Dáil Éireann Debate, Tuesday - 17 May 2016
760. Deputy Pearse Doherty asked the Minister for Health when he will make a decision on an application to include the drug Kuvan sapropterin in the drug reimbursement programme; and if he will make a statement on the matter. [10033/16]
View answer767. Deputy Peter Fitzpatrick asked the Minister for Health if the Health Service Executive has made a decision to reimburse the cost of the drug Kuvan to persons (details supplied); and if he will make a statement on the matter. [10044/16]
View answerI propose to take Questions Nos. 760 and 767 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 item, 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.
Kuvan (sapropterin) was considered under the national pricing and reimbursement process 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.
As the application process is ongoing, it is not possible to discuss potential outcomes or comment further at this time.
