Integrative Review of Managed Entry Agreements: Chances and Limitations

Carolina Zampirolli Dias, Brian Godman, Ludmila Peres Gargano, Pâmela Santos Azevedo, Marina Morgado Garcia, Maurílio Souza Cazarim, Laís Lessa Neiva Pantuzza, Nelio Gomes Ribeiro-Junior, André Luiz Pereira, Marcus Carvalho Borin, Isabella de Figueiredo Zuppo, Roberto Iunes, Tomas Pippo, Renata Curi Hauegen, Carlos Vassalo, Tracey Lea Laba, Steven Simoens, Sergio Márquez, Carolina Gomez, Luka VoncinaGisbert W. Selke, Livio Garattini, Hye Young Kwon, Jolanta Gulbinovic, Aneta Lipinska, Maciej Pomorski, Lindsay McClure, Jurij Fürst, Rosana Gambogi, Carla Hernandez Ortiz, Vânia Cristina Canuto Santos, Denizar Vianna Araújo, Vânia Eloisa Araujo, Francisco de Assis Acurcio, Juliana Alvares-Teodoro, Augusto Afonso Guerra-Junior*

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

31 Citations (Scopus)


Background and Objective: Managed entry agreements (MEAs) consist of a set of instruments to reduce the uncertainty and the budget impact of new high-priced medicines; however, there are concerns. There is a need to critically appraise MEAs with their planned introduction in Brazil. Accordingly, the objective of this article is to identify and appraise key attributes and concerns with MEAs among payers and their advisers, with the findings providing critical considerations for Brazil and other high- and middle-income countries. Methods: An integrative review approach was adopted. This involved a review of MEAs across countries. The review question was ‘What are the health technology MEAs that have been applied around the world?’ This review was supplemented with studies not retrieved in the search known to the senior-level co-authors including key South American markets. It also involved senior-level decision makers and advisers providing guidance on the potential advantages and disadvantages of MEAs and ways forward. Results: Twenty-five studies were included in the review. Most MEAs included medicines (96.8%), focused on financial arrangements (43%) and included mostly antineoplastic medicines. Most countries kept key information confidential including discounts or had not published such data. Few details were found in the literature regarding South America. Our findings and inputs resulted in both advantages including reimbursement and disadvantages including concerns with data collection for outcome-based schemes. Conclusions: We are likely to see a growth in MEAs with the continual launch of new high-priced and often complex treatments, coupled with increasing demands on resources. Whilst outcome-based MEAs could be an important tool to improve access to new innovative medicines, there are critical issues to address. Comparing knowledge, experiences, and practices across countries is crucial to guide high- and middle-income countries when designing their future MEAs.

Original languageEnglish
Pages (from-to)1165-1185
Number of pages21
Issue number11
Publication statusPublished - 1 Nov 2020


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