Mesothelioma (Withdrawal of Alimta)
The final item of business is a members' business debate on motion S2M-4742, in the name of Shona Robison, on the withdrawal of Alimta for mesothelioma patients. The debate will be concluded without any question being put.
Motion debated,
That the Parliament regrets that the National Institute for Health and Clinical Excellence's (NICE) final appraisal determination on Alimta does not recommend Alimta for the treatment of mesothelioma except as part of ongoing or new clinical trials; is concerned that the drug could potentially be withdrawn if NICE repeats that opinion in its final report due to be published in October 2006; realises that, in practice, NICE's decisions ordinarily supersede Scottish advice which could lead to the withdrawal of this drug for Scottish sufferers; recognises that such a move would have a devastating effect on mesothelioma sufferers here in Scotland given that Alimta has been shown to be effective in increasing life expectancy and improving the quality of life of patients; is aware that NHS Quality Improvement Scotland (QIS) will be reviewing its decision to offer the drug in Scotland in light of the NICE recommendation; therefore urges NHS QIS to recognise the contextual differences in Scotland, such as in epidemiology, with a large concentration of mesothelioma cases in Dundee and other post-industrial areas of Scotland; furthermore recognises the existing advice from the Scottish Medicines Consortium that Alimta should be freely available in Scotland, and therefore believes that the Scottish Executive should guarantee the availability of Alimta to existing and future sufferers of mesothelioma in Scotland.
I thank the members who have stayed for this debate, particularly those who signed my motion. I also pay tribute to members across the chamber who have campaigned to improve the deal of those affected by asbestos. To its credit, this Parliament has done good work on behalf of sufferers, one example of which is the Rights of Relatives to Damages (Mesothelioma) (Scotland) Bill, which was published today and will allow mesothelioma sufferers to claim full compensation and their families to claim for their own loss. Until now, people have been forced to make a distressing and unreasonable choice in that respect.
I pay important tribute to those involved in campaigns in various parts of Scotland from Clydeside to Tayside and, indeed, very much welcome to the public gallery some of those campaigners. I must also thank Ian Babbs and Asbestos Action (Tayside) for their work on behalf of sufferers and their families in Dundee and the rest of Tayside. As a result of their pressure, politicians have been made to sit up and take notice of the injustice that has been suffered by those affected by asbestos.
It is predicted that, by 2025, 25,000 Scots will have died from asbestos-related diseases. Mesothelioma is a terrible lung disease caused by exposure to asbestos. It is a cancer of the lining of the lung, which is unlikely, in its early stages, to cause any symptoms. However, as it progresses, it typically causes patients to feel breathless and to experience chest pain. Men and women who worked in the foundries or on the building sites of our industrial past have been left with a silent killer that creeps up on them without notice. One of its most cruel aspects is its speed; a constituent of mine recently died within 14 weeks of being diagnosed.
The speed of the disease means that people have little time to make arrangements with their families, let alone to apply for compensation. That is why Alimta has been such an important treatment and a lifeline for many sufferers who are clinically assessed as being suitable for the treatment. Around 80 to 90 per cent of sufferers in Scotland are currently getting the drug, and Alimta is the first and only chemotherapy treatment to be licensed in the United Kingdom. It is not a cure, but it has been proven to alleviate symptoms of what is a very painful disease, and it has also been shown to prolong life, with a proven survival increase of between 23 and 40 per cent, giving people a bit more time to spend with their families.
It is of great concern that the guidance released in June by the National Institute for Health and Clinical Excellence said that the use of Alimta was not considered to be cost-effective. If that is the conclusion of NICE's final report, it will lead to the drug's withdrawal next month. There are real concerns about the NICE process that has been used to assess the drug and about whether the reports on clinical and cost-effectiveness are representative of the evidence available; an appeal is likely.
Relatively few people in Scotland—around 200 last year—receive Alimta, at a cost of less than £500,000. That is not a huge amount out of a predicted budget of £10 billion by 2007-08. Although the number of patients will increase as we approach 2015, the cost is unlikely to rise above £750,000 even then. Furthermore, it is not as if there are other, cheaper alternative treatments available. This is it, and it would be cruel in the extreme to withdraw the only available treatment to any group of patients. However, that is likely to be NICE's decision, and we in Scotland must decide how we will respond.
The question is whether Scotland will follow suit. To date, it has been custom and practice for National Health Service Quality Improvement Scotland and the Scottish medicines consortium to follow the recommendations of NICE, but that does not need to be the case. It is the role of NHS QIS—I apologise to those in the public gallery for the NHS jargon, which is hard to avoid—to review its decision to offer Alimta to patients in the light of the NICE recommendation, but NHS QIS guidance makes it clear that that body should consider the suitability of NICE guidance for Scotland in the light of any contextual differences, such as epidemiology. It can be shown that Scotland has some of the highest rates of asbestos-related conditions, because of our industrial past, and the number of cases is predicted to peak in 2015. That is further strengthened by the guidance which also states that NHS QIS should take account of the existing guidance of the Scottish medicines consortium. The existing advice from the SMC is clear: that Alimta should be freely available to patients with mesothelioma. In fact, the consortium's position could not be clearer.
Those guidance sources, taken together, show that a clear case can be made for taking a different approach in Scotland, but political support and pressure are needed to help us to get to that position. We are looking for some comfort from the minister and an assurance that he understands the concerns that are being expressed. More important, we need him to give a clear signal to those considering the issue that the Government has a view on the matter and that its view is that Alimta should be made available to existing and future mesothelioma patients. I look forward to hearing what the minister has to say, not only to this Parliament but to those people who are already affected by this terrible condition and to those who will be affected in future. I hope that he can provide some assurance to them and to their families.
I am glad to have a chance to speak in the debate and I am grateful to you, Presiding Officer, for calling me early, which I requested because I have to leave before the end of the debate. I apologise for that, but I look forward to reading the speeches, especially the minister's response.
As Shona Robison said, mesothelioma is a rare form of cancer, the most common form of which is pleural mesothelioma: in other words, it affects the lining of the lungs. It is almost always caused by exposure to asbestos fibre, and occupations that are at risk typically include jobs in the military, vehicle builders and shipbuilders, construction workers, painters, welders, joiners and electricians.
Although the use of asbestos has now been banned in the European Union, it is estimated that 250,000 workers in western Europe alone will have died from mesothelioma by 2029, and the UK has the highest rates of mesothelioma in western Europe. There were 1,862 cases in 2002, or 39 cases per million of the population, which is roughly double the rate in other countries, apart from the Netherlands. The incidence of mesothelioma in western Europe is expected to peak between 2010 and 2020. There is no recognised first-line treatment for the condition.
Where does Alimta come in? Alimta is the brand name for a drug whose name I can never pronounce—pemetrexed—that was developed by Eli Lilly and Company. Although it does not offer a cure, several trials have shown that Alimta is helpful for people with mesothelioma. For some, it can help to relieve symptoms. Recent trials in the United Kingdom and the United States of America show that, in combination with another drug, it can control mesothelioma for longer than any other drugs that have been tried. As Shona Robison said, Alimta can give significant increases in survival time and quality of life. The cost of £1,600 per cycle might seem to be a lot, but we are not talking about a large number of people or about lengthy treatments. However, we could be talking about a significant benefit for the people who would receive the treatments.
I want to clarify some things for which Alimta has been approved. In 2005, the Scottish medicines consortium advised that Alimta
"in combination with the drug cisplatin is accepted for restricted use within NHS Scotland for the treatment of patients who have not had cancer treatment and have mesothelioma that is spreading and inoperable. In these patients pemetrexed"—
that is, Alimta—
"in combination with cisplatin prolonged survival compared with cisplatin alone."
Alimta is the first licensed drug for the treatment of mesothelioma.
What would be the effect of withdrawal of the drug? Well, no other medicines are specifically licensed for the treatment of unresectable malignant pleural mesothelioma. If the Scottish Parliament continued the support of Alimta, it would send a strong signal to bodies such as the SMC and NICE, but also to patients and carers.
Shona Robison was right to speak about post-industrial areas. As I said at the beginning of my speech, mesothelioma is associated with particular occupations that used to be prevalent in Scotland.
I agree that we have to be wary of big drug companies lobbying to get new drugs fast-tracked if that means subverting the independent appraisal process. However, I believe that in this case, on balance, it appears that for the few patients about whom we are talking, Alimta can be of benefit. It should continue to be available when appropriate.
I begin by congratulating the Clydebank Asbestos Group and Clydeside Action on Asbestos, both of which are here in the gallery. Their campaign has led to the Rights of Relatives to Damages (Mesothelioma) (Scotland) Bill, which has been published today. In my view, it represents a significant step forward for the relatives of sufferers and for the victims themselves. It represents a strong statement by the Scottish Parliament about taking into account the human consequences of the dreadful disease of mesothelioma. Scotland is significantly ahead of the rest of the United Kingdom in responding. I congratulate everyone who has been involved in the campaign, and I say to them that we will continue to work on their behalf.
I welcome this debate on Alimta because real issues arise—not just about the drug itself but, more broadly, about treatments for people who suffer incurable cancer conditions such as mesothelioma. It is important to get the factual background about Alimta correct. I am grateful to the Clydebank Asbestos Group and the Scottish Trades Union Congress, which gathered people together for a highly successful conference in Clydebank some 15 months ago. There were international and national speakers, including senior medical experts who were able to lay out some of the details not only on Alimta but on the whole background of cancer treatments in the UK and internationally.
As Shona Robison said, when it is used in combination with cisplatin, Alimta is a drug that is probably efficacious for only a relatively limited number of people who suffer from mesothelioma; it is not necessarily useful for everyone who suffers from the condition. According to current estimates, it is beneficial for between 15 per cent and 25 per cent of sufferers. As she also said, that limits some of the cost implications that are associated with the drug's use. Perhaps that should be addressed as part of NICE's consideration of the evidence.
Another factor that should be weighed is the fact that NICE probably overestimated the number of treatment cycles on which it based its calculation of whether the use of Alimta offers value. The indications are that as few as four treatment cycles might bring significant measurable benefits. I am not someone who says that we should license any drug just because of the dreadfulness of the condition. We must ensure that Alimta delivers significant benefits within an acceptable cost framework.
When NICE hears the appeals against the final appraisal determination on 27 October, I hope that it not only takes into account all the technical and medical evidence, but recognises that getting for people who have incurable cancer medicines that are efficacious and that provide easement of the condition, even if not a cure, must be treated on an even plateau with the provision of other kinds of drug treatment.
At the Clydebank conference, we heard that it is extremely difficult to get drug companies to invest in research into such drugs because of the difficulty of getting them licensed. Alimta is a drug that is licensed and is prescribed to people in Scotland and people in parts of England, including Newcastle, although not throughout the country, which seems unfair. It would be a huge mistake to make the drug inaccessible to those patients without strong evidence that it simply is not working, and I am not sure that we have such evidence.
I hope that when NICE makes its final judgment, it will move from the current position and so allow the benefits of Alimta to continue to be investigated and not to stop its use as a treatment. I hope, too, that when the Scottish medicines consortium, NHS Scotland and NHS QIS consider the issue they will take account of both the NICE evidence and the circumstances that exist in Scotland.
It is my understanding that there are no circumstances under which anyone who receives Alimta at the moment would not continue to do so and I seek an assurance from the minister that that will remain the case. I also want to be assured that when NHS QIS assesses the use of Alimta, it does so in the context of what the families and communities that have been affected have suffered. In other words, I am arguing for the history of mesothelioma and asbestos-related disease in Scotland to be taken into account because it seems to me that there is an argument for special consideration to be given to the continued use of the drug in this country, provided that it can be demonstrated that there is a good medical case for that course of action. It is always necessary to strike a balance, but as well as the medical evidence, the social circumstances surrounding mesothelioma, the nature of the disease and the suffering that it has resulted in must be examined carefully.
I congratulate Shona Robison on securing a debate on an issue that is of enormous importance to the relatively small but still growing number of people in Scotland for whom Alimta offers the only hope of reduced pain and breathlessness and of extended survival.
Patients who have malignant pleural mesothelioma are paying a heavy price for their exposure to asbestos fibres in the course of their employment. They know that their days are numbered, that they may face severe pain as the disease spreads beyond the pleura and that they are likely to become increasingly breathless as a result of pleural effusions.
Prior to the development of Alimta, no product was licensed in the UK for the treatment of mesothelioma. Its statistically proven efficacy, in combination with cisplatin, in increasing survival time up to 40 per cent beyond what cisplatin can achieve as a single agent means that there is a ray of hope for terminally ill patients. There is hope for them to have a few more months with their families and friends, and hope for a reduction in their symptoms.
Other treatments have been tried, but there is no standard of care for mesothelioma in the UK, so comparisons between treatment regimes are not easy. However, as we have heard, the Scottish medicines consortium gave its approval for the use of combined Alimta-cisplatin therapy for patients who have not had any cancer treatment and who have spreading and inoperable mesothelioma.
During the past year, that therapy has indeed improved the quality of life for patients who have been treated with it in Scotland and in the parts of England where it has been approved. Indeed, I heard just this afternoon of a patient in Manchester whose tumour growth is static a full year after he was given a course of Alimta. It is now very likely that he will see the birth of his first grandchild, which he could not have contemplated a year ago.
Naturally, the NICE provisional guidance that was issued in June this year came as a body blow to patients who hoped to be eligible for treatment with Alimta. As we know, NICE guidelines are usually adopted by NHS QIS and implemented by the SMC. However, the latter organisation can, in fact, maintain its current position whatever NICE's final guidance. The Clydeside Action on Asbestos charity is, rightly, urging us to reinforce to the minister that that option is available.
NICE does more detailed work on the cost- effectiveness of drugs than the SMC does, which brings out its guidance well in advance of NICE. I, and I am sure most of us, would be happy to accept NICE's recommendations without question, in most cases. However, in this case, in which no other option of effective treatment is available and Alimta's manufacturer has challenged the provisional guidance on the grounds that all the evidence available to the appraisal committee was not appropriately taken into account and the summaries of cost and clinical effectiveness are not reasonable interpretations of the evidence, I am happy to endorse the call for the Executive to guarantee the availability of Alimta to existing and future sufferers of mesothelioma in Scotland who qualify for it, particularly given its satisfactory results over the past year.
The patients who will be affected by the decision are ill through no fault of their own. They and their families have little to look forward to. However, Alimta gives such patients the hope of a better quality of life in the latter stages of their illness and the prospect of more precious time with their loved ones. We owe that to those innocent victims and I am therefore happy to support the motion.
I congratulate Shona Robison on securing what is a most important and timely debate on this particular subject.
When I approached the subject, I decided to do a little bit of research into the history of asbestos to find out where it comes from and what it is. We talk about it all the time as if it is an industrial product, and we are used, certainly in the west of Scotland, to all the terrible diseases that result from its use, particularly in the shipbuilding industry. Therefore, I was surprised to find out that asbestos is in fact a Greek word that means inextinguishable and that it has been in use for more than 2,000 years.
It is all the more surprising that we ended up using asbestos so widely in industry in the 20th century when we discover that almost 2,000 years ago Pliny the elder—23 to 79 AD—wrote about the sickness of the lungs that affected the slaves who wove asbestos into cloth. In other words, nearly 2,000 years ago people observed the connection between asbestos and a disease of the lungs, but nearly 2,000 years later we were using asbestos on a daily basis in most of our heavy industry in the west of Scotland and in other parts of Scotland.
It is clear, from the industrial revolution and the fact that Scotland was so involved in that process, why mesothelioma strikes so heavily in Scotland. Asbestos is responsible for 90 per cent of mesothelioma cases. Unfortunately, the area with the highest standardised mortality rate from the disease is West Dunbartonshire, in the west of Scotland, which has a rate that is more than six times the average for Britain. Other areas in Scotland that have high rates are Inverclyde, Renfrewshire, East Dunbartonshire, Glasgow and, as Shona Robison said, Tayside. They are industrialised areas that have suffered the results of that industrialisation.
Unfortunately, the median survival period from diagnosis ranges from about nine to 13 months. Anything that extends that short period and improves the quality of life for those who suffer from mesothelioma should be supported.
I have two short quotations on the subject. The first is:
"Over 18 weeks, patients treated with pemetrexed"—
no wonder we call it Alimta—
"plus cisplatin demonstrated statistically significant symptomatic improvements when compared with those who received cisplatin alone."
The second is:
"The results of the EMPHACIS trial suggest that"
Alimta
"plus cisplatin confers a survival benefit of approximately 3 months, compared with cisplatin alone."
The surprising thing about those quotations is that they come not from doctors or those who support the use of Alimta, but from the NICE document that, despite those statements, ended up rejecting the use of the drug.
As members have said, an extension of three months is a quarter to a third of the expected lifespan of those who are unfortunate enough to be diagnosed with the disease. It is a substantial amount of time for somebody who has been given only nine months to live. Who would deny patients the right to that extra life? It is extremely surprising that NICE rejected the use of the drug. The reasons for that cannot be clinical, so they must be financial. We all accept that finance comes into the decisions on such matters and that it must do so. However, I am puzzled by the NICE decision. I hope that the appeal is successful and that NICE overturns its original decision.
I am delighted that the SMC decided to support the use of the drug in Scotland, but the problem is that, because of the decision south of the border by NICE, the danger exists that it may be withdrawn in Scotland, not for current patients but for possible future patients. The circumstances in Scotland are different. As I said, the case rate in Scotland is six times greater than that in the rest of the UK, which is why NHS QIS must support the continued use of Alimta in Scotland. In the words of Professor Nick Thatcher, the professor of medical oncology at the University of Manchester,
"Alimta and cisplatin is the only licensed treatment for mesothelioma patients and has been shown not only to increase quality of life but also to extend life".
As members have said, there is no other option. I join them in supporting the call for the continued use—certainly in Scotland, but, I hope, elsewhere—of Alimta for patients with mesothelioma.
I, too, congratulate Shona Robison on bringing the matter to the Parliament for debate. I also congratulate the campaigners, who have brought the issue to public attention so effectively, and Des McNulty, whose work has led to the publication today of the Rights of Relatives to Damages (Mesothelioma) (Scotland) Bill, which will provide some acknowledgement of the loss that families face. We all acknowledge that mesothelioma is a devastating condition. I add my words of sympathy for those who have the condition and for the families who have been touched by it. As members have said, there is no cure, sufferers do not tend to live long after diagnosis and, whatever treatment is provided, their last months are never easy.
As has been said, rates of mesothelioma are increasing. As I said in the Parliament last week, the most recent complete figures, which are for 2003, show an incidence that is about three times that of 20 years earlier. We expect the figures to peak some time between 2011 and 2015 at between 195 and 245 diagnoses annually in Scotland. Members have mentioned the clear link between mesothelioma and exposure to asbestos fibres. Most of those who suffer are men who were exposed to asbestos in the course of their work, but the disease can also affect families who have been exposed to the fibres.
Pemetrexed disodium, or Alimta, is licensed as a treatment for mesothelioma in conjunction with cisplatin. As has been said, there is no current standard care pathway for people with mesothelioma, but other treatment regimes are being evaluated in research trials.
Although we are discussing the NICE advice on pemetrexed this afternoon, appeals against NICE's final appraisal determination are being considered. Therefore, we have not yet seen NICE's final advice, and we will not do so until those appeals have been resolved later this year.
According to the draft of the final appraisal determination, NICE takes the view that the drug offers a relatively modest benefit. It has concluded that it can extend life by between three and five months compared with treatment with cisplatin alone. The treatment is associated with serious side effects, although those seem to be manageable in most cases. It does not fundamentally alter the course of the disease, although it has an impact on life expectancy. The final appraisal determination says:
"there was insufficient evidence to demonstrate that pemetrexed plus cisplatin was superior to other, far less costly treatment regimens."
In other words, NICE was not persuaded that it was the best drug to deploy in the treatment of mesothelioma and was unable to recommend the drug for general use. Although it is critical that that should be understood to be the basis of NICE's advice, as I said, that view is subject to the appeals process. It is different from the advice previously given by the Scottish medicines consortium.
It might be helpful briefly to review the process by which drugs are approved. Every new drug and treatment that becomes available is considered by the SMC, which looks at initial evidence from the manufacturer to decide whether a drug is cost- effective and whether it should be made available for routine use. That examination takes place at the point at which the drug becomes available on the market and is licensed for use in health care treatment. As further evidence becomes available, NICE may conduct a full evaluation of the drug, often in comparison with other treatments.
NICE is a UK body, which draws on knowledge from throughout the country. It uses seven independent centres to review evidence of drug efficacy, including—although not in this case—the University of Aberdeen. Therefore, its process is not divorced from Scottish expertise. The committee that considered pemetrexed included Professor John Cairns of the London school of hygiene and tropical medicine, who is also a member of the SMC. It includes a number of other prominent clinicians from different areas of the health profession. NICE is respected the world over and its appraisals are carried out at a later stage in a drug's history than the initial SMC recommendation.
When NICE has come to a view on a drug, the drug is not returned to the SMC for further consideration. Instead, as Shona Robison indicated, NHS Quality Improvement Scotland considers the NICE appraisals and advises on whether they should apply in Scotland. NHS QIS is the key body for interpreting NICE conclusions for Scottish application. It considers whether there are particular reasons to vary those conclusions to reflect Scottish circumstances and it is its job to do so on the basis of the best possible scientific appraisal of the evidence and its application to Scottish circumstances.
Other members made the point that the level of mesothelioma in Scotland is high, which is the legacy of Scotland's shipbuilding heritage. Des McNulty referred to the fact that the highest rates of all are found in the north-east of England. That is a phenomenon: a disease that exists in a number of areas that have the same kind of industrial heritage. However, prevalence of itself is unlikely to lead NHS QIS to vary its advice. The effectiveness of a treatment for an individual patient is not altered by the number of patients. Epidemiology has been mentioned, and the question that NHS QIS will consider is whether the delivery of treatment has a particular Scottish angle. Once NHS QIS has come to a view, the Scottish NHS boards will be expected to follow its advice.
I take it that the minister is saying that there is no barrier to NHS QIS coming up with the recommendation that the drug should be offered to patients in future. If NHS QIS reaches that conclusion, will the minister be happy with that?
I would look to NHS QIS to make absolutely sure that it had considered all the angles in preparing its advice to NHS boards on the basis of the NICE appraisal. It should do that in the context of the ethos and values of the NHS in Scotland, the circumstances of patients in Scotland and what is right for patients, families and communities and on the basis of scientific evidence and advice. In large part, that will be derived from the appraisal carried out by NICE, which will have conducted a more thorough scientific examination of the evidence than would be available from elsewhere.
The minister has referred to the severe concentrations of the condition in certain parts of Scotland, I would suggest particularly in areas of Clydeside, Tayside and Lothian. Before a final decision is reached in Scotland, will the minister consult the relevant health boards, which will have a locus in understanding the health needs in their areas? Has he had any representations so far from Greater Glasgow and Clyde NHS Board, Tayside NHS Board or Lothian NHS Board?
I am not aware of any specific representations, but the Scottish medicines consortium, which considered pemetrexed on its initial availability, includes NHS boards. Greater Glasgow and Clyde NHS Board, for example, is regularly represented at the consortium's meetings at chief executive level. There is very active involvement there, and I would expect QIS to consider any evidence that became available to it from particular areas or that was brought to it by particular boards. I would expect QIS to take all those factors into account in carrying out its appraisal of the evidence.
I will conclude with one further reassurance to Des McNulty on a specific point that he raised. Whatever the final appraisal by NICE and the final advice from NHS QIS, patients who are currently receiving pemetrexed and cisplatin will continue to receive those treatments unless their doctor prescribes another form of treatment. What is at issue here is the advice that will be provided in the event of future diagnoses. I will ask NHS QIS to make absolutely sure that it has considered all the issues that have been raised in this evening's debate before it comes to a final view on the NICE appraisal.
Meeting closed at 17:47.