Lung cancer accounts for only 7% of new cancer cases in Latin America and the Caribbean but is the region's leading cause of death. In 2022, 90,846 people died from lung cancer, approximately 12.1% of all cancer deaths that year.

Men's incidence and mortality rates from this disease are twice as high as women's—a disparity largely attributed to the historically higher rates of tobacco use and less aggressive immune system responses in the male population. That incidence contributes to a significant burden on economies across Latin America.

Despite this burden, access to innovative medications has lagged because of disparities in capacity, capability, and administrative inefficiencies in regulatory systems. Regional agencies have begun to prioritize faster approvals and to adopt technological solutions to streamline the regulatory process.

A new analysis published in The Lancet outlines the clinical and economic consequences of delaying access to innovative therapies for lung cancer and illustrates how Latin American countries can reduce cancer-related morbidity, save lives, and boost economic output.

Regulatory Delays in LATAM

Slow regulatory approval processes hamper the availability of cancer drugs in Latin America. A study found that between 2006 and 2021, Argentina, Brazil, Chile, and Mexico approved drugs approximately two years after the U.S. Food and Drug Administration (FDA). In Colombia, the delay averaged three years, the longest approval time in the region. Those lags are attributable to a lack of priority-drug programs, conditional authorizations, or expedited procedures.

Across those five countries, 8,694 deaths and 114,477 years of life could have been saved without delays in drug access. The burden of years of life lost mostly affected working-age men and correlated with a $439 million loss in economic productivity.

Drug Approvals for Lung Cancer

In the United States, a rising number of cancer drug approvals between 2000 and 2016 correlated with significant reductions in mortality among the 15 most common tumors, represented in 1.3 million cancer deaths avoided in that period. Although innovative therapies are readily available in most high-income countries thanks to expedited pathways in their regulatory agencies, such as the FDA and the European Medicines Agency (EMA), low- and middle-income countries, including those in the Latin America region, struggle to obtain the same drugs. In the United States, 40% of the 100 drugs approved by the FDA in 2020 and 2021 were for various cancers, such as thyroid, urothelial, and colorectal, but fewer than 30 medications were developed for lung cancer from 2006 to 2021.

Economics of Cancer

Health-care spending and productivity losses from cancer result in an economic burden for patients, health-care systems, and countries. Cancer morbidity and premature mortality are associated with a cumulative productivity loss of more than $165 million between 2007 and 2021 across Latin America. This number, calculated by linking the years of life lost to each country's gross domestic product (GDP) per capita, illustrates that health and wealth are inextricably connected. When a country's workforce is healthier and lives longer, the economy benefits. In contrast, when life-saving treatments are delayed, nations lose out on the contributions of experiences and the labor of citizens.

A cancer patient takes part in a protest demanding better medical assistance, at General Hospital, in La Paz, Bolivia, on April 13, 2017. REUTERS/David Mercado

Argentina reported the highest clinical impact in terms of potentially avoided deaths despite having the highest lung cancer mortality rate in the region. Although 70% of FDA-approved medications are approved by Argentina's regulatory body and available for prescriptions within the country, the absence of the 30% remaining therapies still contributed to 2,185 of the total avoidable deaths and more than $901 million in productivity loss between 2014 and 2021. That loss, using Argentina's high national GDP per capita adjusted by purchasing power parity (GDP-PPP), was the highest of any country in the study.

Brazil, which has the largest population in Latin America, demonstrated that even relatively small delays can have massive shocks in a large country. It reported 2,014 avoidable deaths from lung cancer and a productivity loss of more than $579 million adjusted by age-specific mortality rate. Chile, in contrast, recorded 407 deaths and a productivity loss of more than $30 million. Both Colombia and Mexico were significantly affected by regulatory delays, leading to 1,977 and 2,111 avoidable deaths, respectively. These delays are directly linked to estimated productivity losses of $546 million for Colombia and $477 million for Mexico standardized by GDP-PPP.

Data shows that the cost of illness for lung cancer in the Americas is estimated at $31.4 billion [PDF]. This equates to a cost per patient of delivering health between an average of $9,752 in Brazil and $16,537 in Mexico. In Colombia, 43% of services are not included in health benefit packages, complicating the estimation of per patient costs.

Changes in the Regulatory Landscape

The message is clear: Innovation saves lives. Access to new therapies is not an abstract idea but a measurable reality, one that reduces deaths and improves survival for people in their prime working years. For adult men in Latin America, among whom this disease is significantly more common, innovative treatments can make the difference between extending their lives and delaying their deaths.

Recognizing this, several countries in the region have begun taking steps to expedite regulatory approvals. Early experiences in Argentina, Brazil, and Chile show that reliance pathways and expedited reviews can reduce delays, although most have been applied to rare diseases so far. Many are adopting regulatory reliance [PDF], a process that allows agencies to use assessments already completed by trusted regulators to shorten review times. Expanding these strategies to life-threatening conditions such as lung cancer and incorporating tools used by the FDA and EMA, including conditional approvals and modern evidence approaches [PDF] such as real-world data, could help bring promising therapies to patients sooner.

By speeding approval of medical breakthroughs, countries can give their people longer, healthier lives while strengthening national economies. New therapies for lung cancer are not just for the elderly; they're extending the lives of working-age men. As research shows, health systems should prioritize making innovative medicines available for everyone.

Cancer patient Gabriel, 13, looks at his parents Roseli and Lourival as they place a Brazilian flag on top of his bed, at the Cancer Itaci Hospital, in Sao Paulo, Brazil on June 17, 2014. — Cancer patient Gabriel, 13, looks at his parents Roseli and Lourival as they place a Brazilian flag on top of his bed, at the Cancer Itaci Hospital, in São Paulo, Brazil on June 17, 2014. REUTERS/Nacho Doce

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The Economics of Lung Cancer and Drug Delays in Latin America

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