International analysis of reimbursement rates and clinical benefit of genitourinary cancer drugs across Canada, France, England, Wales, Scotland, Spain, Italy, and Portugal

We analysed reimbursement differences for prostate (PC), renal cell (RCC), and urothelial (UC) cancers drugs in Canada, France, England, Wales, Scotland, Spain, Italy, and Portugal, assessing substantial clinical benefit (SCB) and pivotal trials characteristics. This is a retrospective analysis of PC, RCC, and UC drug-indication pairs (2005-2024). Approvals were identified via FDA and EMA. Reimbursement recommendations were reviewed. Primary endpoint was reimbursement rate by SCB, tumour type, and country. Trial characteristics, overall survival (OS), and quality of life (QoL) were analysed. SCB was defined by ESMO-MCBS v1.1. Statistical significance set at p < .05. Fifty-five drug-indication pairs for PC (20), RCC (20), and UC (15) were analysed. Most trials were randomized, open-label, phase 3, and in the metastatic settings. Canada (PC: 85%, RCC: 75%, UC: 53%) and France (PC: 85%; RCC: 75%; UC: 33%) had highest reimbursement rates; while Portugal, lowest (PC: 65%; RCC: 50%; UC: 20%). Among SCB indications, PC reimbursement was highest in Canada, France, and Spain (91%), and lowest in England (64%). For RCC, was highest in Canada, France, and Italy (100%), and lowest in Portugal (57%). For UC, was highest in Canada (100%), and lowest in Wales and England (33%). OS was primary endpoint in 47% trials; QoL was assessed in 25%. OS benefit was observed in 53%; QoL in only 9%. This study reveals marked international variation in genitourinary cancer drug reimbursement, particularly in Europe and for UC-even for indications with SCB. Most trials lacked evidence of OS or QoL benefit.