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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 Figueiredo Zuppo (), Roberto Iunes (), Tomas Pippo (), Renata Curi Hauegen (), Carlos Vassalo (), Tracey-Lea Laba (), Steven Simoens (), Sergio Márquez (), Carolina Gomez (), Luka Voncina (), Gisbert 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 () and Augusto Afonso Guerra-Junior ()
Additional contact information
Carolina Zampirolli Dias: Federal University of Minas Gerais (UFMG)
Brian Godman: University of Strathclyde
Ludmila Peres Gargano: Federal University of Minas Gerais (UFMG)
Pâmela Santos Azevedo: Federal University of Minas Gerais (UFMG)
Marina Morgado Garcia: Federal University of Minas Gerais (UFMG)
Maurílio Souza Cazarim: Pharmacy School, Federal University of Juiz de Fora (UFJF)
Laís Lessa Neiva Pantuzza: Federal University of Minas Gerais (UFMG)
Nelio Gomes Ribeiro-Junior: SUS Collaborating Centre for Technology Assessment and Excellence in Health (CCATES)
André Luiz Pereira: Gerência de Planejamento, Monitoramento e Avaliação Assistenciais Fundação Hospitalar do Estado de Minas Gerais
Marcus Carvalho Borin: Federal University of Minas Gerais (UFMG)
Isabella Figueiredo Zuppo: Federal University of Minas Gerais (UFMG)
Roberto Iunes: The World Bank
Tomas Pippo: Pan American Health Organization (PAHO)
Renata Curi Hauegen: Oswaldo Cruz Foundation (Fiocruz)
Carlos Vassalo: Facultad de Ciencias Médicas, Universidad Nacional del Litoral
Tracey-Lea Laba: University of Technology Sydney
Steven Simoens: KU Leuven
Sergio Márquez: Economista, Administradora de los Recursos del Sistema General de Seguridad Social en Salud (ADRES)
Carolina Gomez: National University of Colombia
Luka Voncina: Faculty of Health Studies
Gisbert W. Selke: AOK Research Institute (WIdO)
Livio Garattini: IRCCS Institute for Pharmacological Research ‘Mario Negri’
Hye-Young Kwon: Strathclyde Institute of Pharmacy and Biomedical Sciences, Strathclyde University
Jolanta Gulbinovic: Vilnius University
Aneta Lipinska: Agency for Health Technology Assessment and Tariff System (AOTMiT)
Maciej Pomorski: Agency for Health Technology Assessment and Tariff System (AOTMiT)
Lindsay McClure: NHS National Services Scotland
Jurij Fürst: Health Insurance Institute
Rosana Gambogi: National Resources Fund
Carla Hernandez Ortiz: National Resources Fund
Vânia Cristina Canuto Santos: Ministry of Health
Denizar Vianna Araújo: Ministry of Health
Vânia Eloisa Araujo: Federal University of Minas Gerais (UFMG)
Francisco de Assis Acurcio: Federal University of Minas Gerais (UFMG)
Juliana Alvares-Teodoro: Federal University of Minas Gerais (UFMG)
Augusto Afonso Guerra-Junior: Federal University of Minas Gerais (UFMG)

PharmacoEconomics, 2020, vol. 38, issue 11, No 3, 1165-1185

Abstract: 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.

Date: 2020
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Citations: View citations in EconPapers (3)

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DOI: 10.1007/s40273-020-00943-1

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