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Multiple Sclerosis
Earl Howe rose to ask Her Majesty's Government whether the risk-sharing scheme, designed to allow eligible patients with multiple sclerosis to have access to beta interferon and glatiramer acetate in controlled trials, is working satisfactorily.
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The noble Earl said: My Lords, I need not, I think, spend too much time setting out the background to my Question, but a few words of introduction may help.
In 1999 the Department of Health and the Welsh Assembly asked the National Institute for Clinical Excellence to appraise beta interferon and glatiramer acetate as treatments for multiple sclerosis. NICE concluded in July 2000 that routine use of these treatments could not be recommended, but following a reappraisal, it issued guidance in early 2002 that confirmed that the therapies were clinically effective for certain groups of patients but that sufficient evidence of long-term cost effectiveness was lacking. Shortly after this, the Department of Health announced the MS risk-sharing scheme. This is a scheme whose aims are to enable all eligible MS patients—that is to say, patients who meet the guidelines of the Association of British Neurologists—to receive treatment with disease modifying drugs and for the NHS to acquire these drugs in a manner which could be considered cost effective.
I am sure I was not alone in my utter dismay at the NICE determination in 2002. Nevertheless, the risk-sharing scheme seemed to me then, as it does now, a brave and welcome move by the Government to try to square the circle. The targets set under the scheme were for between 7,500 and 9,000 eligible patients to receive treatment with disease modifying therapies by November 2003, with 5,500 to 7,000 in the formal monitoring cohort. Clinical trials of their very nature last only two to three years, which means that the long-term benefits of MS treatments cannot be discerned with any accuracy from such trials. MS evolves over decades and it is therefore reasonable to evaluate the costs and benefits of the treatments over a period of 10 to 20 years. Any shorter period than that and we run the serious risk of failing to uncover possible long-term benefits. Also, the cost-effectiveness of the drugs will appear to be commensurately lower.
The risk-sharing scheme therefore represented a huge opportunity not just to demonstrate the long-term benefits of these therapies but to help real patients. The international comparisons are stark. In 2002, the proportion of MS patients in the UK receiving disease-modifying therapies was 6 per cent. In the EU as a whole, the figure was 28 per cent and in the United States it was 46 per cent. One of the looked-for benefits of the scheme was to redress that imbalance.
Unfortunately, the whole process got off to a very slow start. In many areas there was simply no infrastructure to get it off the ground—clinic space, administrative support and appropriately qualified clinicians and nurses were simply absent. There was a large backlog of patients to assess, and quite a number of PCTs did not have a precise idea of how many patients there actually were. Even one year into the scheme, many qualifying patients were still waiting for the drugs to which they were entitled.
The main reasons were stretched PCT budgets; systems that had not really been well prepared to cope with administering the scheme; and over-burdened
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neurologists struggling to keep up with the workload. However, by late 2003 progress had been made. At the end of October, about 7,000 patients were being treated with a disease-modifying therapy—some 500 below the original target. Nevertheless, more than 3,000 people had been enrolled into the scheme over the 18 months from May 2002. Fifty-three new specialist nurse posts had been created, and there were 65 prescribing centres for multiple sclerosis around the UK, since increased to 67. All that is positive, but it really is not positive enough.
We are now more than two years into the scheme. After this length of time, we really would expect to see it working in the way that everyone had been hoping for, but I am sorry to say that it is not. The scheme was the subject of a formal ministerial direction. It is therefore mandatory. The detail of the scheme has the status of NICE guidance. Dedicated funding was made available to PCTs to implement it. Despite this, it is clear that many PCTs have relegated the scheme to a box marked "low priority".
Of the 67 prescribing centres, one—namely, Truro—is still not prescribing disease-modifying therapies at all. Of the rest, Aberdeen has not begun to recruit to the risk-sharing scheme, Leicester and Gloucester have stopped recruiting because of resource constraints, Swansea has not started, although it looks as though it may in the next couple of months, and North Staffordshire has a very long waiting list. Most serious of all is what appears to be a giant misunderstanding about the scheme targets. It is clear that some PCTs are under the mistaken impression that once the target for recruitment to the monitored cohort has been met—that involves 5,500 to 7,000 patients—the shutters can come down and no new patients need be given the therapies.
We understand from the Government that the patient number targets that were originally set are likely to be met later this year—about a year late. That target cannot be, and was never intended to be, the end of the story. This is a programme that places an obligation on PCTs to continue funding new access to treatment for 10 years. That obligation must be met for the sake of all MS patients.
One of the prime bottlenecks in rolling out the risk-sharing scheme is the chronic shortage of neurologists. In the UK, we have only one neurologist for every 177,000 people. In France, the ratio is four and a half times better—one in 38,000; in the Netherlands, it is nearly seven times better; and, in Denmark, it is eight times better. We are miles behind the bare minimum ratio recommended by the Association of British Neurologists of one in 80,000.
The key point here is that getting into the risk-sharing scheme in the first place depends on being seen and assessed by a neurologist. A lot of patients cannot get to see a neurologist at all. Someone in that position must resort to their GP, who almost certainly does not have any in-depth knowledge of MS and is unable to assess them for their eligibility to receive the therapies. The potential tragedy of the situation is this: should an MS patient suffer a significant delay in access to
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treatment, he or she may be unable to benefit from it. The earlier we treat someone with MS, the more effective the treatment is. If someone suffers a progression of his disability, it may be irreversible, and the window of opportunity is lost. The risk-sharing scheme may have helped to iron out part of the postcode lottery of funding for drugs, but there is still a considerable regional variation in access to neurologists. In 2001, the Emergency Medicine Journal highlighted those wide regional differences.
In 2004, the percentage of MS patients in the UK receiving disease-modifying therapies is still only 8 per cent. In the EU as a whole, it is 35 per cent, and in the United States, it is 50 per cent. Let us, for the sake of simplicity, ignore the United States. What on earth can count as a satisfactory rationale for the gap between ourselves and the rest of the EU? There is no such rationale. The monster gap calls into question the estimates of the number of patients eligible for treatment under the ABN guidelines. It suggests that a great many more people might benefit from the therapies than actually receive them.
The European Parliament recently published a report on discriminatory treatment afforded to MS patients in the EU in consequence of a petition submitted by a UK citizen, Louise McVay. There are some pretty damning conclusions in that report, on which the Minister's comments would be welcome. On the UK, it says that the risk-sharing scheme,
"represented a big step forward though it has not managed to resolve the therapy-related problems experienced by the majority of MS sufferers even today".
"the disparities between the types of care and support available are much too great both within and between the member states of the Union. This must be remedied by raising the level of care provided across the board, bringing about equality of access as a clear objective. With free movement of persons recognised as a binding principle of the Union, better provisions must be put in place to enable the disabled person, including MS sufferers, with equal rights to treatment in all EU states".
The denial of healthcare to people with disabilities is described in the report as,
"disastrously on an individual's ability to work, on his or her family life, freedom of movement and integration into society".
The designated therapies are recognised as making an "enormous difference" to sufferers and the enhancement of their lives. Securing best practice for equal access to therapies and treatments for people with MS should become a,
In each member state, there should be,
What official comment does the Minister have on those conclusions?
We ought to be getting a regular progress report on the number of patients receiving MS therapies within the formal monitoring arrangements. I should be grateful if the Minister could tell us what the current
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number is and how many patients have started receiving treatment since the inception of the scheme. How many patients are on the waiting lists for formal assessment?
It is not good enough for the Department of Health to adopt a laissez-faire stance on regional variations. Strategic health authorities need to remind PCTs of their statutory responsibilities. Above all, they should stress that the risk-sharing scheme is not a clinical trial about the efficacy of MS therapies; rather it is a study aimed at reducing the uncertainty around previous estimates of their cost-effectiveness over the long term. What action does the department plan to take to ensure that, when the monitored cohort has been recruited, disease-modifying therapies continue to be prescribed under the scheme? That is vitally important. PCTs need to be made aware that the time has passed for the "wait and see how it goes" attitude before treatment is started.
This is not a low-priority matter in any sense. Real patients are suffering as a result of systemic blockages, inadequate resourcing and, I think, basic misunderstandings. That situation cannot and must not go on.
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