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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guidelines on the standard of care that people with MS in England and Wales are entitled to expect are now hopelessly out of date because the risk-sharing scheme is not even scheduled to be updated until 2015.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 The scheme has become outdated and sclerotic.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the great strides made in medical science over the past few years, the disease-modifying drugs risk-sharing scheme is out of date and sclerotic.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.
The Minister of State, Department of Health (Mr. Mike O'Brien): 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.
Lembit Öpik: 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.
Mr. O'Brien: 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.
Mr. Gray: 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?
Mr. O'Brien: 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.
Mr. Gray: 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.
Mr. O'Brien: 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.
Mr. Gray: 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?
Mr. O'Brien: 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.
John Robertson (Glasgow, North-West) (Lab): I am delighted to have secured the debate and to have the opportunity to exchange views with my hon. Friend the Minister. I look forward to hearing his comments on the wider issues that I shall raise. I would like to discuss the future of the education maintenance allowance scheme and the effects of cuts on the young people who rely on it. I will mention the fears of charities and other non-governmental organisations that represent further education students, and tell the Minister my experience of what has happened in relation to cuts made to the EMA north of the border. That is an example to keep in mind of what could happen.
The Government have a record second to none on funding further education. For those listening today who are unaware of EMAs, let me give a brief explanation of what they are and why they are such an essential part of further education support. EMAs are means-tested allowances of £10, £20 and £30 a week that are paid to 16 to 19-year-olds who stay in education and come from families where the annual household income is below £30,000. The EMA payment is conditional on attendance. The policy intent of the EMA is to broaden participation and improve the retention and attainment of young people aged 16 to 19 in post-compulsory education. EMAs were introduced nationally in September 2004 to reduce this country's post-16 drop-out rate, which was one of the worst in the developed world at that time.
What success has the EMA scheme had since 2004? Research by the Institute for Fiscal Studies shows that attainment in GCSEs and A-levels by recipients of the EMA has risen by 40 per cent. since its introduction. That figure is even greater for those living in the most deprived neighbourhoods. In addition, RCU market research services carried out research on the national scheme and published a report entitled "Evaluation of EMA National Roll-Out 2007", which concluded
"that EMA has had a positive impact on the retention, achievement and success of certain groups of learners...traditionally associated with lower levels of achievement such as: male learners; learners from minority ethnic groups; those with backgrounds of high deprivation and learners on lower level and vocational courses."
Ipsos MORI published a report in 2008 entitled, "Evaluation of Extension of EMA to Entry to Employment and Programme Led Apprenticeships", which reached similar conclusions to the RCU research. It stated that the EMA has reduced the number of NEETs-those not in education, employment or training-and has
"motivated learners to...work harder."
It was with mixed emotions that I welcomed last week's statement by the Secretary of State for Children, Schools and Families, in which he announced plans to spend £580 million on the EMA in order to fund a further 80,000 places, because he also mentioned that, from 2011, poorer pupils who qualify for the EMA-a payment of £10 to £30 each week, as I said-will no longer receive an extra £100 for every six months they stay in education.
Charities and organisations that represent young people receiving the EMA are extremely concerned about recent announcements to scrap the £100 bonuses, particularly when the evaluation evidence for the bonus scheme found that around two thirds of EMA recipients who were questioned agreed that the bonus system made them work harder. The same proportion said that they attended more lessons because of the EMA attendance bonus rule. Furthermore, those who work closely with students on the EMA inform me that payments and bonuses are an important part of what allows them to continue in further education. I would be interested to hear the Minister's views on that matter.
Unfortunately that is not the only fear regarding EMAs. There is a growing fear among all those interested in the subject that when the school leaving age is raised to 18 in 2015, the need for an incentive will become redundant. Will the Minister also comment on that and say whether it is to do with the problem that the EMA is classed as an incentive rather than a welfare payment, because receipt of an EMA does not affect other family benefits? The Government should consider reclassifying EMAs as payments that are intended to be supportive, rather than solely an incentive, so they can be viewed in the same way as jobseeker's allowance. Otherwise, when the school leaving age is raised to 18 in 2015, EMAs will become defunct as an incentive.
My hon. Friend should consider, for example, those who are living independently at an early age, as they may need particular support. Access to financial support may be one of the main barriers to participation in education. In general, some of the key barriers include course fees, travel expenses, the cost of food and other essential items, and costs associated with a course or placement, such as equipment. There is a lack of comprehensive advice and guidance for young people on their entitlement to benefits. For those living with families on low incomes, the overall impact on family finances should be considered. In some instances, young people have been discouraged from taking part in education. That is why I believe that the EMA should be guaranteed beyond 2011.
Let me give a Scottish example. I am aware that we live in a time when finances are tight and budgets must be pruned, but I believe there is a good example showing why such action should not be taken on EMAs. As my hon. Friend will be aware, the EMA system is devolved and each Administration have their own policy responsibility for it. However, not all Administrations have been as considerate as this one in protecting students who come from low-income families during the recession. For example, this academic year, in my constituency of Glasgow, North-West, the EMA has been cut by 20 per cent. My MSP colleague, Bill Butler, has informed me of the upsurge in constituents who are worse off because the Scottish National party-led Administration have cut the EMA budget by 20 per cent. and there have been changes to the scheme's eligibility criteria which lowered the threshold for the £30 payment and axed the £10 and £20 payments.
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