Tommy Broughan (Dublin Bay North, Independent)
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912. To ask the Minister for Health the status of the assessment of Kuvan; when a final decision will be made to make Kuvan available to persons with PKU; and if he will make a statement on the matter. [55246/17]

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.

The HSE assessment process is ongoing and the HSE will take into account any relevant expert advice when making its decision, in line with the Health (Pricing and Supply of Medical Goods) Act 2013.