I am delighted to have the opportunity of introducing this short debate on an incredibly important subject.
I have been involved with multiple sclerosis issues for many years now. I am chairman of the all-party group on MS and patron of two MS organisations, the North Wiltshire branch of the Multiple Sclerosis Society and Mutual Support, which is the military forces’ branch of the MS Society. I am glad to have the opportunity to bring a very important issue related to MS to the Minister’s attention.
In doing so, I want to start by paying tribute to the outstanding work of the MS Society, without which it would not be possible to raise these issues. It is a first-class organisation and shortly I will be talking about the manifesto that it intends to publish—later this week, I think—in the run-up to the forthcoming general election, which will raise a variety of issues related to MS. I know that all Members of Parliament will be sent a copy of that manifesto in due course and hopefully they will find time to pay attention to it.
Of course, this is not a party political issue of any kind at all. It is one that we in this place ought to pay attention to, because there are ways of making things better for the 100,000 or so people in England who suffer from this most debilitating disease. Sometimes I feel that cancer and heart disease achieve a higher profile in public awareness or in Parliament, but MS, in many respects and for many people who suffer from it, is no less debilitating and no less wicked a disease than those two more high-profile ones.
Will the hon. Gentleman give way?
This is an Adjournment debate, so if the hon. Gentleman does not mind I will not give way, as I have a lot to get through. I thank him all the same.
MS is a curious disease. However, we are getting closer to understanding what causes it and therefore to finding a cure, or at least a partial cure. There are oddities with MS. For example, the further one gets from the equator, the less likely one is to suffer from MS. Also, if one lives in a largely vegetarian society, such as those in Japan or China, one is much less likely to develop MS than people who live in western Europe. It is because of such curiosities that we are beginning to achieve some understanding of this dreadful disease, and as a result we can begin to find a cure.
Today’s debate, however, is not about the attempt to find some cure for MS; it is about those drugs that ameliorate the symptoms of the disease. In particular, I am referring to the disease-modifying drugs, such as beta interferon and glatiramer acetates. Some 10 years ago, there was a terrible postcode lottery associated with those types of drugs. I remember very clearly being much engaged in the campaign to allow them to be prescribed on the NHS. I remember the particular example of Stephanie Millward, the Olympic swimmer from the village of Box in my constituency, who was not allowed to have beta interferon prescribed for her MS. She lived about 100 yards away from the border with Bath and at the time the local health service in Bath was prescribing beta interferon. That was a terrible postcode lottery and we campaigned very hard against it.
As a result of that campaign, we came up with a new scheme, the risk-sharing scheme. Under that scheme, it was established that, although the National Institute for Health and Clinical Excellence had said that beta interferon and the like were not cost-effective for the treatment of all MS sufferers, if the drug companies producing the drugs could demonstrate that the drugs were effective, the cost element could be balanced out at a later stage, as it were, by the NHS being given a discount for the provision of the drugs.
That is a broad-brush description of the scheme that we agreed to some 10 years ago. I remember that, seven years ago, there was a reception in Portcullis House and we all welcomed the introduction of the scheme, which was a very good outcome both for MS sufferers and for the NHS. Having said that, the purpose of this debate is to consider whether the risk-sharing scheme has worked to benefit either those people suffering from MS or the NHS.
The scheme has delivered some benefits. To begin with, more people have been prescribed beta interferon or the other disease-modifying drugs than would otherwise have been the case. For example, Stephanie Millward has been prescribed beta interferon for the last seven years. I see her very often and she tells me that it has definitely improved the symptoms of her MS. So, it is a good thing that more people have had such drugs than would otherwise have been the case.
There have been one or two positive side effects of the scheme. There are now about 200 specialist MS nurses provided to the NHS, which is hugely beneficial. They do a superb job and it is very important that we find ways of keeping them going in our local communities, although they have been somewhat challenged in recent years.
Has the risk-sharing scheme really and truly worked, however? Do we now know more about whether beta interferon and the other drugs work? Do we now know whether they work for particular types of patient? Also, is the scheme cost-effective?
One would have thought that, after a seven-year scheme such as this one, the Government would be ready to come forward with a few answers to those questions and would be able to say that the scheme is working, that it is working for some patients, that it is saving us money, or that it has made the world a better place. That is why those of us in the MS community, as it were, find it very curious that we still do not know the answers to those questions. The Government have delayed publishing the first analysis of the scheme. I hope that the Minister, in his winding-up speech, will be able to tell us when the Government plan to publish that.
Those people who know about these things—particularly those who work for the MS Society and other such organisations—have detected what seem to me to be absolutely fatal flaws in the scheme as a whole. The whole methodology of how the scheme was put together is flawed. It has taken us seven years to realise that, but the statistical and methodological inadequacies of the scheme mean that, even when the Government come out and publish the interim report on whether it has worked, we will question whether an accurate conclusion has been reached.
Of the 5,000 people who were part of the tests under the scheme, quite a large number are sadly no longer with us and others are unable to say whether the scheme has worked. Since there was no cohort of people who were not suffering from MS but who were tested on the drugs, it is very difficult to say statistically whether the scheme has worked.
The first two-year cost-effectiveness analysis of the scheme, which took a very long time to produce, finally appeared in the British Medical Journal in December 2009. That analysis appears, at first sight, to show that the progression of the disease was worse than predicted for those people who were on the disease-modifying drugs and it was also worse than it was for those people with MS who had not taken the drugs. So, at first glance at that BMJ article in December, it would appear that the scheme has not worked and that the drugs themselves do not work. However, the article goes on to undermine its own conclusions by saying that the methods used in coming to them were flawed, so the conclusions can be questioned.
What is more, under current plans the scheme will run for another five years and the same flawed methodology will be used for that time. So, conclusions reached in 2015 as to whether the scheme is a good thing will be made using flawed statistical analysis. In any case, by 2015, when those conclusions come out, most of the drugs in question will have reached the end of their patent date, and so it will no longer be interesting to know whether they have worked.
Furthermore, the cost adjustments that the drug companies may or may not have to provide to the NHS at the end of that time are not retrospective. The scheme will have been running for 10 or 15 years; it may be concluded that the drug companies should pay money back to the NHS; but because the scheme is not retrospective, it will not matter. Any cost adjustments will apply only looking forward from 2015, not looking back. Therefore, there is no financial benefit for the NHS.
Perhaps the scheme is working for people with MS. After all, its purpose was to try to demonstrate that the drugs are available to people with MS on an equitable basis. However, a glance at the league table of the drugs’ availability across Europe demonstrates that Britain is near or at the very bottom. Anywhere else in Europe, people with MS stand a better chance of getting the drugs on their national health scheme. We do not supply the drugs ourselves; the scheme that we implemented to judge whether they work is not working because the arithmetic that it uses is flawed; and people with MS here are less likely to get the drugs than those in France, Germany or elsewhere.
In addition, the prescribing theory for the drugs is out of step with medical science. They are injectable drugs, but since the scheme was implemented, a variety of non-injectable oral drugs to treat MS or its symptoms have been introduced. It is widely presumed that within a year or two, the oral drugs will be better than injectable beta interferons for treating symptoms. In other words, the scheme is desperately trying to prove whether a drug works, but by the time the proof arrives, the drug will be out of date anyhow. It is entirely flawed.
The Association of British Neurologists has said that oral drugs are well advanced along the pipeline and that, in two years, they rather than injectable drugs will be the right drugs to prescribe for MS. People with relapsing-remitting MS will have up to 10 drug options within two years. The MS Society and the MS community want equity of availability of oral drugs, but the continuation of the risk-sharing scheme for injectable drugs may well mean that oral drugs become more difficult to obtain or prescribe for MS patients than if the scheme were scrapped.
The NICE guidelines on MS risk-sharing drugs have stagnated while we await the data. The NICE clinical guidelines on the standard of care that people with MS in England and Wales are entitled to expect are now hopelessly out of date because the risk-sharing scheme is not even scheduled to be updated until 2015.
What do I hope the Government will do? I must not make a party political point in a debate such as this about what an incoming Government, of whatever party, might do after the general election. The scheme cannot be mended. It has been in place for seven years; its statistical flaws have been present for seven years. It cannot be mended in the hope that it will become better by 2015, when it will end. The scheme, frankly, is knackered. It is flawed and it is not doing the job that it was set up to do.
Advances in medical science—along with advances in policy such as patient access schemes, which are a rather good thing allowing patients to access the drugs that they need—have overtaken what we thought at the time was a good scheme. The scheme has become outdated and sclerotic. Its outcome will be little more than an academic exercise of limited benefit to people with MS.
Some 100,000 people in the UK suffer from this most appalling and debilitating disease. They want better than they are getting. MS must become a priority today for the next five years; it must not wait five years to become a policy priority. That point is brought out clearly in the excellent manifesto that the MS Society will publish later this week.
The fact is that despite the great strides made in medical science over the past few years, the disease-modifying drugs risk-sharing scheme is out of date and sclerotic. It does not work for the national health service or people with multiple sclerosis. Anyone with half a brain would call for its abolition.
As is traditional, I congratulate the hon. Member for North Wiltshire (Mr. Gray) on securing this debate. The effective treatment of multiple sclerosis is important for the Government, for health professionals and, of course, for sufferers of multiple sclerosis and their friends and families. As chair of the all-party group on multiple sclerosis, he has been closely involved with the Multiple Sclerosis Society, whose concern about the risk-sharing scheme appears to have prompted this debate. I associate myself with his expressions of support for the good work done by the MS Society, which is an important national health service stakeholder. We certainly regard the treatment of MS as a priority for the NHS.
My Department has been working with the MS Society to understand its perspective better and, if possible, to address some of its concerns. It may help, therefore, if I set out the Department’s position.
Does the Minister accept that many of the points made by the hon. Member for North Wiltshire (Mr. Gray) also apply to motor neurone disease? I thank the Government for the significant support that they have given the Motor Neurone Disease Association in its efforts to find better forms of care and a cure for the disease. I exhort the Minister to carry on the strong relationship between the association and relevant Departments that has done much to give hope to those experiencing motor neurone disease.
I appreciate the hon. Gentleman’s concerns. I assure him that we as a Department wish to continue the close working relationships that we have developed in dealing with motor neurone disease.
Multiple sclerosis can be difficult to diagnose and treat. There is no conclusive diagnostic test, and symptoms may also indicate other conditions. A thorough clinical examination is key to diagnosing MS, and the progression of the condition is variable and unpredictable.
There are four different categories of multiple sclerosis: benign, primary progressive, relapsing-remitting and secondary progressive. Since the first drug for treating relapsing-remitting MS was licensed in 1995, views have differed about the clinical and cost-effectiveness of treatments. That has led in turn to variable access for patients and justifiable allegations of postcode prescribing. For that reason, the issue was one of the first to be referred to the National Institute for Health and Clinical Excellence when it was established in 1999.
In January 2002, NICE published its appraisal guidance on the use of four treatments for multiple sclerosis: the beta-interferons Rebif, Avonex and Betaferon, and the drug Copaxone. NICE was unable to recommend those treatments for NHS use at 2002 prices, largely because it was not possible for NICE to reach a positive evaluation of the drugs’ long-term cost-effectiveness from the short-term results available from existing clinical trials. NICE then invited the Department of Health and the Welsh Assembly to consider how the drugs could be made available to patients in a cost-effective manner.
In February 2002, the UK health Departments and the four relevant pharmaceutical companies set out the agreed basis for a risk-sharing scheme that would allow the four treatments to be prescribed according to the Association of British Neurologists’ 2001 guidelines. The scheme established a 10-year monitoring study to collect data on the progression of the disease among treated patients. The aim is to help assess the uncertainties that concerned NICE.
At the time, the scheme was supported by all the relevant parties, including those who represent health professionals and the MS Society. Under the scheme, all people with MS who meet the criteria developed by the Association of British Neurologists are eligible for treatment if their clinicians consider that they will benefit. A statutory direction requiring the NHS to fund such treatment was expected to eliminate some of the vagaries of postcode prescribing for the treatments, and we are not aware of any evidence to the contrary, including from the MS Society.
If the treatments in question do not perform as expected over the life of the scheme, the manufacturers will share the risk of failing to achieve the anticipated outcomes by subsidising their future cost to the NHS. Gauging whether the drugs are performing better or worse than anticipated is the most difficult aspect.
The MS risk-sharing scheme has brought together patient and professional groups, the Department of Health and the pharmaceutical industry in a unique way. It has improved significantly the overall care and support available to people with MS. It has given more than 12,000 people with MS access to drugs to treat their condition, funded an increase in specialist MS nurses and strengthened the development of a UK network of more than 70 specialist MS treatment centres.
The MS risk-sharing scheme is extremely complex. Data are being collected on about 5,500 patients.
I think the Minister will find that 5,500 was the number of patients at the beginning of the scheme in 2002. Sadly, a significant number of those have died or have left the scheme. How many people are currently being studied under the scheme?
I do not have the current figure, but I am advised that data have been collected on those people. Some of them are no longer with us. However, the data are being analysed to identify the efficacy of the drugs. The fact that somebody has passed away does not mean that their data are irrelevant to the analysis. In fact, they may be of enormous relevance in identifying how effective a drug is.
The first two-year interim analysis of the scheme was published on 2 December 2009 in the British Medical Journal. Acting on advice from the scheme’s independent scientific advisory group, the study concluded that it was too early to reach firm conclusions about the cost-effectiveness of the drugs. That is not surprising for a scheme with a much longer time scale. The scientific advisory group is addressing several important methodological issues that are integral to the scheme, including the need for an additional comparator data set to ensure that there can be appropriate comparisons. I hope that its work will lead to more meaningful results when the next analysis takes place later this year.
Only one other treatment has been licensed for MS and is available to sufferers. Tysabri received a positive recommendation from NICE in 2007. The NHS is therefore obliged to fund treatment considered by clinicians to be within the terms of that recommendation. We will, of course, investigate any concerns that primary care trusts are refusing to fund the use of Tysabri as recommended by NICE. NHS figures show that the observed use of the drug is rising and, when they are available, the 2009 figures are likely to reach or exceed the level predicted by NICE. If there is any evidence of postcode prescribing, we will be anxious to see it.
I note the point about comparisons between countries, but with all these drugs it must be recognised that different patients and their clinicians take different views on the balance between a drug’s benefits and its side effects. That leads to some legitimate variation in use. We must be careful not to ascribe to postcode lotteries variations in clinical views about the use of particular drugs. Clinical judgments should not be confused with the way in which the financing of a system or scheme works.
As the hon. Gentleman said, there are two new oral therapies. Cladribine and Fingolimod are being developed for the treatment of relapsing-remitting MS. Cladribine, also known by its brand name Leustat, is an anti-cancer agent used in the treatment of leukaemia. It is not yet licensed for the treatment of MS, but it is currently in clinical trials. Fingolimod is a new oral treatment, which is currently in phase 3 clinical trials for relapsing-remitting and primary progressive MS.
Both drugs have been referred to NICE for appraisal, subject to receiving a licence from the regulatory authorities. If they are recommended by NICE, the MS risk-sharing scheme will not detract from their appropriate use. Although the trial results for the drugs are promising, it is impossible to say whether they will remove the need for the drugs in the risk-sharing scheme.
The process of developing drugs is happening in parallel with the risk-sharing scheme. Not all drugs necessarily go into the risk-sharing scheme. We are anxious to work with the MS Society to develop a process that works, by which drugs are made available to people with MS. We cannot pretend that the data are available when they must still be analysed properly. NICE must be satisfied that it is in a position to take a view.
The Minister is saying that the right drugs must be given to the right people at the right time, and I am sure that all sensible people would endorse that view. I judge from a hint in his remarks that if over the next two or three years medical science developed drugs more effective than those being used under the risk-sharing scheme, there is a possibility that the scheme would be abandoned in favour of those newer drugs.
That is potentially right, although I cannot give the absolute reassurance that the hon. Gentleman seems to want. New drugs are coming forward that operate outside the risk-sharing scheme. The issue is whether the clinical trials produce enough data to enable NICE to take a view on the efficacy of the drugs and their cost-effectiveness. If that is possible, approval might be given, as it has been for drugs that treat other conditions and one that treats MS. Consent will be given only if there are adequate data.
I accept the hon. Gentleman’s point that we are using the risk-sharing scheme to evaluate drugs that are being overtaken by other drugs. That should not invalidate the risk-sharing scheme; if in the meantime it is producing an outcome that benefits MS sufferers, such as giving them access to the drugs, and if that is cost-effective for the NHS, that is good. The issue would be of legitimate concern if we were trying to funnel every drug into the scheme, but we are not. We are saying that we should look at the data, evaluate the evidence and examine the extent to which particular drugs work. NICE has the independent role of doing that. If it is able to approve particular drugs, it will approve them and they will become available to MS sufferers outside the risk-sharing scheme. I hope that that provides him with some reassurance.
I have listened with great care to the hon. Gentleman and I understand his concerns and those of the MS Society. The risk-sharing scheme has brought significant benefits to people living with multiple sclerosis across the UK. We are determined to make further progress on these issues and will continue to work with patient groups, professionals and pharmaceutical companies to ensure that, through the risk-sharing scheme and other approaches, we continue to provide good quality NHS services and drugs for people with MS.
If it were brought to the Minister’s attention by officials or other people that some of the methodology used in the analysis of the statistics in the risk-sharing drug scheme was wrong and that the usefulness and cost-effectiveness of the drugs could not be assessed, would he consider dropping the scheme?
The appropriate organisation to talk to about the methodology is NICE. The object of having an independent body to consider such issues is that it will have access to all the data, it will not be subject to political pressures and it will respond to objective scientific analysis and, we hope, cost-effectiveness. As a result, if there is a problem, NICE should be able to address it. That is where the information should go. If the hon. Gentleman wishes to give the information to the Department, I will be happy to forward it to NICE on his behalf.