Clinical and economic impact of the availability of innovative therapies for advanced lung cancer in men in Latin America: a population-based secondary data study.

BACKGROUND

Over the last decade, the development of innovative cancer treatments has accelerated and has been associated with improved mortality trends; however, local regulatory approval times are extensive. This study estimated the clinical and economic impact of delays in the approval of innovative therapies for the treatment of advanced lung cancer in men in five Latin American countries.

METHODS

Using public data, we estimated the relationship between available innovative therapies (AIT) and age-specific mortality rate (ASMR) for Argentina, Brazil, Chile, Colombia, and Mexico through a regression model. Based on the difference between the number of FDA-approved therapies and the number approved by each local agency, we calculated the avoidable deaths (ADs) if innovation had been available. We estimated the Years of Life Lost (YLLs) using the life expectancy, the median age of death, and the ADs. Productivity loss (PL) was calculated using each country's retirement age and yearly Gross Domestic Product per capita (GDPc) in 2022 constant USD.

FINDINGS

Total ADs, YLLs, and PL were 8694, 114,477, and USD 439,179,876, respectively. Argentina had the highest impact of AIT on ASMR. Brazil's results showed a high clinical and economic impact, primarily due to its large population. Chile's high GDPc led to high PL. Colombia and Mexico showed a high clinical impact, suggesting a benefit of early approval. Differences in availability and approval times have increased with the number of FDA-approved therapies, yet local time gaps have recently increased.

INTERPRETATION

Our study shows the substantial clinical and economic impact of delays in approving innovative therapies, underscoring the potential of improving regulatory processes to increase the availability of lung cancer treatments. Accelerating the introduction of innovative therapies for advanced lung cancer in Latin America represents a significant opportunity to enhance survival rates, instilling hope and optimism while also avoiding substantial PL.

FUNDING

This study was conducted as a research partnership between Roche and CTIC. No funding was received. Authors participated in the study design, data collection, data analysis, interpretation, and writing of the report.