Finian McGrath (Dublin Bay North, Independent) | Oireachtas source

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.

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