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Select Committee on Health Minutes of Evidence

Memorandum by Dr Martin Duerden (NC 117)


  1.1  My background is that of a General Practitioner with a particular interest in prescribing and therapeutics. After seven years as a full time principal in general practice I worked for several years as a Health Authority Medical Adviser, with a particular remit for prescribing advice. Following a period spent training in public health medicine I subsequently worked for three years as medical adviser/medical director of the National Prescribing Centre. In that role I was closely involved in identifying and evaluating drug innovations that had potential to change clinical practice. Over the last year I have worked as a medicines policy adviser at University College London Hospitals Trust. From the beginning of this month I moved to work as a clinical author for PRODIGY (a computerised decision support system for GPs).

  1.2  I continue to work as a part time general practitioner. I also am involved in therapeutics training for GPs and other health care professionals.

  1.3  The viewpoint I give is my personal view as a result of these experiences. I do not represent any particular organisation. I will comment specifically on drug technology appraisals and the guideline development roles of NICE. There are political and philosophical issues in relation to the rationing role, and tensions with the media, drug companies and patient groups that I have not covered.


  2.1  Over the last decade or so the mechanisms to allow the use of new drugs within the NHS have appeared poorly co-ordinated and fragmented. There has been a popular perception that new drugs are necessarily better and older drugs are "old fashioned" and also that new drugs can cure many ills previously not amenable to therapy. The licensing process has been designed to strike a balance between enabling innovation, encouraging a strong drug industry and protecting patients from adverse drug reactions. Pressure has been applied by drug companies, interested clinicians and patient representatives to rapidly assimilate new drugs into clinical practice. The dilemma is that in many instances new drugs do not necessarily represent major advances and that at the time of licence the safety profile of the drugs has not been fully evaluated. Of particular concern is that drug trials required to get a drug licensed do not necessarily reflect the information needed to decide the place of that drug in clinical practice. As a response to these dilemmas and as a result of budgetary constraints many Health Authorities developed mechanisms to rationalise uptake and funding of new drugs, usually through evaluation by their Public Health departments. This has resulted in different decisions being arrived at in different localities, so-called postcode prescribing. Many felt that the only way to improve on this lack of co-ordination was to have a central process for assessing the value and clinical worth of new drugs. For this reason the concept of NICE was positively received by many involved in prescribing advice, including myself; there was considerable expectation that NICE would avoid duplication of effort and produce credible guidance, satisfying commissioners, prescribers and patients, and avoiding inequities in provision.


  3.1  Alongside varying access to drugs there has also been concern about variation in practice in hospitals and general practice for relatively common interventions. This concern has been alongside emerging evidence about variation in outcome. An obvious solution to this problem is the development of evidence-based guidelines to guide practice for commonly encountered complaints. Also the concepts of clinical governance encouraged by A First Class Service help to drive quality practice. One problem that has arisen from development of guidelines, often supported and promoted by drug companies, has been the sheer multiplicity of guidance that has emerged, often of varying quality. The role of NICE in developing clear, consistent quality national guidelines has also been eagerly awaited.


  4.1.  The intention was that NICE would provide guidance on use at the time a new drug came to market. Possibly as a result of the time taken for NICE to develop its infrastructure, this has certainly not been achieved and this has proved a major problem for those agreeing drug use on a local basis (now commonly called "NICE blight"). A vacuum is created where it has been difficult to provide local interim guidance in case it is subsequently contradicted by NICE; also simply advising "no use" in anticipation of guidance has been deemed by the Department of Health as unacceptable. In many respects this is worse than the previous arrangements where at least on a local basis, following due process, firm decisions could be reached. As a result new drug use has become less controlled, more subject to idiosyncrasies and is also less well informed. A good example of this was seen with the anti-inflammatory drugs, the COX-2 inhibitors (rofecoxib and celecoxib). Hopefully the appraisals will become more timely as NICE evolves.

  4.2.  In mitigation, the expectations placed on NICE have been tremendous and there was a perception that the appraisal work and guideline development could happen immediately. As NICE has started off the sheer scale of work has become evident, and there has been increased recognition of the cost of such processes. The original intention that the Institute should be "cost neutral" has clearly been unrealistic (it was expected to draw on funding already available for drug evaluation), and I suspect even with its current level of funding, it is not capable of performing its role of new drug appraisal in a timely manner. With hindsight it might have been better to clearly separate the catch up role, where central guidance was required for drugs already on the market, being used subject to local vagaries (for example, beta-interferon for multiple sclerosis) from the need to horizon scan and have guidance available for drugs at point of licence (even if the latter was an interim appraisal). Also it might have been better, rather than expecting technology appraisals on established therapies (as part of the catch up role) to occur in isolation from overall disease management guidance, to have included these appraisals as part of the guideline function.

  4.3  Similar problems exist in relation to national guideline development. The guideline programme suggests that many needed guidelines will not be available for several years. Ideally National Service Frameworks should be underpinned at launch by clear national policies on best practice, provided by NICE. Lack of these clear guidelines has been deemed "guideline blight". To a certain extent this has been circumvented by good guidance provided by professional Colleges; that produced by PRODIGY and the exemplary guidelines produced for Scotland by SIGN. Again I suspect that expectations of immediate solutions have been unrealistic but there has been lack of clarity about what to do in the interim.

  4.4  Another problem that has arisen with new drug appraisals by NICE are concerns about the technical integrity of some of the guidance. Sometimes the guidance seems to be at odds with the supporting Health Technology Assessment (for example, riluzole for motor neurone disease). Up to a point this can be accepted in that a fine judgement is required to balance a pure evidence based medicine (EBM) determination against social needs and practical delivery of care, but the balance seems to be overly weighted against EBM, which should be the prime driving force. There also appear to be technical mistakes or omissions. For example the zanamavir revised appraisal (Relenza, `the flu drug) recommended use in patients with asthma or chronic lung disease, whereas the Summary of Product Characteristics (SPC—specifications that lay down the licensing recommendations which are designed to ensure safety) advises caution with this group of patients and also clearly states that there is no evidence of benefit in this group. Another example is that the sibutramine guidance failed to state that the SPC advises that the drug should be used by "under the care of a physician skilled in the treatment of obesity" This is a key point and recommendations for the use of the drug hinge on the definition of this group. In future it might be worth involving drug information pharmacists who are highly skilled and trained to identify these points. I am aware that confidentiality has been an issue, but this should not hamper appropriate professional involvement.

  4.5  From a GP perspective there are concerns about how realistic and how useful the guidance, so far issued has been. For example, the advice on the use of proton pump inhibitors seemed too general to change or refine practice. This guidance also omitted a crucial issue; that of concomitant prescribing of PPI with anti-inflammatory drugs to reduce risk of adverse gastrointestinal events (it has been estimated that as much as 20 per cent of PPIs are used in this context). Another area of contention was the advice on the new anti-inflammatory drugs, the COX-2 inhibitors, that appeared to sanction widespread use of "black-triangle" drugs (those that are still under intense surveillance by the Committee on Safety of Medicines to determine their adverse effect profile). Another technical point is that again it would have been useful to have some comment on how COX-2 inhibitors compare with the use of PPI plus conventional anti-inflammatory drugs in reducing risk of adverse gastrointestinal events. Also this appraisal included two drugs which were not strictly in this class, and where the evidence base was less secure—meloxicam and etodolac. Why these latter drugs were included is unclear.

  4.6  The real problem that has challenged the credibility of NICE with GPs has been the change in guidance for use of zanamavir (Relenza, the `flu drug) without an obvious change in the evidence base to support this approach. This could have major implications for GP workload at the time of a flu epidemic and it is unclear how practical this advice is. There is a concern that there was insufficient involvement of GPs at the time of this appraisal.

  4.7  A major current issue is the recent directive stating that NICE recommendations should be funded within three months of release. This creates major conflict with local priority setting. The problem is that the guidance recommended may be relatively unimportant alongside other local issues. It may divert resources away from other important projects, particularly diverting manpower (the NHS seems more personnel and resource strapped than cash-strapped, at present). At present it seems perverse to progress straight from the situation of "NICE blight" to rapid implementation at the point of release; this does not enable strategic planning. One solution here is to carefully demarcate where guidance is intended to reduce postcode prescribing; for example certain high cost low volume drugs, which are deemed to require immediate action, from those other appraisals where service development has greater importance (for example, drugs in Alzheimer's disease). There should be greater flexibility allowed in local implementation.

  4.8  A concern already alluded to, is the development of advice on using a drug outside the context of a disease management framework. The two anti-obesity drugs, orlistat and sibutramine give an example of this. These clearly should be used within a carefully constructed and agreed obesity management guideline. Taken in isolation it is difficult to know how best to use these; for example, which should be used in preference and in what circumstances. Part of this problem is that NICE appears constrained by the very narrow focus they are given for their appraisal questions. It would seem better to make this more flexible so that the appraisal could have greater range, where necessary, which would make the guidance more workable.


  Apart from those mentioned earlier in my report, some suggestions that may improve the process are:

  5.1  Greater independence from political processes. This may be possible if decisions on clinical effectiveness are separated from decisions on affordability. Also prioritising of topics for NICE should be more closely focused on the NHS service needs, rather than driven by media interest or political choice.

  5.2  NICE seems to have a very large agenda. Is this realistic for one body? One suggestion is to divide this into separate functions; for example, a National Cancer Institute, a National Guideline Institute, and a National New Drug Advisory Committee.

  5.3  Enhance funding of NICE to enable more robust processes and speed up the work. At present there is a concern that much support is provided on the basis of good will and this may be overstretched.

  5.4  Ability to be more reactive to urgent needs. The advent of the drug imatinib for chronic myeloid leukaemia was sudden, but the appraisal will not be until later this year. The NHS needs urgent guidance in cases like this.

  5.5  Greater involvement of the service; involving prescribers and drug information specialists more closely, (hospital doctors, GPs, nurses and pharmacists) and seeking views of health care commissioners in the consultation process. Also, it might be better to have a greater mix of these people on the various committees. I was quite perturbed to hear from NICE, at a recent conference, that there is no mechanism of feedback or appeal from within the NHS.

  5.6  Mechanisms to enable local priorities to be incorporated within plans to use the appraisals and guidelines. Maybe the output could be stratified so that subjects for immediate implementation are highlighted (rather than a blanket requirement).

  5.7  In conclusion, my view is that NICE should be welcomed and when it has fully developed and evolved, will be very useful and improve equity of health care provision. If the process becomes timelier it will enhance and speed up access to effective treatments. The main impact of NICE will be seen with the further development of national clinical guidelines.

January 2002

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