Gino Kenny (Dublin Mid West, People Before Profit Alliance)
Link to this: Individually | In context | Oireachtas source

76. To ask the Minister for Health if a decision has been made by the HSE on the drug, Kuvan, for those that are living with PKU; and if he will make a statement on the matter. [6094/18]

John Brassil (Kerry, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

186. To ask the Minister for Health the position regarding the reimbursement of Kuvan by the HSE after the recent drugs group meeting on 18 January 2018. [6495/18]

Simon Harris (Wicklow, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I propose to take Questions Nos. 76 and 186 together.

The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drug schemes, under the Health (Pricing and Supply of Medical Goods) Act 2013.

In reaching a decision, the HSE examines all the evidence which may be relevant in its view for the decision and will take into account such expert opinions and recommendations which it may have sought, including, for example, advice from the National Centre for Pharmacoeconomics (NCPE).

Sapropterin (Kuvan) was considered under the national pricing and reimbursement processes in 2009. At that time, insufficient evidence was available to support the pricing and reimbursement application submitted.

In 2016, the HSE was advised that a new health technology assessment dossier would be submitted on sapropterin. The NCPE completed its assessment of the new dossier in September 2017 and did not recommend sapropterin for reimbursement, as it was not deemed cost effective at the price sought by the company.

The Department of Health was advised that Sapropterin was discussed at the most recent HSE Drugs Group Meeting on the 18 January 2018. The Drugs Group was not in a position to make a recommendation to HSE Leadership following that meeting. It has sought additional information and deliberations are ongoing.