Select Committee on Health Appendices to the Minutes of Evidence


Memorandum by Dr Andrew Bamji (NC 8)


  I do not believe that NICE presently offers a fully credible assessment system for new drugs and health technologies:

  1.  The internal evidence on which it bases judgements is open to question.

  2.  It cannot respond in a timely way to new evidence.

  3.  Its cost-effectiveness judgements are arbitrary and open to challenge.

  4.  There remains the potential for drugs and procedures to be refused on cost grounds alone, even when the evidence of clinical benefit is overwhelming.

  5.  Refusal may relate to population rather than individual cost, which is unfair to individuals.

  6.  The process of submission from interested parties is time-consuming and costly.

  7.  The appeal system causes delays.

  8.  It does not enable by default the prescription of new remedies in a system of cost competition and limited budgets.

  9.  Its decisions have been questioned (and modified) outside the standard system of evidence-based medicine.

  10.  NICE has no parallel within the European Union, and thus decisions it makes may be at odds with decisions of other EU countries and could potentially be challenged in the European Court under Human Rights legislation. In the current circumstances I believe that equity in prescribing will not be achieved unless NICE or some equivalent body has pan-European powers.

  11.  If NICE suggests that longitudinal data must be collected to inform a decision, but then indicates that it will not support the introduction of a drug or procedure until such data is available, then post-marketing surveillance will die in the UK.

  12.  If NICE proscribes a drug or procedure which is later, by virtue of such evidence, found to be appropriate one has to ask whether patients denied treatment would have a case for legal redress. This is particularly likely if that drug is clearly effective clinically, but has been turned down on cost grounds alone. The costs of any judicial review, class action and/or damages could be substantial.

  13.  If a decision from NICE is agreed by all parties (clinicians, patients and government) then there is no problem. In the case of a refusal the decision needs only to be questioned by one of the parties for trouble to ensue. As I have signed a confidentiality agreement I cannot reveal details of NICE advice in draft to which I am privy, but the ß-interferon saga is sufficient evidence; even though the clinical evidence of benefit is weak, patient pressure has forced a change of attitude by government which effectively overturns the NICE ruling. If this can happen then NICE's position as an independent body is fatally compromised.

  Neither do I consider that there is any need for NICE to develop clinical guidelines because other national bodies (such as the Royal Colleges, specialty societies and other professional and patient organisations) have shown that they can produce robust guidelines. Any produced by NICE are likely to duplicate effort


  1.1  I am grateful for the opportunity to submit a written statement to the Select Committee. I do so as an individual.

  1.2  I am a consultant in rheumatology and rehabilitation in a District General Hospital within the London Region. I have a busy practice in the former (I have over 420 patients with Rheumatoid arthritis under regular follow-up) and on the Elmstead Rehabilitation Unit I supervise the ongoing care of 190 severely disabled patients, the majority of whom suffer from multiple sclerosis (MS). Until April of this year I was Chairman, Clinical Affairs Committee of the British Society for Rheumatology and a member of the Society's Council. In that capacity I have been responsible for or involved in the preparation and co-ordination of submissions to NICE made either by the BSR or by the umbrella organisation, the British League against Rheumatism (BLAR). These have included:

    —  Participation in the development of guidelines for the referral of back pain and osteoarthritis of the hip and knee.

    —  Submissions to NICE on autologous cartilage transplantation COX-2 selective anti-inflammatory drugs TNF- blockade in rheumatoid arthritis (RA).

  1.3  I remain Chairman of the BSR's TNF- Register Committee and of the Data Monitoring Board.


  2.1  Is NICE providing clear and credible guidance?

  2.1.1  The documents produced by NICE have from my experience been clearly expressed, but the guidance has not always been credible, or usable. Two examples suffice:

  2.1.2  The involvement of the British Society for Rheumatology in the production of GP referral guidelines (vide supra) occurred by chance; an enquiry to NICE by one of our officials on another matter revealed that they were in preparation, but representation had only been sought from GPs, orthopaedic surgeons, therapists and patient groups. All of the conditions discussed are frequently seen by rheumatologists and specialty involvement should have been automatic. Similar omissions may have occurred elsewhere and would clearly undermine any decisions. In this case significant alterations to the draft proposals were suggested, and agreed; but the late involvement of the specialty led to tensions with other representatives who resented major changes being made to documents that they had already agreed. Indeed the plethora of groups involved resulted in guidelines that were so loose (to accommodate differing points of view) that they added little to existing material. I was clearly given the impression at the time that the omission occurred because NICE was under government pressure to deliver on a large number of targets and was simply unable to cope with the workload. It may therefore be that my experience was a "teething problem", but it will be counter-productive to load so much work onto NICE that it either cuts corners or fails.

  2.1.3  Guidance on the use of COX-2 selective agents is clear but unworkable. These agents are used to treat the pain and inflammation of arthritis, being part of a larger group of drugs known as non-steroidal anti-inflammatory agents (NSAIDS) which have a propensity to cause bleeding within the gastro-intestinal tract. COX-2 selective agents have a much lower risk, but are more expensive than older drugs. NICE has set criteria for prescription related to age and risk of bleeding, but indicates that they should not be co-prescribed with anti-ulcer drugs (such as H2 antagonists or proton pump inhibitors). However such guidance does not take into account the clinical situation of a patient who has been unable to tolerate standard NSAIDs with or without such drugs, gets good relief from a COX-2 selective agent but gets indigestion on it. I doubt that any consultant rheumatologist would not co-prescribe an anti-ulcer drug in such circumstances and on that basis the NICE recommendations are being ignored. If they were to become mandatory, as has been suggested, then specialists would have to consider the risk to themselves of breaking the guidelines set against the risk that their patient might sue them if they conform when the clinical situation suggests they should not.

  2.2  Has NICE ended confusion by providing a single national focus?

  2.2.1  Certainly not. While a drug is still under consideration by NICE, Health Authorities and Primary Care Trusts have prevaricated over introduction. The assessment process takes at least 11 months, longer if there are disputes or appeals, and NICE does not always decide on assessment immediately a new drug or health technology is launched. Thus a drug may be available, but cannot be funded because purchasers invoke a reference to NICE as an excuse to delay a decision (notwithstanding the original provision of HSC (99) 176 and interventions in the House of Lords). Once NICE has deliberated, then government interference may anyway subvert its decision. The classic example of this is the case of ß-interferon in MS, where a preliminary decision was leaked, with awkward consequences, and the final decision (being unpalatable to patient groups in particular) being effectively overruled by a decision that the drug could be freely used but that the NHS would only pay if it worked, leaving the drug companies to pick up the bill for patients where it didn't. If NICE is to be independent then this sort of thing must not happen.

  2.2.2  A further issue is that of the level of cost effectiveness that NICE deems to be acceptable, and on what basis the cost effectiveness calculations are made. When NICE was established its aim was to judge clinical effectiveness. However it appears from recent preliminary and final rulings that even if a drug is found to be effective it may yet fall foul of NICE by being too expensive; at present the "cut-off" figure appears to be about £30,000 per patient per year. The derivation of this arbitrary figure is unclear. There also appears to be a differential applied depending on the number of patients likely to benefit. Thus a drug used on a short term basis in small numbers of cancer patients may pass, while an equivalent in cost per patient terms but suitable for long term use in large numbers may fail. Furthermore while NICE has questioned some submitted cost analyses and found them wanting, it has then applied its own analysis which may be no less suspect.

  2.2.3  NICE have, in one draft judgement, expressed the view that there may be a need for large scale studies or surveys (over and above those conducted as part of any standard post-marketing surveillance programme) to assess both longer term benefit and risk. However it is unreasonable to expect that such data could be collected by what effectively is an indefinite clinical trial at the expense of the drug company, particularly if the company is not required to do this elsewhere in the world. Some rare side-effects may take years to be appreciated while long term benefits from short or medium term treatment, for instance in the field of arthritis, may take decades to quantify. For example, it is recognised that the development of joint damage from RA will result in a need for later joint replacement surgery; also the life expectancy of RA sufferers is reduced. Any new drug which, by stopping early inflammation, may reduce these risks will not demonstrate this within 10 years. If NICE proscribes a drug then the research it requires to approve use will necessarily be driven overseas while British patients may be denied treatment freely available elsewhere.

  2.3  Is NICE providing guidance that is locally owned and acted on in the right way?

  2.3.1  Experience so far suggests that clinicians have questioned some NICE conclusions (in particular those that deny or restrict a drug's use) while purchasers use the guidance to block prescription. The guidance on uncemented hip replacements was widely condemned by orthopaedic surgeons on the basis that the evidence had been inadequately reviewed. However there are local variations, and because of this postcode prescribing still occurs. In some instances the guidelines have been generally accepted, and clinicians have worked with purchasers to devise rational prescribing strategies.

  2.3.2  But evidence may continue to accumulate following a NICE ruling, and that evidence may have a fundamental effect on the decision. For example, initial reports suggested that one COX-2 selective agent might predispose patients who took it to an increased incidence of adverse cardiac events, while later research appears contradictory. Such shifting of ground inevitably means that much time could be wasted at a local level in continual review of evidence, and I doubt whether NICE has the capacity to run rolling reviews.

  2.4  Is NICE actively promoting interventions with good evidence of clinical and cost-effectiveness so that patients have faster access to treatments known to work?

  2.4.1  NICE promulgates its advice most comprehensively; paper documents are circulated widely and material is available on the Internet. However the promotion and introduction of new and expensive treatments does not in my experience involve NICE at all, but is driven by local discussions between clinicians and purchasers on the one hand and by political pressure by patient groups on the other. When new treatments are clearly of benefit and cost-neutral then no problems arise. When they are expensive (though potentially just as beneficial) then if they fail on cost grounds the patients may not get treated.

  2.4.2  Further, in a limited budget the funding of an expensive new treatment may require the diversion of funds from elsewhere. We have had local experience of just such an episode; Bexley & Greenwich Health Authority, when given extra funding of some £9 million two years ago, chose to place £6 million with Greenwich Hospital to "bail out" a financial crisis, almost £2 million with the local mental health Trust, just £150k to my own hospital and £1.5 million for two patients (that is £750k for each patient) with haemophilia who required a special preparation of Factor VIII. In such a situation the movement of money to fund TNF- blockade in RA (which we estimate to be about £200k for Queen Mary's) is going to cause extreme stress in the financial system.

  2.4.3  The only way for NICE recommendations, if expensive, to be implemented with equity is for all necessary funds to be ring fenced and delivered to providers on top of their normal allocation.


  3.1  I have been involved in the preparation of three submissions to NICE in my capacity as an official of the British Society for Rheumatology. I have not been the designated witness for the Society in any of those three, but estimate nevertheless that I have spent a minimum of three hundred hours in meetings, discussions, teleconferences and document reviews in the last 18 months. In two cases the review process has involved over 20 people. This expenditure of effort is unpaid and interferes significantly with clinical work.

  3.2  I have been party to some pharmaceutical company submissions. The time and cost of these submissions is substantial. I have also seen some of the officially commissioned evidence on which NICE has based its cost-effectiveness decisions. These too are lengthy and expensive; those produced by clinicians must necessarily interfere with clinical work, but not all have been underpinned by the input of a health economist.

  3.3  I have several concerns about the process.

  1.  There is much duplication of effort (thus, professional submissions necessarily repeat much of the evidence base quoted by NICE's advisers, but are essential inclusions for clarity and completeness).

  2.  It far from clear whether all of the official evidence is robust (in other words I would question the competence of some of it).

  3.  It is lengthy and expensive.

  4.  The usual terms of reference make it difficult if not impossible to include data on non-NHS costs or savings. Thus assessments of potential changes to Social Services spending, or the effects of keeping patients in work by providing treatments are not addressed fully.


  1.  It is already apparent that political pressure can subvert or even overrule a NICE decision, which raises questions about its independence.

  2.  Decisions may require review in the light of new evidence, and I do not believe that NICE has the capacity to maintain a comprehensive review system.

  3.  Decisions on cost-effectiveness are apparently arbitrary, do not have any internal comparison and may fly in the face of both clinical evidence and practice in other countries. It makes it impossible for clinicians to manage patients who know that a drug that is unavailable on the NHS may be available in Europe or the USA and this simply results in a shift of the discussion from the medical to the political arena. It seems to me that then the "anything for a quiet life" philosophy takes over.

  4.  In the absence of resources a NICE decision to recommend a new and expensive treatment does not deliver the needed resources to the prescribing clinicians, who still have to negotiate locally, placing their bid against other competing requests. Local differences in priorities lead to postcode prescribing on that basis.

  5.  I have no doubt that the NICE process has to some extent informed the cost-effectiveness debate. However such debates have taken place at a local level for decades and have resulted, for example, in the development of drug formularies by hospitals and prescribing committees that recognise the different costs of preparations that do the same thing, allowing economies by avoidance of expensive drugs and bulk buying others.

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Prepared 8 July 2002