[Drug evaluation in France: comparison of two approaches]

Area of Science:

• Pharmacoeconomics and Drug Evaluation
• Health Technology Assessment
• Pharmaceutical Policy Research

Background:

• Independent expert bodies in France, Prescrire (P) and the Transparency Commission (CT), evaluate new medications.
• Both groups utilize distinct 5-level scales to assess the therapeutic contribution of new drugs.
• A comparative analysis was conducted on their gradings for new drugs between 1993 and 1998.

Purpose of the Study:

• To compare the therapeutic contribution gradings assigned by Prescrire (P) and the Transparency Commission (CT) for new medicines.
• To identify and analyze discrepancies between the two expert groups' assessments.
• To understand how differing objectives and evaluation timelines influence drug assessment outcomes.

Main Methods:

• Collected and compared gradings for 264 new drug entries (new substances, combinations, indications, formulations, dosages, packaging) from P and CT.
• Excluded vaccines, generics, and hospital-exclusive items from the analysis.
• Analyzed discordances, defined as a difference of two or more gradings, and assessed agreement across different drug categories.

Main Results:

• Significant discordances (21 cases) were observed for new substances and new combinations.
• Adjusting Prescrire's gradings by one level improved concordance, reducing discordances to 2.
• New indications showed notable discordance (15 cases, 30%) with high CT gradings, while new formulations, dosages, and packaging demonstrated good concordance.

Conclusions:

• Despite differing objectives (drug use vs. reimbursement indications) and time lags, Prescrire and the Transparency Commission generally reach similar conclusions on new drug assessments.
• Discrepancies are partly explained by these differing goals and temporal factors.
• Some differences in expert opinion may stem from subjective interpretation of available data.