ArticleLancet regional health. Americas2023
Marketing authorisation and pricing of FDA-approved cancer drugs in Brazil: a retrospective analysis.
Article in Lancet regional health. Americas, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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Who cites it
11 citing papers in PubMed.
- Clinical Benefit of Multiple Myeloma Drugs at Regulatory Approval in Brazil, Europe, and the USA: A Retrospective Cohort Study (2003-2024).Clinical drug investigation · 2026Article
- 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.Lancet regional health. Americas · 2025Article
- Precision Medicine for Cancer and Health Equity in Latin America: Generating Understanding for Policy and Health System Shaping.International journal of environmental research and public health · 2025Review
- Financial challenges of being on long-term, high-cost medications.Neuro-oncology practice · 2025Review
- Impact of Funding Source on Long-Term Outcomes in Prostate Cancer: Analysis of a Large Public Database From Sao Paulo, Brazil.JCO global oncology · 2025Article
- Trust Beyond Borders: European External Regulatory Influence on Access to Medicines.The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2025Article
- Article
- Disparities in availability of new cancer drugs worldwide: 1990-2022.BMJ global health · 2024Article
- International Cost-Effectiveness Analysis of Durvalumab in Stage III Non-Small Cell Lung Cancer.JAMA network open · 2024Article
- Cancer drug indication approvals in China and the United States: a comparison of approval times and clinical benefit, 2001-2020.The Lancet regional health. Western Pacific · 2024Article
- Regulatory histories of recently withdrawn ovarian cancer treatment indications of 3 PARP inhibitors in the US and Europe: lessons for the accelerated approval pathway.Journal of pharmaceutical policy and practice · 2024Article
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Most cancer drugs enter the US market first. US Food and Drug Administration (FDA) approvals of new cancer drugs may influence regulatory decisions in other settings. The study examined whether characteristics of available evidence at FDA approval influenced time-to-marketing authorisation (MA) in Brazil, and price differences between the two countries. Methods: All new FDA-approved cancer drugs from 2010 to 2019 were matched to drugs with MA and prices approved in Brazil by December 2020. Characteristics of main studies, availability of randomised controlled trials (RCTs), overall survival (OS) benefit, added therapeutic benefit, and prices were compared. Findings: Fifty-six FDA-approved cancer drugs with matching indications received a MA at the Brazilian Health Regulatory Agency (Anvisa) after a median of 522 days following US approval (IQR: 351-932). Earlier authorisation in Brazil was associated with availability of RCT (median: 506 vs 760 days, p = 0.031) and evidence of OS benefit (390 vs 543 days, p = 0.019) at FDA approval. At Brazilian marketing authorisation, a greater proportion of cancer drugs had main RCTs (75% vs 60.7%) and OS benefit (42.9% vs 21.4%) than that in the US. Twenty-eight (50%) drugs did not demonstrate added therapeutic benefit over drugs for the same indication in Brazil. Median approved prices of new cancer drugs were 12.9% lower in Brazil compared to the US (adjusted by Purchasing Power Parity). However, for drugs with added therapeutic benefit median prices were 5.9% higher in Brazil compared to the US, while 17.9% lower for those without added benefit. Interpretation: High-quality clinical evidence accelerated the availability of cancer medicines in Brazil. The combination of marketing and pricing authorisation in Brazil may favour the approval of cancer drugs with better supporting evidence, and more meaningful clinical benefit albeit with variable degree of success in achieving lower prices compared to the US. Funding: None.
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