Dáil Éireann Debate, Thursday - 2 July 2026
482. Deputy Pádraig O'Sullivan asked the Minister for Health the timeline for a decision by the HSE Drugs Group regarding the reimbursement of risdiplam for adults living with spinal muscular atrophy; and if she will make a statement on the matter. [50505/26]
View answerThe Government is committed to investing in new medicines. Budgets 2021-2025 allocated an additional €158 million for new drugs, which has facilitated the introduction of 270 new medicines, to date. Budget 2026 allocated €30 million of funding available for new drugs to be allocated from the overall additional €217 million in funding allocated for medicines.
Under the Health (Pricing and Supply of Medical Goods) Act 2013, the Health Service Executive (HSE), through its Senior Leadership Team has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices, therefore the HSE have been asked to provide an update in this matter.
The HSE has advised that it is committed to providing access to as many medicines as possible, in as timely a fashion as possible, from the resources available (provided) to it.
The HSE must robustly assess 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.
HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds.
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.
In terms of the specific details of the application for pricing and reimbursement of risdiplam (Evrysdi®):
Restricted reimbursement approval is in place for risdiplam (Evrysdi®) for the treatment of 5q SMA in patients aged between 2 months and <18 years of age, with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 under the High Tech arrangements from the 1st September 2023. As a condition of reimbursement, an individual patient approval system has been put in place by the HSE, to enable reimbursement for patients who meet the pre-defined criteria as per a HSE devised managed access protocol: www.hse.ie/eng/about/who/cspd/medicines-management/managed-access-protocols/risdiplam-evrysdi/risdiplam-evrysdi-managed-access-protocol.pdf.
The HSE received a further application for pricing and reimbursement on the 22nd October 2025 from Roche (the applicant) for risdiplam (Evrysdi®) indicated for the treatment of 5q spinal muscular atrophy (SMA) in adult patients with a clinical diagnosis of SMA Type 2 or Type 3 or with one to four SMN2 copies.
Further information on the progress of risdiplam (Evrysdi®) for adult patients through the HSE assessment and approval processes is available via the Pricing and Reimbursement Application tracker available at
www.hse.ie/eng/about/who/cspd/medicines-management/managed-access-protocols/risdiplam-evrysdi/risdiplam-evrysdi-managed-access-protocol.pdf.
HSE application ID HSE100076 has been assigned to this application.
The application remains under consideration with the HSE. The HSE cannot make any comment on possible outcomes from the ongoing process.
