High-cost medicine litigation in Brazil: A scoping reviewBrazil 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.
Keywords:
Medicines; Health litigation; Costs; Pharmaceutical Services; Scoping review
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Source: Prepared by the authors, 2023.Notes: * Others = Products originating from search in bibliographic databases, some of which also capture dissertations and theses; the 19 products were not included in the BDTD and ARCA FIOCRUZ search results.** The migration format of the search results for academic products in the BDTD and ARCA FIOCRUZ did not allow the identification of duplications via the reference manager; this verification was conducted using the research database generated in Google Forms, with all products examined in the selection from full texts.*** Academic product with results in article format but not found in the full text made available in the D&Ts database (and also not found in the search for bibliographic references).
Note: The medicines in the academic article/product could meet more than one operational definition criterion.Captions: CEAF - Specialized Pharmaceutical Care Component; CMDE - Exceptionally Dispensed Drug Component; SUS - Unified Health System.Source: Prepared by the authors.