Michael Collins (Cork South West, Independent)
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778. To ask the Minister for Health when the 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. [4023/21]

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.

I am advised by the HSE that in April 2020, the National Centre for Pharmacoeconomics (NCPE) received an application for Zolgensma. On 13 May 2020, the NCPE completed the rapid review 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 is now being undertaken as a part of the Beneluxa collaboration as a joint HTA assessment between Ireland, the Netherlands and Belgium, with Austria acting as a reviewer.

The first draft of the HTA report has been forwarded to the applicant company for consideration, along with further questions and the assessment remains in process.

Based on the final outcome of this joint HTA, the participating countries will decide whether the joint assessment will be followed by a joint pricing negotiation.