Carol Nolan (Offaly, Sinn Fein)
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262. To ask the Minister for Health if the drug kuvan will be made available for persons with PKU; and if he will make a statement on the matter. [47638/17]

Gerry Adams (Louth, Sinn Fein)
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340. To ask the Minister for Health the status of the ongoing HSE assessment process with regard to funding of the drug kuvan for the treatment of phenylketonuria; and if he will make a statement on the matter. [48081/17]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 262 and 340 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 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 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.

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

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

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.