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Integrative Review of Managed Entry Agreements: Chances and Limitations

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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.

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Authors and Affiliations

  1. Graduate Program in Medicines and Pharmaceutical Services, Faculty of Pharmacy, Federal University of Minas Gerais (UFMG), Av. Pres. Antônio Carlos, 6627. Pampulha, Belo Horizonte, 31270-901, Minas Gerais, Brazil

    Carolina Zampirolli Dias, Ludmila Peres Gargano, Pâmela Santos Azevedo, Marina Morgado Garcia, Laís Lessa Neiva Pantuzza, Marcus Carvalho Borin, Isabella de Figueiredo Zuppo, Vânia Eloisa Araujo, Francisco de Assis Acurcio, Juliana Alvares-Teodoro & Augusto Afonso Guerra-Junior

  2. SUS Collaborating Centre for Technology Assessment and Excellence in Health (CCATES), Belo Horizonte, Minas Gerais, Brazil

    Carolina Zampirolli Dias, Ludmila Peres Gargano, Pâmela Santos Azevedo, Marina Morgado Garcia, Nelio Gomes Ribeiro-Junior, Marcus Carvalho Borin, Isabella de Figueiredo Zuppo, Francisco de Assis Acurcio, Juliana Alvares-Teodoro & Augusto Afonso Guerra-Junior

  3. Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, UK

    Brian Godman

  4. Health Economics Centre, University of Liverpool Management School, Liverpool, UK

    Brian Godman

  5. Division of Clinical Pharmacology, Karolinska Institute, Karolinska University Hospital Huddinge, Stockholm, Sweden

    Brian Godman

  6. School of Pharmacy, Sefako Makgatho Health Sciences University, Ga-Rankuwa, South Africa

    Brian Godman

  7. Department of Pharmaceutical Sciences, Pharmacy School, Federal University of Juiz de Fora (UFJF), Juiz de Fora, Minas Gerais, Brazil

    Maurílio Souza Cazarim

  8. Gerência de Planejamento, Monitoramento e Avaliação Assistenciais Fundação Hospitalar do Estado de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil

    André Luiz Pereira

  9. The World Bank, Washington, DC, USA

    Roberto Iunes

  10. Pan American Health Organization (PAHO), Brasília, Brazil

    Tomas Pippo

  11. National Institute of Science and Technology for Innovation on Diseases of Neglected Populations (INCT-IDPN), Center for Technological Development in Health (CDTS), Oswaldo Cruz Foundation (Fiocruz), Rio de Janeiro, Brazil

    Renata Curi Hauegen

  12. Facultad de Ciencias Médicas, Universidad Nacional del Litoral, Santa Fe, Argentina

    Carlos Vassalo

  13. Centre for Health Economics Research and Evaluation, University of Technology Sydney, Haymarket, Sydney, NSW, Australia

    Tracey-Lea Laba

  14. Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Louvain, Belgium

    Steven Simoens

  15. Economista, Administradora de los Recursos del Sistema General de Seguridad Social en Salud (ADRES), Bogotá, Colombia

    Sergio Márquez

  16. Think Tank “Medicines, Information and Power”, National University of Colombia, Bogotá, Colombia

    Carolina Gomez

  17. Faculty of Health Studies, Rijeka, Croatia

    Luka Voncina

  18. AOK Research Institute (WIdO), Berlin, Germany

    Gisbert W. Selke

  19. CESAV, Centre for Health Economics, IRCCS Institute for Pharmacological Research ‘Mario Negri’, Ranica, Bergamo, Italy

    Livio Garattini

  20. Division of Pharmacoepidemiology, Strathclyde Institute of Pharmacy and Biomedical Sciences, Strathclyde University, Glasgow, United Kingdom

    Hye-Young Kwon

  21. College of Pharmacy, Seoul National University, Seoul, South Korea

    Hye-Young Kwon

  22. Department of Pathology, Forensic Medicine and Pharmacology, Faculty of Medicine, Institute of Biomedical Sciences, Vilnius University, Vilnius, Lithuania

    Jolanta Gulbinovic

  23. Agency for Health Technology Assessment and Tariff System (AOTMiT), Warsaw, Poland

    Aneta Lipinska & Maciej Pomorski

  24. Procurement, Commissioning and Facilities, NHS National Services Scotland, Edinburgh, UK

    Lindsay McClure

  25. Health Insurance Institute, Ljubljana, Slovenia

    Jurij Fürst

  26. National Resources Fund, Montevideo, Uruguay

    Rosana Gambogi & Carla Hernandez Ortiz

  27. Secretariat of Science, Technology and Strategic Inputs, Ministry of Health, Brasília, Brazil

    Vânia Cristina Canuto Santos & Denizar Vianna Araújo

  28. Pontifical Catholic University of Minas Gerais, Belo Horizonte, Minas Gerais, Brazil

    Vânia Eloisa Araujo

Authors
  1. Carolina Zampirolli Dias
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  2. Brian Godman
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  3. Ludmila Peres Gargano
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  4. Pâmela Santos Azevedo
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  5. Marina Morgado Garcia
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  6. Maurílio Souza Cazarim
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  7. Laís Lessa Neiva Pantuzza
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  8. Nelio Gomes Ribeiro-Junior
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  9. André Luiz Pereira
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  10. Marcus Carvalho Borin
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  11. Isabella de Figueiredo Zuppo
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  12. Roberto Iunes
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  13. Tomas Pippo
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  14. Renata Curi Hauegen
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  15. Carlos Vassalo
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  16. Tracey-Lea Laba
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  17. Steven Simoens
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  18. Sergio Márquez
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  19. Carolina Gomez
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  20. Luka Voncina
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  21. Gisbert W. Selke
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  22. Livio Garattini
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  24. Jolanta Gulbinovic
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  25. Aneta Lipinska
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  26. Maciej Pomorski
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  27. Lindsay McClure
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  28. Jurij Fürst
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  29. Rosana Gambogi
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  30. Carla Hernandez Ortiz
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  31. Vânia Cristina Canuto Santos
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  32. Denizar Vianna Araújo
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  33. Vânia Eloisa Araujo
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  34. Francisco de Assis Acurcio
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  35. Juliana Alvares-Teodoro
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  36. Augusto Afonso Guerra-Junior
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Contributions

CZD, BG, LPG, PSA, MMG, MSC, LLNP, ALP, FAA, JA-T and AAG-J participated in the conception of the paper, design of the search strategy, data and information collection including the systematic review, writing of the first and subsequent drafts, as well as endorsing the content of the submitted paper. RI, TP, RCH, CV, TLL, SS, S.M, CG, LV, GWS, LG, HYK, JG, AL, MP, LM, JF, RG, CHO, DVA and VC work for health authorities and/or are advisers to them as well as engaged in implementing/reviewing managed entry agreements in their countries. They all contributed to the writing and design of the section “Key considerations for MEAs from a payer’s perspective” and commented on successive drafts. They also endorsed the final submission. In addition, RCH, DVA and VC also participated in the conception of the paper. VEA, NGR-J, IFZ and MCB contributed to the design and conduct of the search strategy, successive drafts and the final review of the paper. All the authors endorsed the final version of the paper.

Corresponding author

Correspondence to Augusto Afonso Guerra-Junior.

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Conflicts of interest/competing interests

Carolina Zampirolli Dias, Brian Godman, Ludmila Peres Gargano, Pâmela Santos Azevedo, Marina Morgado Garcia, Maurílio de 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 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 Canuto, Denizar Vianna Araújo, Vânia Eloisa Araujo, Francisco de Assis Acurcio, Juliana Alvares-Teodoro and Augusto Afonso Guerra Junior have no conflicts of interest that are directly relevant to the content of this article. However, most of the co-authors are employed by health authorities or are advisers to health authorities.

Funding

No funding was received to conduct the research or write this paper.

Informed consent

There was no need for informed consent or ethical approval as the senior-level personnel providing advice and contextualising the findings from the literature review were the co-authors.

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Zampirolli Dias, C., Godman, B., Gargano, L.P. et al. Integrative Review of Managed Entry Agreements: Chances and Limitations. PharmacoEconomics 38, 1165–1185 (2020). https://doi.org/10.1007/s40273-020-00943-1

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  • DOI: https://doi.org/10.1007/s40273-020-00943-1

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