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Integrative Review of Managed Entry Agreements: Chances and Limitations

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Listed:
  • Carolina Zampirolli Dias

    (Federal University of Minas Gerais (UFMG)
    SUS Collaborating Centre for Technology Assessment and Excellence in Health (CCATES))

  • Brian Godman

    (University of Strathclyde
    University of Liverpool Management School
    Karolinska University Hospital Huddinge
    Sefako Makgatho Health Sciences University)

  • Ludmila Peres Gargano

    (Federal University of Minas Gerais (UFMG)
    SUS Collaborating Centre for Technology Assessment and Excellence in Health (CCATES))

  • Pâmela Santos Azevedo

    (Federal University of Minas Gerais (UFMG)
    SUS Collaborating Centre for Technology Assessment and Excellence in Health (CCATES))

  • Marina Morgado Garcia

    (Federal University of Minas Gerais (UFMG)
    SUS Collaborating Centre for Technology Assessment and Excellence in Health (CCATES))

  • 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)
    SUS Collaborating Centre for Technology Assessment and Excellence in Health (CCATES))

  • Isabella Figueiredo Zuppo

    (Federal University of Minas Gerais (UFMG)
    SUS Collaborating Centre for Technology Assessment and Excellence in Health (CCATES))

  • 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
    Seoul National 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)
    Pontifical Catholic University of Minas Gerais)

  • Francisco de Assis Acurcio

    (Federal University of Minas Gerais (UFMG)
    SUS Collaborating Centre for Technology Assessment and Excellence in Health (CCATES))

  • Juliana Alvares-Teodoro

    (Federal University of Minas Gerais (UFMG)
    SUS Collaborating Centre for Technology Assessment and Excellence in Health (CCATES))

  • Augusto Afonso Guerra-Junior

    (Federal University of Minas Gerais (UFMG)
    SUS Collaborating Centre for Technology Assessment and Excellence in Health (CCATES))

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.

Suggested Citation

  • 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 & Andr, 2020. "Integrative Review of Managed Entry Agreements: Chances and Limitations," PharmacoEconomics, Springer, vol. 38(11), pages 1165-1185, November.
  • Handle: RePEc:spr:pharme:v:38:y:2020:i:11:d:10.1007_s40273-020-00943-1
    DOI: 10.1007/s40273-020-00943-1
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    References listed on IDEAS

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