Marketing authorisation and pricing of FDA-approved cancer drugs in Brazil: a retrospective analysisResearch in context
Summary: 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 a...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2023-06-01
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| Series: | The Lancet Regional Health. Americas |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2667193X23000807 |
| _version_ | 1797824533215838208 |
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| author | Adriana M. Ivama-Brummell Fernanda L. Marciniuk Anita K. Wagner Claudia G.S. Osorio-de-Castro Sabine Vogler Elias Mossialos Carla L. Tavares-de-Andrade Huseyin Naci |
| author_facet | Adriana M. Ivama-Brummell Fernanda L. Marciniuk Anita K. Wagner Claudia G.S. Osorio-de-Castro Sabine Vogler Elias Mossialos Carla L. Tavares-de-Andrade Huseyin Naci |
| author_sort | Adriana M. Ivama-Brummell |
| collection | DOAJ |
| description | Summary: 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. |
| first_indexed | 2024-03-13T10:40:23Z |
| format | Article |
| id | doaj.art-c91ea72b5e9b4153a9c6acbbc454a7e2 |
| institution | Directory Open Access Journal |
| issn | 2667-193X |
| language | English |
| last_indexed | 2024-03-13T10:40:23Z |
| publishDate | 2023-06-01 |
| publisher | Elsevier |
| record_format | Article |
| series | The Lancet Regional Health. Americas |
| spelling | doaj.art-c91ea72b5e9b4153a9c6acbbc454a7e22023-05-18T04:40:24ZengElsevierThe Lancet Regional Health. Americas2667-193X2023-06-0122100506Marketing authorisation and pricing of FDA-approved cancer drugs in Brazil: a retrospective analysisResearch in contextAdriana M. Ivama-Brummell0Fernanda L. Marciniuk1Anita K. Wagner2Claudia G.S. Osorio-de-Castro3Sabine Vogler4Elias Mossialos5Carla L. Tavares-de-Andrade6Huseyin Naci7Department of Health Policy, London School of Economics and Political Science, Cowdray House, Houghton Street, London, WC2A 2AE, United Kingdom; Office of Assessment of Safety and Efficacy, General Office of Medicines, Brazilian Health Regulatory Agency, SIA, Trecho 05, Área Especial 57, Brasília-DF CEP 71.205-050, Brazil; Corresponding author. Department of Health Policy, London School of Economics and Political Science, Cowdray House, Houghton Street, London, WC2A 2AE, United KingdomExecutive Secretariat of the Drug Market Regulation Chamber, Brazilian Health Regulatory Agency, SIA, Trecho 05, Área Especial 57, Brasília-DF CEP 71.205-050, BrazilDepartment of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, 401 Park Drive, Suite 401 East, Boston, MA, 02215, USADepartment of Medicines Policy and Pharmaceutical Services, Sergio Arouca National School of Public Health, Oswaldo Cruz Foundation, Rua Leopoldo Bulhões, 1480, sala 632, Manguinhos, Rio de Janeiro, RJ, 21041-210, BrazilWHO Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policies, Pharmacoeconomics Department, Austrian National Public Health Institute, Stubenring 6, Vienna, 1010, Austria; Department of Health Care Management, Technical University of Berlin, Berlin, 10623, GermanyDepartment of Health Policy, London School of Economics and Political Science, Cowdray House, Houghton Street, London, WC2A 2AE, United KingdomDepartment of Health Administration and Planning, Sergio Arouca National School of Public Health, Oswaldo Cruz Foundation, Rua Leopoldo Bulhões, 1480, sala 727A, Manguinhos, Rio de Janeiro, RJ, 21041-210, BrazilDepartment of Health Policy, London School of Economics and Political Science, Cowdray House, Houghton Street, London, WC2A 2AE, United KingdomSummary: 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.http://www.sciencedirect.com/science/article/pii/S2667193X23000807BrazilUnited StatesPharmaceutical preparationsHealth technology assessmentCancerDrug legislation |
| spellingShingle | Adriana M. Ivama-Brummell Fernanda L. Marciniuk Anita K. Wagner Claudia G.S. Osorio-de-Castro Sabine Vogler Elias Mossialos Carla L. Tavares-de-Andrade Huseyin Naci Marketing authorisation and pricing of FDA-approved cancer drugs in Brazil: a retrospective analysisResearch in context The Lancet Regional Health. Americas Brazil United States Pharmaceutical preparations Health technology assessment Cancer Drug legislation |
| title | Marketing authorisation and pricing of FDA-approved cancer drugs in Brazil: a retrospective analysisResearch in context |
| title_full | Marketing authorisation and pricing of FDA-approved cancer drugs in Brazil: a retrospective analysisResearch in context |
| title_fullStr | Marketing authorisation and pricing of FDA-approved cancer drugs in Brazil: a retrospective analysisResearch in context |
| title_full_unstemmed | Marketing authorisation and pricing of FDA-approved cancer drugs in Brazil: a retrospective analysisResearch in context |
| title_short | Marketing authorisation and pricing of FDA-approved cancer drugs in Brazil: a retrospective analysisResearch in context |
| title_sort | marketing authorisation and pricing of fda approved cancer drugs in brazil a retrospective analysisresearch in context |
| topic | Brazil United States Pharmaceutical preparations Health technology assessment Cancer Drug legislation |
| url | http://www.sciencedirect.com/science/article/pii/S2667193X23000807 |
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