Multiple Sclerosis (Tysabri)

– in the Scottish Parliament at 5:00 pm on 1st March 2007.

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Photo of Murray Tosh Murray Tosh Conservative 5:00 pm, 1st March 2007

The final item of business today is a members' business debate on motion S2M-5305, in the name of Tricia Marwick, on Tysabri for people with multiple sclerosis. The debate will be concluded without any question being put.

Motion debated,

That the Parliament deplores the decision by the Scottish Medicines Consortium not to recommend that Tysabri be prescribed to people with multiple sclerosis (MS); notes that, for a small number of those with the most aggressive form of relapsing-remitting MS for whom existing treatments do not work, Tysabri represents the only treatment available; believes that Tysabri has the potential to alleviate suffering for MS patients in Fife and across Scotland; notes that Tysabri is prescribed in Germany, Ireland and the United States of America but not in Scotland, which has the highest rate of MS in the world, and considers that NHS boards in Scotland should prescribe Tysabri which had been described by Dr Gavin Giovannoni, of the National Hospital for Neurology and Neurosurgery in London, as the most significant advance in MS treatment for nearly a decade.

Photo of Tricia Marwick Tricia Marwick Scottish National Party 5:05 pm, 1st March 2007

I thank those members from all parties who signed the motion in my name and the two motions that were lodged by other members.

MS affects almost 10,000 people in Scotland; we have the highest rate of MS per capita anywhere in the world. In the past, I have argued that that statistic should spur us on to ensure that Scotland becomes a centre of excellence for the treatment of MS. It is appropriate to record that, since the Scottish Parliament was opened in 1999, services for MS patients have improved. Most health board areas now have MS nurses, and beta interferon is widely prescribed rather than being available only on a postcode basis. Some of the credit for that goes to the Scottish Executive, but much more of it goes to the MS Society Scotland, its director Mark Hazelwood and its patron J K Rowling. Many of the improvements have come about only because of the financial support of the MS Society.

I cannot begin to express the anger and frustration that were felt following the Scottish medicines consortium's decision in December not to recommend that Tysabri be made available on the national health service to people with MS in Scotland. A number of issues need to be put on the record. The drug has been licensed for use, so it is an approved product. It is being prescribed in the United States, Germany and Ireland. In total, 10,000 people worldwide are using Tysabri.

Why is Tysabri important? For a very small number of people with aggressive and rapidly progressing MS, who have recurring attacks, existing drugs are not working. Tysabri reduces the number of attacks. Every attack causes more damage, with the result that the patient gets progressively and rapidly worse. Given that many people in that category are young and economically active, it is vital that we use everything at our disposal to ensure that they have a better quality of life for longer. Tysabri is not a miracle drug or a cure for MS—there is none—but, as clinical trials have shown, it is twice as effective as any other licensed drug on the market in reducing recurring attacks.

Photo of Brian Adam Brian Adam Scottish National Party

Does the member agree that there is no doubt whatever about the drug's efficacy, but that there seems to be some doubt about the cost benefit analysis? Does she share my concern that the use of QALYs—quality-adjusted life years—to measure the cost benefit analysis does not seem to be an adequate way of assessing a drug that is vital to a significant group of patients with a significant disease that is more prevalent in Scotland—especially in the north-east—than elsewhere?

Photo of Tricia Marwick Tricia Marwick Scottish National Party

I could not agree more. I will address later in my speech some of the points Brian Adam makes.

From discussions with neurologists and the MS Society, I have learned that they estimate that between 40 and 50 people in Scotland will be prescribed Tysabri in any one year. It is not a drug for everyone. We are not talking about thousands of people beating a path to their general practitioner's surgery to demand the latest wonder drug; Tysabri is not another Viagra. It will be prescribed only to the very few people who, in the clinical judgment of neurologists, will benefit from it.

The decision to deny the provision of Tysabri on the NHS to such a small group of people is mean spirited. The option exists for neurologists to make a case to health boards for the provision of Tysabri to named patients, but that will create unnecessary delay and lead to postcode prescribing, which I am sure we all wish to avoid.

The SMC's decision is based on cost, not on whether the drug will bring benefits, although its acknowledgement of those benefits is grudging and flies in the face of the evidence that it has been shown. The MS Society is of the view that the SMC's decision was based on flawed evidence. It and the neurologists believe that the cost of prescribing Tysabri will be less than half what the SMC says it will be. The SMC's economic case for not prescribing is therefore quite different from the economic case that is claimed by the neurologists and the MS Society.

The difficulty is that there is no mechanism to appeal an SMC decision. As far as I am aware, it is not an organisation set up by statute; rather, it is a forum of representatives of health boards. The MS Society has asked ministers to intervene and to ask the SMC to revisit the estimates on which it based its decision. Ministers have said that it would be inappropriate for them to do so, but I do not agree. If there is no appeals mechanism, will the minister advise us how decisions can be revisited? Why cannot ministers write to the SMC to say that they have additional information and to invite the SMC to reconsider? No one is arguing that ministers should direct the SMC, but when there is a dispute about the evidence, it is not unreasonable for ministers to ask the SMC to look again at the evidence that is available.

Dr Gavin Giovannoni of the National hospital for neurology and neurosurgery in London described Tysabri as the most significant advance in MS treatment in a decade. It is, but for it to be effective in Scotland it must be prescribed on the national health service. I urge ministers at least to write to the SMC to ask for the decision to be revisited.

Photo of Nanette Milne Nanette Milne Conservative 5:11 pm, 1st March 2007

I congratulate Tricia Marwick on securing this debate on a matter that affects only a relatively small group of people but is nonetheless of major importance to their quality of life and to those who care for or depend on them.

I well remember that way back in the mists of time, when I was a medical student in Aberdeen, I saw a number of patients with quite advanced MS. I learned that there was a higher incidence of the condition in the north of Scotland—particularly in Shetland, if I remember rightly—than in the rest of the country, and that the prevalence in Scotland was the highest in the world. The cause of the condition, although essentially unknown, was thought to be some sort of trigger event—perhaps environmental or viral—in a genetically predisposed individual. There was no cure. Forty years on, that remains the case, but in the past few years there have been significant advances in treatments that can delay the progress of MS and relieve its symptoms.

Early diagnosis before damage becomes irreversible, followed swiftly by the administration of beta interferon, has been of enormous benefit to many patients who could not previously be helped. The recent SMC decision not to approve beta interferon for patients with a single demyelinating event is disappointing. By reducing the incidence of relapse, beta interferon and glatiramer acetate can avoid the necessity to prescribe high doses of corticosteroids, with their consequent side-effects. For people with severe relapsing-remitting MS who do not respond to those drugs or whose disease is rapidly progressive, there was no effective licensed treatment until Tysabri became available.

The SMC's decision not to recommend Tysabri for use in the NHS has come as a bitter blow to patients with the most aggressive form of the disease, who had looked forward to the possibility of slowing down the progression of their disability. Those patients are usually in the prime years of their lives, with young families and financial commitments. A drug such as Tysabri, which could allow them to continue to work or to live without the need for a wheelchair, would make a huge difference not only to their lives, but to the lives of their friends and families. To be denied the drug, which is the product of groundbreaking biotechnology, is even more upsetting when patients know that it is being prescribed in the United States, Ireland and Germany.

Tysabri's clinical efficacy is not in doubt, but it has clearly failed to meet the economic criteria that the SMC has to take into consideration when making a judgment. I would like to know more about those criteria. Do they take into account the cost of the consequences of appropriate patients not getting the drug, including loss of income, the need for state benefits, the effect on relatives—who may have to give up work to become carers—and the cost to the NHS and social services of supporting a person with increasing disability? Are those factors taken into consideration by the SMC when it makes its judgment? In the case of Tysabri, with its proven clinical efficacy, did the SMC consider a worst-case scenario as a basis for its recommendation?

At a cost of nearly £15,000 a year, no one denies that it is an expensive treatment, but—as Tricia Marwick said—the number of people who would benefit is not large, and the cost would not be an enormous burden on the NHS, although obviously it would impact more on health boards where the incidence of MS is highest.

Photo of Tricia Marwick Tricia Marwick Scottish National Party

Does the member acknowledge that the cost that she cited includes the cost of existing drugs? If the patient is not on existing drugs, the cost of Tysabri comes down to about £7,000 a year.

Photo of Nanette Milne Nanette Milne Conservative

I accept what Tricia Marwick says.

I know that it is difficult for the minister to go against the advice of an expert body such as the SMC, but I hope that he will look at the threshold criteria that have to be met before drugs are approved, because they appear to be particularly stringent.

Tysabri is not the only product that has been rejected recently that could delay the progress of incurable disability. It is not long since we had a similar discussion about Alzheimer's disease, and it is only a few years since the battle for beta interferon was won, to the enormous benefit of many MS sufferers. We still await the National Institute for Health and Clinical Excellence's decision on Tysabri, which I believe is due in a few months' time. If NICE approves the drug for national health service use in England, will the minister put pressure on NHS Quality Improvement Scotland and on the SMC to reverse its decision? In the meantime, will he encourage health boards to fund Tysabri in cases where a neurologist wants to prescribe it? Without the drug, the most severely affected MS sufferers face a bleak future; with it, they could significantly extend their productive lives. Surely that benefit must outweigh a judgment based on cost alone.

In the absence of detailed knowledge of what the SMC considered, I am not at this stage prepared to deplore its decision, because it is tasked with making a very difficult judgment, but in all other respects I am more than happy to support the motion.

Photo of Eleanor Scott Eleanor Scott Green 5:16 pm, 1st March 2007

I thank Tricia Marwick for bringing forward the motion for debate. I also thank those from the MS Society who briefed us yesterday and the consultant neurologist who came along and told us about treating patients with severe and aggressive multiple sclerosis.

As we have heard, MS is a disease whose cause is unknown, for which there is no cure and which is commonest in northern Europe, especially in Scotland and particularly in the north of Scotland. Therefore, as a north of Scotland MSP I am very interested in the issue.

There is no cure for MS, but there are treatments. Tysabri is used for the small group that has very aggressive attacks. The nature of MS, which is perhaps the issue that gives the Scottish medicines consortium some problems, is that it is a disease that remits and relapses. The experience of patients with MS can vary hugely. Some people live their lives with MS with quite minimal disability, but for others the disease takes a rapid course with increasing disability. It is a very distressing disease in those cases. That is where Tysabri comes in, because it is used for the treatment of acute episodes. Beta interferon has also been used in the treatment of those episodes. It stops roughly one in three relapses; Tysabri does so in two thirds—67 per cent—of cases. As the neurologist put it, it is important to stop relapses because that stops the chance of accumulating disability. That is how she put it, and that comment is very telling. We have to be able to treat the acute, aggressive episodes in the small group of patients who have such aggressive episodes.

As far as we can see, the SMC's decision seems to be based only on cost. As Nanette Milne said, NICE has not yet made a decision. The SMC is usually slightly more humane than NICE, which is described by many professionals as the national institute of cost-effectiveness—it seems to look not so much at the patient as at the cost.

We have heard that Tysabri is a licensed drug, which is allowed in Ireland, Germany and the USA. The neurologist whom we spoke to yesterday feels that the SMC struggles to deal with long-term fluctuating conditions and to model the costs. I can understand that that must be difficult. It is perhaps not a coincidence that we are talking about another MS drug. The situation is hauntingly familiar after what we went through with beta interferon. Perhaps the SMC struggles to model costs for a disease that fluctuates in the way that MS does, because there are costs of not treating that are difficult to quantify and factor in. There are social, personal and economic costs of the increasing disability in people who suffer from MS. Preventing disability is always better.

Is it the case that people can never get this treatment? It is not quite the case, because we heard from the neurologist that if a consultant who is treating a patient feels that Tysabri is the only treatment that will be effective for his or her patient, they can plead the case with their health board and perhaps get it on a named-patient basis. We have heard how, in some areas, such requests have been accepted by the health board and, in others, refused. That brings us right back to postcode prescribing.

Compared with any other drug that prevents relapses in this aggressive condition, Tysabri is doubly effective. I do not doubt the Executive's publicly stated commitment to dealing with long-term conditions; however, MS is a particular long-term condition in Scotland, and this treatment can prevent patients from accumulating disability. The SMC's decision not to make Tysabri available should be reversed.

Photo of Maureen Watt Maureen Watt Scottish National Party 5:20 pm, 1st March 2007

I, too, thank my colleague Tricia Marwick for securing the debate and for highlighting the anomalies in the treatment of MS. MS is a hugely debilitating condition for which there is, as yet, no cure. However, I hope that, with the cracking of MS's genetic code and with medical advances taking place at a significant pace, a cure will be found soon. In the meantime, the pharmaceutical industry continues to make significant advances in the treatment of debilitating illnesses and conditions such as MS, and Tysabri is a real addition in that respect.

As Tricia Marwick pointed out, almost 10,000 people in Scotland have MS. The UK Multiple Sclerosis Society estimates that if the Association of British Neurologists' criteria for receiving treatment were properly implemented, somewhere between 28,000 and 40,000 people with MS—or 32 to 47 per cent of the UK's MS population—would be eligible for disease-modifying therapies. However, in the UK, only 9,000 to 10,000—or 11 per cent—of people with MS are on DMTs. That figure compares poorly with other countries in Europe and beyond. In the Netherlands, 24.7 per cent of the MS population is on DMTs; in France, 30.4 per cent; in Italy, 32.9 per cent; in Ireland, 36.1 per cent; in Germany, 37.1 per cent; in Spain, 40.6 per cent; in the United States, 47.1 per cent; and in Portugal, a massive 61 per cent.

As Eleanor Scott indicated, one important factor is the cost-effectiveness of MS treatments, and the figure for the relapses avoided by treatment is much better for Tysabri than for any of the other drugs that are available. Obviously, the number of relapses in a non-treated population will be much higher than that in a treated population; however, under a model developed in the US, the cost per relapse per year avoided was between $12,000 and $23,000 lower for Tysabri than for the other DMTs. As Nanette Milne made clear, Tysabri helps people to avoid relapses, which means that they avoid having to take days off work; it helps them to avoid treatments that worsen the condition and debilitate them further; and it helps them to avoid having to employ carers.

Surely, in deciding whether Tysabri should be available to MS sufferers, the Minister for Health and Community Care should weigh all those factors and costs against the cost of prescribing Tysabri. I look forward to hearing the deputy minister's views on the matter.

Photo of Jamie Stone Jamie Stone Liberal Democrat 5:24 pm, 1st March 2007

As Eleanor Scott pointed out, the prevalence of MS is highest in the Shetland islands, the Orkney islands and parts of Caithness. As a result, statistically, my constituency contains a very high number of sufferers. In that regard, I recently spoke to the Caithness branch of the MS Society, which has, quite understandably, asked me to support Tricia Marwick's motion. I have no hesitation whatever in doing so.

The speeches made by members who have already spoken are more far reaching and knowledgeable about the situation than anything that I can say. However, it is true that, with the introduction of MS nurses in most parts of Scotland and the availability of beta interferon, advances have been made in the treatment of the condition. I accept the intelligent arguments that have been made for the use of this drug.

I crave the indulgence of colleagues in the chamber while I broaden the issue slightly to a matter that is of pressing constituency interest. MS Caithness is lobbying for all the things that Tricia Marwick and other members have spoken about. It does a good job in representing people who suffer from this dreadful disease. However, MS Caithness faces difficulties, one of which I want to highlight in the debate. I refer to the simple issue of water rates relief for charities.

Charities can gain exemption if they satisfy the six criteria that the Scottish Executive established in 2002. The criteria are:

"The premises concerned must have been occupied by the charity at both 31 March 1996 and 31 March 1999 ... They must be being used for the same purposes now as they were on 31 March 1999 ... They are not retail outlets ... They do not have a permanent liquor licence ... They are neither owned nor occupied by a council".

As members will know, if a charity moves from one premises to another between certain cut-off dates, the relief goes. MS Caithness has lost any exemption that it had for water rates. Its properties in Wick and Thurso are used for two hours a week for physiotherapy for sufferers; each property is used on average for 40 weeks a year. It is having to pay approximately £10 an hour for its water rates. We are talking about a charity that raises money from ordinary money to try to push issues such as the one that Tricia Marwick rightly brought before the chamber, yet it is having to fund £10 an hour out of money that could be used to highlight the sort of issue that Tricia Marwick has raised or to give people physiotherapy that they cannot get through the national health service.

The prevailing regime of water rates relief is inconsistent and arbitrary. It is thoroughly unhelpful for a small, hard-working charity that fully backs Tricia Marwick in what she is saying. I say that on the record because it is a disgrace. Something should be done to sort it out.

Photo of Dr Jean Turner Dr Jean Turner Independent 5:27 pm, 1st March 2007

I congratulate Tricia Marwick on bringing an important subject to the chamber. I also congratulate the members who have spoken before me. They are certainly well versed in the subject. I am not an expert on MS. I treated people with MS, or tried to diagnose them. I want to give the chamber some idea of why I think that we are talking about a small number of people—indeed, a very small number of those with MS.

I was 35 years in the NHS. In my 25 years in general practice, I met one lady who came into this category. As Nanette Milne said is often the case, the person was young. She was in her mid-20s and had two children under five. In medicine, one knows that someone can have an acute onset, but it is impossible to imagine what that is like. I had to go to the neurological unit of the Southern general hospital to visit this lady, to see for myself what it was like. I could not believe how quickly the onset of cerebral demyelination could occur. She was unable to feed herself or to do anything for herself. She had tubes in and out and about her body.

She was in bed for three weeks and it was a further three or four weeks before she was able to return to her home and look after her children. Her husband was a young man and he was devastated by what had happened, as were her children. She had to go to her parents' house. Her mother had MS of a different nature—as we know, MS affects people in different ways.

I plead with the minister—with anybody—to reconsider the prescribing of Tysabri in cases where the neurologist thinks that the drug will help. Neurologists will not prescribe a drug again and again if it does not help. If we weigh up the costs of preventing such devastation from happening in anybody's life, and in the lives of those who live round about them, against the costs of keeping that girl in a hospital bed for weeks, unable to do anything for herself—including the costs of the nursing and care she received and of dealing with subsequent problems in the community, before she returned to full health—the cost of prescribing a licensed drug to people in similar situations is worth it.

Scotland is almost the MS capital of the world. I have never forgotten meeting about 200 MS sufferers two or three years ago, up the road in the Hub. I met people whose condition was not as bad as that of the girl I mentioned, and it was devastating to hear them describe their difficulties in getting physiotherapy and the other services that they needed if they were to live normal lives. The money that we put into looking after such people well is well spent and represents a saving in the long run, so I plead with the minister to consider the matter.

Photo of John Scott John Scott Conservative 5:30 pm, 1st March 2007

I, too, congratulate Tricia Marwick on securing the debate on the need for Tysabri to be prescribed to MS sufferers. I declare an interest: I am a supporter of MS Ayrshire. This is perhaps immodest of me, but I also draw members' attention to motion S2M-5307, in my name, which calls for Tysabri to be prescribed, and I take this opportunity to thank the members who supported it. I pay tribute to the many volunteers throughout Scotland who support MS sufferers, particularly in Ayrshire. I have an enormous regard for the tremendous work they do.

The decision by the Scottish medicines consortium not to recommend the use of Tysabri in the NHS in Scotland is, quite simply, a huge disappointment for people who have relapsing forms of MS. It is all the more disappointing that the decision has been taken on cost grounds alone, because no one doubts that the clinical case for Tysabri's use has been made and is widely acknowledged. The fact that Tysabri is available to MS sufferers in England and Wales is particularly upsetting for sufferers in Scotland. A more obvious example of postcode prescribing will be hard to find if the situation is allowed to persist.

The director of the MS Society Scotland said:

"No other drug has shown this potential to reduce disability, and any short-term savings are likely to be outpaced by the devastating financial costs of living with severe, progressive disability—not to mention the emotional costs to people with MS and their friends and families."

That says it all.

It is particularly hard for sufferers to understand the position, given that Tysabri is available and afforded not just in other parts of the UK but elsewhere in the world, such as in the United States and Germany. At a cost of £15,000 per patient per year, Tysabri is not an inexpensive drug. However, in areas such as Ayrshire, which has an inexplicably high incidence of MS—the incidence of the condition appears to be different in different parts of Scotland—the money would be well spent. The cost of the drug must be compared with the current cost of treatment, which is £7,000 per patient, as Tricia Marwick said.

Some 10,000 patients worldwide use Tysabri. On behalf of MS sufferers in Ayrshire, I ask the minister to ignore the SMC's decision and to support those people throughout Scotland who desperately need access to the drug, to treat that most dreadful of illnesses.

Photo of Christine Grahame Christine Grahame Scottish National Party 5:33 pm, 1st March 2007

I will try not to repeat what members have said and to provide additional data.

There is no national register of people with MS in the UK or in Scotland, so the figures that are quoted are an estimate and are based on local studies. Work in that regard should be progressed. Similarly, there is no accurate record of the number of new cases of MS that are diagnosed each year. The nationwide application of the results of local studies suggests that about 2,500 people in the UK and perhaps some 250 in Scotland are diagnosed with MS each year. We need to start gathering information on the condition.

I applaud Tricia Marwick's dedication to the cause of MS since she entered the Parliament in 1999. I also applaud the hard work of the MS Society Scotland, which has lobbied hard and successfully on various occasions in the Parliament and has made progress for sufferers of the disease.

In the most recent parliamentary answer on the matter, in response to a question from Irene Oldfather, Andy Kerr said:

"As at 30 September 2005, NHSScotland employed 10 Multiple Sclerosis Nurse Specialists".—[Official Report, Written Answers, 19 December 2006; S2W-30479.]

If I have got my figures right, that is about one specialist nurse per 1,000 people with MS, but the distribution will not be as neat as that and some areas will have none. I draw the minister's attention to the fact that those nurses, like other specialist nurses, are usually funded partly or wholly by charities. That is inappropriate, because they are highly skilled staff who provide a lot of information and support to sufferers in places such as the Borders.

Members said a lot about Tysabri. I challenge the idea that it is expensive. The MS Society states:

"No other drug has shown this potential to reduce disability, and any short-term savings are likely to be outpaced by the devastating financial costs of living with severe, progressive disability—not to mention the emotional costs to people with MS and their friends and families."

My colleague Maureen Watt and others described the broader picture. Tysabri costs £14,740 per patient per year. I do not think that that is dear. I would not argue about spending that sum, which is less than £15,000. As Tricia Marwick said, if we subtract the cost of other drugs, the cost is reduced to about £7,000. The cost is small, especially given the small number of people that the drug will help—40 to 50, as I understand it.

What will happen next? People will be rejected by NHS boards—Eleanor Scott alluded to that. People with money will buy the drug and will be treated, but people who do not have the money will not be treated. We will have not just a postcode lottery, but an economic divide between those who can pay and those who cannot.

The SMC has no appeals process. I do not want to give ideas on the hoof, but it seems to me that there is scope for a procedure to review the SMC's decisions. The Government should not have its fingers in the pie. Instead, an independent board should consider the decisions. Individuals or organisations that can demonstrate an interest—such as the MS Society—should have the right to have decisions reviewed. They should not find that a decision has been taken and that that is the end of the process.

Photo of Lewis Macdonald Lewis Macdonald Labour 5:37 pm, 1st March 2007

I acknowledge the importance of the issue that has been brought for debate by Tricia Marwick and I acknowledge the interest in the issue of many people who live with multiple sclerosis. Like many people in Scotland, I have a number of friends and acquaintances who live with MS. I take the opportunity to underline the Executive's commitment to people who have MS—as part of our work on long-term conditions—and to those who provide care, either professionally or as friends and family.

As has been said, there is a high incidence of multiple sclerosis in Scotland. We do not know the reason for that, but research continues into its causes as well as into treatments. MS is a complicated condition that can have devastating consequences. It affects people in complex ways and its effects need to be considered in the context of the particular circumstances of each individual who has the condition. Accordingly, management of individual patients requires a tailored package of care. Professionals and carers work with people who have the condition to ensure that they can, as far as possible, live the lives they want to live. One part of that care package is the provision of drug treatments, which is the subject of this evening's debate.

The taking of decisions on new drugs is a demanding and painstaking process in which many factors have to be taken into account, including the benefits that a medicine will provide, its side effects, the alternative treatments that are available and the relationship between benefits and costs. The key questions are whether a drug will offer worthwhile benefits to patients and whether those benefits can be achieved effectively and at proportionate cost. Decisions have to be made on the basis of the best available evidence, but the evidence that is available might be limited in the early stages of the development of a new drug.

Photo of Jim Wallace Jim Wallace Liberal Democrat

Does the minister agree that the United States Food and Drug Administration sets some of the highest tests for drugs to get through? It has unanimously supported the prescription of Tysabri. Does not that add weight to the call for it to be allowed in Scotland?

Photo of Lewis Macdonald Lewis Macdonald Labour

The point that Jim Wallace makes is correct. However, he will be aware that the FDA did not take that view at first because of some of the drug's serious side effects, and that it came to that judgment only at a later stage.

It is also important to bear it in mind that the drug is licensed for use in the United Kingdom and that the decision that the SMC has to take is different from the one that the FDA had to take because there is no national health service as such in the United States. That lack may be a matter for regret, but it is not one over which we have any say. The SMC considers not whether the drug should be licensed: it considers only whether it is appropriate for use in the national health service, which is a different question.

The SMC provides a tried and tested method of assessing drugs, which we consider to be robust for Scotland. It is intentionally separate from the Scottish ministers and the Health Department and provides an informed and expert scientific assessment of the available evidence that manufacturers present on new drugs for use in the NHS. It is worth recording that, in its recent report "The Pharmaceutical Price Regulation Scheme: An OFT market study", which was published in February this year, the Office of Fair Trading commented:

"the bodies that carry out health technology assessments in the UK, particularly NICE and SMC, are among the most respected in the world."

We share that view and believe that it is entirely appropriate that such decisions are made by those who have professional and clinical expertise, not by ministers.

A number of members have asked about the process that the SMC follows. It is important to state that, once a recommendation has been made, a manufacturer can make a complaint, request an independent review panel or resubmit if new evidence is available. If a company feels that there has been significant deviation from due process, it can express that concern and a process would then be followed. In the rare event of a disagreement on the science, a request for review should be submitted to the chairman of the SMC, who will discuss it and take it forward if it is appropriate. If it is agreed that there is a substantial change in the data, that a reanalysis of the data is necessary or that there is a change to the drug positioning, the case will be treated as a new one, and there is a process for resubmission in such circumstances. In the event that there is a scientific disagreement that cannot be resolved and there are no new data, the chairman of the SMC will, at the request of the manufacturer, report the facts to the next meeting of the SMC and establish a group to carry out an independent review of the science.

Photo of Tricia Marwick Tricia Marwick Scottish National Party

The minister has spoken about manufacturers' right to approach the SMC to request reviews. What possibility is there for patient groups, such as the MS Society Scotland, to be part of that review process?

Photo of Lewis Macdonald Lewis Macdonald Labour

There is the opportunity for a patient submission in the earlier consideration. If there is significant new evidence or a new approach to the evidence, a resubmission is counted as a new process and there is again an opportunity for a patient submission.

Photo of Christine Grahame Christine Grahame Scottish National Party

I understand that the basis of review is the scientific and clinical evidence, not costs.

Photo of Lewis Macdonald Lewis Macdonald Labour

I am glad that Christine Grahame gives me the opportunity to put on record the fact that the SMC does not make judgments on the basis of cost alone. It is important to make that point because a number of members have suggested that the SMC's decision on Tysabri is simply a cost judgment. However, the SMC has previously approved treatments that cost more per patient or that have a higher total cost to the NHS. It is important to be clear about that.

Instead of being driven by costs, the main work that the SMC does in considering a submission is to try to establish how many patients would feel better and by how much. In other words, it is not a crude calculation but a judgment on the treatment's value to the national health service and to patients. The SMC's view is that the manufacturer of Tysabri has failed to make that case and the SMC has issued its guidance because of that judgment. It found that Tysabri indeed brings clinical benefit, particularly to MS patients with more severe symptoms, but the SMC's point of view is that the evidence on the degree of clinical benefit and the cost benefit is simply not sufficiently clear to make the judgment that it should be used in the national health service. In other words, the SMC concluded that the evidence that had been submitted by the manufacturer did not provide a sufficient basis to support the use of the drug.

Photo of Tricia Marwick Tricia Marwick Scottish National Party

The letter that the minister's department sent to the MS Society Scotland stated in reference to the SMC that

"It found that although the therapy provided some clinical benefit it did not provide sufficient benefit for it to be recommended for use."

I wonder how much benefit there needs to be for therapy to pass such a test, given that in all the clinical trials that have taken place it has been clearly shown that the drug is

"twice as effective in reducing MS relapses as previous MS drugs."

Previous MS drugs are still being prescribed, but the benefits are twice as good with Tysabri. I am afraid that I just do not understand why the proven clinical benefits are not sufficient for the SMC to approve the drug.

Photo of Lewis Macdonald Lewis Macdonald Labour

In the process of assessment, the evidence that is submitted is subjected to rigorous examination by clinical and professional experts in the areas concerned. Clearly, they have not been satisfied in this case. It is not for me, any more than it is for other members, to second-guess that scientific assessment, but we would expect the SMC to apply the same criteria and judgment in all such cases. If it has a judged that the evidence that has been provided to it is not sufficient to reach the conclusions that Tricia Marwick suggests it should reach, that puts the ball firmly in the manufacturer's court. It is not a small company; it is a significant pharmacological company, which certainly has the resources to respond readily. It is up to the company to resubmit if it believes that the representation and analysis of its evidence has not been fair. It is not appropriate for us to second-guess such judgments, as I said. We expect the SMC to make its judgments professionally and responsibly—it certainly has the expertise to do that.

Photo of Christine Grahame Christine Grahame Scottish National Party

I want to explore some of the issues around the SMC. This is new territory for me in some respects. Are the SMC's deliberations and decisions, along with the reasons for its decisions, in the public domain?

Photo of Lewis Macdonald Lewis Macdonald Labour

Its conclusions are in the public domain, as Christine Grahame will be aware, as is the basis on which it reaches its conclusions. That is perhaps what Christine Grahame wishes to see.

I emphasise the significant range of expertise that the SMC brings together. The chair and vice-chair are clinicians, as are the majority of its members, in one respect or another: they are members of clinical professions and include general practitioners and nurses as well as people who are otherwise involved in medicine or pharmacy. The SMC makes judgments—that is what we task it to do. Following the SMC's judgment in this case, we would expect the manufacturer, if it feels that it has more evidence or that the evidence that it presented was not fully considered, to use the processes that are in place to return to the issues.

Although this evening's focus has been on drug interventions in relation to MS, there are wider considerations for the management of long-term conditions. I join other members in acknowledging the contribution of the MS Society and I emphasise its potential to influence the Long-term Medical Conditions Alliance in Scotland, which is crucial to our work on long-term conditions including MS. The chief medical officer is in the process of developing our national strategy for long-term conditions; clearly, we would look to the MS Society to play a part in that work.

We all agree that we want to provide the most effective treatments, including drug interventions, where it can be demonstrated that they will have the best outcomes for MS patients. Clearly, we want to do that in parallel with other processes, such as research into causology and treatment. We look forward to the MS Society continuing to play an important role in that work.

Meeting closed at 17:50.