Noel Rock (Dublin North West, Fine Gael)
Link to this: Individually | In context | Oireachtas source

283. To ask the Minister for Health his plans and the plans of the HSE to approve the drug Kuvan for persons with PKU; and if he will make a statement on the matter. [17286/19]

Pearse Doherty (Donegal, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

396. To ask the Minister for Health when a decision will be made on the drug sapropterin; and if he will make a statement on the matter. [17721/19]

Simon Harris (Wicklow, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I propose to take Questions Nos. 283 and 396 together.

The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies the criteria for decisions on the reimbursement of medicines.  

I am advised by the HSE that HSE Leadership has approved the reimbursement of Sapropterin (Kuvan) subject to Start-Stop criteria and appropriate protocols and processes being in place to ensure reimbursement is only targeted to those cohorts covered by the Start-Stop criteria.

The HSE has advised that reimbursement will be in place from 1 July 2019.