Health technology assessment reports for oncology medications in Canada from 2018 to 2025: methodological critiques on manufacturers’ submissions and a comparison between manufacturers and Canada’s Drug Agency (CDA) analyses

Objective Providing an analytical framework to evaluate critiques by Canada’s Drug Agency (CDA) and to compare the manufacturers’ economic analyses versus CDA’s reanalyses for oncology medications.Methods We reviewed CDA oncology reports from 2018 to 2025. Clinical data and methodological critiques were compared between submissions receiving positive versus negative recommendations.Results Positive recommendations were significantly more frequent in submissions that included randomized trials (90.1% vs. 61.9%), trials with a control arm (90.8% vs. 65.4%), and trials incorporating phase III or phase IV evidence (79.6% vs. 41.9%) (p < 0.001). Although CDA was generally receptive to indirect treatment comparisons (ITC), studies using naïve ITC (73.0% for naïve ITC vs. 88.1% for others, p = 0.031) or matching-adjusted indirect comparison (MAIC) (75.0% for MAIC vs. 91.2% for other ITCs, p = 0.009) had significantly lower rates of positive recommendations. When comparing submissions with positive versus negative recommendations, certain critiques were significantly more frequent in the latter. These included not having enough evidence available (82.2% vs. 100%, p = 0.011), and using surrogate outcomes (23.9% vs. 51.6%, p = 0.002).Conclusion Using MAIC or naïve ITC, submitting a dossier that includes limited clinical evidence, and surrogate outcomes are associated with a negative recommendation.