Netherlands Kicks Off Zolgensma Review for BeNeLuxA

AMSTERDAM, The Netherlands – The Netherlands’ Zorginstituut (ZIN) has started its assessment of AveXis/Novartis’ gene therapy Zolgensma (onasemnogene abeparvovec) for the treatment of spinal muscular atrophy (SMA).

Zolgensma is currently conditionally approved in Europe for the treatment of patients with 5q 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.

Following conditional approval for Zolgensma in May, BeNeLuxA announced it wanted to enter discussions with AveXis/Novartis on access and affordability. Belgium, Ireland, and the Netherlands decided to undertake a joint health technology assessment (HTA) of Zolgensma as part of the application by the drugmaker, with Austria acting as expert reviewer during the procedure.

“The Zorginstituut is now going to assess, together with two other European countries, what added value the drug has for SMA patients, and advise whether Zolgensma should be admitted to the basic package,” announced ZIN.

As such, the HTA agencies of Belgium, Ireland, and the Netherlands are aligning the timing and content of their national HTA procedures, the first step for joint price negotiations within the BeNeLuxA initiative.

ZIN explained, “The Zorginstituut has to make a complicated decision in the assessment of Zolgensma. After all, when we collect the costs of this medicine, we can no longer spend that money on other good care. In addition to assessing the effectiveness and the associated costs of this medicine, the assessment therefore also concerns the distribution of our jointly raised premium money.”

Dutch Minister for Medical Care Van Ark parked Zolgensma in the lock for expensive medicines due to its high price tag of around 1.9 million euros. Once ZIN concludes its assessment, the Minister for Medical Care can negotiate a price with the manufacturer, along with fellow BeNeLuxA countries if all parties see eye to eye in the end.

At large, once HTA is completed in spring 2021, the five BeNeLuxA countries will determine if the joint assessment will lead to joint price negotiations.

ZIN noted that rival SMA treatment Biogen’s Spinraza (nusinersen), for which pricing was negotiated through BeNeLuxA, is already reimbursed in the Netherlands, following advice from ZIN, which the agency will consider when assessing Zolgensma.

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