Recent G-BA decision - Secukinumab fails the HTA in Germany in the context of the indication extension for hidradenitis suppurativa
Secukinumab fails the health technology assessment (HTA) in Germany in the context of the indication extension for hidradenitis suppurativa (HS), according to a recent G-BA decision published on December 7, 2023 (https://www.g-ba.de/downloads/40-268-10020/2023-12-07_AM-RL-XII_Secukinumab_D-942_TrG.pdf)
The main reason for that decision was missing comparative evidence against the Standard of Care, Adalimumab. The submitted randomized pivotal studies compared Secukinumab against Placebo, the G-BA rejected this evidence. Another reason for that was that the randomized follow-up period of 16 weeks was too short to adequately assess the long-term benefits and harms (24 weeks minimum required). The path regarding the reimbursement price is now pre-defined: The maximum reimbursement price for Secukinumab is to be set at the cost level of Adalimumab.
This example shows the high importance of comparative evidence in Germany. In addition, such evidence will even play a more important role in the upcoming Joint Clinical Assessments (JCA) on EU level from 2025 onwards.
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