Integrative Review of Managed Entry Agreements: Chances and Limitations.


Journal

PharmacoEconomics
ISSN: 1179-2027
Titre abrégé: Pharmacoeconomics
Pays: New Zealand
ID NLM: 9212404

Informations de publication

Date de publication:
11 2020
Historique:
pubmed: 1 8 2020
medline: 14 9 2021
entrez: 1 8 2020
Statut: ppublish

Résumé

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. 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. 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. 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.

Sections du résumé

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.

Identifiants

pubmed: 32734573
doi: 10.1007/s40273-020-00943-1
pii: 10.1007/s40273-020-00943-1
doi:

Types de publication

Journal Article Research Support, Non-U.S. Gov't Review

Langues

eng

Pagination

1165-1185

Subventions

Organisme : World Health Organization
ID : 001
Pays : International

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Auteurs

Carolina Zampirolli Dias (C)

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

Brian Godman (B)

Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, UK.
Health Economics Centre, University of Liverpool Management School, Liverpool, UK.
Division of Clinical Pharmacology, Karolinska Institute, Karolinska University Hospital Huddinge, Stockholm, Sweden.
School of Pharmacy, Sefako Makgatho Health Sciences University, Ga-Rankuwa, South Africa.

Ludmila Peres Gargano (LP)

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

Pâmela Santos Azevedo (PS)

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

Marina Morgado Garcia (MM)

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

Maurílio Souza Cazarim (M)

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

Laís Lessa Neiva Pantuzza (LLN)

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.

Nelio Gomes Ribeiro-Junior (NG)

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

André Luiz Pereira (AL)

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

Marcus Carvalho Borin (MC)

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

Isabella de Figueiredo Zuppo (I)

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

Roberto Iunes (R)

The World Bank, Washington, DC, USA.

Tomas Pippo (T)

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

Renata Curi Hauegen (RC)

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.

Carlos Vassalo (C)

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

Tracey-Lea Laba (TL)

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

Steven Simoens (S)

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

Sergio Márquez (S)

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

Carolina Gomez (C)

Think Tank "Medicines, Information and Power", National University of Colombia, Bogotá, Colombia.

Luka Voncina (L)

Faculty of Health Studies, Rijeka, Croatia.

Gisbert W Selke (GW)

AOK Research Institute (WIdO), Berlin, Germany.

Livio Garattini (L)

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

Hye-Young Kwon (HY)

Division of Pharmacoepidemiology, Strathclyde Institute of Pharmacy and Biomedical Sciences, Strathclyde University, Glasgow, United Kingdom.
College of Pharmacy, Seoul National University, Seoul, South Korea.

Jolanta Gulbinovic (J)

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

Aneta Lipinska (A)

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

Maciej Pomorski (M)

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

Lindsay McClure (L)

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

Jurij Fürst (J)

Health Insurance Institute, Ljubljana, Slovenia.

Rosana Gambogi (R)

National Resources Fund, Montevideo, Uruguay.

Carla Hernandez Ortiz (CH)

National Resources Fund, Montevideo, Uruguay.

Vânia Cristina Canuto Santos (VC)

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

Denizar Vianna Araújo (DV)

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

Vânia Eloisa Araujo (VE)

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

Francisco de Assis Acurcio (FA)

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

Juliana Alvares-Teodoro (J)

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

Augusto Afonso Guerra-Junior (AA)

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

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