342. Deputy Eamon Gilmore asked the Minister for Health the reason the drug Kuvan is not available from the Health Service Executive for children with the genetic condition phenylketonuria; and if he will make a statement on the matter. [6644/15]

The pharmaceutical company Merck Serono made an application to the HSE seeking pricing and reimbursement of Sapropterin or Kuvan® to give it its brand name, under the High Tech arrangements in 2009.

The HSE considered that application in line with the National framework agreement around pricing and reimbursement of new medicines that was in place at that time.

That process included requiring the company to submit a full dossier of the information it had available to support pricing and reimbursement. The application failed to satisfy the criteria in place at that time and required to allow reimbursement.

All applications for pricing and reimbursement of pharmaceuticals are now required to be considered in line with criteria set out in the Health (Pricing and Supply of Medical Goods) Act 2013.

No application has been received by the HSE since 2009 in relation to the pricing or reimbursement of Sapropterin.