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https://www.arca.fiocruz.br/handle/icict/59334
INTEGRATIVE REVIEW OF MANAGED ENTRY AGREEMENTS: CHANCES AND LIMITATIONS
Risk-sharing arrangements
Cancer drugs
End-points
Health
Medicines
Reimbursement
Performance
Technology
Outcomes
Author
Dias, Carolina Zampirolli
Godman, Brian
Gargano, Ludmila Peres
Azevedo, Pâmela Santos
Garcia, Marina Morgado
Souza Cazarim, Maurílio
Pantuzza, Laís Lessa Neiva
Ribeiro-Junior, Nelio Gomes
Pereira, André Luiz
Borin, Marcus Carvalho
Zuppo, Isabella de Figueiredo
Iunes, Roberto
Pippo, Tomas
Hauegen, Renata Curi
Vassalo, Carlos
Laba, Tracey Lea
Simoens, Steven
Márquez, Sergio
Gomez, Carolina
Voncina, Luka
Selke, Gisbert W.
Garattini, Livio
Kwon, Hye Young
Gulbinovic, Jolanta
Lipinska, Aneta
Pomorski, Maciej
McClure, Lindsay
Fürst, Jurij
Gambogi, Rosana
Ortiz, Carla Hernandez
Santos, Vânia Cristina Canuto
Araújo, Denizar Vianna
Araujo, Vânia Eloisa
Acurcio, Francisco de Assis
Alvares-Teodoro, Juliana
Guerra-Junior, Augusto Afonso
Godman, Brian
Gargano, Ludmila Peres
Azevedo, Pâmela Santos
Garcia, Marina Morgado
Souza Cazarim, Maurílio
Pantuzza, Laís Lessa Neiva
Ribeiro-Junior, Nelio Gomes
Pereira, André Luiz
Borin, Marcus Carvalho
Zuppo, Isabella de Figueiredo
Iunes, Roberto
Pippo, Tomas
Hauegen, Renata Curi
Vassalo, Carlos
Laba, Tracey Lea
Simoens, Steven
Márquez, Sergio
Gomez, Carolina
Voncina, Luka
Selke, Gisbert W.
Garattini, Livio
Kwon, Hye Young
Gulbinovic, Jolanta
Lipinska, Aneta
Pomorski, Maciej
McClure, Lindsay
Fürst, Jurij
Gambogi, Rosana
Ortiz, Carla Hernandez
Santos, Vânia Cristina Canuto
Araújo, Denizar Vianna
Araujo, Vânia Eloisa
Acurcio, Francisco de Assis
Alvares-Teodoro, Juliana
Guerra-Junior, Augusto Afonso
Affilliation
Graduate Program in Medicines and Pharmaceutical Services. Faculty of Pharmacy. Federal University of Minas Gerais. Belo Horizonte, MG, Brazil / SUS Collaborating Centre for Technology Assessment and Excellence in Health. Belo Horizonte, MG, Brazil.
Strathclyde Institute of Pharmacy and Biomedical Sciences. University of Strathclyde, Glasgow, United Kingdom / Health Economics Centre. University of Liverpool Management School. Liverpool, United Kingdom / Division of Clinical Pharmacology. Karolinska Institute. Karolinska University Hospital Huddinge. Stockholm, Sweden / School of Pharmacy. Sefako Makgatho Health Sciences University. Ga-Rankuwa, South Africa.
Graduate Program in Medicines and Pharmaceutical Services. Faculty of Pharmacy. Federal University of Minas Gerais. Belo Horizonte, MG, Brazil / SUS Collaborating Centre for Technology Assessment and Excellence in Health. Belo Horizonte, MG, Brazil.
Graduate Program in Medicines and Pharmaceutical Services. Faculty of Pharmacy. Federal University of Minas Gerais. Belo Horizonte, MG, Brazil / SUS Collaborating Centre for Technology Assessment and Excellence in Health. Belo Horizonte, MG, Brazil.
Graduate Program in Medicines and Pharmaceutical Services. Faculty of Pharmacy. Federal University of Minas Gerais. Belo Horizonte, MG, Brazil / SUS Collaborating Centre for Technology Assessment and Excellence in Health. Belo Horizonte, MG, Brazil.
Department of Pharmaceutical Sciences. Pharmacy School. Federal University of Juiz de Fora. Juiz de Fora, MG, Brazil.
Graduate Program in Medicines and Pharmaceutical Services. Faculty of Pharmacy. Federal University of Minas Gerais. Belo Horizonte, MG, Brazil.
SUS Collaborating Centre for Technology Assessment and Excellence in Health. Belo Horizonte, MG, Brazil.
Gerência de Planejamento. Monitoramento e Avaliação Assistenciais Fundação Hospitalar do Estado de Minas Gerais. Belo Horizonte, MG, Brazil.
Graduate Program in Medicines and Pharmaceutical Services. Faculty of Pharmacy. Federal University of Minas Gerais. Belo Horizonte, MG, Brazil / SUS Collaborating Centre for Technology Assessment and Excellence in Health. Belo Horizonte, MG, Brazil.
Graduate Program in Medicines and Pharmaceutical Services. Faculty of Pharmacy. Federal University of Minas Gerais. Belo Horizonte, MG, Brazil / SUS Collaborating Centre for Technology Assessment and Excellence in Health. Belo Horizonte, MG, Brazil.
The World Bank. Washington, USA.
Pan American Health Organization. Brasília, DF, Brazil.
Oswaldo Cruz Foundation, Center for Technological Development in Health. National Institute of Science and Technology for Innovation on Diseases of Neglected Populations. Rio de Janeiro, RJ, Brazil.
Facultad de Ciencias Médicas. Universidad Nacional del Litoral. Santa Fe, Argentina.
Centre for Health Economics Research and Evaluation. University of Technology Sydney. Sydney, Australia.
Department of Pharmaceutical and Pharmacological Sciences. KU Leuven. Louvain, Belgium.
Administradora de los Recursos del Sistema General de Seguridad Social en Salud. Bogotá, Colombia.
Think Tank “Medicines, Information and Power”. National University of Colombia. Bogotá, Colombia.
Faculty of Health Studies. Rijeka, Croatia.
AOK Research Institute (WIdO). Berlin, Germany.
Centre for Health Economics, IRCCS Institute for Pharmacological Research ‘Mario Negri’. Ranica, Italy.
Division of Pharmacoepidemiology. Strathclyde Institute of Pharmacy and Biomedical Sciences. Strathclyde University. Glasgow, United Kingdom / College of Pharmacy. Seoul National University. Seoul, South Korea.
Department of Pathology. Forensic Medicine and Pharmacology. Faculty of Medicine. Institute of Biomedical Sciences. Vilnius University. Vilnius, Lithuania.
Agency for Health Technology Assessment and Tariff System. Warsaw, Poland.
Agency for Health Technology Assessment and Tariff System. Warsaw, Poland.
Commissioning and Facilities. NHS National Services Scotland. Edinburgh, United Kingdom.
Health Insurance Institute. Ljubljana, Slovenia.
National Resources Fund. Montevideo, Uruguay.
National Resources Fund. Montevideo, Uruguay.
Secretariat of Science. Technology and Strategic Inputs. Ministry of Health. Brasília, DF, Brazil.
Secretariat of Science. Technology and Strategic Inputs. Ministry of Health. Brasília, DF, Brazil.
Graduate Program in Medicines and Pharmaceutical Services. Faculty of Pharmacy. Federal University of Minas Gerais. Belo Horizonte, MG, Brazil / Pontifical Catholic University of Minas Gerais. Belo Horizonte, MG, Brazil.
Graduate Program in Medicines and Pharmaceutical Services. Faculty of Pharmacy. Federal University of Minas Gerais. Belo Horizonte, MG, Brazil / SUS Collaborating Centre for Technology Assessment and Excellence in Health. Belo Horizonte, MG, Brazil.
Graduate Program in Medicines and Pharmaceutical Services. Faculty of Pharmacy. Federal University of Minas Gerais. Belo Horizonte, MG Brazil / SUS Collaborating Centre for Technology Assessment and Excellence in Health. Belo Horizonte, MG, Brazil.
Graduate Program in Medicines and Pharmaceutical Services. Faculty of Pharmacy. Federal University of Minas Gerais. Belo Horizonte, MG Brazil / SUS Collaborating Centre for Technology Assessment and Excellence in Health. Belo Horizonte, MG, Brazil.
Strathclyde Institute of Pharmacy and Biomedical Sciences. University of Strathclyde, Glasgow, United Kingdom / Health Economics Centre. University of Liverpool Management School. Liverpool, United Kingdom / Division of Clinical Pharmacology. Karolinska Institute. Karolinska University Hospital Huddinge. Stockholm, Sweden / School of Pharmacy. Sefako Makgatho Health Sciences University. Ga-Rankuwa, South Africa.
Graduate Program in Medicines and Pharmaceutical Services. Faculty of Pharmacy. Federal University of Minas Gerais. Belo Horizonte, MG, Brazil / SUS Collaborating Centre for Technology Assessment and Excellence in Health. Belo Horizonte, MG, Brazil.
Graduate Program in Medicines and Pharmaceutical Services. Faculty of Pharmacy. Federal University of Minas Gerais. Belo Horizonte, MG, Brazil / SUS Collaborating Centre for Technology Assessment and Excellence in Health. Belo Horizonte, MG, Brazil.
Graduate Program in Medicines and Pharmaceutical Services. Faculty of Pharmacy. Federal University of Minas Gerais. Belo Horizonte, MG, Brazil / SUS Collaborating Centre for Technology Assessment and Excellence in Health. Belo Horizonte, MG, Brazil.
Department of Pharmaceutical Sciences. Pharmacy School. Federal University of Juiz de Fora. Juiz de Fora, MG, Brazil.
Graduate Program in Medicines and Pharmaceutical Services. Faculty of Pharmacy. Federal University of Minas Gerais. Belo Horizonte, MG, Brazil.
SUS Collaborating Centre for Technology Assessment and Excellence in Health. Belo Horizonte, MG, Brazil.
Gerência de Planejamento. Monitoramento e Avaliação Assistenciais Fundação Hospitalar do Estado de Minas Gerais. Belo Horizonte, MG, Brazil.
Graduate Program in Medicines and Pharmaceutical Services. Faculty of Pharmacy. Federal University of Minas Gerais. Belo Horizonte, MG, Brazil / SUS Collaborating Centre for Technology Assessment and Excellence in Health. Belo Horizonte, MG, Brazil.
Graduate Program in Medicines and Pharmaceutical Services. Faculty of Pharmacy. Federal University of Minas Gerais. Belo Horizonte, MG, Brazil / SUS Collaborating Centre for Technology Assessment and Excellence in Health. Belo Horizonte, MG, Brazil.
The World Bank. Washington, USA.
Pan American Health Organization. Brasília, DF, Brazil.
Oswaldo Cruz Foundation, Center for Technological Development in Health. National Institute of Science and Technology for Innovation on Diseases of Neglected Populations. Rio de Janeiro, RJ, Brazil.
Facultad de Ciencias Médicas. Universidad Nacional del Litoral. Santa Fe, Argentina.
Centre for Health Economics Research and Evaluation. University of Technology Sydney. Sydney, Australia.
Department of Pharmaceutical and Pharmacological Sciences. KU Leuven. Louvain, Belgium.
Administradora de los Recursos del Sistema General de Seguridad Social en Salud. Bogotá, Colombia.
Think Tank “Medicines, Information and Power”. National University of Colombia. Bogotá, Colombia.
Faculty of Health Studies. Rijeka, Croatia.
AOK Research Institute (WIdO). Berlin, Germany.
Centre for Health Economics, IRCCS Institute for Pharmacological Research ‘Mario Negri’. Ranica, Italy.
Division of Pharmacoepidemiology. Strathclyde Institute of Pharmacy and Biomedical Sciences. Strathclyde University. Glasgow, United Kingdom / College of Pharmacy. Seoul National University. Seoul, South Korea.
Department of Pathology. Forensic Medicine and Pharmacology. Faculty of Medicine. Institute of Biomedical Sciences. Vilnius University. Vilnius, Lithuania.
Agency for Health Technology Assessment and Tariff System. Warsaw, Poland.
Agency for Health Technology Assessment and Tariff System. Warsaw, Poland.
Commissioning and Facilities. NHS National Services Scotland. Edinburgh, United Kingdom.
Health Insurance Institute. Ljubljana, Slovenia.
National Resources Fund. Montevideo, Uruguay.
National Resources Fund. Montevideo, Uruguay.
Secretariat of Science. Technology and Strategic Inputs. Ministry of Health. Brasília, DF, Brazil.
Secretariat of Science. Technology and Strategic Inputs. Ministry of Health. Brasília, DF, Brazil.
Graduate Program in Medicines and Pharmaceutical Services. Faculty of Pharmacy. Federal University of Minas Gerais. Belo Horizonte, MG, Brazil / Pontifical Catholic University of Minas Gerais. Belo Horizonte, MG, Brazil.
Graduate Program in Medicines and Pharmaceutical Services. Faculty of Pharmacy. Federal University of Minas Gerais. Belo Horizonte, MG, Brazil / SUS Collaborating Centre for Technology Assessment and Excellence in Health. Belo Horizonte, MG, Brazil.
Graduate Program in Medicines and Pharmaceutical Services. Faculty of Pharmacy. Federal University of Minas Gerais. Belo Horizonte, MG Brazil / SUS Collaborating Centre for Technology Assessment and Excellence in Health. Belo Horizonte, MG, Brazil.
Graduate Program in Medicines and Pharmaceutical Services. Faculty of Pharmacy. Federal University of Minas Gerais. Belo Horizonte, MG Brazil / SUS Collaborating Centre for Technology Assessment and Excellence in Health. Belo Horizonte, MG, Brazil.
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.
Keywords
Multicriteria decision-analysisRisk-sharing arrangements
Cancer drugs
End-points
Health
Medicines
Reimbursement
Performance
Technology
Outcomes
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