                              faster rate than patients on PD.

                                              4. The renal registry does not provide critical information on
                                              patients commencing HD with a functioning fistula versus those
                                              with a temporary or permanent neck line against their actual
                                              haemoglobin at commencement and over the following 3
                                              months.

                                              5. The UK (bar USA) has one of the highest rates of patients
                                              commencing HD with a neck line.

                                3 d)          1. There is wide variation in the treatment of anaemia because
                                              there is gross disparity in funding such treatment nationally.

                                              2. Proactive units recognise and treat iron deficiency early thus
                                              improving and maintaining haemoglobin and delaying the need
                                              for ESA therapy thus affording a huge financial saving whilst
                                              initiating appropriate therapy early.
 UK Anaemia                     4.1.1 b)      1. Will you define pre-dialysis as approaching dialysis or             1. Thank you – we agree and will use the stages 1–5 in the
                                              according to KDOQI stages (preferably stage III-IV). The               guideline (but not in the Scope).
                                              definition “approaching dialysis” is too late “the damage is
                                              already done” Using KDOQI staging and defining the criteria for
                                              “diabetic and non-diabetic” patients will optimise the patients
                                              chances of receiving treatment at the appropriate time.

                                              2. Some patient post renal transplant may continue to have sub-        2. Thank you – noted.
                                              optimal renal function and will continue to require anaemia
                                              management.
 UK Anaemia                     4.1.2 a)      1. Many renal patients have co-morbid disease. 25% of patients         Thank you – noted.
                                              diagnosed with Multiple Myloma will have significant renal
                                              impairment. Myloma will be the primary diagnosis and CRD
                                              secondary these patients will be managed by a haematologist.
 UK Anaemia                     4.2           1. It should be emphasised that anaemia management with                Thank you. We need a firm evidence-base for healthcare
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                                         Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses
                                                                             7 June – 5 July 2004
         Organisation              Section                                Comments                                                         Response
                                              nephrological support may be effectively managed in primary        setting issues. Published evidence that these factors are
                                              care and may be more cost effective and patient friendly.          important can then be considered. It would be extremely
                                                                                                                 helpful if you could please submit any references directly
                                                                                                                 pertaining to this that you would wish the developers to
                                                                                                                 consider during the stakeholder evidence submission stage.

                                                                                                                 If there is indeed a published evidence-base relevant to
                                                                                                                 these factors we will be able to consider this.
 UK Anaemia                     4.3 b)        1. WHO definition of anaemia:                                      Thank you.
                                              women <12g/dl
                                              men   <13g/dl

                                              It is imperative that the Hb should only be allowed to FALL to a
                                              target of 11g/dl implying that therapy should be commenced
                                              before this occurs. To aim for a blanket level of ALL patients
                                              achieving a Hb of 11g/dl the target needs to be at least 2g
                                              higher.
 UK Anaemia                     Appendix      1. WHO definition of anaemia:                                      Thank you.
                                              women <12g/dl
                                              men      <13g/dl

                                              2. Hb should be individualised.

                                              3. Diabetic patients should be treated at a higher GFR. Low Hb
                                              and swings in the level of Hb will have a detrimental effect on
                                              blood glucose monitoring.

                                              4. Anaemia should be corrected early to prevent left ventricular
                                              hypertrophy.

                                              5. Anaemia has been shown to contribute directly to early death
                                              in patients with CRF – DOPPS Study.

                                              6. Patients with cardiac disease compound their disease with low
                                              Hb. Hb <13g/dl associated with poorer outcome.

                                              7. Quality of life should be a measurement of an appropriate Hb
                                              level.
 UK Renal Pharmacy              4.1.1.        Whole-heartedly agree with the groups to be covered. Do we         Yes, we are including people with failing transplants.
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                                                                                  Page 43 of 45
                                          Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses
                                                                              7 June – 5 July 2004
         Organisation              Section                                 Comments                                                              Response
 Group                                         need to include people with failing transplants?
 UK Renal Pharmacy              4.1.1.         Where the guidance says it will include people directly after        Thank you.
 Group                                         transplant surgery, how long are they proposing to follow-up the
                                               patients post-transplant?                                            We agree with your point but it is difficult to define.
                                                                                                                    Potentially this is until, or if, stable transplant function is
                                                                                                                    achieved.
 UK Renal Pharmacy              4.3 (c)        Management of, and factors which have an impact on anaemia           Concomitant medication will be considered amongst the
 Group                                         in renal disease – is there a place here to add concomitant          evidence base outcomes where relevant.
                                               medication? Certain drugs, or combinations of drugs are well-
                                               known to cause anaemia, so need to be considered.
 UK Renal Pharmacy              4.3            Clinical management – should a section be included here on           Thank you – the evidence base will be considered.
 Group                                         what to do with non-responders, what further tests should be
                                               carried out, and how should they now be managed?
 University Hospital                                                                                                This organisation was approached but did not respond.
 Birmingham NHS Trust
 Vitaline                       4.1.1.a        CKD should be classified into the 5 stages of CKD as defined by      Thank you – we agree and will use the stages 1–5 in the
 Pharmaceuticals UK                            the K.DOQI guidelines.                                               guideline (but not in the Scope).
 Ltd
 Vitaline                       4.1.1.b        We agree with the overall term of ‘pre-dialysis’ as including the    Thank you – we agree and will use the stages 1–5 in the
 Pharmaceuticals UK                            patients as described in stages 1-4 K-DOQI.’Pre Dialysis’ is         guideline (but not in the Scope).
 Ltd                                           commonly described by patients and clinicians especially in
                                               primary care. This term aids identification, diagnosis and
                                               communication of the guideline and the subsequent
                                               management of the patients.
 Vitaline                       4.1.1.b        People directly after transplant surgery, this statement needs to    We agree with your point but it is difficult to define.
 Pharmaceuticals UK                            refer to the continuation of anaemia monitoring of these patients,   Potentially this is until, or if, stable transplant function is
 Ltd                                           not just directly following transplant.                              achieved.

                                                                                                                    When the transplant is failing this is encompassed under the
                                                                                                                    category of pre dialysis.

                                                                                                                    We confirm that the Scope includes failing transplant.

                                                                                                                    Those who have well functioning transplants may not have
                                                                                                                    anaemia; hence we would not need to expand to encompass
                                                                                                                    the whole of the transplant period.
 Vitaline                       4.3.a          The detection and diagnosis of anaemia in CKD should                 In relation to GFR – we agree that this would be a useful
 Pharmaceuticals UK                            encompass clear in vitro diagnostic tests and should include         development. However it is currently beyond the remit and
 Ltd                                           GFR as this is not a standard primary care test at present.          Scope.
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                                                                                   Page 44 of 45
                                         Anaemia management in chronic kidney disease guideline – stakeholder comments received on draft scope, with developer’s responses
                                                                             7 June – 5 July 2004
         Organisation              Section                                 Comments                                                           Response
                                              Differential tests for anaemia to include FBC, Hb, TIBC ,Ferritin
                                              and hypochromic red blood cells. Markers for inflammation and         In relation to differential test for anaemia – thank you for
                                              infection should also be included.                                    your suggestion. We will consider the evidence base.
 Vitaline                       4.3.b         This statement is not clear and we recommend a ‘threshold of          The word target will be deleted and amended to threshold.
 Pharmaceuticals UK                           11g/dl below which patients should have their anaemia managed
 Ltd                                          accordingly as treatment is not initiated at a target level.
 Vitaline                       4.3.c         iPTH levels should be measured in accordance to K DOQI                Thank you – we will consider the evidence base.
 Pharmaceuticals UK                           staging and phosphate binders initiated as appropriate for an
 Ltd                                          elevated PTH or phosphate level to reduce the risk of
                                              hyperparathyroidism.
 Vitaline                       4.3.c         Vitamin supplementation should be considered as appropriate.          Thank you.
 Pharmaceuticals UK
 Ltd
 Vitaline                       4.3.c         Anaemia management with regard to dialysis types needs to be          Thank you we will consider the evidence base.
 Pharmaceuticals UK                           clearly defined between the different types of RRT as there are
 Ltd                                          varying impacts on their lifestyle and number of hospital visits as
                                              well as adequacy.
 Vitaline                       4.3.c         Should read ‘assessment and optimisation of Erythropoiesis’, to       Thank you. The wording has been amended – please see
 Pharmaceuticals UK                           include iron stores, Iron supplements and epo when stores are         amended text in the Scope.
 Ltd                                          adequate.
 Vitaline                       4.3           Note: We recommend this statement is changed to read – The            It would be helpful to know why you recommend this
 Pharmaceuticals UK                           guideline recommendations will ALWAYS fall within the UK              change.
 Ltd                                          license indications, exceptionally and only where clearly             NICE have recommended indications outside of the licence,
                                              supported by evidence and where no licensed alternative is            exceptionally and where supported by the evidence.
                                              available.
 Vitaline                       General       Following on from the Stake Holders meeting on 28.6.04 we             Thank you. The patient representation will be appropriate for
 Pharmaceuticals UK                           have concerns re; the Patient representation focused on having        the guideline. We take note of your helpful comments.
 Ltd                                          2 haemodialysis patients as being representative of the renal
                                              community. We consider it more appropriate that the patients
                                              represent the various stages and RRT options especially the pre
                                              dialysis, as these patients have the greatest opportunity to
                                              influence their choice and clinical and economical outcome long
                                              term.
 Welsh Assembly                               Thank you for inviting comments from the Welsh Assembly               Thank you.
 Government (formerly                         Government about the draft Scope for the above guideline. We
 National Assembly for                        have no comment to make at this time.
 Wales)


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