RESUMO A regulação de preços visa garantir sustentabilidade à assistência farmacêutica. Com o objetivo de discutir criticamente o tema, elaborou-se um ensaio sustentado em análise documental (2000-2017) da regulação econômica da indústria farmacêutica brasileira na Câmara de Regulação de Medicamentos (CMED), periódicos, teses e publicações do Legislativo e indústria farmacêutica. Vigorando há 15 anos, a Lei nº 10.742/2003 instituiu um modelo de teto de preços, compreendendo estabelecimento de preços máximos para medicamentos e reajustes anuais por fórmula definida em lei. Modelo, implementação e fórmula são alvos de crítica. A fórmula vincula reajustes ao Índice Nacional de Preços ao Consumidor Amplo - IPCA (inflação), agregando índices de custos de produção, concorrência e produtividade setoriais. A longevidade do modelo, sem realinhamento periódico dos tetos aos preços de mercado recomendado na literatura especializada, tem gerado preços máximos descolados da realidade, que aumentam a assimetria de informação e podem respaldar futuros aumentos abusivos. A priorização da eficiência do mercado em detrimento do combate à assimetria de informações no modelo regulatório tem reduzido a força dos consumidores no debate. O atual modelo avançou em relação às políticas de preços liberados, mas seu aperfeiçoamento pressupõe a apropriação do tema e crescente participação de consumidores e profissionais de saúde no processo regulatório.

Background: From 2006 to 2017, the Brazilian federal government provided free of charge traditional insulins for diabetes treatment. This involved public tendering by the Department of Health Logistics of the Ministry of Health (DLOG-MOH) and the reimbursement after direct contracting for supply with commercial private retailers (Brazilian Popular Pharmacy Program - PFPB). Objective: We aim to describe the budget of the Brazilian federal government committed to for the acquisition of insulin, as well as corresponding prices and treatment availability from 2009 to 2017. Methods: Insulin volume and expenditure data were obtained in official administrative databases and in the Electronic System of the Information Service to Citizens. Data were analyzed according to the total provision by the federal government, DLOG-MOH and PFPB. Moreover, data were presented according to insulin type. Volumes were calculated in number of defined daily doses (DDD)/1,000 inhabitants/day. Results: Budgetary commitments due to insulin over nine years amounted to U$1,027 billion in 2017, with an approximate average of U$114.1 million per year. DLOG-MOH was the main insulin provider, despite the increase in PFPB provision along period. DLOG-MOH and PFBP together provided an average of 6.08 DDD/1000 inhabitants/day for nine years. Average prices in PFPB were higher than those in the DLOG series, with a downward trend over the years, narrowing to 2.7 times in 2017, when compared to 2009. Conclusions: Brazil evidenced a moderately sustainable and effective, albeit imperfect, policy for public provision of traditional insulins in the period preceding mandatory free supply of insulin analogues. Future studies must address treatment availability and financial sustainability in the new scenario.

Introduction Pharmaceutical pricing has only recently gained space in mainstream health science literature. Objectives Bibliometric and content description of health science academic literature and ad hoc analysis of grey literature on factors influencing pharmaceutical pricing on databases commonly accessed by healthcare professionals. Methods Scoping study with no time limits performed in Medline, Scopus and Scielo, and relevant sites and databases for grey literature, using search terms with database-appropriate keywords . Results Two hundred four articles were published in 103 peer-reviewed journals between 1981 and 2016 (last search year). In grey literature 78 documents were retrieved in the final selection. Five key thematic clusters for analysing pharmaceutical pricing emerged: market dynamics, segmented into (i) supply-related, (ii) consumer-related and (iii) product-related; (iv) trading strategies, either buyer’s or seller’s and (v) regulatory approach. In peer-reviewed literature there is an overall dominance of themes referring to trading strategies and regulatory approaches and a wide thematic cluster scope. Over half of this literature was produced after the year 2010. International agency technical papers make up the most significant contributions of grey literature, with a clear focus on regulatory approaches to pricing and wider consideration of emerging countries. Research lags in the literature on factors affecting pharmaceutical pricing include impacts of financing schemes, market liberalization, internet trading and biosimilars on prices, with insufficient discussion identified for the effects of discounts/rebates, profits and price transparency. Conclusions Interest in pharmaceutical pricing literature is increasing. Robust evidence-producing study designs for pricing interventions will be a welcome development. Electronic supplementary material The online version of this article (10.1186/s40545-019-0183-0) contains supplementary material, which is available to authorized users.

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A Brazilian cost-utility analysis of trabecular micro-bypass with iStent inject® for the treatment of open-angle glaucoma Análise de custo-utilidade do implante trabecular iStent inject® para o tratamento do glaucoma de ângulo aberto no Brasil