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October 8th, 2021
MDI is delighted to share the news that Belgium, Ireland and the Netherlands have reached an agreement on the pricing of Zolgensma, a gene therapy for the treatment of spinal muscular atrophy (SMA). Zolgensma will be reimbursed for two specific groups of young patients in all three countries.
It is the first time that Belgium, Ireland and the Netherlands have jointly reached an agreement on the price of a drug. The aim of the Beneluxa Initiative is to enhance the access of patients to high quality and affordable treatment. The joint reimbursement process for Zolgensma started with a Health Technology Assessment by Belgium, Ireland and the Netherlands, with Austria as external reviewer in the Belgian procedure. In July 2021, the three directly participating countries initiated price negotiations.
From today, the HSE will provide reimbursement of Zolgensma for a subgroup of patients who meet the specified criteria on which the Beneluxa assessment and negotiation was based: SMA patients with a bi-allelic mutation in the SMN1 gene and a clinical diagnosis of Type 1 and presymptomatic patients with up to three copies of the SMN2 gene.
Stephen Donnelly, Minister for Health:
“The reimbursement of Zolgensma by the HSE represents a great achievement in ensuring access to this gene therapy for two groups of young SMA patients. This is a welcome decision for their families, carers and friends. The success of the joint process for Zolgensma represents a tangible output of the Beneluxa partnership and I wish to take the opportunity to recognise and thank the HSE, including the National Centre for Pharmacoeconomics, and the other participating countries for their significant role in this process.”
Paul Reid, HSE Chief Executive Officer:
“The HSE as its standard, engages in commercial negotiations with drug manufacturers to ensure we obtain the best possible value for new medicines. This enables the HSE to reimburse as many medicines as possible, for as many patients as possible, within its resources. HSE decisions on which medicines are reimbursed by the taxpayer must be made on objective, scientific and economic grounds. Providing funding for new high-cost innovative medicines alongside the many demands of the health service presents a continual challenge and the Beneluxa engagement with international colleagues aims to collectively address this challenge. This is the first time that Belgium, Ireland and the Netherlands have jointly conducted such a negotiation and reached an agreement on the price of a medicine. From today, the HSE will provide reimbursement of Zolgensma for a subgroup of patients who meet the specified criteria on which the Beneluxa assessment and negotiation was based.”
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