Accelerating Therapeutic Innovation: Early Results From France’s Accès Direct Scheme
Author(s)
Arnould Monguillon, MSc, PharmD, de Sauvebeuf Côme, MSc, PharmD, DELPHINE CHAVADE, MSc, PharmD.
Biodimed Conseils, Paris, France.
Biodimed Conseils, Paris, France.
OBJECTIVES: “Accès Direct” scheme, implemented in May 2023 under the 2022 French Social Security Financing Act, aims to accelerate access to innovative therapies. It enables full reimbursement of innovative medicines at a freely set price for one year, immediately after a favorable opinion from the French National Authority for Health (HAS), without price negotiation conclusion with the Comité Économique des Produits de Santé (CEPS). Pricing agreements must follow within one year. This study evaluates early outcomes in terms of time to market and pricing.
METHODS: Medicines included in the scheme were identified from the French Official Journal and cross-referenced with HAS data (evaluation dates and ratings). Access timelines and pricing were analyzed. Comparators were those defined by HAS.
RESULTS: Five medicines entered the scheme: delgocitinib, danicopan, ruxolitinib, recombinant adjuvanted herpes zoster vaccine, and etranacogene dezaparvovec. Target populations ranged from 270 patients to over 16 million. Therapeutic areas included dermatology, rare diseases, infectious diseases, and gene therapy. Two products had orphan drug designation; one was classified as an advanced therapy medicinal product (ATMP). Three products exited the scheme with a median reimbursement time of 203 days (range: 179-310). One was withdrawn after 310 days, likely due to failed pricing negotiations. At the time of analysis, two medicines remained within the program (<179 days).Price analyses showed coherent costs: €163.24 for herpes zoster vaccine and €70.00 for 100g of ruxolitinib cream (vs. €90.00 and no HAS-identified comparators respectively).
CONCLUSIONS: The small number of medicines included and initial rejection of etranacogene dezaparpovec may reflect selection bias favoring suitable candidates. However, preliminary findings suggest that “Accès Direct” effectively reduces time to reimbursement and improves patient access. While the scheme allows earlier funding, pricing remains similar or higher than comparators. Its role appears strategic in the context of restricted early access and extended negotiation timelines.
METHODS: Medicines included in the scheme were identified from the French Official Journal and cross-referenced with HAS data (evaluation dates and ratings). Access timelines and pricing were analyzed. Comparators were those defined by HAS.
RESULTS: Five medicines entered the scheme: delgocitinib, danicopan, ruxolitinib, recombinant adjuvanted herpes zoster vaccine, and etranacogene dezaparvovec. Target populations ranged from 270 patients to over 16 million. Therapeutic areas included dermatology, rare diseases, infectious diseases, and gene therapy. Two products had orphan drug designation; one was classified as an advanced therapy medicinal product (ATMP). Three products exited the scheme with a median reimbursement time of 203 days (range: 179-310). One was withdrawn after 310 days, likely due to failed pricing negotiations. At the time of analysis, two medicines remained within the program (<179 days).Price analyses showed coherent costs: €163.24 for herpes zoster vaccine and €70.00 for 100g of ruxolitinib cream (vs. €90.00 and no HAS-identified comparators respectively).
CONCLUSIONS: The small number of medicines included and initial rejection of etranacogene dezaparpovec may reflect selection bias favoring suitable candidates. However, preliminary findings suggest that “Accès Direct” effectively reduces time to reimbursement and improves patient access. While the scheme allows earlier funding, pricing remains similar or higher than comparators. Its role appears strategic in the context of restricted early access and extended negotiation timelines.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HPR12
Topic
Health Policy & Regulatory, Health Service Delivery & Process of Care, Patient-Centered Research
Topic Subcategory
Public Spending & National Health Expenditures, Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas