Billy Kelleher (Cork North Central, Fianna Fail)
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131. To ask the Minister for Health when a re-evaluation will be carried out on the drug Kuvan for persons with PKU under the reimbursement scheme; and if he will make a statement on the matter. [42039/17]

Mick Wallace (Wexford, Independent)
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132. To ask the Minister for Health if he will make the drug Kuvan, also known as sapropterin, for the treatment of those effected by phenylketonuria here; and when persons may avail of this treatment. [42040/17]

Pat Deering (Carlow-Kilkenny, Fine Gael)
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142. To ask the Minister for Health if the drug Kuvan will be made available for the treatment of PKU (details supplied); and if he will make a statement on the matter. [42076/17]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 131, 132 and 142 together.

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

In reaching its 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 may have been sought by the HSE, including, for example, advice from the National Centre for Pharmacoeconomics (NCPE).

Sapropterin (Kuvan) was previously 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 by Merck Serono for Kuvan.

In December 2015 Merck Serono advised the HSE that the market authorisation for Kuvan was transferring to Biomarin in 2016. The HSE met with the new market authorisation holder Biomarin in May 2016 and was advised that it would be submitting a health technology assessment dossier in relation to Kuvan.

The NCPE assessment of the Biomarin dossier was completed on the 15 September 2017 and the NCPE did not recommend Kuvan for reimbursement as it was not deemed cost effective.

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