Gino Kenny (Dublin Mid West, People Before Profit Alliance)
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I thank the Leas-Cheann Comhairle for the opportunity to raise this issue. Those living with phenylketonuria, PKU, have been engaged in a protracted campaign to get access to the drug, Kuvan. Over the past eight years, access to Kuvan has been assessed and rejected by the National Centre for Pharmacoeconomics, NCPE, on two occasions, namely, in 2009 and 2017. That process is questionable when it comes to orphan drug assessments. A review into all orphan drugs is under way and that should be welcomed by all parties in the House. Even though Kuvan is readily available in most European countries, it is not available for those living with PKU in Ireland. The drug has the potential to transform a person living with PKU. The irony, incredibly, is that the drug is made in Cork and that Ireland has the highest rate of PKU, a genetic condition, in the world. I understand a decision will be made on provision of the drug soon. Hopefully, the Minister of State will have good news and there will be a positive outcome for those living with PKU.

The issue of orphan drugs has been raised a few times since I became a Member. The people requiring them have rare diseases and they cannot access certain drugs. There is clinical evidence but there is also the issue of a price being put on these conditions and on people's lives. The Minister of State will probably agree that is completely unacceptable in society. Hopefully, he will have good news and those living with PKU will get the good news this week to the effect that they can access this drug.

Finian McGrath (Dublin Bay North, Independent)
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I thank the Deputy for raising this important issue and for his work since he became a Member on alternative medicines. I also thank him for having an open mind, as there have been many times when I have strongly agreed with him. I commend him on pushing this agenda.

Securing access to new and innovative medicines in a timely manner is a key objective of the Minister and the HSE. That is why the Department of Health has put in place a robust legal framework under the Health (Pricing and Supply of Medical Goods) Act 2013, which gives full statutory powers to the HSE to assess and make decisions on the reimbursement of medicines, taking account of expert opinion as appropriate. The Act specifics the criteria to be applied in the making of reimbursement decisions, which include the clinical and cost-effectiveness of the product, the opportunity cost and the impact on resources that are available to the HSE. In reaching its decision, the HSE will examine all the relevant evidence and will take into account such expert opinions and recommendations that are appropriate, including from the NCPE. This ensures that reimbursement decisions will be made on objective scientific and economic grounds. Medicines represents one of the largest areas of expenditure across the health service and is expected to increase again in the years ahead. That is why the challenge is ensuring access to new and innovative medicines in an affordable and sustainable way.

Kuvan was first assessed in 2009 under the national pricing and reimbursement process at that time. However, it was concluded that insufficient evidence was available to support the pricing arid reimbursement application submitted by the then promoter, Merck Serono. In December 2015, Merck Serono advised the HSE that the market authorisation for Kuvan was to be transferred to BioMarin in 2016. The HSE met the new market authorisation holder in May 2016 and was advised that the company would be submitting a new pricing and reimbursement application relating to this medicine. The new application was assessed by the NCPE in September 2017 and, in its report to the HSE, it did not recommend Kuvan for reimbursement because it was not deemed cost-effective. However, I would like to make it clear that the HSE leadership, which is the ultimate decision-making authority on reimbursement decisions, has yet to make a decision on the new pricing and reimbursement application submitted by BioMarin. The HSE met the company recently to discuss the report from the NCPE and to explore commercial options. The Department of Health has been advised that the HSE drugs group and the HSE leadership are expected to consider all relevant information, including any commercially confidential offering during the first quarter of 2018.

Gino Kenny (Dublin Mid West, People Before Profit Alliance)
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All Members received an email from the PKU Association of Ireland earlier. The association does amazing work for those living with the condition. I had no knowledge of PKU until a few months ago. It has been enlightening and educational to find out about the condition and how it can be treated. All members received the email and the PKU community is hoping that there will be a positive outcome on Thursday.

I know the Minister of State said the ultimate decision is for the HSE but I hope there can finally be some good news for those living with PKU in Ireland.

Finian McGrath (Dublin Bay North, Independent)
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The Deputy is right that the decision is expected very soon. According to the memo I received from the HSE, it will be in the first quarter of 2018, and while I hear that it could be in the next couple of days, that will be announced independently. It is very important that the HSE is the decision-making body on the reimbursement of medicines under the Health (Pricing and Supply of Medical Goods) Act 2013. It is the HSE, and the HSE alone, which will make the final decision on whether Kuvan will be reimbursed, taking into consideration the statutory criteria as specified under the 2013 Act. This Act does not give the Minister for Health any powers in the reimbursement process. The HSE does not require approval or consent from the Minister or the Government when it is making a reimbursement decision.