Topical Issue Debate – Fampyra

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Dáil Éireann, 14 May 2015

^^ Drugs Payment Scheme Coverage ^^

Deputy Paul J. Connaughton: I thank the Ceann Comhairle’s office for selecting this matter for the Topical Issue debate and I thank the Minister of State for being present to take it. When it was selected I had a four-minute speech prepared outlining the background to this issue and then I thought what is the point of doing that as anybody who does any background check will find all the parliamentary questions that have been tabled on the issue. I would say it has been raised by every Deputy in the House at some stage during the past year. Therefore, I will not bore the Minister of State with the background story to this issue, of which she is only too well aware.
Like every other Deputy, I have been contacted by numerous people in recent weeks and months. It is only when one reads of or listens to the human stories of the people involved that one fully understands how the non-availability of this drug is impacting on people’s lives. I was contacted recently by one woman whose life has been significantly curtailed since she finished on the drug. She can no longer walk as far as she once could and her balance is greatly affected, which makes her more fearful in terms of walking and greatly reduces her independence. Another woman who wrote to me spoke of her anger at being failed by the State, particularly as she knows that many others are in a similar position, having their lives curtailed because of decisions made purely on economic grounds when there is a very human cost to these decisions.
I know the Minister of State is very well aware of this issue. The first Topical Issue debate on this issue took place on 10 June last year but responses to parliamentary questions on 6 May of this year indicate that this issue has not been moved forward much on the basis that the responses state that the company has re-applied again to submit this drug under the schemes and that the Department and the HSE are working with it. The problem is that this has been going on for a year at this stage. Multiple sclerosis sufferers are no further along the line of knowing what the Government can do in their cases and their lives are being terribly curtailed and impacted by the lack of information.
I would like to find out today where those negotiations are at. If the problem is with the pharmaceutical company that is involved, it is important that we would know that. Who is handling the negotiations? When was the last date a meeting took place on this issue? Is it possible to move this topic on, even a little today, for us to be able to say to multiple sclerosis sufferers that we are concerned about where we are at with this process.
I know full well that the drug does not work for everybody but for those for whom it does work, it seems to be a life-changing experience for them. We must be careful and understand that if we can make a difference in one person’s life, it would be a major achievement if we could get this drug included under one of the free schemes. I understand the Department of Health more than any other Department has huge cost containment issues because everybody wants to get the drug that will help save their lives included under the schemes, but if the inclusion of this drug can help change even one person’s life, including those women I mentioned in Galway, I would urge the Minister of State, the Minister, Deputy Varadkar and the Government to get this drug included under the scheme as soon as possible.

Minister of State at the Department of Health (Deputy Kathleen Lynch): I thank the Deputy for raising this issue. He is right in saying that it has been raised on numerous occasions. It is not as if we are unaware of or sympathetic to the circumstances in which people find themselves. We have personal experience of this in that we know people who are desperately awaiting some relief in respect of this issue.
Decisions on which medicines are licensed for use in Ireland and which are reimbursed by the taxpayer are not political or ministerial decisions. These are made on objective, scientific and economic grounds by the HSE on the advice of the National Centre for Pharmacoeconomics. The HSE has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the community drug schemes in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. At the outset I would like to clarify that fampridine, the brand name of which is Fampyra, was never available to multiple sclerosis patients under the general medical services and community drugs schemes. However, I understand that the manufacturer of fampridine supplied the drug free of charge to some patients who were prescribed the drug by their clinician.
The manufacturer has stopped supplying the drug free of charge, thereby requiring patients to finance the drug if they wish to continue with the treatment.
The HSE received an application for the inclusion of Fampridine in the GMS and community drug schemes. In accordance with agreed procedures, the National Centre for Pharmacoeconomics conducted an evaluation of the drug. The evaluation, published in 2012, concluded that the centre was unable to recommend reimbursement of the product as the manufacturer was unable to demonstrate sufficient effectiveness and a fair price for Fampridine in the Irish health care setting. On foot of this, the HSE decided that it was not in a position to add the drug to the list of reimbursable items supplied under the GMS and other community drug schemes. The manufacturer submitted a new application to the HSE on 25 July 2014 for the inclusion of Fampridine in the community drug schemes. The HSE’s corporate pharmaceutical unit has since been engaging with the company seeking improved commercial offerings and the HSE is considering the outcome of these commercial engagements. It has also had discussions with clinical experts about this drug, the outcome of which is also being considered.
The HSE and I fully understand the concerns of patients about the availability of this drug, but it is not possible for the taxpayer to reimburse every licensed medicine at whatever price a drug company demands. It is important that we get the best possible price for this drug which is of benefit to some people. It is fully understood Fampridine benefits some, although not all, MS sufferers. At the same time, it is our duty to ensure we get the best possible price for the taxpayer in this instance. The negotiation process has concluded, but I am not saying that is the final word on the matter. We are looking at the outcome of the negotiations but have not yet come to a final decision.

Deputy Paul J. Connaughton: I thank the Minister of State for her response, but the concern of MS sufferers all over the country is that her response has not changed a lot in the past six or 12 months. I have raised the issue again today and while I understand negotiations to which I am not privy have concluded, it appears that we have not moved even one little bit. I ask the Minister of State to give some indication as to when she believes we will get an answer to this question. I am not looking for a specific date, but it is very important that some indication be given to MS sufferers who see no grounds for hope. They cannot afford this drug which is simply too expensive. To make matters worse, they saw the difference it had made to their lives but then it was taken away from them owing to the expense involved. We cannot continue with a situation where all questions tabled by elected representatives on this issue are answered in the same way. We cannot see the finish line. If we do nothing else today, can we, at least, receive a indication as to whether a decision will be made in six or 12 months? When will the HSE make a decision on whether it will cover the cost of this drug for MS sufferers?

Deputy Kathleen Lynch: My opinion on when we will have an answer is irrelevant. What we need to do is ensure the drug is affordable for the State. It was withdrawn by the drug company involved. Fampridine was never available under the GMS or the drug refund scheme. It was both cruel and unfortunate for people who had obtained huge benefits from it when it was withdrawn. We are still looking at the question of whether it is affordable. That may sound cold and callous, but I do not mean it to come across in that way, as I understand the difference the drug has made to peoples’ lives. We are doing our very best to ensure something that will benefit people will be available to them. However, there are cases where drugs are simply unaffordable. I understand this might appear to be a harsh decision, but we have not given up. We are still looking at the issue. I hope whatever decision is made, whether good or bad, will be relayed to patients as quickly as possible because it is equally cruel to leave them hanging on.