Overview of managed entry agreements : an integrative review towards policy making in Brazil

Dias, Carolina Zampirolli and Ferrario, Alessandra and Godman, Brian and Gargano, Ludmila Peres and Azevedo, Pâmela Santos and Garcia, Marina Morgado and Cazarim, Maurílio de Souza and Lessa, Laís and Pereira, André Luiz and Curi Hauegen, Renata and Canuto dos Santos, Vânia Crisitna and Araújo, Denizar Vianna and de Araújo, Vânia Eloisa and Acurcio, Francisco de Assis and Alvares-Teodoro, Juliana and Guerra Júnior, Augusto Afonso (2020) Overview of managed entry agreements : an integrative review towards policy making in Brazil. In: HTAi Conference, 2020-06-22 - 2020-06-24, The China National Convention Centre. (In Press)

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Abstract

Resuminho (60 palavras): In order to provide legal and scientific embasement for policy making in Brazil, the aim of this study was to provide a panorama of Managed Entry Agreements around the world. A systematic review was conducted and the information about the agreements were summarized. It was included 25 studies, which described 446 agreements performed in 29 countries. Introduction (100 palavras): Managed Entry Agreements (MEA) are a reality in many countries. They are used as a tool to reduce the impact of uncertainty and the high cost of new drugs by providing access to new technologies under pre-established conditions. In Brazil, the Ministry of Health approved a high-cost technology under performance evaluation, being the first experience in the country. The aim of this study was to conduct a review to identify MEA performed worldwide to provide embasement to inform public health policy making in Brazil, as well as critical considerations surrounding the implementation of performance based agreements. Methods (75 palavras): A review of MEA for health technologies was conducted, using the question ‘What are the health technology managed entry agreements that have being performed around the world?’. The searches were conducted in april 2019, through PUBMED, EMBASE, LILACS and Cochrane Library databases, as well as manual search and gray literature. The selection of studies was performed by two independent reviewers and, in cases of disagreement, solved by a third reviewer. Results (75 palavras): A total of 25 studies were included, describing 446 agreements in 29 countries, being Australia (122), Italy (96), the United States (48) and Scotland (42) more frequent. Financial risk-sharing agreements were the most prevalent (43%). About 95% of the agreements involved medicines - more than half antineoplastic agents. The outcomes assessed and the impact of the agreements were not addressed in most studies, which may be due to the confidentiality character of them. Conclusions (100 palavras): We are likely to see a growth in MEA in the future with the continual launch of new high priced and complex treatments, coupled with increasing demands on available resources. They are an important tool to improve access to innovative and high cost medicines to achieve universal health coverage, although there are critical issues to consider. Besides the embedded confidentiality of most of the agreements, learning from already stablished knowledge, experiences and practices across countries can be a crucial strategy to guide Brazil’s initial experiences in this area.

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