Price-Volume Regulation in France: Alignment Between Negotiated Thresholds With the French Economic Committee for Health Products (CEPS) and Real-World Observations
Author(s)
Nicholas Fouilloux, PharmD student, Hakim Sadeddine, PharmD, Philippine Poignant, PharmD, Virginie Beaumeunier, CEPS president.
MINISTERE DE LA SANTE - CEPS, PARIS, France.
MINISTERE DE LA SANTE - CEPS, PARIS, France.
OBJECTIVES: Thresholds are used by the CEPS to regulate healthcare expenditures. While their budgetary impact is expected, the efficiency of their calibration in real-life settings remains underexplored. The aim was to assess whether reference volumes (RV), from either sales forecast or target population, in these agreements reflect real-world use by comparing target and observed treatment costs (TTC vs OTC).
METHODS: We selected drugs for which a threshold was implemented by CEPS from 2020 to 2022, allowing 3-year follow-up, as thresholds are often based on year-3 forecasts. Inclusion was restricted to lump-sum envelopes (LSE - agreements with a marginal payback rate exceeding 80%). From the 28 identified drugs, those with indication extensions during the 3-year period (n=2) and with a different recording method for sales (n=1) were excluded, resulting in a final sample of 25 drugs. For each product, the TTC was based on the assumptions underlying the threshold construction, while the OTC was calculated using observed volumes from Group for the Elaboration and Realization of Statistics (GERS), applying the same posology and population assumptions.
RESULTS: Among the 25 products, 48% had threshold with a regulatory objective (TTC reached when triggered) and 52% with a security objective (designed not to trigger, but to frame reimbursed use within the market authorization scope). For the 13 security thresholds, none reached their RV neither exceeded 80% of the initial threshold. In addition, more than half of them remained below 50%.For the regulatory thresholds, OTC rarely aligned with the target. All products presented a deviation of which 58% were greater than +80% from the TTC.
CONCLUSIONS: Thresholds offer a tool for expenditure predictability. However, real-world use may diverge from initial forecasts, possibly due to differences in posology, target population, or the introduction of new therapeutic alternatives. This highlights the need for ongoing monitoring and better calibration methods.
METHODS: We selected drugs for which a threshold was implemented by CEPS from 2020 to 2022, allowing 3-year follow-up, as thresholds are often based on year-3 forecasts. Inclusion was restricted to lump-sum envelopes (LSE - agreements with a marginal payback rate exceeding 80%). From the 28 identified drugs, those with indication extensions during the 3-year period (n=2) and with a different recording method for sales (n=1) were excluded, resulting in a final sample of 25 drugs. For each product, the TTC was based on the assumptions underlying the threshold construction, while the OTC was calculated using observed volumes from Group for the Elaboration and Realization of Statistics (GERS), applying the same posology and population assumptions.
RESULTS: Among the 25 products, 48% had threshold with a regulatory objective (TTC reached when triggered) and 52% with a security objective (designed not to trigger, but to frame reimbursed use within the market authorization scope). For the 13 security thresholds, none reached their RV neither exceeded 80% of the initial threshold. In addition, more than half of them remained below 50%.For the regulatory thresholds, OTC rarely aligned with the target. All products presented a deviation of which 58% were greater than +80% from the TTC.
CONCLUSIONS: Thresholds offer a tool for expenditure predictability. However, real-world use may diverge from initial forecasts, possibly due to differences in posology, target population, or the introduction of new therapeutic alternatives. This highlights the need for ongoing monitoring and better calibration methods.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HPR165
Topic
Health Policy & Regulatory
Topic Subcategory
Pricing Policy & Schemes, Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas