Regina Doherty (Meath East, Fine Gael)
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I tabled this matter for discussion arising from a meeting I had last Thursday, together with my colleague, Deputy Jerry Buttimer, with two beautiful ladies who are multiple sclerosis sufferers and who were accompanied by Mr. Tom Curran, partner of the late Marie Fleming. The meeting was to discuss their concerns that the drug they are currently taking to alleviate the symptoms of MS, Fampyra, will no longer be available free of cost as a result of its manufacturer, Biogen, being refused access to the general medical services scheme by the Health Service Executive. Having tabled this matter for discussion yesterday, I learned this morning that Biogen has reapplied for inclusion in the GMS scheme, which is great news. I also welcome the indication last week by the Minister of State, Deputy Alex White, of his openness to a new application by Biogen and his acknowledgment of the serious impact the refusal of its application is having on some of the 8,000 MS sufferers in this country.

People have experienced an incredibly positive impact on their condition from taking this drug and are now in fear that they will no longer have access to it in the coming weeks. Will the Minister give an assurance today that he will ask the HSE to fast-track Biogen's application for inclusion in the GMS scheme? In the meantime, it is my intention to ask the company publicly to continue to provide its product free of charge, for the duration of the application process, to the people on whom it is having such a positive impact. The two women I met last week - I am sure the Minister has heard similar testimony from other Deputies - spoke movingly of the impact the drug has had on their health. One of them is younger than me and has a young child. I have been unable to stop thinking of her description of being able, for the first time ever, to plait her daughter's hair. It can seem like a small and insignificant thing to people like me to be able to brush our children's hair every day and make their lunches, but to this woman it was an enormous achievement. Now she faces the prospect of once again being unable to do it because she cannot afford to pay for the drug. Moreover, without access to this medicine, she will be unable to work and will be entitled to a €785 per month disability benefit payment. She is young and full of vitality and wants to return to work.

I am asking for the Minister's commitment that he will request the HSE to fast-track this process. In the period until that process is completed, I will ask the company to continue to provide the drug to those people who are already availing of it under the GMS scheme.

James Reilly (Dublin North, Fine Gael)
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I thank the Deputy for raising this important issue which relates not only to the specific drug to which she referred but to a range of medicines. I understand the manufacturer of Fampyra - a brand name for fampridine - has indicated to the HSE that it intends to submit a revised application to include the drug under the community drugs schemes. The HSE will consider the application on receipt, in line with the agreed procedures and timescales for the assessment of new medicines. The Deputy has indicated that the company submitted a revised application today.

The HSE has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the community drugs schemes in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. The HSE has already considered an application for the inclusion of Fampyra in the GMS and community drugs schemes. This application was considered in line with the procedures and timescales agreed by my Department and the HSE with the Irish Pharmaceutical Healthcare Association, IPHA, for the assessment of new medicines. In accordance with these procedures, the National Centre for Pharmacoeconomics, NCPE, conducted a pharmacoeconomic evaluation of Fampyra and concluded that, as the manufacturer was unable to demonstrate its cost effectiveness in the Irish health care setting, it was unable to recommend the reimbursement of the product. The report is available on the NCPE's website.

The HSE assessment process is intended to arrive at a decision on the funding of new medicines that is clinically appropriate, fair, consistent and sustainable. In these circumstances, the HSE has not approved the reimbursement of Fampyra under the community drugs schemes. I understand studies are ongoing to assess the wider impact of the drug on both walking ability and quality of life for persons diagnosed with MS. I acknowledge the Deputy's clear testament in this regard. The results of these studies will contribute to the evidence base demonstrating the clinical effectiveness of Fampyra, which can be used to support future applications for its inclusion on the lists of reimbursable items supplied under the community drugs schemes. In this context, it is open to the manufacturer at any time to submit a new application to the HSE for its product's inclusion. As we have heard, it did so this morning.

I assure the Deputy that I, and the HSE, fully understand that patients are very anxious that this product be made available under the community drugs schemes. The HSE will consider its manufacturer's revised application in line with the agreed procedures and timescales for the assessment of new medicines so that the matter is addressed and dealt with as quickly as possible.

Regina Doherty (Meath East, Fine Gael)
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In its report, the NCPE stated that it had not managed to prove the cost effectiveness of the drug against the 8,000 patients using it. However, all 8,000 MS patients do not need to use it; it is applicable only to one third of them. Perhaps that message was lost in translation, in which case I hope it will be clearly heard in the new application process.

The Minister indicated that the new application will be considered "in line with the agreed procedures and timescales for the assessment of new medicines". Will he indicate what the standard timescale might be? Is there any way we can speed it up in this case given that the drug in question will no longer be available free of charge to patients from the end of June?

That will have a serious impact. One of the ladies I met last week told me it is the difference between her making it to the bathroom and not making it. This has a really serious impact on these people's lives which is why I again call on Biogen to continue to fund these drugs for the people currently receiving them until this process between it and the HSE can be brought to a conclusion.

James Reilly (Dublin North, Fine Gael)
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Again, I thank the Deputy. I would like to make a few general points. The Irish Pharmaceutical Healthcare Association and the Irish pharmaceutical sector are very important to this country, but we have a problem in that we have a very limited budget. We have just exited a bailout and the pressures of the health budget are well known. In the context of Fampyra, there are more than 7,000 people with multiple sclerosis, and at a cost of €6,000 each, it is €42 million per annum, which is an awful lot of money. For how many of these people will this drug be successful?

I would like to see the pharmaceutical industry engage in risk sharing so that in situations where there is a drug which we can prove by way of a blood test, a biopsy or an independent clinical assessment of the activities of daily living, such as walking distances, that it really improves the situation for patients, we will pay for those patients. However, what about the two thirds or the four fifths of patients for whom it does not work? Are we to pay from them also? Where is the role of the industry in this? Why does it not join us in terms of sharing the risk and if it does not work, let us negotiate what we will pay for those, if anything at all?

For a long time patients have looked to the Government to provide care and it is our duty to provide it, but I would like to appeal to patient groups to join the Government to ensure the new medicines which become available are made affordable for us to provide to our people and that the pharmaceutical industry engages in risk sharing in regard to these very expensive and sometimes hugely effective drugs that can have a life changing impact on people's daily activities which, as a doctor, I fully accept. However, I appeal to the pharmaceutical industry to engage with the health service in a way that these drugs become available at an affordable price for those who can avail of them and will benefit from them and that we look at some other way to deal with the high risk to the system for all those who use these drugs but do not get any benefit from them.