Germany

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

Calls for reform in the assessment of orphan drugs in Germany, upon the implementation of EU Joint Evaluation.

OD (orphan drug) privilege status under the AMNOG procedure means that ODs are currently exempt from providing comparative data for their assessment. They are assumed to have a positive added benefit (with the lowest rating possible being a positive but unquantifiable added benefit), even when the data is insufficient to support this. If sales over 12 months surpass the €30 million mark, this privilege is revoked, and a full assessment is performed based on comparative data. 

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