§ Lord Mackie of Benshie asked Her Majesty's Government:
§ Why sufferers from multiple sclerosis cannot receive the drug Beta Interferon in certain parts of the United Kingdom while in other parts it is available.
§ The Parliamentary Under-Secretary of State, Department of Health (Lord Hunt of Kings Heath)My Lords, it is because of our determination to tackle the problems of postcode prescribing that we asked the National Institute for Clinical Excellence to conduct an authoritative appraisal of the evidence on Beta Interferon as part of its first appraisal programme; NICE has not yet issued any final guidance.
§ Lord Mackie of BenshieMy Lords, I thank the Minister for that reply. Is it not extraordinary that NICE was asked in August 1999 to report on this important drug but there is still no sign of a report? I understand that appeals have been made. What appeals can there be against clinical judgment and scientific evidence?
§ Lord Hunt of Kings HeathMy Lords, NICE undertakes a programme which allows for evidence to be carefully considered, for meetings to be held with manufacturers, sponsors and patient groups, for external submissions to be received and for assessment reports— in this case, from the Northern and Yorkshire Drug and Therapeutic Centre—to be made. When that process has been gone through, the initial appraisal committee meets to consider Beta Interferon. It produces a provisional assessment, which is made available to the interested parties. The final appraisal committee has to meet to consider these matters. There is also an independent appeals process. Clearly, there are a considerable number of stages in that process, but I believe that that is right because the guidance given by NICE is crucial in deciding whether a particular drug or treatment is effective and cost-effective. It is therefore right that it has to take some time to ensure that the final guidance is as good as it possibly can be.
§ Baroness Gardner of ParkesMy Lords, is the Minister aware that the interim report on Beta Interferon issued by NICE was very unfavourably received by sufferers from multiple sclerosis? The report said that the drug should continue to be available to those already taking it but not to others.
940 The matter is now being further considered. Can the Minister say whether NICE takes into account the relative cost of £10,000 for the drug—I know that value for money is one of the considerations—as compared with the cost of supporting the patient if he is unable to work and has to rely entirely on the state? Is that one of the factors taken into consideration by NICE, or is it simply a question of the effectiveness of the drug?
§ Lord Hunt of Kings HeathMy Lords, it is difficult for me to comment on the consideration of Beta Interferon because NICE is still in the process of producing final guidance. It would not be appropriate for Ministers to comment on that process until the final guidance has been received. The noble Baroness asked about the methodology used by NICE. Its task is to access the evidence of all the clinical and other health-related benefits of an intervention. That is taken in a wide sense, to include impact on quality of life, the relief of pain or disability and any impact on likely length of life. It has to estimate the associated costs and reach a judgment on whether, on balance, the intervention can be recommended as a cost-effective use of NHS resources.
§ Lord Clement-JonesMy Lords, is not the real answer to my noble friend's Question a gross lack of resources on the part of NICE? This year, some 26 appraisals along with other work will need to be carried out by NICE. Next year, 45 appraisals will be carried out. Yet NICE operates with only 28 full-time equivalent staff. Is that why the head of NICE's appraisal section resigned in July this year?
§ Lord Hunt of Kings HeathMy Lords, NICE has done a valuable job in the year it has been in operation. It has produced a considerable amount of valuable guidance on drugs and treatments. I can assure the noble Lord that we shall keep under review the budget and scale of work that we commit to NICE in order to ensure that it is able to keep pace with the demands being made of it. Coming back to the issue of Beta Interferon, the time NICE has taken to go through the various stages is absolutely justifiable in terms of reaching the right conclusion at the end of the process.
Lord Bruce of DoningtonMy Lords, can my noble friend give the House the text of the precise factors that are taken into account in determining whether the drug is cost-effective? Can he give an assurance that those who determine whether a particular course of treatment is cost-effective are capable of arriving, from an accounting stand-point, at the precise figures on which he relies?
§ Lord Hunt of Kings HeathMy Lords, in my response to the noble Baroness, Lady Gardner of Parkes, I mentioned the general indicators considered by the National Institute for Clinical Excellence when reaching a judgment on a treatment's efficacy and cost-effectiveness. NICE's own board and advisory committees, which comprise some of the best experts 941 in this country, are able to offer advice on such considerations. The institute must ultimately make a judgment, taking into account factors such as how effective a particular treatment is likely to be, its cost and its impact on patients in the NHS. A balance has to be struck. If drug is expensive but offers only limited clinical benefit, NICE would probably be expected to advise against its use.
Perhaps I may say also that, over the past few months, NICE has sent guidance to NHS organisations recommending that a number of drugs which previously were available only sporadically in the NHS should be made more generally available. As I have said, NICE should have an impact in ensuring that the treatments and drugs used in the health service are both clinically effective and cost-effective. In many cases, if they are, they will be brought into general use within the NHS far more quickly than has been the case in the past.
§ Lord Roberts of ConwyMy Lords, is it not a fact that Beta Interferon has been made available to certain NHS patients in certain NHS trusts? Does the Minister agree that this amounts to what is, in effect, a two-tier health system?
§ Lord Hunt of Kings HeathMy Lords, that is precisely why we have referred this matter to NICE. At the moment, health authorities operate a policy introduced in 1995 by the previous government. Essentially, it provides for individual cases to be considered on their merits. It is clear that that has led to enormous variations in policy in terms of the number of people receiving Beta Interferon in different health authorities. The effect of the guidance from NICE, when eventually it is published, will be a much more uniform application in accordance with that guidance.