Common Drug Review recommendations: an evidence base for expectations?

Area of Science:

• Health Economics
• Pharmaceutical Policy
• Clinical Pharmacology

Background:

• The Common Drug Review (CDR) process in Canada aims to standardize the review of new drugs for publicly funded drug benefit plans.
• CDR recommendations consider comparative clinical efficacy and cost-effectiveness.

Purpose of the Study:

• To analyze Canadian Expert Drug Advisory Committee (CEDAC) recommendations from 2003 to 2009.
• To identify factors predicting 'do not list' (DNL) recommendations.

Main Methods:

• Analysis of 138 publicly available CEDAC final recommendations (September 2003 - December 2009).
• Categorization of recommendations by submission specifics, drug characteristics, clinical factors, and economic factors.
• Statistical analysis to determine independent predictors of DNL recommendations.

Main Results:

• Overall DNL rate was 48%, with significant variation across therapeutic areas (0% for HIV antivirals to 88% for analgesics).
• Key predictors of DNL included clinical uncertainty (OR 14), higher price than comparators (OR 9), and price as the sole economic evidence (OR 18).
• Incremental cost-effectiveness thresholds did not predict recommendations.

Conclusions:

• CEDAC recommendations are evidence-driven, weighing multiple factors.
• Clinical uncertainty and drug pricing strongly influence recommendations, more so than economic results alone.
• Insufficient clinical evidence, often due to pre-launch data gaps, impacts drug listing decisions.