EU

Blogs

IQWiG recommends downgrading Gilead’s Yescarta to ‘no added benefit’ – a sign of things to come for orphan drugs in Germany? 

Yescarta, Gilead’s CAR-T cell therapy recently underwent a full HTA assessment in Germany after breaching the annual sales threshold for orphan drugs. Upon reassessment, Germany’s lower HTA body IQWiG recommended downgrading Yescarta’s rating in one indication to ‘no added benefit’, which is likely to negatively impact pricing negotiations.

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Blogs

Swissmedic and FOPH are joining forces next year to provide a simultaneous regulatory and reimbursement review process. 

From 2024, the Swiss regulatory body (Swissmedic) and health technology assessment (HTA) organization (Federal office of public health; FOPH) are introducing a simultaneous reimbursement and regulatory review process, to promote earlier access of medicines. This approach will enable manufacturers to submit both applications at the same time, making it possible to achieve marketing authorization and reimbursement in situ (1). This has been evidenced under a successful pilot with Roche’s Lunsumio (completed in March 2023).

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