New lung cancer treatments in Brazil, inequalities in patient access between the private and public health systems and differences in market access compared with the USA

Abstract Objective To assess the differences in market access in Brazil and the USA for lung cancer treatment other than chemotherapy, and to assess Brazilian patient access to these drugs comparing the public health care system and private setting. Method New lung cancer drugs other than chemotherapy, and approved since 2006, were assessed in the US Food and Drug Administration (FDA) online database. For approvals prior to 2006 we consulted cross-references. We assessed the corresponding Brazilian Health Surveillance Agency (ANVISA) approval dates and indications until 2018. In order to assess patient access, we consulted the online lists in the official organization responsible for the incorporation of new drugs in the Brazilian public health care system and private setting. Results The FDA approved 19 lung cancer drugs, 14 of which were registered in Brazil until 2018. The market access for new lung cancer drugs diverged between Brazil and USA in 23 months however, in the past years probably due to Brazilian changes in law for faster drug approval, it decreased to 12 months or less. The label indications were similar between the FDA and ANVISA in almost 80 % of cases. The ANVISA online database, unlike the FDA database, has scarce information about drug approvals. Around 80 % (11 in 14) of lung cancer drugs approved in Brazil were available in Brazilian private setting and 14 % (2 in 14) in the public health system, divergence might be explained by divergences in regulatory standards for health technology assessment. Conclusion Time to market access for lung cancer drugs varied between the FDA and ANVISA but its difference decreased in the past years. Patient access for cancer drugs can vary among patients attending in the same country and it depends on regulatory standards for health technology assessment.