Comparative assessment of recommendations for the incorporation of biologic drugs for rheumatoid arthritis and cancer in brazil, england, and australia
1
Federal University of Bahia, Salvador, Brazil
Popul. Med. 2026;8(Supplement Supplement 1):A3823
ABSTRACT
BACKGROUND:
Health Technology Assessment (HTA) is essential for monitoring the incorporation of medicines into publicly funded health systems. Delays between regulatory approval and incorporation decisions may restrict access to effective therapies, particularly for high-burden conditions such as rheumatoid arthritis and cancer. Monitoring incorporation timelines is therefore critical for evaluating health system performance, equity, and decision-making efficiency. This study compares incorporation timelines for biological medicines within Brazil’s Unified Health System (SUS) and reference systems in England and Australia.
METHODS:
A retrospective and comparative evaluation was conducted of biological medicines recommended for incorporation by the Brazilian National Commission for the Incorporation of Technologies in the Unified Health System (Comissão Nacional de Incorporação de Tecnologias no SUS – CONITEC) between January, 2012, and March, 2024. Time intervals between regulatory approval and recommendation for incorporation were calculated using official data from the Brazilian National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária – ANVISA), regulatory agencies in England, and the Therapeutic Goods Administration in Australia. These data were combined with HTA decisions from CONITEC, the National Institute for Health and Care Excellence, and the Pharmaceutical Benefits Advisory Committee. Kaplan–Meier survival analysis and log-rank tests were applied.
RESULTS:
Thirty-two incorporation processes involving 26 biological medicines were analyzed. Brazil showed the longest incorporation timelines, with mean delays of 2,019 days for rheumatoid arthritis and 3,898 days for cancer. England presented intermediate timelines (1242 and 1683 days), while Australia demonstrated the shortest incorporation periods (744 and 1315 days). Oncology medicines required longer incorporation times across all systems, with the largest disparities observed in Brazil.
CONCLUSIONS:
The findings reveal significant differences in HTA-related decision timelines and identify prolonged delays in Brazil’s SUS as a critical performance gap. Strengthening systematic monitoring and evaluation of HTA processes is essential to improve efficiency and equity in access to biological medicines.
Health Technology Assessment (HTA) is essential for monitoring the incorporation of medicines into publicly funded health systems. Delays between regulatory approval and incorporation decisions may restrict access to effective therapies, particularly for high-burden conditions such as rheumatoid arthritis and cancer. Monitoring incorporation timelines is therefore critical for evaluating health system performance, equity, and decision-making efficiency. This study compares incorporation timelines for biological medicines within Brazil’s Unified Health System (SUS) and reference systems in England and Australia.
METHODS:
A retrospective and comparative evaluation was conducted of biological medicines recommended for incorporation by the Brazilian National Commission for the Incorporation of Technologies in the Unified Health System (Comissão Nacional de Incorporação de Tecnologias no SUS – CONITEC) between January, 2012, and March, 2024. Time intervals between regulatory approval and recommendation for incorporation were calculated using official data from the Brazilian National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária – ANVISA), regulatory agencies in England, and the Therapeutic Goods Administration in Australia. These data were combined with HTA decisions from CONITEC, the National Institute for Health and Care Excellence, and the Pharmaceutical Benefits Advisory Committee. Kaplan–Meier survival analysis and log-rank tests were applied.
RESULTS:
Thirty-two incorporation processes involving 26 biological medicines were analyzed. Brazil showed the longest incorporation timelines, with mean delays of 2,019 days for rheumatoid arthritis and 3,898 days for cancer. England presented intermediate timelines (1242 and 1683 days), while Australia demonstrated the shortest incorporation periods (744 and 1315 days). Oncology medicines required longer incorporation times across all systems, with the largest disparities observed in Brazil.
CONCLUSIONS:
The findings reveal significant differences in HTA-related decision timelines and identify prolonged delays in Brazil’s SUS as a critical performance gap. Strengthening systematic monitoring and evaluation of HTA processes is essential to improve efficiency and equity in access to biological medicines.
| eISSN: | 2654-1459 |
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