Integrative Review of Managed Entry Agreements: Chances and Limitations
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REVIEW ARTICLE
Integrative Review of Managed Entry Agreements: Chances and Limitations Carolina Zampirolli Dias1,2 · Brian Godman3,4,5,6 · Ludmila Peres Gargano1,2 · Pâmela Santos Azevedo1,2 · Marina Morgado Garcia1,2 · Maurílio Souza Cazarim7 · Laís Lessa Neiva Pantuzza1 · Nelio Gomes Ribeiro‑Junior2 · André Luiz Pereira8 · Marcus Carvalho Borin1,2 · Isabella de Figueiredo Zuppo1,2 · Roberto Iunes9 · Tomas Pippo10 · Renata Curi Hauegen11 · Carlos Vassalo12 · Tracey‑Lea Laba13 · Steven Simoens14 · Sergio Márquez15 · Carolina Gomez16 · Luka Voncina17 · Gisbert W. Selke18 · Livio Garattini19 · Hye‑Young Kwon20,21 · Jolanta Gulbinovic22 · Aneta Lipinska23 · Maciej Pomorski23 · Lindsay McClure24 · Jurij Fürst25 · Rosana Gambogi26 · Carla Hernandez Ortiz26 · Vânia Cristina Canuto Santos27 · Denizar Vianna Araújo27 · Vânia Eloisa Araujo1,28 · Francisco de Assis Acurcio1,2 · Juliana Alvares‑Teodoro1,2 · Augusto Afonso Guerra‑Junior1,2
© Springer Nature Switzerland AG 2020
Abstract 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.
1 Introduction Electron
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