Pearse Doherty (Donegal South West, Sinn Fein)
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416. To ask the Minister for Health the timeframe for the processing of the new application submitted by a manufacturer (details supplied) for the pricing and reimbursement of Kuvan, or sapropterin, a drug used to treat persons with phenylketonuria; and if he will make a statement on the matter. [40427/15]

Kathleen Lynch (Cork North Central, Labour)
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The HSE has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the community drug schemes in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. Prior to reimbursing any medicine, the HSE considers a range of statutory criteria, including clinical need, cost-effectiveness and the resources available to the HSE.

The decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds by the HSE on the advice of the National Centre for Pharmacoeconomics. They are not political or ministerial decisions.

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 the manufacturer, Merck Serono.

Merck Serono recently submitted a new application for pricing and reimbursement of Kuvan; this application will now be considered in line with criteria set out in the Health (Pricing and Supply of Medical Goods) Act 2013 and using the processes outlined in national pricing framework agreements.

As the application process is ongoing, it is not possible to discuss potential outcomes or comment further at this time.