High-Cost Medicines: Perceptions and Definitions Present in Brazilian Scientific and Academic Production on Health Litigation

OBJECTIVES: Drugs are one of Brazil's main drivers of health litigation. However, there is no uniform or precise definition of the term high-cost medicines (HCM) in the country's judicialization literature. The study intended to identify the existing definitions and understandings of HCM in Brazilian scientific and academic production related to health litigation.

METHODS: A scoping review was carried out following the JBI guidelines. We searched the databases Medline, Embase, Lilacs, Web of Science and, Scopus, and the Digital Library of Theses and Dissertations for empirical studies related to the judicialization of medicines that included HCM between 2005-2022. Selection and data extraction were carried out by pairs of independent reviewers, with disagreements resolved by a third reviewer. Results were analyzed according to thematic content categories

RESULTS: We included 62 scientific articles and 66 thesis and dissertations. Explicit definitions of HCM were very infrequent (19.1% of articles and 15.2% of academic studies). The cores of meaning most present were related to the high unit cost of the medicine or that had a high total treatment value due to the chronicity of the disease, producing a substantial financial impact on the family budget. Relationships with new technologies recently entered the market, many without registration in the country, medicines absent from Clinical Protocols and Therapeutic Guidelines or for off-label use, and those focusing on rare and genetic diseases were less frequent. Other aspects referred to drugs outside the official public lists of the SUS and medicines belonging to the Specialized Component of Pharmaceutical Care. Some specific classes were associated with high costs, such as biological, orphan, and antineoplastic medicines

CONCLUSIONS: Brazil does not adopt any financial parameter to define HCM. The concept prevents a clearer view of the importance of this group in the scenario of health litigation in Brazil.