Maureen O'Sullivan
Question:42. Deputy Maureen O'Sullivan asked the Minister for Health if the drug Kuvan will be made available for sufferers of PKU through the HSE; and if he will make a statement on the matter. [48132/17]
View answerWednesday, 15 November 2017
Questions (42)
Written answers
The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drug schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
In reaching a decision, the HSE will take into account such expert opinions and recommendations which may have been sought by the HSE, including, for example, advice from the National Centre for Pharmacoeconomics - the NCPE.
Sapropterin (Kuvan) was previously considered under the pricing and reimbursement processes in 2009. At that time, insufficient evidence was available to support the application submitted by Merck Serono.
In December 2015, Merck Serono advised the HSE that the market authorisation for sapropterin was transferring to Biomarin in 2016. The HSE met with the new market authorisation holder in May 2016 and was advised that it would be submitting a health technology assessment dossier in relation to sapropterin.
The NCPE assessment was completed on the 15 September 2017. The NCPE did not recommend Kuvan for reimbursement as it was not deemed cost effective.
The HSE assessment process is ongoing and the HSE will take into account any relevant expert advice when making its decision, in line with the 2013 Act.