Integrative review of managed entry agreements : chances and limitations

Dias, Carolina Zampirolli and Godman, Brian and Gargano, Ludmila Peres and Azevedo, Pâmela Santos and Garcia, Marina Morgado and Cazarim, Maurílio de Souza and Pantuzza, Laís Lessa Neiva and Ribeiro Junior, Nelio Gomes and Pereira, André Luiz and Borin, Marcus Carvalho and Zuppo, Isabella de Figueiredo and Iunes, Roberto and Pippo, Tomas and Curi Hauegen, Renata and Vassalo, Carlos and Laba, Tracey-Lea and Simoens, Steven and Márquez, Sergio and Gomez, Carolina and Voncina, Luka and Selke, Gisbert W. and Garattini, Livio and Kwon, Hye-Young and Gulbinovic, Jolanta and Lipinska, Aneta and Pomorski, Maciej and McClure, Lindsay and Fürst, Jurij and Gambogi, Rosana and Oritz, Carla Hernandez and Canuto, Vânia and Araújo, Denizar Vianna and Araujo, Vânia Eloisa and Acurcio, Francisco de Assis and Alvares-Teodoro, Juliana and Guerra Júnior, Augusto Afonso (2020) Integrative review of managed entry agreements : chances and limitations. PharmacoEconomics, 38 (11). pp. 1165-1185. ISSN 1779-2027 (

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Introduction: 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 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. Afterall, involved senior level decision makers and advisers providing guidance on potential advantages and disadvantages of MEAs and ways forward. Results: 25 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. Conclusion: 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.