Written answer
Medicinal Products
Sepiapterin has not been submitted to the HSE for reimbursement, so assessment cannot begin; the pharmaceutical company must apply following EMA or HPRA authorisation.
525. Deputy Shónagh Ní Raghallaigh asked the Minister for Health if her Department will assess a medication (details supplied) for availability and reimbursement here as a viable treatment option for phenylketonuria; and if she will make a statement on the matter. [66346/26]
Comment on this
The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines, in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013.
The HSE robustly assesses applications for pricing and reimbursement to make sure that it can stretch available resources as far as possible and to deliver the best value in relation to each medicine and ultimately more medicines to Irish citizens and patients.
There are formal processes which govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded and / or reimbursed. HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds.
To commence the pricing and reimbursement process, a pharmaceutical company must submit an application for a new medicine or a new use of an existing medicine to the HSE’s Corporate Pharmaceutical Unit. European Medicines Agency (EMA) or Health Products Regulatory Authority (HPRA) authorisation is required for the medicine prior to submission to the HSE for reimbursement as reimbursement only applies to licensed uses (indications) of the medicine.
Ireland is ‘open for business’ and all pharmaceutical companies are encouraged to submit applications for reimbursement for new medicines that are granted marketing authorisation in Europe.
Further information on the progress of assessment and approval processes is available via the Pricing and Reimbursement Application tracker available at HSE - PCRS: www.sspcrs.ie/portal/rdt/pub/application/home
As of the 20th September 2026, no pricing and reimbursement application has been received by the HSE for sepiapterin (Sephience®). The national assessment and decision process cannot commence in the absence of a pricing and reimbursement application submission.