Denis Naughten
Question:1799. Deputy Denis Naughten asked the Minister for Health when he expects a decision on the approval of a drug (details supplied); and if he will make a statement on the matter. [1861/22]
View answerWednesday, 19 January 2022
Questions (1799)
Written answers
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.
Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.
Following the first joint agreement on the price of a drug between Belgium, Ireland and the Netherlands, the HSE decided to approve Onasemnogene Abeparvovec (Zolgensma) for reimbursement in the treatment of Spinal Muscular Atrophy (SMA) for patients with SMA with a bi-allelic mutation in the SMN1 gene and a clinical diagnosis of SMA Type I, or pre-symptomatic patients with 5q SMA with a bi-allelic mutation in the SMN1 gene and up to 3 copies of the SMN2 gene.
I welcomed the HSE's decision, which represented a very significant development for the State as it is the first time Ireland has agreed to fund a drug for rare diseases in partnership with other countries in the BeNeLuxA Initiative.
Reimbursement is now in place for the above specified indications since 8 October.