DIRECT ORAL ANTICOAGULANTS IN BRAZIL: PRICE TRENDS, MARKET COMPETITION, AND POLICY IMPLICATIONS
Author(s)
Henrique Diegoli, MSc, MD1, Julia Simoes Correa Galendi, PhD, MD2, GIACOMO BALBINOTTO, PhD3, FÁBIO GAZELATO DE MELLO FRANCO, MBA, PhD4, Luiz Henrique Picolo Furlan, MD5, Wilson Follador, MSc, PharmD, PhD6, ELIO TANAKA, MD7, João Grazziotin, BSc(c)1, Letícia Wernke dos Santos, BSN1, Ana B. Zen, BSc1.
1HEOR Valor, Joinville, Brazil, 2Botucatu Medical School, University of the State of São Paulo (UNESP), São Paulo, Brazil, 3UFRGS/IATS, Porto Alegre, Brazil, 4Unimed Uberlandia, São Paulo, Brazil, 5Unimed do Paraná, Brazil, Curitiba, Brazil, 6Sano-Efiko, São Paulo, Brazil, 7TNK Medical Audit Institution, Curitiba, Brazil.
1HEOR Valor, Joinville, Brazil, 2Botucatu Medical School, University of the State of São Paulo (UNESP), São Paulo, Brazil, 3UFRGS/IATS, Porto Alegre, Brazil, 4Unimed Uberlandia, São Paulo, Brazil, 5Unimed do Paraná, Brazil, Curitiba, Brazil, 6Sano-Efiko, São Paulo, Brazil, 7TNK Medical Audit Institution, Curitiba, Brazil.
OBJECTIVES: In Brazil, warfarin is the only oral anticoagulant covered by the Unified Health System (SUS), despite limitations related to effectiveness and safety, and the need for frequent clinical monitoring, dietary restrictions, and drug-drug interactions. Between 2016 and 2020, proposals to incorporate direct oral anticoagulants (DOACs) for patients with atrial fibrillation into the SUS were rejected. We aimed to investigate price trends of DOACs in Brazil, patent expiration and the number of laboratories with active registrations.
METHODS: Weighted average prices based on SUS procurement data in the Health Prices Panel were analyzed from January 2020 to December 2025. Monthly treatment costs per patient were then estimated according to product labels dosing regimens. Data from the Brazilian Drug Market Regulation Chamber (CMED) were used to identify the number of laboratories holding registrations for each medication, and those with commercialization in 2024 (latest available data). Information on patent expiration was obtained from the Brazilian National Institute of Industrial Property (INPI).
RESULTS: There are currently 27 laboratories registered for rivaroxaban (18 active), 16 for apixaban (7 active), 2 for dabigatran (1 active), 1 for edoxaban (1 active), and 3 for warfarin (2 active). Product patents for rivaroxaban and dabigatran expired in 2020 and 2021. The monthly cost for rivaroxaban decreased from BRL 193.67 in 2020 to BRL 5.95 in 2021; for apixaban, from BRL 212.55 to BRL 32.33, for dabigatran it increased from BRL 222.36 to BRL 277.65 and for warfarin it increased from BRL 7.27 to BRL 7.76. No procurements of edoxaban were identified in 2020; in 2025, the cost was BRL 146.82.
CONCLUSIONS: The coverage of DOACs within SUS was largely rejected due to high prices at the time of health technology assessments. However, increased market competition led to substantial price reductions, highlighting the need for reassessment of these technologies.
METHODS: Weighted average prices based on SUS procurement data in the Health Prices Panel were analyzed from January 2020 to December 2025. Monthly treatment costs per patient were then estimated according to product labels dosing regimens. Data from the Brazilian Drug Market Regulation Chamber (CMED) were used to identify the number of laboratories holding registrations for each medication, and those with commercialization in 2024 (latest available data). Information on patent expiration was obtained from the Brazilian National Institute of Industrial Property (INPI).
RESULTS: There are currently 27 laboratories registered for rivaroxaban (18 active), 16 for apixaban (7 active), 2 for dabigatran (1 active), 1 for edoxaban (1 active), and 3 for warfarin (2 active). Product patents for rivaroxaban and dabigatran expired in 2020 and 2021. The monthly cost for rivaroxaban decreased from BRL 193.67 in 2020 to BRL 5.95 in 2021; for apixaban, from BRL 212.55 to BRL 32.33, for dabigatran it increased from BRL 222.36 to BRL 277.65 and for warfarin it increased from BRL 7.27 to BRL 7.76. No procurements of edoxaban were identified in 2020; in 2025, the cost was BRL 146.82.
CONCLUSIONS: The coverage of DOACs within SUS was largely rejected due to high prices at the time of health technology assessments. However, increased market competition led to substantial price reductions, highlighting the need for reassessment of these technologies.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
HPR72
Topic
Health Policy & Regulatory
Topic Subcategory
Insurance Systems & National Health Care, Pricing Policy & Schemes, Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Cardiovascular Disorders (including MI, Stroke, Circulatory), SDC: Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)