Regulação de preços das terapias antineoplásicas no Brasil: uma investigação exploratória ao longo de uma década.

Abstract

Introduction: Cancer is the second leading cause of death in Brazil, surpassed only by cardiovascular diseases. Factors related to lack of access to treatment may contribute to this scenario, with the high cost of antineoplastic drugs being a potential factor, making price regulation crucial to ensure patient access and the sustainability of the healthcare system. In this context, Brazil's Chamber of Regulation of the Medicines Market (CMED) plays a vital role in defining the prices of these therapies, especially new molecules. Six categories are considered for classifying new drugs, with products predominantly applied for and approved in categories 1 and 2. Objectives: This study aims to comprehensively analyze maximum price reports for new antineoplastic therapies with registered prices in Brazil to examine and understand the evolution of pricing strategies over a decade. Methods: This is a documentary study. All new drugs introduced into the national market between February 2013 and February 2023 were selected, considering therapeutic classes corresponding to antineoplastics. Information was collected from technical opinions obtained through the Access to Information Law. The analysis covered price categorization, referenced countries, and maximum prices indicated in the dossiers. Additionally, the relationship between the cost of the drug in purchasing power parity (PPP) dollars and the GDP per capita in PPP dollars in referenced countries was examined. Results: We analyzed opinions on 64 drugs for which the price information document was submitted. The most requested category was Category 1, representing 41 (64.0%) of the products, with only 24 (58.5%) drugs being approved. In Category 2, 22 (34.4%) drugs were requested, with CMED approval in the same category in 95.5% of cases. Regarding the cost of drug packaging compared to other referenced countries, the median prices of the analyzed drugs reveal that, in Brazil, the price accounts for 47.2% of the GDP per capita. Comparatively, this value is significantly higher than in high-income countries such as Australia (6.8%), France (9.8%), and the United States (13.2%). Conclusion: The discrepancy between what was requested and approved in the category highlights the importance of establishing more precise criteria in drug pricing legislation. Additionally, drug prices in Brazil compromise a significant portion of the GDP compared to high-income countries, emphasizing the need for adjustments in CMED legislation to balance innovation and economic reality, considering other countries with similar socioeconomic profiles in the external referencing basket. Continual dialogue with society and the industry is essential to ensure that future legislative changes meet diverse needs, facilitating innovative therapies' efficient and affordable introduction into Brazilian healthcare.