William Aird (Laois, Fine Gael)
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66. To ask the Minister for Health the current status of access to spinal muscular atrophy (SMA) treatments for adult patients; if she will commit to ensuring equitable public reimbursement of therapies for adults living with SMA; considering the urgent need expressed by patient groups; and if she will make a statement on the matter. [34829/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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I recognise the importance of providing the best care to SMA patients including access to new and innovative medicines.

Between 2021 and 2024 the State has allocated €128 million for new drugs. This has allowed the HSE to approve 194 new medicines for patients including 74 oncology medicines and 49 medicines for rare diseases.

The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The 2013 Act ensures a rigorous assessment process for new medicines, providing confidence that the right medicines are chosen at sustainable prices. Economic assessments help stretch HSE funds to provide a range of services and innovative medicines, including cancer treatments. The HSE considers clinical effect, cost-effectiveness, budget impact, opportunity cost, and unmet need when assessing applications.

I have asked the HSE to provide an update in relation to treatments for SMA patients over 18 years of age.

The HSE has advised that once a medicine is approved by the European Medicines Agency, the HSE is dependent on a pharmaceutical company making an application to Ireland for its drug or new indication to be assessed for reimbursement. All medicines are considered for pricing of reimbursement in order of application.

The HSE have also advised that in terms of the two drugs for Spinal Muscular Atrophy in patients over 18 years of age, risdiplam (Evrysdi®) and nusinersen (Spinraza®), the marketing authorisation holders, Roche and Biogen respectively, have not submitted pricing and reimbursement applications for these drugs treatments to commence in patients diagnosed with Spinal Muscular Atrophy over 18 years of age.

It is important for the Deputy to note that patients who receive these treatments before they turn 18 years of age continue to receive these treatments into adulthood.

We strongly encourage the marketing authorisation holders of these treatments to apply for reimbursement with an indication for adult patients over 18 years diagnosed with Spinal Muscular Atrophy.