Cost of care and budget impact of novel first-line treatments in patients with locally advanced or metastatic urothelial carcinoma from the Colombian healthcare system perspective

BACKGROUND: Locally advanced or metastatic urothelial carcinoma (la/mUC) imposes substantial clinical and economic burden. Novel first-line (1L) therapies have expanded treatment options but may significantly increase healthcare expenditures. Economic evidence in Colombia remains limited, warranting cost and budget impact analyses of 1L therapies from the national payer perspective. RESEARCH DESIGN AND METHODS: Direct healthcare costs of the first year of treatment were estimated for patients with la/mUC starting 1L treatment: chemotherapy (CT) followed by avelumab+best supportive care (BSC); CT+BSC; nivolumab+CT (NIV+CT); and enfortumab vedotin+pembrolizumab (EV+PEM). Efficacy and safety data were obtained from JAVELIN Bladder 100, CheckMate 901, and EV-302. Costs (Colombian pesos; COP, and United States dollars; USD) were estimated for medication acquisition and administration, disease management, severe adverse events (grade ≥3), and subsequent treatments. Drug costs were obtained from SISMED (2024) and Suficiencia. Budget impact compared a base-case scenario (CT+avelumab+BSC) versus an alternative scenario incorporating EV+PEM and NIV+CT. RESULTS: CT+avelumab+BSC was associated with a total annual cost of COP 271,530,508 (US$ 66,693), 66% less than EV+PEM and 24% less than NIV+CT. Budget impact analysis showed an increase of COP 160,067,748,642 (US$ 39.32 million) (+42.8%). CONCLUSIONS: CT+avelumab+BSC had the lowest annual cost, suggesting it is affordable versus EV+PEM and NIV+CT.