Author(s)
Zimmermann P1, Tano M2, Siorat V3, Ribault M3, Parent de Curzon O3, Degrassat-Théas A4, Paubel P5
1General Agency of Equipment and Health Products (AGEPS), Assistance Publique-Hôpitaux de Paris (AP-HP); Faculty of pharmacy, University of Paris, Paris, 75, France, 2General Agency of Equipment and Health Products (AGEPS), Assistance Publique-Hôpitaux de Paris (AP-HP); Health Law Institute, INSERM UMR S 1145, University of Paris ; Faculty of pharmacy, University of Paris, France, Paris, 92, France, 3General Agency of Equipment and Health Products (AGEPS), Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France, 4General Agency of Equipment and Health Products (AGEPS), Assistance Publique-Hôpitaux de Paris (AP-HP); Health Law Institute, INSERM UMR S 1145, University of Paris ; Faculty of pharmacy, University of Paris, France, Paris, France, 5General Agency of Equipment and Health Products (AGEPS), Assistance Publique-Hôpitaux de Paris (AP-HP) ; Law and Health Economics Department, Faculty of Pharmacy & Health Law Institute (INSERM UMR S1145) University of Paris, Paris, France
OBJECTIVES The Temporary Authorization for Use (ATU) is the French compassionate use program (CUP) providing an early access to drugs before their marketing authorization (MA) and before price and reimbursement decisions (post-ATU). A major reform of CUP is taking place in 2021. It aims to simplify the process and to control the market access of drugs when they‘re coming back to the common rights path by sanctioning long negotiation time after the MA and by reserving CUP to only supposed innovative drugs. The objective of this study is to take stock of drugs currently under CUP for the 37 public hospitals of Paris (AP-HP). METHODS Data were retrieved from 2018 to 2020 for all ATU and post-ATU drugs available in AP-HP in their first indication: annual costs, time spent under post-ATU, the opinion of the French HTA agency (Haute Autorité de Santé), if any, which assesses the innovative character based on an improvement of actual clinical benefit (ASMR) rated from I to III. RESULTS In 2018/2019/2020, respectively 114/118/112 drugs were listed as ATU and 42/50/46 drugs as post-ATU for a total cost of 151M€/161M€/116M€ which represent about 16% of annual drug budget. Only 19 drugs over 79 (24%) were deemed innovative. The average time of the post-ATU stage is 598 days [191;2069] and the 180 days delay enforced by the European Union law is over for 22 drugs that are still under HTA review. CONCLUSIONS Beginning of July 2021, discounts will apply by the French Healthcare products pricing committee to manufacturers for drugs that do not respect the new CUP criteria. The reform put HTA at the core of the CUP in order to control the free pricing window but at the risk of being less attractive.
Conference/Value in Health Info
2021-11, ISPOR Europe 2021, Copenhagen, Denmark
Value in Health, Volume 24, Issue 12, S2 (December 2021)
Code
POSA217
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes, Pricing Policy & Schemes, Public Spending & National Health Expenditures, Systems & Structure
Disease
Drugs
