Tommy Broughan (Dublin Bay North, Independent)
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669. To ask the Minister for Health the approval process for the drug Kuvan for persons with phenylketonuria; when persons will be informed of the HSE's decision; and if he will make a statement on the matter. [12898/18]

Simon Harris (Wicklow, Fine Gael)
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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.

My Department was advised that Sapropterin was discussed at a recent HSE Drugs Group Meeting. 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.