OBJECTIVES: This research aims to analyze potential drivers of coverage decisions for cancer pharmacological interventions submitted to the Brazilian Private Healthcare System under the new submission process, established in October 2021.

METHODS: Publicly available critical appraisal reports of submissions with a final recommendation for cancer pharmacological technologies between October 2021 and December 2022 were selected. Preliminary and final recommendations, public consultation participation, expected clinical benefits (progression-free survival [PFS] and overall survival [OS]), potential safety issues, evidence certainty, cost-effectiveness, and budget impact (BI) analysis were extracted and analyzed.

RESULTS: 23 cancer pharmacological technologies appraisals were included. Favorable preliminary and final recommendations were provided for 13 (57%) and 18 (78%) appraisals, respectively. Most incorporated technologies were based at least on phase III evidence, showing increased PFS versus no intervention or similar benefit to other available technologies (17/18). All submissions presenting potential savings/neutral BI were incorporated (n=6), including one based on phase II, single-arm evidence, with a preliminary negative recommendation. Other submissions including matching-adjusted indirect comparison based on phase II (n=2) or phase III data (n=1) were rejected. Considering submissions with phase III evidence and presenting no savings in the BI analysis (n=15), 11 of the 12 favorable decisions presented favorable recommendations by at least one international agency. On the other hand, all negative decisions presented negative recommendations by at least one international agency (n=3). Very low and low evidence certainty (12/18), high incremental cost-effectiveness ratio (11/18 higher than 3 GDP per capita), and no gain in OS versus relevant comparators (5/18) did not prevent positive final recommendations. No substantial safety issues were reported among favorable decisions.

CONCLUSIONS: Potential savings/neutral BI, evidence based on phase III studies, and external positive recommendations were identified as potential drivers of recent favorable recommendations for cancer technologies in the Brazilian Private Healthcare System.