Clare Daly (Dublin North, United Left)
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745. To ask the Minister for Health if the Health Service Executive has agreed to make a drug (details supplied) available to sufferers of phenylketonuria. [30518/15]

Olivia Mitchell (Dublin South, Fine Gael)
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749. To ask the Minister for Health if the Health Service Executive will consider including the sapropterin drug, Kuvan, in its reimbursement scheme, in order to help patients here with phenylketonuria; and if he will make a statement on the matter. [30532/15]

Clare Daly (Dublin North, United Left)
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815. To ask the Minister for Health if the Health Service Executive will make available the drug sapropterin or Kuvan, for the treatment of those effected by the condition phenylketonturia, PKU, here; and when patients may avail of this treatment. [30784/15]

Bernard Durkan (Kildare North, Fine Gael)
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820. To ask the Minister for Health his plans to make available the medication Kuvan through the Health Service Executive, which stabilises phenylalanine levels in those diagnosed with phenylketonuria; and if he will make a statement on the matter. [30811/15]

Michael McGrath (Cork South Central, Fianna Fail)
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994. To ask the Minister for Health if the Health Service Executive has been approached by the manufacturer of a medicine called Kuvan or sapropterin, which is used to treat persons with phenylketonuria, PKU, for reimbursement on the condition that the company will cover the initial cost of the drug and only if the patient responds to treatment will the HSE take over the cost; and if he will make a statement on the matter. [31412/15]

Seán Fleming (Laois-Offaly, Fianna Fail)
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1088. To ask the Minister for Health his plans to approve a treatment (details supplied); and if he will make a statement on the matter. [31879/15]

Kathleen Lynch (Cork North Central, Labour)
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I propose to take Questions Nos. 745, 749, 815, 820, 994 and 1088 together.

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 commenced the process of resubmitting 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 still at a very early stage, it is not possible to discuss potential outcomes or comment further at this time.