§ Motion made, and Question proposed, That this House do now adjourn.—[Mr. Hill.]2.35 pm
§ Mr. John Bercow (Buckingham)
I am moved to raise the issue of the funding of beta interferon for the treatment of multiple sclerosis by the sad plight of two brave young constituents of mine, Miss Caroline Cripps and Mr. Marc Smith. However, it is only right to say at the outset that there is widespread interest on both sides of the House and outside the House in the subject of beta interferon for the treatment of multiple sclerosis. As the Minister is well aware, that interest is reflected in the 114 written representations that his Department has received from Members of Parliament, patients groups and the public since 1 January 1999; the nine oral questions on the subject since June 1998; the Adjournment debate on a closely related subject introduced by the hon. Member for Sutton and Cheam (Mr. Burstow) on 15 February this year; the 32 written questions on the subject since 1 May 1997; and, last but not least, early-day motion 47, which has attracted 145 signatures, including my own.
In preparing for today's debate, I have spoken to several people who have a direct interest in the subject. I have of course spoken to Caroline Cripps and Marc Smith, but I have also had contact with Dr. Dennis Briley, consultant neurologist at Stoke Mandeville hospital; Dr. Chris Fursdon Davis, consultant neurologist at the Radcliffe Infirmary; Mrs. Jackie Haynes, the chief executive of Buckinghamshire health authority; and Katherine Mercer, the government and industry affairs manager of Schering Health Care plc, which is one of the three manufacturers of beta interferon in this country and the only one thus far to have received a licence for that version of the product that treats people, not with the relapsing-remitting form of the disease, but with the secondary progressive form. Last but not least, I have spoken to and benefited from the briefing of Dr. Matthew Sowemimo, the policy officer of the Multiple Sclerosis Society.
Caroline Cripps is 28 years old; she lives in Westcott, a village in my constituency, and is by training a senior hair stylist at Diamonds in Aylesbury. I am sorry to say that, in June 1997, she was diagnosed with multiple sclerosis. She suffers from the relapsing-remitting form and, shortly after diagnosis, she was obliged to give up her work, although she has subsequently taken a computer training course and would be qualified and equipped to return to work, if her condition were to improve. After three relapses, she applied through her consultant neurologist Dr. Dennis Briley for funding of beta interferon to treat her condition. That request, made in June 1998, was rejected by Buckinghamshire health authority.
Caroline Cripps has to live with the misery and turmoil of that rejection. She has to live with the physical symptoms of multiple sclerosis, with which the House will be familiar—symptoms that are many, varied, unpredictable and the source of continuing fear and anxiety. She has to live with the social consequences of her condition and the denial of the most effective currently available treatment for it: the loss of independence, the deprivation of unemployment, the 613 problem of transportation from one part of the country to another and the unenviable challenge of access to and movement within buildings.
Marc Smith is 32 years old and works for Reynard Motorsport as an assembly technician. He was diagnosed as having multiple sclerosis in 1996, although he had in fact been suffering from the disease since 1991. After suffering three relapses, he, too, applied through his consultant neurologist for funding for beta interferon. Like Caroline Cripps, he was also rejected by Buckinghamshire health authority. That leads me to ask: what evidence is available on the effectiveness of beta interferon as a treatment?
We know that there have been four independent and separate clinical trials of the effectiveness of the drug. The results of those trials have shown that beta interferon can reduce the frequency and severity of relapses, increase the period of remission and slow down the progression of that chronic and debilitating neurological disease. What is more, that evidence has been accepted by the Government—as I hope the Minister will acknowledge. The Department of Health acknowledged that beta interferon could be an effective treatment and issued guidance to health authorities in November 1995 encouraging the prescription of it when consultant neurologists believe that it is clinically appropriate.
Yet how have those at the grassroots responded to that national guidance? Their response has been depressing. For at least two years, Buckinghamshire health authority wholly ignored the national guidance. After much pressure, it now funds only three patients for treatment with beta interferon, even though—and this emphasises the significance of the denial of funding—experts believe that between 20 and 40 people in the county of Buckinghamshire alone could benefit from treatment with it in the short term and that potentially up to half of the relevant client group, some 200 people, could benefit in the long term.
Earlier this year, the priorities forum established by Buckinghamshire health authority recommended against the provision and funding of beta interferon. That caused a furore. There was outrage. I believe that that furore and that outrage were justified, and I was part of it along with several of my right hon. and hon. Friends. On 24 March, Buckinghamshire health authority held a meeting and changed its position. It acknowledged the outcry and strength of feeling and the specialists' belief that the health authority was wrong. It said that it would provide some funding, although it added the caveat—which is enormously distressing to the sufferers and their loved ones, and arguably highly insulting—that it was "not a high priority" and that only "limited funding" of the drug treatment should be identified.
I regret to inform the Minister that, 51 days later, we still do not know how much money the authority will make available, how many people will be treated or by what means those who are to benefit will be identified. This is a serious state of affairs, but it is not peculiar to the county of Buckinghamshire. The problem is widespread—as the Minister, to his credit, has regularly acknowledged. There is a patchwork of provision the length and breadth of the United Kingdom and great disparities between what particular areas and health authorities might provide. That is a serious problem.
614 The Association of Quality in Healthcare has said that few authorities seem to know how much money they are spending on beta interferon or who exactly should qualify for the treatment. We know that 16 per cent. of authorities treat fewer than six patients with beta interferon. We know that only 1.5 to 2 per cent. of multiple sclerosis sufferers in the United Kingdom are treated with beta interferon and that that level compares unfavourably with other countries. In other western industrialised nations, the percentages of sufferers who benefit from the treatment range from 8 to 25 per cent.—the figure is slightly higher in north America than in western Europe, but the rate on the continent is still much better than in this country.
I draw attention to a point that arose during Health questions last week. The Minister of State will recall that, on 4 May, he said that the patchwork of provision and gross disparities in what was available were, as often as not, attributable to differences of opinion among consultant neurologists about whether it was appropriate to prescribe the drug. I counsel the hon. Gentleman against over-egging that pudding. I hope that he will not pray that in aid of his response. Above all, I hope that he will not use it as a cloak for a covert change of policy against the existing funding of beta interferon altogether. I shall tell the hon. Gentleman why I say that.
I have no doubt whatever that the Minister was sincere and his motives were, as always, of the highest, but I believe that he was wrong for two reasons. First, all 18 consultant neurologists in the south-west of England were convinced of the clinical appropriateness of prescribing beta interferon and yet it was continually denied patients in that area for a long period. In other words, even where there was unanimity among consultants, the drug was not provided, so the argument that its lack of provision is due to a difference of opinion is not valid.
Secondly, even where there are differences of opinion—as there are about many medical matters that are not subject to certain correctness and exactitude—surely it does not follow that because some consultant neurologists do not believe that the drug is appropriate for their patients and do not therefore want to prescribe it, it should be denied to patients whose consultants have judged that it is appropriate and should be provided. My challenge is that the drug should ordinarily be prescribed if it is judged to be clinically appropriate.
I have a series of specific challenges to the Minister, to which I should very much appreciate his response. First, I hope that he will put on the record today that it would be wholly unacceptable for any health authority to use the interim period between now and the issue of updated guidance by the National Institute for Clinical Excellence as an excuse to stop or restrict its current funding of beta interferon. That would be cynical; it would be wrong; it would be resented, and I hope that the Minister will declare it thus.
Secondly, I seek the Minister's reassurance that the National Institute for Clinical Excellence will be genuinely independent of the Department of Health and able to make its own clinical judgments. The hon. Gentleman will know that on 11 May, a mere three days ago, in Standing Committee A, which is considering the Health Bill, he was pressed on those important matters, first, by my hon. Friend the Member for Runnymede and Weybridge (Mr. Hammond), at column 505 of Hansard; then by my hon. Friend the Member for Lichfield
615 (Mr. Fabricant), at columns 506 and 512, and finally by my right hon. Friend the Member for Maidstone and The Weald (Miss Widdecombe), the shadow Secretary of State for Health, at column 513.
I hope that the Minister, who is a very agreeable fellow, will not take offence if I say that his answers to their challenges did not inspire me with confidence. He wobbled; he sat on the fence; he was non-committal; he committed the abiding politicians' sin of failing to answer a simple question. 1 hope today that he will make it clear that NICE will be independent of the Department of Health.
Thirdly, I hope that the Minister will tell me that NICE guidance will be mandatory and enforceable; otherwise it will be useless. The problem until now is that guidance has not been mandatory, and therefore it has not been capable of being readily enforced. Authorities have cocked a snook and said, "Well, we don't have to implement the guidance, so we won't." Will the Minister invoke the powers of the National Health Service Act 1977 to force recalcitrant authorities to come into line, and not welsh on their obligations but honour their responsibilities to the patients who look to them for assistance?
Fourthly, I am concerned about the appraisal committees that are to be established. It appears, from the consultation document, that only three specialist doctors will sit on each of those committees, but health economists, local commissioners and academics will also sit on them. Many hon. Members believe that the process of making a clinical judgment about what should be provided should be driven by a majority of people who are concerned not with the theory or financing of health care but with the professional responsibility of day-to-day delivery of health care to those who depend on it. Will such people be in the majority?
Fifthly, should the appraisal committee be anonymous to protect its integrity, as Ministers suggested in the consultation document? No, it should not be anonymous. These people will be highly qualified. They will have important responsibilities. Their decisions will greatly impact upon the health and life chances of thousands, tens of thousands or perhaps hundreds of thousands of people suffering from a variety of conditions. It is crucial that they should be identified to the public.
Sixthly, the economic appraisal should not just be about prescribing costs; it should take account of the costs of home care, of domestic adaptation, of social security costs, of forgone tax revenues. I hope that, as "The Pharmacoeconomics Journal" has requested, the Minister will make clear his commitment on this.
Seventhly, he should not strengthen the criteria on the targeting of the drug, either. There is already targeting. There are already criteria that must be satisfied. There are already limits beyond which people will not get the drug. I hope that he will not use that as an excuse to back down on existing commitments.
Eighthly, the Minister has raised the issue of specialist nursing provision, which of course is an important part of a package of care. Yet although there are great merits in specialist nursing care, there is no evidence that it can reduce the progression of the disease. There is evidence 616 that beta interferon can reduce the progression of the disease. That is why it should be in pole position in this debate.
Finally, the Government have floated the possibility that there could be a significant management challenge in a change of policy resulting in a significant funding of a new drug. I acknowledge that it is a challenge. It is a problem and it is not to be sniffed at in any way, but it must not be an obstacle to doing what is right by the people who look to us for assistance.
I have spoken today with conviction and with passion—and without apology for that conviction or that passion—on behalf of my constituents, but also on behalf of a great many other people throughout the country in other constituencies, who look to the Government for help. I look forward with eager anticipation to what the Minister of State says in reply.
§ The Minister of State, Department of Health (Mr. John Denham)
I congratulate the hon. Member for Buckingham (Mr. Bercow) on securing the debate, and thank him for the way in which he has presented the case—not just the way in which he spoke about his constituents, but the way in which he addressed the issues, which was mercifully free of some of the more rhetorical elements of the debate that sometimes surround this important issue.
With regard to the hon. Gentleman's constituents, Caroline Cripps and Marc Smith, whom he obviously knows, I cannot comment on individual cases, but he spoke movingly of their position. Many of us know, from constituents or through people who are known personally to us, of the enormous impact that multiple sclerosis can have.
As the hon. Gentleman said, multiple sclerosis—one of the commonest diseases of the central nervous system—is an issue of great importance to the Department of Health, to health professionals, to sufferers and to their families and friends. That is reflected in the constant concern that is shown in the House about the matter.
I will try to answer the hon. Gentleman's specific questions in the time available. He knows what Adjournment debates are like. I assure him that, should I fail to do so, I shall write in follow-up. I hope that I can touch on some of the key points that he raised.
Multiple sclerosis can be very difficult to diagnose and treat. There is no conclusive diagnostic test. The symptoms that patients experience could be symptomatic of many other conditions. A complete clinical examination is key to the diagnosis.
Four categories of multiple sclerosis are recognised by experts: benign, primary progressive, relapsing-remitting and secondary progressive MS. As the hon. Gentleman suggested, until earlier this year, the immunomodulating drug beta interferon was licensed only for the treatment of the relapsing-remitting form of the disease.
Relapsing-remitting multiple sclerosis is characterised by periodic attacks of the symptoms characteristic of multiple sclerosis, such as fatigue, disturbed vision, difficulties in eating and drinking, and the inability to walk. Those attacks are followed by full or partial recovery.
617 Following guidance issued in 1995, health authorities now have procedures by which suitable patients with relapsing-remitting multiple sclerosis can receive treatment with beta interferon. The guidance recommends that prescribing should be initiated by hospital neurologists, where clinically appropriate, and asks health authorities to develop local arrangements with hospitals for purchasing and prescribing the treatment.
Not all patients with the relapsing-remitting form of multiple sclerosis will be suitable for treatment with beta interferon. The licensed indications for those drugs specify certain criteria for treatment, relating, for example, to the frequency of relapse and degree of disability, and—as with all licensed drugs—there are various contra— indications, including pregnancy and severe depression. There will, of course, be some patients who may otherwise be suitable but who are unable or unwilling to tolerate regular injections, or the side effects that may be associated with taking beta interferon, including inflammation at the site where the drug is injected, flu-like symptoms and mood changes.
Earlier this year, Schering's beta interferon product with the brand name Betaferon was licensed for treating the secondary progressive form of multiple sclerosis, which is characterised by deterioration without periods of relief, and more severe disablement. Again, only certain patients will be suitable for, or will want, beta interferon treatment. I understand that Schering is undertaking further research, which may identify further subgroups of patients with secondary progressive multiple sclerosis who may benefit.
I know that the hon. Gent did not do this, but it is terribly important that no one raises false expectations about the ability of beta interferon or any other drug to combat an extremely debilitating and distressing condition. Beta interferon is not a cure for multiple sclerosis; there is no cure for it. The evidence seems to suggest that some patients with a particular form of the disease can benefit, perhaps briefly, from the use of beta interferon. Sadly, the evidence also suggests that those short-term improvements are not always sustained.
I understand that current evidence suggests that beta interferon drugs reduce the rate of relapses in relapsing-remitting MS by some 30 per cent. on average, in a range from 14 to 44 per cent. Betaferon was licensed for treating secondary progressive MS on the basis of evidence suggesting that, if used for three years, it delays disease progression by up to one year.
In dealing with beta interferon, clinicians treating individual patients and those advising health authorities on their overall policy need to take account of both the clinical and cost-effectiveness of this drug. As I said, the evidence appears to suggest that some patients with the relapsing-remitting and secondary progressive forms of multiple sclerosis can benefit from the use of beta interferon, but that, sadly, those short-term improvements are temporary. The cost of beta interferon treatment is some £10,000 a year per patient.
However, it is entirely right that existing treatments for that debilitating disease should be evaluated constantly. We should also support research into new and better treatments. Indeed, the Government are directing funding into research in that area. The Medical Research Council spent approximately £640,000 specifically on MS research during 1997–98, and we have awarded the 618 Multiple Sclerosis Society £15,000 a year from 1997–98 until 1999–2000 for its emergent therapies project. In addition, two pieces of work have been funded through the Department of Health's health technology assessment programme, and we have actively supported the Royal Pharmaceutical Society in developing the protocol for a trial of cannabinoids in multiple sclerosis.
§ Mr. Bercow
Can the Minister confirm that, in appraising the cost of beta interferon treatment, the social costs to which I referred will be considered as part of the equation?
§ Mr. Denham
The hon. Gentleman anticipates one of the points that I wanted to cover. The position is that we published a document earlier this year on the method of appraisal to be used by the National Institute for Clinical Excellence. One part of that document looked at how the cost-effectiveness of various interventions might be measured against national health service costs, and invited comments on the circumstances in which wider costs might be taken into account. As with a number of the questions that the hon. Gentleman raised about NICE, which stem from the discussions about that document, we are, as I told the Standing Committee the other day, considering a wide range of responses, and we shall make our position clear in due course. The document certainly did not rule out the possibility of wider costs being taken into account, but we must consider very carefully whether, and the extent to which, that happens.
The Department is also in the process of commissioning systematic reviews of existing evidence across the range of specific service interventions and service delivery options, including beta interferon, for people with multiple sclerosis. Those will help identify further research questions, and will provide technical evidence to enable a rigorous appraisal to be completed as rapidly as possible.
The Government are committed to improving standards of health care and to ensuring that newer treatments, including new medicines, are introduced into the national health service as fast as possible where they represent a genuine therapeutic advance and are cost-effective.
Unfortunately, there is at present no consistent view about whether that can be said about beta interferon, even among specialists. A wide spectrum of views is held by the 250 or so neurologists in the UK about beta interferon's place in treating multiple sclerosis. It is clear that some neurologists are keen to prescribe beta interferon, although even they acknowledge that it is no wonder drug, but others think that other health care options represent a more responsible use of resources. Those differing opinions can occur within a single health authority.
At Question Time recently, I drew attention to the fact that those differing views are one reason why there are differences in practice. I understand that the four neurologists working in Buckinghamshire hold differing views—two generally choose to prescribe beta interferon according to defined clinical guidance; the others, given the resources available, prefer to provide MS nurse specialist support.
It is clear from what the hon. Gentleman said that discussions in Buckinghamshire on a wider level—within the health authority's priorities forum, in the health
619 authority itself and in public life—reflect the differing priorities that different people might put on the approaches to handling this condition.
I understand that, since the board meeting in March, the health authority has met local neurologists within the county to agree a protocol for identifying which patients are eligible for treatment. That process has yet to be finalised, but Buckinghamshire health authority will of course review the situation as new evidence or guidelines become available. Without authoritative national guidance, the current uncertainty is bound to lead to variations from one part of the country to another when 100 health authorities and their neurologists are taking such complex decisions.
We have set up the National Institute for Clinical Excellence to help to ensure that patients can have access to consistent, high-quality NHS services. I have made it clear previously that we are likely to ask NICE to prepare guidance on the place of beta interferon among the range of interventions and services available to MS patients.
Under the appraisal system, companies will be free to submit any relevant data, with the core of NICE's appraisal focusing on the health benefits achievable from NHS budgets—including hospital beds and staff, not only the cost of drugs.
The hon. Gentleman asked about the current position, ahead of any referral to NICE. My officials will shortly be consulting with the Multiple Sclerosis Society, the medical profession, health authorities and the pharmaceutical industry on a draft health service circular relating to the treatment of the secondary progressive form of multiple sclerosis. For the avoidance of doubt, that circular will make it clear that existing guidance on the treatment of relapsing-remitting multiple sclerosis continues to apply until further guidance is available.
620 It is important that we do not lose sight of the other treatments and services available to MS patients and new health care options that may be on the horizon, such as MS nurses, physiotherapy, treatments for fatigue and for pain and immunomodulating therapies, including beta interferons, copolymer 1, azathioprine, and others. It is likely that we will want NICE to examine all the elements that make up the complete management of MS.
In respect of the independence of NICE, which is a special health authority, I made it clear in Committee this week that NICE will operate within a framework agreement set with the Secretary of State. As I have said, the consultation on the appraisal approach has produced a wide range of views about the form that that guidance should take, which we are currently considering. I made the promise that the process would be open and transparent, which is important.
The hon. Gentleman asked for NICE guidance to be mandatory and enforceable, but I ask him to consider the fact that clinicians have to take judgments with their patients in the consulting room. However, we will of course be reviewing the way in which NICE guidance in general is applied in the health service through the Commission for Health Improvement. That will be one of its important roles.
The hon. Gentleman raised a number of issues, but I fear that the clock will beat me. He referred to NHS resources, and he would expect me to draw attention to the £21 million of extra investment in the NHS that the Government are making over the next three years. I thank him for the way in which he has approached the debate; the House will return to this matter, which is of great interest to all our constituents, on many occasions.
§ Question put and agreed to.
§ Adjourned accordingly at five minutes past Three o 'clock.