Conor Sheehan (Limerick City, Labour)
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314. To ask the Minister for Health when there will be equal access for spinraza treatment for adults with spinal muscular atrophy treatment; and if she will make a statement on the matter. [30952/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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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. Therefore, I have asked the HSE to provide an update in relation to Risdiplam(Evrysdi®) 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.

While many companies engage proactively with the HSE, Ireland, by virtue of its size and market share, may not always be prioritised by some companies in the first stages of marketing a new medicine. Reports describing timelines for reimbursement from EMA approval to HSE reimbursement approval do not consider this important factor, as statutorily the HSE are not able to add a new medicine to the reimbursement list until an application is received.

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®):

Reimbursement approval is in place for Risdiplam (Evrysdi®) for the treatment of 5q spinal muscular atrophy (SMA) under the High Tech arrangements from the 1st September 2023. Reimbursement support is for a subgroup of the licensed indication.

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.

If the manufacturer of Risdiplam(Evrysdi®) (Roche) submits a de novo application for adult patients with a clinical diagnosis of SMA Type 1, Type 2 or Type 3, that application will be duly progressed through the formal processes governing the pricing and reimbursement of medicines.

In the absence of a de novo application for adult patients with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 from the company a pricing and reimbursement application cannot progress.