Integrative Review of Managed Entry Agreements: Chances and Limitations
| Autor(a) principal: | |
|---|---|
| Data de Publicação: | 2020 |
| Outros Autores: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Tipo de documento: | Artigo |
| Idioma: | eng |
| Título da fonte: | Repositório Institucional da FIOCRUZ (ARCA) |
| Texto Completo: | https://www.arca.fiocruz.br/handle/icict/59334 |
Resumo: | 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. |
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Dias, Carolina ZampirolliGodman, BrianGargano, Ludmila PeresAzevedo, Pâmela SantosGarcia, Marina MorgadoSouza Cazarim, MaurílioPantuzza, Laís Lessa NeivaRibeiro-Junior, Nelio GomesPereira, André LuizBorin, Marcus CarvalhoZuppo, Isabella de FigueiredoIunes, RobertoPippo, TomasHauegen, Renata CuriVassalo, CarlosLaba, Tracey LeaSimoens, StevenMárquez, SergioGomez, CarolinaVoncina, LukaSelke, Gisbert W.Garattini, LivioKwon, Hye YoungGulbinovic, JolantaLipinska, AnetaPomorski, MaciejMcClure, LindsayFürst, JurijGambogi, RosanaOrtiz, Carla HernandezSantos, Vânia Cristina CanutoAraújo, Denizar ViannaAraujo, Vânia EloisaAcurcio, Francisco de AssisAlvares-Teodoro, JulianaGuerra-Junior, Augusto Afonso2023-06-30T19:56:21Z2023-06-30T19:56:21Z2020DIAS, Carolina Zampirolli et al. Integrative Review of Managed Entry Agreements: Chances and Limitations. PharmacoEconomics, New Zealand, v. 38, n. 11, p. 1165-1185, Nov. 2020.1170-7690https://www.arca.fiocruz.br/handle/icict/5933410.1007/S40273-020-00943-11179-2027engAdis InternationalBiomedical TechnologyBrazilCommerceDrug IndustryHumansIncomeMulticriteria decision-analysisRisk-sharing arrangementsCancer drugsEnd-pointsHealthMedicinesReimbursementPerformanceTechnologyOutcomesIntegrative Review of Managed Entry Agreements: Chances and Limitationsinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleGraduate 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.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.info:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txttext/plain1748https://www.arca.fiocruz.br/bitstream/icict/59334/1/license.txt8a4605be74aa9ea9d79846c1fba20a33MD51ORIGINAL10.1007_s40273-020-00943-1.pdfapplication/pdf1100013https://www.arca.fiocruz.br/bitstream/icict/59334/2/10.1007_s40273-020-00943-1.pdf8f401b5d18a3579d8e3306463492ccaeMD52icict/593342023-07-01 22:17:36.346oai:www.arca.fiocruz.br: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Repositório InstitucionalPUBhttps://www.arca.fiocruz.br/oai/requestrepositorio.arca@fiocruz.bropendoar:21352023-07-02T01:17:36Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)false |
| dc.title.en_US.fl_str_mv |
Integrative Review of Managed Entry Agreements: Chances and Limitations |
| title |
Integrative Review of Managed Entry Agreements: Chances and Limitations |
| spellingShingle |
Integrative Review of Managed Entry Agreements: Chances and Limitations Dias, Carolina Zampirolli Biomedical Technology Brazil Commerce Drug Industry Humans Income Multicriteria decision-analysis Risk-sharing arrangements Cancer drugs End-points Health Medicines Reimbursement Performance Technology Outcomes |
| title_short |
Integrative Review of Managed Entry Agreements: Chances and Limitations |
| title_full |
Integrative Review of Managed Entry Agreements: Chances and Limitations |
| title_fullStr |
Integrative Review of Managed Entry Agreements: Chances and Limitations |
| title_full_unstemmed |
Integrative Review of Managed Entry Agreements: Chances and Limitations |
| title_sort |
Integrative Review of Managed Entry Agreements: Chances and Limitations |
| author |
Dias, Carolina Zampirolli |
| author_facet |
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 |
| author_role |
author |
| author2 |
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 |
| author2_role |
author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author |
| dc.contributor.author.fl_str_mv |
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 |
| dc.subject.mesh.en_US.fl_str_mv |
Biomedical Technology Brazil Commerce Drug Industry Humans Income |
| topic |
Biomedical Technology Brazil Commerce Drug Industry Humans Income Multicriteria decision-analysis Risk-sharing arrangements Cancer drugs End-points Health Medicines Reimbursement Performance Technology Outcomes |
| dc.subject.en.en_US.fl_str_mv |
Multicriteria decision-analysis Risk-sharing arrangements Cancer drugs End-points Health Medicines Reimbursement Performance Technology Outcomes |
| description |
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. |
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2020 |
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2020 |
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2023-06-30T19:56:21Z |
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2023-06-30T19:56:21Z |
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DIAS, Carolina Zampirolli et al. Integrative Review of Managed Entry Agreements: Chances and Limitations. PharmacoEconomics, New Zealand, v. 38, n. 11, p. 1165-1185, Nov. 2020. |
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https://www.arca.fiocruz.br/handle/icict/59334 |
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1170-7690 |
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10.1007/S40273-020-00943-1 |
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1179-2027 |
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DIAS, Carolina Zampirolli et al. Integrative Review of Managed Entry Agreements: Chances and Limitations. PharmacoEconomics, New Zealand, v. 38, n. 11, p. 1165-1185, Nov. 2020. 1170-7690 10.1007/S40273-020-00943-1 1179-2027 |
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Adis International |
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Adis International |
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