Tuesday, 5 October 2021

Questions (701)

Michael Collins


701. Deputy Michael Collins asked the Minister for Health if he will address a matter in relation to zolgensma gene therapy (details supplied); and if he will make a statement on the matter. [48243/21]

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Written answers (Question to Health)

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 licensed 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) for the treatment of patients with 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the SMN1 gene and a clinical diagnosis of SMA type 1, or patients with 5q SMA with a bi-allelic mutation in the SMN1 gene and up to 3 copies of the SMN2 gene. 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. The HTA was undertaken as a part of the Beneluxa collaboration between Ireland, the Netherlands and Belgium, with Austria acting as a reviewer in the Belgian procedure. The HTA was completed in May 2021. The NCPE recommended that Zolgensma not be considered for reimbursement unless cost-effectiveness could be improved relative to existing treatments. Pricing/reimbursement negotiations are currently underway, having commenced in July 2021. A final decision on the pricing/reimbursement application for Zolgensma will be made in accordance with the 2013 Health Act.