Topical Question Time
Orphan and Ultra-orphan Medicines (Value-based Pricing)
1. To ask the Scottish Government how value-based pricing will impact on the availability of orphan and ultra-orphan medicines such as Kalydeco. (S4T-00197)
Pricing of medicines is currently a reserved matter, and negotiations on the value-based pricing scheme are on-going. The proposals are being taken forward by the Department of Health in England and the Association of the British Pharmaceutical Industry throughout the United Kingdom.
We hope that agreement can be achieved on a pricing system that reflects the value of medicines in terms of clinical effectiveness. That should make a wider contribution to benefit society and help meet unmet needs.
In the meantime, work is under way in Scotland to develop a fund to cover the costs of successful individual patient treatment requests for high-cost, low-volume orphan medicines that have not been recommended for routine use by the Scottish Medicines Consortium, such as Kalydeco. That approach is a response to interim advice from the independent expert, Professor Charles Swainson, who is leading the strand of work within the new medicines review to examine the current IPTR arrangements.
The fund will cover the cost of orphan medicines for individual patients in relation to whom there are clear clinical grounds for their prescription through the IPTR arrangements. The fund of £21 million will be available from 1 March 2013 for a period of 13 months until the UK system of value-based pricing is established. The fund is in addition to the existing national health service board funding allocations and will not be applied retrospectively. Detailed operational arrangements will be developed and announced in due course.
I thank the cabinet secretary for that comprehensive response. In light of what he has just said, does he share my concerns that Kalydeco was offered at a higher cost in Scotland than it was in England? Can he give any insight into the impact of the higher cost on the decisions made by the Scottish Medicines Consortium?
I am concerned that any pharmaceutical company would offer its drugs at a more expensive rate here than it does south of the border. The SMC is independent and it published the detail of its decision on its website, which also includes reference to costs.
Kalydeco’s manufacturer, Vertex Pharmaceuticals, has indicated that it will resubmit the drug to the SMC with a patient access scheme, as was the case in England. Clearly, it is for the SMC to carry out the reassessment of the drug once it has been submitted.
I observe that specialised commission groups, who carried out the drug’s first assessment, were clear that without the patient access scheme discount the quality-adjusted life year ratio would be more than the range that the National Institute for Health and Clinical Excellence has set out for ultra-orphan drugs.
Given that the cabinet secretary said that medicines pricing is currently reserved, can he explain the Scottish Government’s role in the development of a value-based pricing model for new medicines?
Scottish Government officials are in regular contact with the Department of Health, and I have written to Jeremy Hunt to seek a meeting to discuss value-based pricing and its impact on access to new medicines in Scotland. We support the principle of value-based pricing, but like many patient groups we are still seeking greater clarity and detail.
I welcome the cabinet secretary’s announcement about the new fund. Can he advise when the fund will be established and open to applications?
Does the cabinet secretary agree with me that the fund’s effectiveness will be curtailed if the IPTR system is not currently working for the benefit of patients? Is the current system sufficient to guarantee access to Kalydeco for patients who need it?
The fund will start from 1 March 2013. Yesterday, I wrote to all 14 territorial health boards to remind them of a similar circular that they received last year from the then health secretary, Nicola Sturgeon, asking them to process and turn around individual patient treatment requests speedily and expeditiously. Clearly, time is of the essence, particularly for patients with conditions such as cystic fibrosis or cancer. Boards should take that into consideration to ensure that they deal with the applications timeously.
The cabinet secretary will be aware of the case of Maisie Black, a constituent of mine who is a cystic fibrosis sufferer and much in need of Kalydeco. Yesterday’s decision by the SMC and the cabinet secretary’s welcome announcement of the drugs fund brings the issue into focus.
Can the cabinet secretary give some clarification of how the application process will work? Specifically, can he guarantee that anyone making an application who has a proven clinical need for Kalydeco will be granted access to the necessary funding to get provision of the drug?
I spoke to Maisie’s mother, Tilda Black, yesterday afternoon to make her aware of the announcement that we had made. Maisie is obviously one of the people who could potentially benefit from the new fund. There are many others who could do so, not just those with cystic fibrosis but those with other conditions. Obviously, the fund relates to any rare drug and not just to the particular drug about which the SMC announced its decision yesterday.
I stress that there is no change to the IPTR process itself—it must be a clinical decision as to whether an individual would benefit from a particular drug—but I want to ensure that money is not a constraint. In other words, if the clinicians agree that an individual should get a particular drug that is not generally available because of an SMC decision, the money should not be a constraint on ensuring that the patient gets access to the drug.
I welcome yesterday’s announcement, but is it not the case that the IPTR referral criteria have proved extremely difficult to satisfy for orphan medicines? Can the cabinet secretary confirm that the independent appraisal will continue? Further, can he assure us that some changes will be made before 1 March in order that the fund’s money can be accessed?
As the member will know, there is an on-going thorough review of the entire process, including the SMC process and the IPTR process. I hope to have the report with recommendations from Professor Routledge—along with recommendations from Professor Swainson, who is specifically looking at the IPTR process—by the end of February. If quick changes are required, I will be more than happy to make them once I see the recommendations.
Montgomery Litho Ltd (Liquidation)
2. To ask the Scottish Government what steps it is taking to support the workforce of Montgomery Litho Ltd following its liquidation. (S4T-00198)
This will be an anxious time for the employees of Montgomery Litho Ltd and their families, and the Scottish Government will offer them every support possible.
I can confirm that the Scottish Government will do everything that it can through its partnership action for continuing employment—PACE—initiative to help those employees of Montgomery Litho who are affected by redundancy. Montgomery Litho is a well-respected company that had earned its place on the Scottish Government collaborative framework for design, print, publishing and associated services.
I have just been advised that the purchase of Montgomery Litho Glasgow has been announced in the press.
The management buyout to protect some of the jobs in the company is of course welcome, but it will not help in any way the 79 staff members of Montgomery Litho in my constituency in Haddington whose jobs have gone. I welcome the implementation of PACE to provide support to that workforce. However, 35 staff in the company were paid off immediately prior to Christmas, so the job loss is actually around 114. Can the minister, through his good offices, ensure that those 35 staff who were so recently made redundant can be included in the PACE approach for the 79 more recent redundancies?
I am happy to provide that undertaking to Iain Gray. He is perfectly correct in what he says about those who have been made redundant in his constituency: it will be a bitter experience for them and their families at this time.
PACE has been working at the Haddington site since October 2012 following receipt of media reports that jobs could be lost. Services were provided by PACE partners in November last year, including benefits advice, job search support, CV preparation advice, money advice and business gateway support.
That intervention was possible because of engagement with the company late last year. It is always beneficial that a company’s invitation to PACE—and the PACE intervention—is made at the earliest opportunity to provide employees with as much time as possible to receive advice about alternative options for them, whether that involves training, education opportunities or, indeed, seeking other employment.
I stated—this was an adjustment to my written notes—that I have just been advised that a buyer has been secured for the part of the Montgomery Litho business in Glasgow. The joint provisional liquidator, Blair Nimmo from KPMG, is quoted on the BBC website as saying:
“The sale of the business represents the best possible outcome for the Glasgow operation which will now continue to trade.”
The article states that 76 jobs in the Glasgow arm of the company may be saved as a result of the management buyout. I sought to speak to Mr Nimmo earlier, but we were unable to make contact with each other. I hope to speak to him at 4 o’clock to get a further report.
I will feed any further information to Iain Gray, who is quite rightly raising the matter on behalf of his constituents. I will personally oversee that PACE’s efforts are as good as they always have been—his constituents deserve nothing less—to ensure that his constituents get every possible support at this most difficult time.
I thank the minister for a constructive answer. I appreciate that the PACE process is being applied more widely than those who have lost their jobs in the past couple of days.
The loss of more than 100 jobs in a small town such as Haddington is significant, but those are not the only job losses that we have seen recently in East Lothian. Lothian Fabrics and Fords Bakery have closed, there are job losses at First Bus at Musselburgh, Cockenzie power station will close within the next few weeks, and jobs are under threat at Bankton Building Services. My constituents need PACE’s help, which I appreciate, but they need jobs to apply for, too. I know of a recent case when someone applied for a job for which there were 300 applicants.
What help will the Scottish Government offer to East Lothian—the council or otherwise—to see what new jobs can be created locally to provide opportunities for my constituents?
Iain Gray is quite right to point out the difficulties facing East Lothian. I am more than happy to meet East Lothian Council—indeed, I have written to it in connection with other matters, and I hope to meet it to discuss more positive aspects in relation to tourism. With its agreement, I will certainly take the opportunity to discuss what more can be done.
PACE’s record is formidably good. I chair the meetings in which PACE brings together its partners to ensure that we do everything that we can as team Scotland to help those who are being made redundant. The PACE client experience survey, which brings together the total results of its input throughout Scotland, reported in October 2010 that almost two thirds of PACE service users who had left their redundant job role had either found new employment or undertaken training or development. I understand that the more recent survey will show an improvement on that figure.
That is a pretty good record, but it can be improved and we are taking steps to do that. There is a message of hope for those who face redundancy during this difficult economic time: jobs are available in parts of Scotland. However, as Iain Gray rightly pointed out, in some parts of Scotland there are particular difficulties for people who are seeking re-employment. Therefore, we will continue to do everything, working with Scottish Enterprise and others, to help people to find jobs to replace those that they have lost.