EVALUATING THE IMPACT OF FRANCE'S DEROGATORY DIRECT ACCESS SCHEME:INSIGHTS FROM THE PUBLIC HOSPITALS OF PARIS (AP-HP) FRAMEWORK
Author(s)
BILLEL BOUALEM, PhD1, ALBANE DEGRASSAT THEAS2, VIRGINIE SIORAT3, PASCAL PAUBEL3, ISABELLE FUSIER, PharmD4.
1Student, Paris Cité University, Paris, France, 2AGEPS, PARIS, France, 3AGEPS - APHP, France, 4APHP - AGEPS, PARIS, France.
1Student, Paris Cité University, Paris, France, 2AGEPS, PARIS, France, 3AGEPS - APHP, France, 4APHP - AGEPS, PARIS, France.
OBJECTIVES: Direct Access scheme (DAs), an experimental programme introduced in France in May 2023, provides early 100% reimbursement for medicines with important clinical benefit (SMR) and clinical added value (≥ASMR-IV) following the French Health Authority assessment, pending price negotiation with the Economic Committee for Health Products (CEPS), within one year. This study assesses the profile of the medicines and the hospital impact from AP-HP perspective.
METHODS: This study is based on the list of medicinal products included in the derogatory access scheme from 05/2023 to 12/2025, cross-referenced with AP-HP Pharmacy and Therapeutics Committee (PTC) assessment, expenditures and consumption data, price variations.
RESULTS: Compared to the early access scheme, which included >50 products (excluding indication extensions and renewals), the DAs included 6 products (3 ASMR-III/ 3 ASMR-IV; Three dermatology, one oncology product, one haemophilia treatment and one vaccine). Five products were included in the hospital formulary following internal PTC evaluation, with one excluded due to therapeutic alternatives. Four were listed in the hospital outpatient dispensing system (HODS). The DA procedure had a mean duration of 185 days, with including an average 84 day evaluation and access period within AP-HP, leaving 101 days of effective use, 27 of 37 AP-HP hospitals used DAs, with expenditures of €7.3 million (6341 units consumed), representing <1% of total pharmaceutical expenditures. One product was withdrawn during price negotiations, and 2 of non-hospital-restricted products were no longer included in the hospital formulary after DAs termination. Agreements with the CEPS resulted in an average price reduction of 13% (SD=14.25%) versus initial price.
CONCLUSIONS: The DAs facilitate faster access to therapeutic innovations while enabling cost control through rapid CEPS price adjustments. In contrast to Early Access, DAs allow community physicians to prescribe treatments dispensed via HODS; however, hospitals retain discretion over formulary inclusion, and the short duration of the procedure complicates drug management.
METHODS: This study is based on the list of medicinal products included in the derogatory access scheme from 05/2023 to 12/2025, cross-referenced with AP-HP Pharmacy and Therapeutics Committee (PTC) assessment, expenditures and consumption data, price variations.
RESULTS: Compared to the early access scheme, which included >50 products (excluding indication extensions and renewals), the DAs included 6 products (3 ASMR-III/ 3 ASMR-IV; Three dermatology, one oncology product, one haemophilia treatment and one vaccine). Five products were included in the hospital formulary following internal PTC evaluation, with one excluded due to therapeutic alternatives. Four were listed in the hospital outpatient dispensing system (HODS). The DA procedure had a mean duration of 185 days, with including an average 84 day evaluation and access period within AP-HP, leaving 101 days of effective use, 27 of 37 AP-HP hospitals used DAs, with expenditures of €7.3 million (6341 units consumed), representing <1% of total pharmaceutical expenditures. One product was withdrawn during price negotiations, and 2 of non-hospital-restricted products were no longer included in the hospital formulary after DAs termination. Agreements with the CEPS resulted in an average price reduction of 13% (SD=14.25%) versus initial price.
CONCLUSIONS: The DAs facilitate faster access to therapeutic innovations while enabling cost control through rapid CEPS price adjustments. In contrast to Early Access, DAs allow community physicians to prescribe treatments dispensed via HODS; however, hospitals retain discretion over formulary inclusion, and the short duration of the procedure complicates drug management.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
PT41
Topic
Economic Evaluation, Health Policy & Regulatory, Real World Data & Information Systems
Topic Subcategory
Pricing Policy & Schemes, Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas