High-cost medicine litigation in Brazil: A scoping review

Abstract Brazil has no established or universally adopted definition for high-cost medicines (HCM). The study mapped the profile and participation of HCM among those cited in the scientific and academic output on health litigation. A scoping review followed the methodology proposed by the Joanna Briggs Institute, searching Medline, Embase, LILACS, Web of Science, and Scopus databases, besides the Digital Library of Dissertations and Theses, for empirical studies produced between 2005 and 2022 regarding litigation for access to medicines that included HCM. Sixty-two articles and 66 theses and dissertations were included. Most date from 2014 to 2022 and were developed in the South and Southeastern regions, focusing on medicines, including HCM. These medicines were specifically approached by case studies. States were the main defendants, joined or not by other government bodies. Mention of values involved in HCM litigation was mostly absent from studies. The most cited HCM criteria were high cost to households and the public health system, followed by absence on the official SUS lists. Conceptual constraints and heterogeneity in how HCM were mentioned prevented a precise accrual of their percent participation in litigation in Brazil or regarding expenditures.