Dados do Trabalho

Título

NEW ANTICANCER DRUGS FOR SOLID TUMORS IN THE LAST 10 YEARS: DIFFERENCES IN APPROVAL AND ACCESS BETWEEN THE UNITED STATES AND BRAZIL IN THE PUBLIC AND PRIVATE SECTORS.

Introdução

Advances in cancer treatment happen, in part, due to the creation of new anticancer drugs (ACD). In recent years, ACDs with new mechanisms of action were developed through the discovery of new targets or new ways to block them, however access to these drugs is uneven across different countries and between different health insurances.

Objetivo

To compare the new ACDs for solid tumors approved in the last 10 years by the United States Food and Drug Administration (FDA), Agência Nacional de Vigilância Sanitária (ANVISA), Agência Nacional de Saúde (ANS) and Comissão Nacional de Incorporação de Tecnologias no Sistema Único de Saúde (SUS) (CONITEC).

Método

Data were collected on the FDA, ANVISA, ANS and CONITEC online databases regarding new ACDs for solid tumors approved between January 2011 and May 2021 (date of submission and approval, mechanism of action and indication). Normal distribution was tested by the Shapiro-Wilk test, comparisons were made with the Mann-Whitney test and the data are reported using median and interquartile range (med, IQR).

Resultado

74 new ACDs for solid tumors were approved by the FDA from Jan/2011 to May/2021 and 19 (25.6%) were designated as first in class. Checkpoint inhibitors (n=9), anti-HER2 (n=6), anti-EGFR, anti-ALK and antiandrogens (n=5 each) were the most approved. ANVISA approved 43/74 (58.1%). ANS approved 14 oral ACDs out of 29 available by ANVISA (48.2%). CONITEC approved only 4 (abiraterone, pertuzumab, nivolumab and pembrolizumab). Time to approval after submission at the FDA was 198 days (med, IQR 156-276) and at ANVISA 357 days (med, IQR 253-554) (p<0.00001). Dividing into two periods, ANVISA approved new ACDs submitted from 2011 to 2015 after 473 days (med, IQR 356-892) of analysis and from 2016 to 2021 this time was of 291 days (med, IQR 208-355) (p0.001). The median difference in days between the submission dates for FDA and ANVISA to review was 289 days (IQR 131-618). ANVISA made the same approvals 556 days (med, IQR 360-962) later than FDA. Oral medications were approved by the ANS 769 days (med, IQR 699-956) after approval by ANVISA.

Conclusão

New ACDs for solid tumors are submitted at the brazilian agency considerably later than at the FDA and take longer to be reviewed, which causes a significant difference in available medications between the two countries. ANVISA has approved ACDs faster in the last 5 years, but the delay in acceptance by both the brazilian private and publich health systems create even more inequity in access.

Palavras-chave

Anticancer drug, ANVISA, Government agencies

Área

Oncologia - Políticas Públicas, Acesso, Farmacoeconomia e Gestão em Saúde