Parliamentary Question addressed to the Minister for Health

To ask the Minister for Health if the Health Service Executive will consider including the Sapropterin drug, Kuvan, in its Re-imbursement Scheme, in order to help patients here with Phenylketonuria; and if he will make a statement on the matter?

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.