Robert Troy (Longford-Westmeath, Fianna Fail)
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1940. To ask the Minister for Health if she will ensure the drug tofersen is approved for the treatment of motor neurone disease in suitable cases as a matter of urgency. [59312/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices; therefore, I have asked the HSE for an update in this matter.

The HSE has advised that there is a National Application, Assessment & Decision Process for new medicines which is underpinned by Primary Legislation (Health (Pricing and Supply of Medical Goods) Act 2013) put in place by the Oireachtas. The HSE must comply with the relevant legislation when considering investment decisions around new medicines.

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.

Pharmaceutical companies are required to submit formal applications to the HSE if they wish for their medicines to be added to the list of reimbursable items / funded via hospitals.

On the 29th May 2024 the European Commission granted EU marketing authorisation for tofersen (Qalsody®) indicated for the treatment of adults with amyotrophic lateral sclerosis (ALS), associated with a mutation in the superoxide dismutase 1 (SOD1) gene.

As of the 31st October 2025, a pricing and reimbursement application has not been received by the HSE for tofersen (Qalsody®).

As per the processes outlined above, the HSE will process and assess any pricing and reimbursement application received from a company as efficiently as possible within the resources available to the HSE.