The route – which is being piloted for two years – allows drugs deemed to be innovative and with a major medical benefit by the Haute Autorité de Santé (HAS) to be made eligible for reimbursement by French social security without the usual pricing and sometimes lengthy negotiations with the Economic Committee for Health Products (CEPS).
It allows treatments to be fully reimbursed by the health insurance system for up to a year and is targeted at drug types that are not covered by France’s AAP early access scheme, which came into force in 2021 but only covers drugs that are “presumed to be innovative, including with regard to a potential clinically-relevant comparator.”
