Tommy Broughan (Dublin Bay North, Independent)
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442. To ask the Minister for Health if he will review and reverse the decision of the HSE not to approve the use of the drug Kuvan for persons with phenylketonuria, PKU, and accept the request by an organisation (details supplied) to provide funding for this drug which has significant long-term health improvements for persons affected by PKU; and if he will make a statement on the matter. [41912/17]

Tommy Broughan (Dublin Bay North, Independent)
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443. To ask the Minister for Health if he will request the National Centre for Pharmacoeconomics to review its decision not to fund the provision of the drug Kuvan for persons affected by phenylketonuria which was approved by EU regulatory agencies in 2009 for use in 20 European countries; and if he will make a statement on the matter. [41913/17]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 442 and 443 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 15th September and the NCPE did not recommend Kuvan for reimbursement as it was not deemed cost effective.

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.