Market Access for Anti-Cancer Drugs: Is the Demonstration of a Clinical Benefit on Survival Correlated With Price Level?

OBJECTIVES: In France, reimbursable medicines pricing is a regulated system under the authority of the French Economic committee for health products (CEPS). After receiving the opinion of the Transparency Committee (TC) of the French National Authority for Health (HAS), the CEPS negotiates the drug price with the pharmaceutical company, considering particularly the improvement in actual benefit (ASMR), depending on efficacy data. In oncology trials, the efficacy of a treatment is generally measured using survival analysis methods. Thus, the objective of this study is to determine if a correlation exists between the results of survival analyses and the price negotiated with the CEPS for oncology drugs.

METHODS: Oncology TC opinions published between January 2018 and December 2022 with survival data (available on the HAS website) were analyzed, and the daily treatment costs (DTC) corresponding were calculated taking the recommended dosage of the summary of product characteristics (from European Medicines Agency website). Then, an exploratory correlation analysis between survival results, in terms of hazard ratio (HR) and absolute survival gain, and DTC was conducted.

RESULTS: Of the 25 specialties evaluated during the study period, 7 were assessed on overall survival (OS group) and 18 on a surrogate endpoint (surrogate group). DTC were between 86€ and 395€. The correlation analysis showed an absence of correlation between results of survival analyses (HR and absolute survival gain) and DTC. Nevertheless, the median and mean DTC were slightly higher for an HR under 0.7 (OS group) or 0.5 (surrogate group) and for an absolute survival gain better than 5 months for the surrogate group.

CONCLUSIONS: Although correlation analyses between HR value and DTC are not significant, we observed a better price level when the HR of OS <0.7 and < 0.5 for surrogate criteria.