Brendan Griffin (Kerry, Fine Gael)
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493. To ask the Minister for Health if he will make the drug Kuvan available on the long-term illness scheme to sufferers of Phenyketonuria and BH4; and if he will make a statement on the matter. [5750/16]

Brendan Griffin (Kerry, Fine Gael)
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494. To ask the Minister for Health the annual immediate cost if he made the drug Kuvan available on the long-term illness scheme to sufferers of Phenyketonuria and BH4; the number of sufferers who would benefit; and if he will make a statement on the matter. [5751/16]

Leo Varadkar (Dublin West, Fine Gael)
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I propose to take Questions Nos. 493 and 494 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.

The manufacturer recently submitted a new application for pricing and reimbursement of Kuvan; this application is now being 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. Based on previous pricing information supplied by the company, reimbursing Kuvan to phenylketonuria patients in Ireland could cost somewhere between €3m and €10m per year, given an estimated treatment cohort of 60-180 patients.

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