– in the Scottish Parliament at 5:03 pm on 7th June 2007.
The final item of business is a members' business debate on motion S3M-29, in the name of Des McNulty, on Alimta for mesothelioma sufferers. The debate will be concluded without any question being put.
That the Parliament recognises that mesothelioma is a particularly aggressive cancer of the lungs, almost exclusively caused by exposure to asbestos; also recognises that West Dunbartonshire has the highest incidence of this work-related disease in Scotland and the second highest in the United Kingdom; further recognises that Alimta is the only drug licensed to treat mesothelioma, where it has been found to deliver significant improvements in the quality of life of sufferers, and considers that Scottish Executive ministers should ensure that Alimta continues to be made available to all existing and new mesothelioma sufferers who, in the professional opinion of consultant oncologists, would benefit from it.
My motion asks—not for the first time—for the assistance of Parliament on behalf of sufferers of asbestos-related diseases. The number of mesothelioma diagnoses has quadrupled since 1980. The minister will be well aware that mesothelioma sufferers live throughout Scotland; however, more than half live in the west of Scotland—a toxic legacy of the shipbuilding industry on the Clyde.
Until recently, there was no treatment for mesothelioma, but now we have a licensed drug—Alimta—that has made a big difference to the lives of mesothelioma sufferers for whom, in the view of their consultant oncologists, it is suitable.
Dr David Dunlop from the Beatson oncology centre was a clinical expert adviser to the Scottish medicines consortium. In a submission to the Public Petitions Committee, he said:
"I am one of the largest prescribers of this drug in Scotland and have been involved in several clinical trials .... since the positive appraisal of Alimta by SMC, I and many other oncologists in Scotland, have seen the benefits of this drug in many patients."
One of Dr Dunlop's colleagues, Dr Marianne Nicolson at Aberdeen, advised the committee that she had
"no doubt that we must do everything possible to maintain our patients' opportunity to access Alimta to treat their mesothelioma. I have prescribed it for many patients here in Aberdeen since the SMC approved its use and I have been impressed with the rapidity and duration of the responses seen."
Alimta is not a wonder drug. It is not a cure and not every mesothelioma sufferer would benefit
In a few months, unless NHS Quality Improvement Scotland takes a contrary view, recommendations from the National Institute of Health and Clinical Excellence will supersede existing advice from the Scottish medicines consortium and new patients will not have access to Alimta. The costs involved in continuing to make Alimta available are not massive—hundreds of thousands of pounds rather than millions—and the context in which it might be denied to new patients must be recognised. West Dunbartonshire has the highest incidence of mesothelioma in Scotland. It is six times the Scottish level which, in turn, is significantly higher than that in the UK as a whole. Too many of the people whom I represent are victims of negligence on the part of their employers—or, in some instances, their spouses' employers—who knew the risks of exposure to asbestos but continued with working practices that left time bombs in the bodies and on the clothes of their workers.
NICE should recommend that Alimta be made available on the national health service to everyone in the United Kingdom who would benefit from it. However, if it does not, it will fall to NHS QIS and ultimately the Scottish ministers to decide what happens as far as Scottish patients are concerned. The drugs approval process in Scotland is set up so that it recognises differences between the two sides of the border, and the distinctiveness of Scotland provides evidence and justification for taking a different stance on Alimta, should that prove necessary.
I wrote to the minister on the day she was appointed requesting a meeting to discuss Alimta. I hope that she will grant me that meeting, to which I will bring some of the campaign organisations. She will doubtless be aware that the First Minister responded in very positive terms to a letter from the Clydebank Asbestos Group before the election. He stated:
"I strongly support continuation of the present position which allows Alimta to be prescribed to those who would benefit from it."
Given that commitment and the strong support that we have received from the leaders of each of the four main political parties in Parliament, I hope that the minister will be able to make a very clear statement of principled support for mesothelioma sufferers.
I also hope that NHS QIS will take full account of the context in Scotland and decide that mesothelioma sufferers—including newly diagnosed patients who, in the opinion of
Parliament has a proud record of helping sufferers of asbestos-related diseases and their families. I was deeply grateful—as were campaigners—for the work that Parliament did and the decision that it reached on the Rights of Relatives to Damages (Mesothelioma) (Scotland) Bill to help the families of asbestos victims. I do not want to keep coming back, but the plight of people who suffer from asbestos-related diseases is pressing, so I hope that Parliament will respond again to the call that they make and deal with the situation sympathetically.
I began by quoting the views of leading specialists who, on the basis of their experiences, strongly advocate continued availability of Alimta. I will conclude with a different testimony, from Joan Baird, whose husband Willie died of mesothelioma and who has committed herself to working voluntarily to support other victims and their families. Joan said:
"It is a horrific disease. I'd describe it as the silent dust death sentence.
It is a very painful disease and to watch anyone suffering with this takes the heart right out of you.
I was lucky that my husband was in his 70s when he died but what I am seeing now is younger people dying from this horrendous disease and that is very hurtful."
Alimta will not cure mesothelioma, but it appears to ease the pain. It prolongs life and provides some dignity to the unfortunate people whose lungs have been destroyed by working conditions that they experienced 20, 30 or 40 years ago. I believe that our obligation here in the Scottish Parliament is to do all that we can on their behalf.
I congratulate Des McNulty on securing the debate on the continued use of Alimta, and on his tenacity in pursuing the matter tirelessly throughout his parliamentary career and before it.
As we enter the third session of Parliament, in which consensus seeking and co-operation have been talked of, it is interesting to note that back in March, all parties came together to support the Right of Relatives to Damages (Mesothelioma) (Scotland) Bill. In February, at stage 1 of the bill, I expressed concern that the National Institute for Health and Clinical Excellence's rejection of Alimta would lead to the drug's being withdrawn in
Des McNulty mentioned support from the party leaders. The First Minister, Alex Salmond, said in his letter to the Clydebank Asbestos Group:
"To deny access to a drug which can extend their life and greatly reduce the worst features of the disease would be unacceptable."
The former Minister for Health and Community Care, Andy Kerr, said:
"We will make sure NHS QIS has considered the impact on Scottish...sufferers"
The Liberal Democrats offered this welcome statement:
"We want to see the SMC decision remain in place." and Annabel Goldie said that
"It is not reasonable to blindly follow rulings elsewhere."
I am glad that my colleagues throughout Parliament have reached agreement on the issue. The sentiment is shared throughout Scotland by people whom I meet.
The Scottish medicines consortium promotes the Scottish interest. We in Parliament will demand that NHS QIS go forward with the recommendations that the people want regarding Alimta. I call on my colleague in the Scottish Government, Shona Robison, to make a firm commitment to seek ways to ensure that the drug continues to be available for present and new sufferers. I am sure that everyone is aware of the terrible consequences of mesothelioma, the highest incidence of which is in Scotland. Therefore, I believe strongly that we should say to NICE and NHS QIS that NICE cannot interfere in NHS QIS. It is a Scottish decision and we in the Scottish Parliament have said that we support NHS QIS on sufferers' access to the drug.
I thank Des McNulty for his continued efforts in pushing for the drug to be made available.
I thank Des McNulty for securing the debate. It is good to be back in Parliament and to be debating health issues.
The first issue that I want to discuss is the role of the SMC and NHS QIS in Scotland. I remember that when those organisations took on their responsibilities, it was made clear that they would not simply tartanise or rubber-stamp NICE appraisals and rulings and that decisions that were made in Scotland would be appropriate for Scotland. In a written answer to Dr Nanette Milne, the former Minister for Health and Community Care wrote:
"The Scottish Executive is satisfied that NHS Quality Improvement Scotland ... fully evaluates the suitability of National Institute for Health and Clinical Excellence ... guidance for implementation in Scotland based on the criteria in respect of contextual differences outlined by NHS QIS in July 2003."—[Official Report, Written Answers, 7 March 2007; S2W-32032.]
The process that has been outlined by NHS QIS confirms the suitability of NICE guidance in Scotland in the light of the epidemiology, the predicted uptake, and the existing advice from the Scottish medicines consortium. I hope that, on all three counts of contextual difference, NHS QIS will break the habit of its existence and overrule the NICE ruling on Alimta.
There is an important principle for the future of the SMC and NHS QIS in the drug and therapy appraisal system in Scotland. As Annabel Goldie stated before the election:
"We must listen to the advice given by clinicians in Scotland and always act in the best interests of patients in Scotland. Whilst it is reasonable to keep such matters under review in light of emerging evidence, it is not reasonable to blindly follow rulings elsewhere. The final decision must be made here in Scotland."
The matter is of particular interest in Scotland, because, as others have said, we have the highest number of mesothelioma sufferers in the United Kingdom and a third more than England and Wales.
Treatment with Alimta involves a one-off course of eight treatments, which in full costs £8,000. However, I understand that 87 per cent of patients do not need the full cycle and benefit after four treatments at a cost of £4,000. Alimta is available in all European Union countries and beyond. It is available in Australia and America. If an alternative were available for mesothelioma sufferers, we would probably not be having tonight's debate. As Des McNulty said, the drug is known to prolong life, to improve the quality of life and to alleviate pain. I hope that the absence of an alternative will also be taken into account in the final appraisal of the drug.
Alimta is an innovative drug that can be effective where traditional cancer treatments are not. One point that struck me—along with all the other reasons for prescribing the drug—is that clinical trials are being undertaken on the treatment of non-small-cell lung cancer with Alimta. That
None of us—except perhaps Dr Ian McKee or Dr Richard Simpson—has the medical knowledge to say that the drug should be prescribed, but we know the incidence of mesothelioma in Scotland. We know that it has been passed down through the generations as well as affecting those who worked directly with asbestos, and we can listen to the advice of people such as Dr David Dunlop, lead clinician for the patient group at the Beatson centre in Glasgow, who has written in strong support of Alimta.
Mesothelioma is relatively rare, but its incidence is rising and is expected to peak in the next decade. If a decision is taken not to prescribe Alimta for mesothelioma patients, we as responsible members of Parliament would expect the people who make the decision to suggest an alternative that is equally effective in terms of patient care.
I, too, am grateful to Des McNulty for bringing the issue to the Parliament once again.
Unless someone takes a contrary view, there is no disagreement between the parties about the desire for Alimta to be available. The issue that is before us is that the technical reasoning of those who assess the drug might impede it being made available. In addition to the wording of Des McNulty's motion for tonight's debate, we are all encouraged by the wording of a motion on the withdrawal of Alimta that the Parliament debated on 28 September 2006. That motion was, of course, in the name of Shona Robison, who is now the Minister for Public Health. I am sure that she does not need me to remind her, but I will, that the final sentence ends:
"and therefore believes that the Scottish Executive should guarantee the availability of Alimta to existing and future sufferers of mesothelioma in Scotland."
I am sure that, now that she is the minister in charge, she will wish to fulfil the thrust of that motion.
However, we understand that the matter has become even more complex than it was when the minister lodged that motion. It would be helpful if, in addition to clarifying the Executive's position, which I hope will be to continue to support the drug's availability, she gave some clarification on the juxtaposition of NHS QIS, NICE and the SMC. The situation seems to have become even more confused in relation to the drug in question.
As we know, NICE in its original determination recommended against the general availability of the drug, contrary to what was expressed by the SMC. NICE expressed reservations on clinical efficacy, but its biggest finding was that the drug was not cost effective. As Mary Scanlon mentioned, it is open to NHS QIS to contextualise NICE's findings, but that would be more helpful if NICE had had available to it all the evidence that caused the SMC to reach its conclusion. As I read through the findings on the appeal against NICE's initial decision to reject the drug's availability, I found that the appeal panel ruled that NICE was not required to take account of the views of the SMC or any other external body.
That seems to put NICE in an odd position. How can it come to a conclusion when it does not have the advice available to it? It also places NHS QIS in an even more difficult position, because it is then asked to make a determination on a NICE ruling without the Scottish context having been considered.
I noticed a letter from the Scottish Executive sent on 12 April, when we were contesting the election, to health bodies and the chairs of area drug and therapeutics committees on multiple technology appraisals. It repeats the advice:
"Where NHS QIS decides that an MTA should apply in Scotland, their recommendations supersede SMC advice."
That advice is in normal type. Then, to confuse us, in bold type in the conclusions, the letter tells us that
"the Scottish Medicines Consortium remains the main source of advice and recommendations".
I hope that the minister can clarify first that the latter paragraph is the more appropriate advice, secondly the manner in which NHS QIS is able to consider properly the advice that is before it, and thirdly that NHS QIS can conclude that, as the minister sought in her excellent motion that the Parliament debated on 28 September 2006, the drug Alimta will continue to be available in Scotland.
I thank Des McNulty for the opportunity afforded by his motion to speak on this subject and to do so as my maiden speech in this session, having just returned to the Parliament.
All cancers are unpleasant when they are incurable, but mesothelioma is a particularly unpleasant condition. It is important to note that it is essentially an industrial disease and that, as Mary Scanlon said, by the middle of the next decade the number of people who suffer from it is likely to drop. It might be of comfort to the minister
A current problem is that if drug companies produce drugs that are designed to improve the quality of life rather than to be curative, they risk not being approved by the authorities. That is unfortunate. Improvement of quality of life is of great importance to those who suffer this unpleasant condition, so I strongly support the general tenor of the previous parliamentary session and tonight's debate in suggesting that the drug's use can reasonably be supported. The costs are not excessive—they are reasonable.
I support what has been proposed, but urge that there be clear and effective monitoring so that those who do not respond to treatment have it stopped and those who respond early to it and therefore do not need the full course of treatment do not have the full course. As a result, the drug's cost effectiveness would be improved. I do not believe that the NICE evidence took such factors into account adequately.
I will finish my speech without taking up all my time—I hope that the Presiding Officer will note that when I am called to speak in the future. When I was Deputy Minister for Justice, I met the Clydebank Asbestos Group and endeavoured to support it in the court work on compensation. I am pleased that the issue was subsequently resolved in an appropriate way, although legislation was required.
We are talking about people with an industrial disease that is caused by man, and we should support anything we can to improve their quality of life.
I, too, congratulate Des McNulty on his persistence in advocating the cause of a desperately seriously ill group of patients. Indeed, it is a tribute to him that we are having this debate. I should also congratulate Richard Simpson on his maiden speech, although it seems rather strange to do so, as he has much more parliamentary experience than me.
One problem with speaking towards the end of a debate in which everyone seems to be pulling in the same direction is finding something new to say. Most of the points that I have written down to make in a delicate little speech have already been clearly made, so I will put that speech down.
One of the main objections that bodies such as NICE make relates to the headline cost of Alimta,
One interesting thing about Alimta is that it is available in many other countries, such as Belgium, Canada and Germany, but it is actually cheaper in the UK because of agreements through the NHS. If other places can make it available, surely we in Scotland, taking into account the causes of the disease, can make it available to those who need it in the particular circumstances that are involved.
Des McNulty has kindly finished off the final point that I wanted to make.
I reiterate that there is not a huge demand for Alimta—we are talking about a finite number of patients, which will probably fall rather than increase. Those people are desperately seriously ill, and Alimta can help many of them. Withholding it when, in the overall health budget, its costs are very little, is sheer thoughtlessness and not caring for the sick.
I congratulate Des McNulty on securing the debate and welcome the opportunity to consider difficult issues. I recognise the commitment of those who are actively campaigning on the matter and thank those in the gallery for attending the debate and for their understandable interest and concern. I put on record that I am happy to meet Des McNulty and the campaigners to discuss the issue in more detail.
At the outset, I underline that the opinions and views that the First Minister expressed on Alimta in a letter to the Scottish Trades Union Congress and that I expressed only a few weeks ago have not changed. We still think that it should continue to be made available as per the SMC's standing recommendation, for all the reasons that Des McNulty and other members have given.
The Government has a clear view on this issue—Ross Finnie referred to the debate on it that I initiated last September—but we have to recognise that there is a process and that Alimta is currently being assessed by NICE. The results will be considered by NHS QIS in due course.
These are complex health care issues and we are discussing decisions that will affect people directly. No decisions have yet been finalised. The advice from NICE is pending. I cannot provide
Mesothelioma is a devastating condition and I offer my deepest sympathy to those who have it and to every family touched by it. There is no cure, sufferers do not live long, and their final months are not easy. As members might know, I have previously highlighted the importance that I attach to these matters.
Members have spoken about the higher levels of mesothelioma in Scotland compared with other parts of United Kingdom. The disease has been attributed to Scotland's heritage of shipbuilding and past working practices that led to high exposure to asbestos fibres. There are clear links between mesothelioma and such exposure. Most sufferers are men who were exposed to asbestos in the course of their work, but others, including their families—often the women who did the washing—might also have come into contact with the fibres.
The incidence of mesothelioma in Scotland ranges from 178 new diagnoses in 2000 rising to 200 in 2004. Those are the latest confirmed figures. As Des McNulty said, 62 per cent of diagnoses in 2000 and 52 per cent of diagnoses in 2004 occurred in the west of Scotland. However, in Tayside, during the five years 2000 to 2004 inclusive, 54 cases of mesothelioma were registered. In the UK as a whole, approximately 1,800 new diagnoses are made each year and we expect the figures to peak sometime between the 2011 and 2015.
It is clear from tonight's debate that a number of issues could be considered in conjunction with the evidence on cost and clinical effectiveness but, as I have already said, I agree with much of what has been said tonight and previously about the features of the disease and its treatment.
Alimta is licensed for the treatment of mesothelioma in conjunction with cisplatin. Many members will be familiar with the process of evaluating new drugs, but others might not and I want to touch on that subject.
The SMC considers every new drug in Scotland and, on the basis of the manufacturer's evidence, recommends whether a drug should be available for use, and whether it should be made available for routine or restricted use. The SMC recommended that Alimta should be made available for restricted use as an option in the treatment of a small group of patients with mesothelioma. That very important point was made by Ross Finnie and others, and it is key to our deliberations.
A benefit of the SMC is that it makes decisions here in Scotland as early as possible once a drug becomes available. We should recognise that we have often been able to recommend new drugs ahead of other UK countries, but as medical science moves forward and further evidence becomes available, NICE may conduct a full evaluation of a drug, often alongside other treatments. Such evaluation is known as a multiple technology appraisal or MTA. An MTA considers a broader evidence base and additional research commissioned by NICE.
It is easy to be blinded by the acronyms and the science, but there are real people behind the process. NICE draws on expert advice from all around the United Kingdom, taking evidence from oncologists, nurses and lay panel members. Because NICE appraisals tend to take place further down the track from the initial SMC recommendation, it is obviously prudent that we look at them and consider them. As I have said, Scotland benefits from a system to consider new drugs very quickly, but we realise that evidence can emerge after a therapy has had a period of use. That is inevitable, and it is why NHS QIS considers the outcome of NICE multiple technology appraisals and advises on whether they should apply in Scotland. The decisions are ultimately Scottish decisions; they are for people in Scotland who, I am sure members agree, would be best served by the most up-to-date evidence.
NHS QIS considers the therapy in relation to specifically Scottish contextual factors. It is NHS QIS's role to consider the implications of a range of issues on a case-by-case basis. The decision-making process takes into account the principles and values of NHS Scotland, epidemiology in Scotland—which has been an important issue in this debate—and the structure and provision of NHS services in Scotland. That provides the opportunity to ensure that the issues that we have debated tonight are fully considered.
I hope that members will agree that I should not pre-empt the final recommendation from NICE, or the NHS QIS advice. However, I will seek assurances about the processes and, in the following weeks, I will consider a number of options available to me as minister. I will consider all the options and do what is in the best interests of mesothelioma patients in Scotland. As Minister for Public Health, let me be clear: I believe that interests would be best served by the continued availability of this drug to patients who, according to clinical assessment, would benefit.
I can assure members that I will do my utmost to ensure that the needs of those who suffer from mesothelioma are put at the centre of any decisions about treatment and care.
Meeting closed at 17:46.