House of Commons Hansard Debates for 14 May 1999 (pt 25)

2.51 pm

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.

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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

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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

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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.

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