HC Deb 27 June 2000 vol 352 cc183-90WH

12 noo

On resuming—

Mr. Steve Webb (Northavon)

Provision for people with multiple sclerosis is an issue that has concerned hon. Members of all parties throughout the lifetime of this Parliament, and doubtless before that. The specific issue of beta interferon has been raised a by a number of hon. Members. It was raised last year by the hon. Member for Buckingham (Mr. Bercow), and more recently by my hon. Friend the Member for Sutton and Cheam (Mr. Burstow).

Today's short debate is timely, given a recent leak from the National Institute for Clinical Excellence, suggesting that NICE will recommend that provision of beta interferon for new applicants should not be funded by the national health service. That announcement was one of the few that has made me genuinely angry since becoming a Member of Parliament, because the hopes and expectations of MS sufferers had been raised by the involvement of NICE. Given the drug's effectiveness for particular groups of sufferers—which I shall discuss in a moment—the assumption was that there would be a positive outcome. I know from first-hand experience that both those who receive and those who might receive the drug were angry at the leaked announcement.

In this short debate, I want to discuss three aspects. The first is the effectiveness or otherwise of beta interferon, the second is why and whether the drug should cost so much, and the third is the process through which any Government must decide whether to pay for expensive drug treatments of this type.

On the drug's effectiveness, I shall begin by reading an excerpt from a letter that I received from a constituent. She first contacted me more than two years ago, at a time when her health authority, Avon, would not pay for beta interferon, although she would have got it had she lived in a neighbouring authority. She and I, with the Multiple Sclerosis Society and others, waged a campaign and were delighted when Avon health authority agreed at the beginning of last year to fund a limited number of courses of treatment—about 12.

My constituent was one of those who benefited. She now receives beta interferon, and it is paid for on the national health service. She said that the drug is effective in slowing down the progression of my disease. During 1997 I suffered several attacks and was unable to work for three months. I was faced with the prospect of having to use a wheelchair within months. Since starting with Beta Interferon in December 1997— at which point, she was paying for private treatment— I have had only two attacks and I am still managing to walk and work. It is easy for those who do not suffer from this disease unthinkingly to use the phrase "a relapse", but it is clear that relapses can be devastating to MS sufferers who, as a result, cannot work or look after their children. Any drug that can reduce the number and frequency of relapses will make more than a marginal difference to those concerned. I am not saying that beta interferon is a cure, but it is clear that, for some, it can bring about a real and substantial improvement in the quality of life.

Mr. Paul Burstow (Sutton and Cheam)

My hon. Friend is right to draw attention to the many MS sufferers who feel that beta interferon treatment results in reduced relapses. Does he agree that the Minister needs to explain why NICE has apparently refused to take evidence from MS sufferers on the drug's impact on the quality of their lives?

Mr. Webb

My hon. Friend makes an important point. Clearly, anecdotal, individual experience does not provide the cast-iron proof that, say, a double-blind controlled trial might provide. If a body that is charged with assessing the consequences of spending money on a drug does not hear at first hand about the effects of that drug and the benefits that it can bring to real people in their real lives, it misses part of the story. It is therefore regrettable that that does not appear to have been fed into the process.

After I had secured this debate, my office received a phone call from a head teacher in Essex, who said that three members of staff in his school suffer from multiple sclerosis. Two of them receive beta interferon, and have benefited greatly from it. One had previously taken six months' sick leave. Since receiving the drug, one has taken just two days off sick and the other has taken three days. Furthermore, they are less dependent on steroids.

The head teacher pointed out that at his school the public sector pays £150 a day for supply teaching, and remarked on the cost to children in terms of disruption. His closing comment was that, as an employer, he feels that the Government need to do some joined-up thinking. One of my concerns about the process is that the cost-benefit comparison does not take a broad enough view of the potential benefits to people who receive the drug—not only to their individual lives, but to society and the economy as a whole. NICE is receiving only a partial picture.

I discussed the drug with Dr. Malcolm Campbell of Frenchay health care trust, who is one of the leading MS specialists in my area. His key point was that there is no alternative to the drug. People who can benefit from it have access to no other form of treatment to make their relapses less frequent. I accept that NICE is considering general provision for people with MS, and that there is a strong case for greater and improved provision for such people. However, it is a false dichotomy to say that some people can have a drug that prevents the disease from progressing, slows it down or makes it less awful, or other people can have proper community care—as though there is a fixed pot for MS sufferers, which can supply drugs or support, but not both. NICE is not there to make those kinds of decisions.

The consultant said that in the rest of Europe about one in eight MS sufferers typically benefit from the drug, whereas in the United Kingdom the figure is around one in 30. That leads to a fundamental question. Is the rest of Europe wrong, in that the drug is being given to people who do not need it or benefit from it, or we are wrong? During last week's Prime Minister's Questions, the Prime Minister said that only 12 per cent. of sufferers in France, Germany and Italy receive the drug. However, in this country the figure is only 3 per cent. He argued that the treatment will not benefit everyone, which is true, but it could certainly benefit more people than are currently receiving it.

There is currently no viable alternative to beta interferon. It clearly benefits people who suffer from relapses followed by periods of remission. In the long term, the situation is less clear. The consultant told me that some people have been taking the drug for five years, and that we do not know much beyond that in terms of whether it wears off or has long-term beneficial effects. However, the potential is there, and it would be disturbing if funding were to be cut off at this stage.

I want to refer briefly to the vexed issue of the cost of the treatment. I believe that a figure of £10,000 for a year's course is frequently used. Dr. Campbell told me yesterday that £8,500 is now more accurate, because of the Government's efforts to put pressure on suppliers to bring the cost down. The Government are to be applauded for that. However, he also told me that whereas the figure is £8,500 in the United Kingdom, it is $8,500 in the United States. For some reason, the same drug is substantially cheaper in the US. I have been told that the same is true of Portugal, but I do not know whether that is so.

In all debates on expensive drugs, questions must be asked about the prices that are charged by drug companies and manufacturers, and whether the Government are doing enough to apply pressure to bring those prices down. I accept that companies need a return on their research and an incentive to do that research, but is the balance right? If they are prepared to sell the drug for $8,500 a year in the US, why should the figure in the UK be £8,500?

My final point concerns the process by which the Government, or any Government, should decide about such issues: the NICE approach, so to speak. The principle that there should be an independent body that can do what dozens of individual health authorities across the country cannot reasonably be expected to do—that is, to review the written clinical evidence, take oral evidence and spend time and money evaluating the clinical effectiveness of the drug—is right. It will help to reduce unevenness in this country, of which we are all aware.

Of what should the institute take account? I believe that it is taking account of matters that are not its legitimate concern. Hon. Members do not have the clinical expertise to judge whether the treatment works, although such evidence exists. It is widely accepted that it reduces the number of relapses by about a third.

Originally, NICE had a remit for clinical excellence and effectiveness, but its remit has been extended. In August 1999—I do not suppose that August is prime time for hon. Members to scrutinise legislation—a short statutory instrument was laid before the House stating that NICE's constitution should be amended. It stated: after the words "promotion of clinical excellence" there should be inserted the words "and of the effective use of available resources". In a sense, no one could object to that—rather like motherhood and apple pie, all of us approve of the effective use of available resources. The question is, who should decide what is available? The answer must be that the elected Government of the day, rather than clinicians, should do so. If NICE took such decisions, it would be second-guessing political decisions on the Government's behalf. For example, the Government could have decided to put up the standard rate of income tax by 1p, and they could have put approximately £2.5 billion into the health service, which would have increased available resources. NICE could say, "Available resources are greater, and the health service should pay for beta interferon," but would it do so in that context? That would affect the resources that were available.

What is going on? Are not the Government abrogating their responsibilities? No one doubts that such decisions are difficult, and that prioritisation is needed, but the Government should not palm off such decisions to what is, in effect, a quango. Should not the Government accept responsibility for such decisions? They should say to the electorate, "We shall increase taxation to pay for the expensive drugs that we want in the NHS, or we shall not increase taxation, and you cannot have those expensive drugs." People elect us to take such decisions—they should not be handed to an allegedly independent third party.

Ms Oona King (Bethnal Green and Bow)

Obviously, the Government have increaed resources to the NHS. On transparency, does the hon. Gentleman agree that it would be helpful if the clinical guidelines on the overall management of MS, which the Government have asked for, were made available before a decision was taken about the availability of beta interferon?

Mr. Webb

I am sure that greater openness in this whole process would be advantageous. I have no problem with making more explicit the criteria that are used to take such decisions—in a sense, that is the thrust of my argument. A body is needed to examine clinical effectiveness and excellence, and it cannot exist in a world in which there are no financial constraints. Cost-effectiveness involves saying, "If £1 is involved, that is great, but if £1 million is involved, that is silly." We need to sort out the finer details concerning political priorities and available resources.

Why was the statutory instrument produced during the summer recess, when there was limited scope for scrutiny? I accept that the instrument was subsequently debated, but why was the provision introduced as an afterthought? My concern is that the Government felt that they had let the cat out of the bag—they had set up NICE and asked it to examine effectiveness, but they were worried that it would give the wrong answers. The provision was designed to stop it from doing so—that is what it was doing with regard to beta interferon.

I hope that the Minister will assure us that clinical judgments will be made by clinicians and that political judgments will be made by politicians. Those decisions affect my constituents and those of many hon. Members. I welcome the fact that many hon. Members have attended this debate in an effort to show their solidarity with those constituents who need beta interferon. I see many nods around the Chamber. I hope that the Minister agrees that clinical effectiveness is the key and that the Government will not simply say no and abrogate their responsibilities. They should take the political decision and decide whether money should be found for a treatment that many of our constituents need and expect.

12.15 pm
The Minister of State, Department of Health (Mr. John Denham)

I congratulate the hon. Member for Northavon (Mr. Webb) on securing this debate. This is a good time for me to place on record a few comments following the controversy aroused by the unauthorised release—the leak— of the National Institute for Clinical Excellence's provisional guidance on beta interferon.

I hope that the hon. Gentleman will understand that it was a leak, and that the Government do not intend to comment on it at this stage. There are further stages to be completed in the National Institute for Clinical Excellence's approval process. We have not made public comment on any of the draft appraisals so far circulated by NICE, and we do not intend to change our position on the issue. However, it is a matter of great public interest and I recognise how this discussion must appear to those who face this disabling condition and whose hope for any relief is entirely understandable.

Multiple sclerosis, as we know, is a disabling neurological disease affecting about 85,000 people in the United Kingdom. We have great sympathy for those patients and their families. It usually strikes early in adulthood, and affects about twice as many women as men. The course of the disease is unpredictable, and it varies in progression rate and severity between patients. It has a major adverse impact on the patient's quality of life, especially during relapses, which may require hospitalisation. Disabilities that arise can include weakness, chronic fatigue, impairment of speech, vision and movement, incontinence and complete paralysis, as the hon. Gentleman and the hon. Member for Sutton and Cheam (Mr. Burstow) said. The hon. Gentleman also said that there was no cure for MS.

A variety of services exists to minimise the suffering from this distressing disease, including skilled nursing support, physiotherapy and symptomatic drug treatment to help to manage symptoms such as fatigue, spasticity, pain and depression. Acute relapses are managed, when necessary, with corticosteroids. All those provisions require close collaboration between primary and secondary care services, and the development of pathways of care that we are promoting is well suited to foster the right management of care.

There are three beta interferon products. They are licensed for the treatment of the relapsing remitting form of the disease and one of them, Betaferon, is licensed for the treatment of the secondary progressive disease. The treatments are targeted at modifying and possibly slowing the course of the disease. The beta interferons commonly cause some side effects. The cost of beta interferon treatment is about £10,000 a year per patient.

Clinical trials have shown that all three products reduce the relapse frequency in patients with the relapsing remitting disease. The drugs may also reduce the severity of relapse. Disability progression also appears to be delayed by active treatment, but the longer-term effects are not certain, in part because of the production of neutralising antibodies whose clinical significance is still uncertain. Studies of the secondary progressive disease also show reduced frequency of relapses. There are inconsistent findings in the available clinical trials about the effects on slowing the accumulation of disability in secondary progressive MS.

However, the experts have so far placed differing emphasis on the evidence from clinical trials. Some neurologists are keen to prescribe these products, at least to some patients, but others remain sceptical as to the value of prescribing beta interferon or argue that available resources for MS care would better be used in providing alternative forms of health care support such as specialist nursing or physiotherapy.

The various policies adopted across the country for the use of this treatment confirm that clinicians disagree. There is also widespread agreement that we do not know as much as we would like about the longer-term effects of prescribing beta interferon year after year. These differences in clinical opinion were graphically illustrated only last week in interviews broadcast on the BBC news, when two consultants expressed diametrically opposite views on the clinical value of the drug.

Betaferon was the first product to receive a licence, in 1995. Differing views about the evidence from clinical trials were apparent at the time. The previous Government issued guidance in 1995 that left many of the key decisions to be taken at a local level. It recommended that prescribing should be initiated by hospital neurologists when clinically appropriate and asked health authorities to develop local arrangements with hospitals for purchasing and prescribing the treatment. Resource implications were left for local assessment.

The emphasis on local decision taking is the origin of the lottery of care often referred to as postcode prescribing. We continue to receive a steady influx of complaints across a range of issues from patients and clinicians, who cannot understand why there are wide divergences in local policies. All health authorities currently have policies in place by which some patients can receive beta interferon, but some are more restrictive. The percentage receiving beta interferon varies from about 0 per cent. to about 7 per cent. That amount of variation has given rise to great concern.

Mr. Barry Gardiner (Brent, North)

Does my hon. Friend accept that the beta interferon decision will be critical to the future of NICE? If NICE loses public confidence over this issue, that will undermine its important work in providing medical solutions that are clinically rather than politically or financially led.

Mr. Denham

My hon. Friend will understand that one reason why I believe it is inappropriate for me to comment in this debate on what is currently a draft proposal is that the integrity of the NICE decision-making process must be seen to be intact and not subject to guidance, expressions of opinion or anticipation of outcomes from Ministers. The credibility of NICE is indeed important.

On this issue, as on a number of others, the Government believed that leaving decisions to local health authorities without any guidance or support was an evasion of the Department's responsibility at central level. That is the background to the development of NICE and the referral of beta interferon to it.

We have acknowledged on a number of occasions that priority setting is a necessary part of any health care system. It has always been done in the national health service and will continue to be. It is right and proper that priorities are set that make the best use of the NHS's available resources. We do not deny that difficult issues can arise that generate controversy, as when we are dealing with a devastating condition such as multiple sclerosis. That has been made worse in the past when the significance of the evidence has been uncertain.

That is the situation in which we found ourselves. It was an unfair situation and we were determined to tackle it. The National Institute for Clinical Excellence was set up to ensure that the NHS's resources could be used to maximum effect and to remove inconsistent and unacceptable variations in care.

Mr. David Watts (St. Helens, North)

Does my hon. Friend agree that it would be ironic if NICE were to replace a system based on postcodes with a system based on whether one developed an illness or medical condition before a certain date?

Mr. Denham

Let me deal with a number of issues that have been raised about affordability and with the comments about the patients receiving the drugs.

The institute's extensive programme of work will set clear standards to ensure that the NHS can focus on treatments that are clinically and cost-effective. It is right to have a single source of authoritative guidance and information to assist health professionals in making complex decisions about patient care. NICE has begun its work. Its guidance to date relates to a number of topics such as wisdom teeth, Relenza, on which the guidance has been restrictive, and ways of promoting the wider use of drugs and technologies such as taxanes and stents, for example.

The hon. Member for Northavon asked about affordability and the changes made to NICE's directions last summer. We have been over this ground before. We made it clear on many occasions well before last summer that NICE would advise on clinical and cost-effectiveness and would issue guidance to the NHS. As we have always said, it is right and proper that NICE should consider clinical and cost-effectiveness side by side.

The hon. Gentleman also said that Ministers should decide the level of resources that are available to the NHS. We have already done so. We recently announced the largest ever injection of resources into the NHS, amounting to an average growth of 6.1 per cent. over four years.

The Government have always said that NICE guidance would take account of cost-effectiveness. The amendment order that we laid in August was a clarification, because we recognised that the original wording of the establishment order did not fully reflect our policy intention to take cost-effectiveness, as well as clinical effectiveness, into account. The amendment simply ensured that the order reflected the policy position that the Government had previously taken.

Mr. Webb

The Minister gave the example of wisdom teeth, on which NICE had made a recommendation. Is there not a difference between that and beta interferon? The argument is that taking wisdom teeth out does not work, not that we cannot afford to do so. That does not appear to be the argument on beta interferon. Is there not a danger that NICE is taking a decision that should be taken by Ministers?

Mr. Denham

Of course I recognise the difference in magnitude between the issues of multiple sclerosis and wisdom teeth. The hon. Gentleman will understand that. We established NICE to advise the service on the clinical and cost-effectiveness of a range of treatments and procedures. We asked NICE to review all the evidence on the clinical and cost-effectiveness of beta interferon for MS and to make recommendations on its use, based on that evidence. Those conclusions were issued in confidence on 16 June. The process is still running, and it would be premature to comment further.

However, following the leak last week of the draft appraisal conclusions, the institute's chairman, Professor Sir Michael Rawlins, said: In order to avoid any further uncertainty in the minds of patients and those who care for them, I have no option other than to confirm that the provisional opinion of the Institute's Appraisal Committee is that other than for those patients who are already receiving these medicines, they should not be made available at the present time. This is because, on the basis of a very careful consideration of the evidence, their modest clinical benefit appears to be outweighed by their very high cost.

Mr. Burstow

Given what the Minister has just said, does he not find it surprising that NICE did not seek evidence directly from MS sufferers in making that determination?

Mr. Denham

The exact way in which NICE seeks information is its responsibility. However, I know that NICE consulted patients' organisations directly as part of the appraisal process. Given that the Multiple Sclerosis Society in particular is a highly respected organisation, I am sure that it will have made adequate representation—although I have not seen it—about the impact on patients. It is also worth noting that from the outset NICE has been structured, through its partners council and in other ways, to ensure that patients' interests are taken fully into account in the way in which it takes decisions.

The final judgment will be taken by NICE. The current period of consultation ends on 17 July, and NICE will listen carefully to all the comments that it receives from those consulted. The procedures then allow for an appeal. It is only after those procedures have been exhausted that NICE will reach final conclusions.

A number of other issues have been raised, but I am not sure whether I can deal with all of them adequately. The hon. Member for Northavon asked about NICE's role in considering wider costs and benefits to society in making its appraisals. Again, I cannot comment specifically on the draft appraisal that is the subject of this debate. However, we have made it clear that companies are free to submit any relevant evidence to NICE that they want taken into consideration. NICE's task is to consider the evidence of clinical and other health-related benefits of an intervention and to judge whether a particular treatment can be recommended as a clinical and cost-effective use of national health service and personal social services resources. That is our position, which we have set out before.

My hon. Friend the Member for Bethnal Green and Bow (Ms King) referred to our request to NICE to produce clinical guidelines. Our research and development division has undertaken some preliminary work on the guidelines which will shorten the period—

Mr. Deputy Speaker (Mr. John McWilliam)

Order. Time is up.