Background:

The Canadian Expert Drug Advisory Committee (CEDAC) delivers evidence-informed formulary recommendations for drug reimbursement based on data from clinical systematic reviews and critiques of health economic information. Past work suggests that value judgments play a role in evidence interpretation and recommendations.

Objectives:

To explore the role of value judgments in CEDAC recommendations.

Methods:

CEDAC recommendations from 2009-2010 were reviewed. Recommendations were evaluated which had (1) a partial or full listing, where evidence consisted of only placebo controlled trials; and (2) a do not list recommendation, where evidence consisted of only active comparator trials. Information was gathered on factors potentially influencing the recommendation, such as: drug novelty (i.e. first drug for indication or first in drug class); indication risk and rarity; insufficiency of evidence; study quality; economic considerations; and harms concerns.

Results:

Nine partial or full listing recommendations were identified based on only placebo controlled trials, and 8 'do not list’ recommendations, based only on active comparator trials, were identified. Of the nine 'list’ recommendations, factors were related to therapeutic need (3/9) and potential for cost savings (6/9). Reasons underlying the 8 'do not listá recommendations related to cost/cost-effectiveness (8/8; increased cost or uncertainty around cost-effectiveness), insufficiency of evidence versus comparators (7/8; lack of studies versus key comparators, lack of meaningful improvements over other active therapies, inconsistency of findings across studies), and study quality (6/8; issues regarding blinding or withdrawals/missing data, appropriateness of non-inferiority margin, other design issues). For the 'do not list’ category, recommen- dations were largely made in consideration of ≥2 criteria.

Conclusions:

The absence of active comparator trials may not be the determinant of a recommendation as value judgments related to the reliability of clinical trial data, therapeutic need, and other factors play a role in CEDAC recommendations.