On May 19 the European Commission granted conditional approval for Zolgensma (onasemnogene abeparvovec) 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 for patients with 5q SMA with a bi-allelic mutation in the SMN1 gene and up to three copies of the SMN2 gene.

The Beneluxa Initiative welcomes a dialogue with the company AveXis/Novartis on access and affordability of the product in each country. Belgium, Ireland and the Netherlands aim to undertake a joint HTA assessment of Zolgensma as part of a reimbursement application by the manufacturer, with Austria acting as the reviewing expert in the procedure. The company AveXis/Novartis has stated its willingness to collaborate on this joint assessment and dialogue on reimbursement. As a consequence, HTA agencies in the three countries will align on the timing and content of the local HTA procedures. Joint price negotiations within the Beneluxa Initiative always start with a joint HTA procedure. Based on the outcome of the HTA assessment,countries will determine if the joint assessment will be followed by a joint price negotiation.



Last update: 19 May 2020