Abstract
In France, patients can benefit an early access to innovation, ahead of the marketing authorization or final reimbursement, since 1992. This early access program (EAP) was reformed on July 1, 2021. The new process involves a joint assessment by ANSM and HAS. Thus, HAS is now involved in granting EAP (HAS decision) while continuing to assess drugs for reimbursement (Transparency Committee (TC) opinions). According to HAS, this ensures consistency between derogation-based schemes (EAP) and the common law funding scheme (based on TC opinions). This study aimed at analyzing TC opinions for reimbursement of drugs which have also been assessed for EAP with new process.
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