Michael Healy-Rae (Kerry, Independent)
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190. To ask the Minister for Health when zolgensma gene therapy will be approved for reimbursement for the treatment of spinal muscular atrophy; and if he will make a statement on the matter. [30601/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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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.

In line with the 2013 Health Act and the national framework agreed with industry, if a company would like a medicine to be reimbursed by the HSE, the company must submit an application to the HSE to have the new medicine added to the reimbursement list. Reimbursement is for licenced indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.

In making a relevant reimbursement decision, the HSE is required under the Act to have regard to a number of criteria, including efficacy, the health needs of the public, cost effectiveness and potential or actual budget impact.

HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE).

I am advised by the HSE that, in April 2020, the NCPE received a reimbursement application dossier for Onasemnogene abeparvovec (Zolgensma). On 13 May 2020, the NCPE completed a rapid review with respect to this application and recommended a full Health Technology Assessment (HTA) to assess the clinical effectiveness and cost effectiveness of Zolgensma compared with the current standard of care.

This HTA was undertaken as a part of the Beneluxa collaboration as a joint HTA between Ireland, the Netherlands and Belgium, with Austria acting as a reviewer.

The HTA was completed in May 2021 and an agreement on a draft joint mandate for potential joint negotiations was reached by the working group on 9 June 2021. If this mandate is approved by the national authorities in the participating countries, notice will be given to the applicant company that joint negotiations can commence in July.

A final decision on the pricing/reimbursement application for Zolgensma will be made in accordance with the 2013 Health Act.