The Faculty of Old Age Psychiatry of the Royal College of Psychiatrists (the Faculty) welcomes the Health Select Committees inquiry into aspects of the work of the National Institute for Health and Clinical Excellence (NICE) and for the opportunity to submit evidence to that inquiry.

  Members of the Faculty have served as members of Guideline Development Groups, Expert Advisors to Health Technology Appraisals, on the Topic Selection Panel for Mental Health, as policy advisors to the Department of Health and have represented the Royal College of Psychiatrists at appeal against appraisals produced by NICE.

  In submitting this evidence the Faculty recognizes the important role that NICE performs informing evidence based practice, in the quality control of clinical practice and the delivery of cost effective health care.

WHY ARE THE DECISIONS OF NICE INCREASINGLY BEING CHALLENGED?

  1.  We believe there are several reasons why this is the case. We have addressed most of these elsewhere in this response but summarise here, with specific reference to the Guidance on Alzheimer's disease, the Guideline for Dementia and the Guideline for Parkinson's disease. We believe these examples demonstrate why both the public and health professionals have good reason to be dissatisfied with decisions from NICE.

  2.  The clinical community and the public are concerned when a NICE judgement lacks a credible link with clinical practice or is irrational. We believe that both of these concerns apply to the NICE Guidance on the use of cognitive enhancing drugs for Alzheimer's disease (TA 111) which we discuss in more detail below. This may explain why this guidance attracted the largest number of responses to consultation of any NICE guidance and extensive criticism from national professional bodies, academic institutes and the public and may be the subject of Judicial Review.

  3.  In this example, the use of a simple scale is applied inappropriately in a rigid way to determine eligibility for treatment. This scale is not necessary in clinical practice and its intrinsic limitations mean that such rigid application is quite irrational and intellectually unsupportable. These points were made by experts during the Appeal against the Final Appraisal Determination but dismissed. The consequence is that people with early disease are ineligible for treatment (NICE confirming that these treatments are equally effective in the early stage as later) which they can only receive once they have deteriorated to a more disabled state. This is irrational, the recommendations have no meaning in clinical practice and, consequently, lack credibility in the eyes of both the clinical community and the public.

  4.  Such an approach seems completely inconsistent with views expressed by Sir Michael Rawlins, the Chairman of NICE, in the British Medical Journal (2004) "Underlying all the decisions, however, is one fundamental social value judgment: that advice from NICE to the NHS should embody values that are generally held by the population that the NHS serves". Further, we believe it is totally inconsistent with the Institutes own position that, while it endorses the use of cost utility analysis in the economic evaluation of particular interventions, such information is a necessary, but not sufficient, basis for decision making. Social value judgements are also required. We believe that one of those generally held values is the early treatment of disease when effective treatment is available.

  5.  This failure of NICE to show consistency with regard to its basic principles must be challenged.

  6.  Furthermore, the Guideline for dementia (clinical guideline 42, also discussed below), published simultaneously, provides rather different guidance on the same matter. This is irrational.

  7.  There is great concern that NICE will totally disregard expert opinion. In the case of TA 111 respected experts, including advisors to NICE and the Department of Health, approached NICE to help resolve their irrational position while still achieve their intention to produce satisfactory guidance on cost effectiveness. These approaches were rejected.

  8.  In the case of Dementia of Parkinson's disease (discussed in more detail below) not only did NICE disregard clinical opinion but also the scientific evidence when they over-ruled the guideline group. This was a serious betrayal not only of clinical opinion but also the fundamental principle of NICE that their recommendations always represent the evidence.

  9.  Discontent with NICE processes, particularly the composition of Health Technology Appraisal Committees and Appeals Panels, are shaking confidence in NICE. We address these below.

  10.  An example of the extent of this discontent was the decision by the Royal College of Psychiatrists Faculties of Old Age and Learning Disability Psychiatry with the British Geriatrics Society to issue a statement to its members reminding them of their professional duties as doctors which they believed were being compromised by the publication of TA111. This is a serious indictment by the major prescribers of the treatments that are the subject of that guidance.

WHETHER PUBLIC CONFIDENCE IN THE INSTITUTE IS WANING?

  11.  We believe this is the case. We believe it is also the case that clinician's confidence in NICE is waning and this has very serious implications. We believe that clinicians are deeply concerned about some NICE procedures, particularly Health Technology Appraisals and the Appeals process, and the "editorial" influence exerted by NICE (see discussion on Dementia in Parkinson's disease). We will expand on these issues with specific examples below.

  12.  Clearly this lack of confidence will influence the implementation of technology appraisals and clinical guidelines and if clinicians hold that opinion this will affect the confidence of the public. A lack of consistent implementation would seriously question the existence of NICE.

THE EVALUATION PROCESS AND WHETHER PARTICULAR GROUPS ARE DISADVANTAGED?

  13.  We wish to cite specific evidence that people with dementia and, by implication older people who are the main group affected by this condition, have been clearly and wrongly disadvantaged by the evaluation process. To demonstrate this belief we will specifically refer to the NICE recommendations on Alzheimer's disease and Dementia in Parkinson's disease as reflected in guidance and guidelines published in 2006.

  14.  The NICE technology appraisal on the clinical and cost effectiveness of cognitive enhancing drugs for the treatment of Alzheimers disease published as Guidance (TA111) in November 2006, has been seriously criticized by the academic and clinical community, and organizations representing patients and carers, may be subject of Judicial Review. The fact that this will be the first claim for Judicial Review against NICE is an indicator of the concerns raised by this appraisal and the increasing concern, or waning confidence, in NICE procedures.

  15.  We appreciate that a detailed criticism of this appraisal is not the purpose of this inquiry but would draw the Committees attention to the notes of the Appeal against this guidance where many of these issues were raised.

  16.  However, it is pertinent to this aspect of the Committees inquiry to note that the Appraisal Committee employed measurements, particularly those for the assessment of intellectual function and quality of life, inappropriately to serve the purpose of the appraisal and not to represent clinical practice. We believe that this is evidence of a flawed process that has disadvantaged older people and people with Alzheimer's disease.

  17.  We believe that this poorly informed judgement is partly explained by the constitution of an appraisal committee which, purposefully, excludes people with expert knowledge of the subject to be appraised. Consequently, a fundamentally crucial understanding of the condition is absent from the appraisal process. In the case of the Alzheimer's disease appraisal no member of the committee had any special expertise or knowledge of the condition and no clinical competence in its treatment. While experts in the field are consulted, we are aware of many who gave evidence in the development of this HTA and the appeal who considered their views were summarily disregarded.

  18.  We believe that this exclusion is unfortunate and misguided. NICE justify this policy decision on the basis that the committee will have no vested interest in the outcome. We believe this is naive as everyone working in the NHS and the public has a vested interest in the distribution of NHS resources, and therefore, the outcome of every health technology appraisal. Furthermore, if the assertion of NICE is true that its guidance and guidelines simply reflect the evidence then it should not matter how the committee is constituted other than to be sure that it has the capability to absorb, understand and interpret that evidence. We believe that a detailed knowledge of the condition or circumstance in question is a necessary prerequisite to establish that capability and a process that only seeks that capability by advice is flawed.

  19.  We believe that a committee that includes experts in the field in question is more likely to have that expertise and produce meaningful guidance. Furthermore, a committee that includes experts in the field will give far greater credibility to that guidance in the eyes of practitioners and the public and this has implications for confidence in the recommendations and subsequent implementation. Clinical guidelines, on the other hand, produced by a stakeholder guideline group involving informed professionals and the public, are received, in our experience, with far greater confidence as they are seen to have clinical validity.

  20.  We believe this point is made, in the case of drug treatments for Alzheimers disease, by contrasting the response to the controversial guidance (TA 111) and the guideline for dementia (NICE clinical guideline 42) that were published simultaneously in November 2006. The former remains highly controversial and may be the subject of Judicial Review while the latter has been received with considerable acclaim. That NICE decided to publish the two documents as one highlights this contrast while at the same time causing confusion with contradictory recommendations about the use of drug treatments sitting within a single document. This is irrational.

  21.  The NICE clinical guideline for the diagnosis and management of Parkinsons disease (PD) was published in June 2006. In the main it has been well received and seen to represent good practice. We wish to draw the Committees attention to the recommendations for the treatment of Dementia in Parkinsons disease (PDD) with cholinesterase inhibitor drugs (pages 121-124 of the full guideline). These are the same class of drugs that were the subject the Alzheimer disease appraisal (TA 111).

  22.  In this instance NICE over-ruled the guideline group, disregarded the evidence, imposed its own position and disadvantaged people with dementia. This is the only recommendation within the guideline where this occurred and, therefore, NICE chose to treat the case of dementia differently.

  23.  It is clear from the evidence that these drug treatments are effective and safe in the treatment of PDD. This is demonstrated by the evidence that was available to the guideline development group. This would normally be considered by NICE to represent a high level of evidence producing a recommendation for use and annotated to reflect that. In the draft version this was properly reflected in the recommendation that these drugs may be used with the appropriate annotation.

  24.  Despite the evidence, NICE refused to publish that recommendation in the guideline and over ruled the opinion of the guideline development group. Contrary to strong objections from the guideline development group the recommendation was changed by NICE. This is a direct contravention of the fundamental principle that NICE guidelines always reflect the evidence.

  25.  And so the published guideline recommendation reads:

"Although cholinesterase inhibitors have been used successfully in individual people with PD dementia, further research is recommended to identify those patients who will benefit from this treatment."

  26.  The rating of the recommendation is that of a good practice point (annotated as D (GPP)), which indicates a low level of evidence and only the opinion of the guideline group. A recommendation based on the findings of a large randomized controlled trial, as in this case, will usually be identified by the NICE annotation A or B, indicating a high level of evidence. In the case of PDD the status of the evidence has been misrepresented by NICE.

  27.  The view of the guideline development group is still contained in the evidence to recommendation section that precedes the recommendation (page 123 of the full guideline) but is not reflected in the recommendation:

"There is evidence from randomized placebo controlled trials of the effectiveness and safety of cholinesterase inhibitors in the treatment of PDD. They are effective in treating both cognitive decline and psychosis in this context.

At the time of writing only one of the cholinesterase inhibitors has a product licence in the UK. The GDG considers that these are useful agents that are commonly used in clinical practice and that they should be available."

  28.  Importantly, the full guideline is rarely consulted by most practitioners who will refer to the short guideline version to inform their practice and will not be aware of these statements that actually reflect the evidence based position.

  29.  We believe, in the case of PDD, that NICE has overruled expert opinion based on evidence and has failed to maintain its fundamental principle of presenting evidence based guidelines.

THE APPEAL SYSTEM?

  30.  We believe the NICE appeal system is unsatisfactory and perverse.

  31.  Members of the Faculty have first hand experience of appeal against NICE guidance and we will focus on the appeal against TA111, the guidance on cognitive enhancing drugs for the treatment of Alzheimer's disease held in July, 2006.

  32.  In this case, there were five appellants with the Royal College of Psychiatrists and British Geriatrics Society submitting a joint appeal. Two members of this joint appeal had acted as expert witnesses to the Health Technology Appraisal Committee. Despite this appraisal being highly controversial every point raised by the five appellants was dismissed by the Appeals Panel.

  33.  In this instance, the Appeals Panel consisted of five members appointed by NICE. Three of these were working for NICE. The Chair of the Panel was the Vice Chair of the Board of NICE itself.

  34.  Regardless of the integrity of individual members of the Appeals Panel this must raise concerns about impartiality and cast doubt on the objectivity and credibility of the Panel's judgement. There can be no doubt that this panel had an obvious conflict of interest. This will inevitably lead to a cynical and deeply suspicious response to the guidance that will, undoubtedly, affect implementation by clinicians and confidence in NICE.

  35.  We consider it unacceptable that a panel charged with the responsibility to hear an appeal against the processes of a NICE appraisal should be either appointed by NICE itself or include people working for NICE.

  36.  It is contradictory that NICE exclude experts from Health Technology Appraisal Committees on the basis that they have a vested interest in the outcome but do not apply the same reasoning to the constitution of an Appeals Panel.

  37.  We believe that an Appeals Panel should be entirely independent of NICE and that this would be in the best interests of NICE and the National Health Service.

COMPARISON WITH THE WORK OF THE SCOTTISH INTERCOLLEGIATE GUIDELINES NETWORK (SIGN)?

  38.  The SIGN Guideline on the Management of Patients with Dementia (SIGN 86) was enthusiastically received across Scotland. This was published before the NICE Guidance (TA111) and the NICE Guideline (clinical guideline 42). The development of the SIGN guideline is broadly similar to that of a NICE guideline.

  39.  In relation to dementia the SIGN Council specifically referred to a study (known as the AD2000 trial) which they felt was methodologically flawed and suspect and the SIGN Guideline Development Group expressed the view that this study was given too much weight in the production of the recommendations of TA111 by NICE. This was also a point of concern raised at the appeal against TA111 but dismissed by the Appeal Panel. Clearly the experts on the SIGN development group had similar concerns to experts in England about the process employed by NICE in producing this particular guidance and the decisions of an appraisal committee without knowledge of Alzheimer's disease.

  40.  SIGN is now absorbed into the remit of NHS Quality Improvement Scotland (QIS) but retains its independence and SIGN guidelines are respected by the Scottish Executive. In relation to dementia NHS QIS, required to endorse NICE guidance, recommends referring to the SIGN dementia guideline when interpreting TA111 guidance. We believe that this provides further evidence that the recommendations contained in TA111 lack the confidence of a large body of experts and our belief that NICE processes have disadvantaged people with dementia.

THE IMPLEMENTATION OF GUIDANCE, BOTH TECHNOLOGY APPRAISALS AND CLINICAL GUIDELINES (WHICH IS ACTED ON, WHICH IS NOT AND THE REASONS FOR THIS)?

  41.  In general, guidelines produced by an informed stakeholder group are less controversial than guidance produced by a health technology appraisal committee that purposefully excludes informed people. This is partly because the former has greater credibility with clinicians who recognize and respect recommendations that reflect good practice produced, as they are, by professionals and the public involved with these aspects of health care. Guideline groups understand the issues in question, understand the clinical context and are able to understand and interpret the evidence.

  42.  Technology appraisal committees on the other hand, as we have stated, lack all of these essential attributes. For psychiatrists to receive a mandatory direction on the treatment of, for example Alzheimer's disease, from cardiologists, anaesthetists, neo-natal paediatricians and others, or, for a neo-natal paediatrician to receive a direction from psychiatrists, orthopaedic surgeons and dermatologists, for example, is a process which is perverse and lacks credibility. This will be reflected in the way such guidance is received by clinicians and this will reflect the likelihood of implementation.

  43.  In answer to the question "which guidance is acted on" the answer would be guidance in which clinicians have confidence because they believe it arises from a reliable and informed source, and evidence base, and has a meaningful connection with clinical practice.

Dr David Anderson

Chair of the Faculty of Old Age Psychiatry

Royal College of Psychiatrists

March 2007