Presentation (CTI)

OBJECTIVES: The French direct access (“accès direct”) pathway was introduced to accelerate patient access to innovative medicines. It allows temporary reimbursement for up to 12 months to medicines with an SMR Important and ASMR I - IV. If no price has already been negotiated, manufacturers set a free price during this period, subject to statutory rebates, before transitioning to a standard reimbursement at a price negotiated with the Comité économique des produits de santé (CEPS). This study aims to evaluate the implementation and outcomes of the direct access pathway since its introduction.
METHODS: We reviewed all medicines granted direct access between May 2023 and May 2026, and assessed the indication in scope, level of competition, Commission de la Transparence (CT) assessment outcomes and dates, time to access, duration of direct access, pricing during and after the scheme, and prior early access applications.
RESULTS: Nine products entered the direct access scheme during the study period, spanning a range of indications. At the time of analysis, five products had transitioned to standard reimbursement, three remained under direct access, and one failed to secure a negotiated price within 12 months. Four products had previously applied for early access, with all applications rejected. Median time from EMA approval to direct access was approximately 300 days. For products that subsequently achieved reimbursement, negotiated prices were 0-30% lower than the provisional direct access price.
CONCLUSIONS: The direct access pathway accelerates patient access through shorter CT assessments and by bypassing CEPS negotiations. Importantly, it provides an alternative route for products not eligible for early access. However, uptake is still limited, with fewer than ten products benefiting from the scheme since its introduction. Additionally, direct access does not guarantee long-term reimbursement, as disconnect between manufacturers' pricing objectives and CEPS willingness to pay may remain.