Journal of multidisciplinary healthcare · 2026
Comparative Analysis of the Average Recommendation Time for the Incorporation of Biological Drugs for Cancer and Rheumatoid Arthritis.
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da Natividade Marcio Santos, Soares Lisboa Erick, Aragão Erika, de Castro Caroline Tianeze, Damasceno de Barros Rafael, Pereira Marcos, Silva Miranda Samilly, Souza Luís Eugênio, de Almeida-Filho Naomar
Аннотация
PURPOSE: To compare the average time between the registration of a biological drug and its recommendation for incorporation for rheumatoid arthritis (RA) and cancer (CA) at national and international levels.
METHODS: This retrospective, comparative study analyzed the time taken to incorporate biological drugs recommended by National Commission for the Incorporation of Technologies (CONITEC) in the Brazilian Unified Health System(SUS) for RA and CA from January 1, 2012, to March 28, 2024. The incorporation time in Brazil was compared to that of regulatory bodies in England and Australia for the same treatments. Kaplan-Meier curves and the Log rank test were used to estimate time differences between countries.
RESULTS: In Brazil, biological drugs for RA took an average of 2,019 days from the National Health Surveillance Agency (ANVISA) approval to CONITEC's incorporation recommendation. In England, the averages were 1,242 days for RA and 1,683 for CA, while in Australia, it was 744 days for RA and 1,315 for CA. Australia incorporated drugs faster than both England and Brazil.
CONCLUSION: The lengthy process in Brazil for incorporating biological technologies for RA and CA may hinder access, delaying treatment for many patients. This barrier is particularly significant for low-income individuals who rely exclusively on the SUS.
METHODS: This retrospective, comparative study analyzed the time taken to incorporate biological drugs recommended by National Commission for the Incorporation of Technologies (CONITEC) in the Brazilian Unified Health System(SUS) for RA and CA from January 1, 2012, to March 28, 2024. The incorporation time in Brazil was compared to that of regulatory bodies in England and Australia for the same treatments. Kaplan-Meier curves and the Log rank test were used to estimate time differences between countries.
RESULTS: In Brazil, biological drugs for RA took an average of 2,019 days from the National Health Surveillance Agency (ANVISA) approval to CONITEC's incorporation recommendation. In England, the averages were 1,242 days for RA and 1,683 for CA, while in Australia, it was 744 days for RA and 1,315 for CA. Australia incorporated drugs faster than both England and Brazil.
CONCLUSION: The lengthy process in Brazil for incorporating biological technologies for RA and CA may hinder access, delaying treatment for many patients. This barrier is particularly significant for low-income individuals who rely exclusively on the SUS.