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

Summary: 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...

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Main Authors: Andrés F. Cardona, Natalia Sánchez, Liliana Gutiérrez-Babativa, Leonardo Rojas, Jairo Zuluaga, Stella Martínez, Lucia Viola, Carlos Carvajal, Juliana Bogoya, Laura Prieto-Pinto, Daniel Samacá-Samacá, Antonio Robles, Joshua Kock, Claudio Martín, Luis Corrales, Luis E. Raez, Vladmir Cordeiro de Lima, Suraj Samtani, Oscar Arrieta
Format: Article
Language:English
Published: Elsevier 2025-09-01
Series:The Lancet Regional Health. Americas
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Online Access:http://www.sciencedirect.com/science/article/pii/S2667193X25001826
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author Andrés F. Cardona
Natalia Sánchez
Liliana Gutiérrez-Babativa
Leonardo Rojas
Jairo Zuluaga
Stella Martínez
Lucia Viola
Carlos Carvajal
Juliana Bogoya
Laura Prieto-Pinto
Daniel Samacá-Samacá
Antonio Robles
Joshua Kock
Claudio Martín
Luis Corrales
Luis E. Raez
Vladmir Cordeiro de Lima
Suraj Samtani
Oscar Arrieta
author_facet Andrés F. Cardona
Natalia Sánchez
Liliana Gutiérrez-Babativa
Leonardo Rojas
Jairo Zuluaga
Stella Martínez
Lucia Viola
Carlos Carvajal
Juliana Bogoya
Laura Prieto-Pinto
Daniel Samacá-Samacá
Antonio Robles
Joshua Kock
Claudio Martín
Luis Corrales
Luis E. Raez
Vladmir Cordeiro de Lima
Suraj Samtani
Oscar Arrieta
author_sort Andrés F. Cardona
collection DOAJ
description Summary: 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.
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spelling doaj-art-d3601d3044cd45f9a94de76f3b2c18ef2025-08-20T03:15:03ZengElsevierThe Lancet Regional Health. Americas2667-193X2025-09-014910117210.1016/j.lana.2025.101172Clinical and economic impact of the availability of innovative therapies for advanced lung cancer in men in Latin America: a population-based secondary data studyResearch in contextAndrés F. Cardona0Natalia Sánchez1Liliana Gutiérrez-Babativa2Leonardo Rojas3Jairo Zuluaga4Stella Martínez5Lucia Viola6Carlos Carvajal7Juliana Bogoya8Laura Prieto-Pinto9Daniel Samacá-Samacá10Antonio Robles11Joshua Kock12Claudio Martín13Luis Corrales14Luis E. Raez15Vladmir Cordeiro de Lima16Suraj Samtani17Oscar Arrieta18Institute of Research, Science and Education, Luis Carlos Sarmiento Angulo Cancer Treatment and Research Center (CTIC), Bogotá, Colombia; GIGA/TERA Research Groups (CTIC/Universidad El Bosque), Bogotá, Colombia; Thoracic Oncology Unit, Luis Carlos Sarmiento Angulo Cancer Treatment and Research Center (CTIC), Bogotá, Colombia; Corresponding author. Institute of Research, Science and Education, Luis Carlos Sarmiento Angulo Cancer Treatment and Research Center (CTIC), Cra. 14 #169-49, Bogotá, Colombia.Institute of Research, Science and Education, Luis Carlos Sarmiento Angulo Cancer Treatment and Research Center (CTIC), Bogotá, Colombia; GIGA/TERA Research Groups (CTIC/Universidad El Bosque), Bogotá, ColombiaInstitute of Research, Science and Education, Luis Carlos Sarmiento Angulo Cancer Treatment and Research Center (CTIC), Bogotá, Colombia; GIGA/TERA Research Groups (CTIC/Universidad El Bosque), Bogotá, ColombiaGIGA/TERA Research Groups (CTIC/Universidad El Bosque), Bogotá, Colombia; Thoracic Oncology Unit, Luis Carlos Sarmiento Angulo Cancer Treatment and Research Center (CTIC), Bogotá, ColombiaGIGA/TERA Research Groups (CTIC/Universidad El Bosque), Bogotá, Colombia; Thoracic Oncology Unit, Luis Carlos Sarmiento Angulo Cancer Treatment and Research Center (CTIC), Bogotá, ColombiaGIGA/TERA Research Groups (CTIC/Universidad El Bosque), Bogotá, Colombia; Thoracic Oncology Unit, Luis Carlos Sarmiento Angulo Cancer Treatment and Research Center (CTIC), Bogotá, ColombiaGIGA/TERA Research Groups (CTIC/Universidad El Bosque), Bogotá, Colombia; Thoracic Oncology Unit, Luis Carlos Sarmiento Angulo Cancer Treatment and Research Center (CTIC), Bogotá, ColombiaGIGA/TERA Research Groups (CTIC/Universidad El Bosque), Bogotá, Colombia; Thoracic Oncology Unit, Luis Carlos Sarmiento Angulo Cancer Treatment and Research Center (CTIC), Bogotá, ColombiaClinical Oncology Unit, Instituto Nacional de Cancerología – INC, Bogotá, ColombiaEvidence Generation Team, Roche Colombia, Bogotá, ColombiaEvidence Generation Team, Roche Colombia, Bogotá, Colombia; Corresponding author. Evidence Generation, Roche Colombia, Cra. 14 #93-68, Bogotá, Colombia.Evidence Generation Team, Roche Colombia, Bogotá, ColombiaEvidence Generation Team, Roche Colombia, Bogotá, ColombiaThoracic Oncology Unit, Instituto Alexander Fleming, Buenos Aires, ArgentinaMedical Oncology Unit, Centro de Investigación y Manejo del Cáncer (CIMCA), San José, Costa RicaThoracic Oncology Department, Memorial Cancer Institute, Memorial Health Care System, Florida Atlantic University (FAU), Miami, FL, United StatesThoracic Oncology Reference Center, A.C. Camargo Cancer Center, São Paulo, BrazilClínica las Condes Cancer Center, Santiago de Chile, ChileThoracic Oncology Unit, Instituto Nacional de Cancerologia (INCan), Mexico City, MexicoSummary: 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.http://www.sciencedirect.com/science/article/pii/S2667193X25001826Lung neoplasmsDrug approvalInnovate therapiesLatin America
spellingShingle Andrés F. Cardona
Natalia Sánchez
Liliana Gutiérrez-Babativa
Leonardo Rojas
Jairo Zuluaga
Stella Martínez
Lucia Viola
Carlos Carvajal
Juliana Bogoya
Laura Prieto-Pinto
Daniel Samacá-Samacá
Antonio Robles
Joshua Kock
Claudio Martín
Luis Corrales
Luis E. Raez
Vladmir Cordeiro de Lima
Suraj Samtani
Oscar Arrieta
Clinical and economic impact of the availability of innovative therapies for advanced lung cancer in men in Latin America: a population-based secondary data studyResearch in context
The Lancet Regional Health. Americas
Lung neoplasms
Drug approval
Innovate therapies
Latin America
title Clinical and economic impact of the availability of innovative therapies for advanced lung cancer in men in Latin America: a population-based secondary data studyResearch in context
title_full Clinical and economic impact of the availability of innovative therapies for advanced lung cancer in men in Latin America: a population-based secondary data studyResearch in context
title_fullStr Clinical and economic impact of the availability of innovative therapies for advanced lung cancer in men in Latin America: a population-based secondary data studyResearch in context
title_full_unstemmed Clinical and economic impact of the availability of innovative therapies for advanced lung cancer in men in Latin America: a population-based secondary data studyResearch in context
title_short Clinical and economic impact of the availability of innovative therapies for advanced lung cancer in men in Latin America: a population-based secondary data studyResearch in context
title_sort clinical and economic impact of the availability of innovative therapies for advanced lung cancer in men in latin america a population based secondary data studyresearch in context
topic Lung neoplasms
Drug approval
Innovate therapies
Latin America
url http://www.sciencedirect.com/science/article/pii/S2667193X25001826
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