Drug Market Access Delays in France: What Role May Cost-Effectiveness Evaluations Play in Varying These Timescales?
Author(s)
Cartolano P1, Tano M2, Siorat V1, Moracchini M3, Ribault M1, Parent de Curzon O1, Paubel P4, Degrassat Theas A2
1General Agency of Equipment and Health Products (AGEPS), Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France, 2General 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 Cité, Paris, France, 3General Agency of Equipment and Health Products (AGEPS), Assistance Publique-Hôpitaux de Paris (AP-HP), Courbevoie, 92, France, 4General 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 Cité, Paris, Paris, France
OBJECTIVES: In France, drug prices are negotiated between industry and the national Economic Committee for Health Products (CEPS) according to a framework agreement. The latest, in 2021, strengthens the weight of medical economics to benefit from the fast track procedure. In fact, France faces important market access delays. Medico-economic evaluations play a role in determining prices, but the impact of these assessments on negotiation times remains unknown.
By examining a recent period, the aim of this study is to observe whether, among the other usual determinants of negotiations, cost-effectiveness assessments may affect negotiation timelines.METHODS: The study focuses on 30 drugs that had their first cost-effectiveness assessment between 2019 and 2023. The data comes from the French health technology assessment agency (HAS) for efficacy and cost-effectiveness evaluations, supplemented by price notices, reimbursement orders, and CEPS annual reports.
RESULTS: In terms of lead times, the median between 2019 and 2023 is 415 days (min: 83 ; max: 945).
From a clinical point of view, it would appear that being an innovative drug, targeting more than 10,000 patients or having few comparators tend to decrease timeframes. On the other hand, it seems that having a moderate added therapeutic benefit, having several comparators, or being expensive extend lead times. From an efficiency point of view, having an undetermined (invalidated or not supplied) budgetary impact seems to increase timeframes. However, having major observations invalidating all or part of the economic study, as well as having an undetermined evaluation of efficiency, do not seem to have a significant effect on delays.CONCLUSIONS: Although evaluating the weight of cost-effectiveness evaluations in negotiating delays is a methodologically difficult task, it seems that efficiency is less important than the typical determinants. In the years to come, we will need to keep an eye on its effects.
Conference/Value in Health Info
Value in Health, Volume 26, Issue 11, S2 (December 2023)
Code
HTA143
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes, Systems & Structure, Value Frameworks & Dossier Format
Disease
No Additional Disease & Conditions/Specialized Treatment Areas