The Assessment for Disinvestment of Intramuscular Interferon Beta for Relapsing-Remitting Multiple Sclerosis in Brazil

Detalhes bibliográficos
Autor(a) principal: Livia Lovato Pires Delemos
Data de Publicação: 2017
Outros Autores: Marion Bennie, Ivan Ricardo Zimmermann, Vânia Crisitna Canuto Dos Santos, Clarice Alegre Pretramale, Francisco de Assis Acurcio, Augusto Afonso Guerra Júnior, Marisa Santos, Carlos Magliano, Isabela Diniz, Kathiaja Souza, Ramon Gonçalves Pereira, Juliana Alvares, Brian Godman
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da UFMG
Texto Completo: http://hdl.handle.net/1843/43480
Resumo: In Brazil, inclusion and exclusion of health technologies within the Unified Health System (SUS) is the responsibility of the National Committee for Health Technology Incorporation (CONITEC). A recent Cochrane systematic review demonstrated that intramuscular interferon beta 1a (IFN-β-1a-IM) was inferior to the other beta interferons (IFN-βs) for multiple sclerosis (MS). As a result, CONITEC commissioned an analysis to review possible disinvestment within SUS. The objective of this paper is to describe the disinvestment process for IFN-β-1a-IM in Brazil. The first assessment comprised a literature review and mixed treatment comparison meta-analysis. The outcome of interest was the proportion of relapse-free patients in 2 years. This analysis confirmed the inferiority of IFN-β-1a-IM. Following this, CONITEC recommended disinvestment, with the decision sent for public consultation. More than 3000 contributions were made on CONITEC’s webpage, most of them against the preliminary decision. As a result, CONITEC commissioned a study to assess the effectiveness of IFN-β-1a-IM among Brazilian patients in routine clinical care. The second assessment involved an 11-year follow-up of a non-concurrent cohort of 12,154 MS patients developed by deterministic-probabilistic linkage of SUS administrative databases. The real-world assessment further demonstrated that IFN-β-1a-IM users had a statistically higher risk of treatment failure, defined as treatment switching or relapse treatment or death, with the assessment showing that IFN-β-1a-IM was inferior to the other IFN-βs and to glatiramer acetate in both direct and indirect analysis. In the drug ranking with 40,000 simulations, IFN-β-1a-IM was the worst option, with a success rate of only 152/40,000. Following this, CONITEC decided to exclude the intramuscular presentation of IFN-β from the current MS treatment guidelines, giving patients who are currently on this treatment the option of continuing until treatment failure. In conclusion, we believe this is the first example of this new disinvestment process in action, providing an exemplar for other treatments in Brazil as well as other countries.
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spelling 2022-07-20T18:09:47Z2022-07-20T18:09:47Z201710.1007/s40273-017-0579-01170-7690http://hdl.handle.net/1843/43480In Brazil, inclusion and exclusion of health technologies within the Unified Health System (SUS) is the responsibility of the National Committee for Health Technology Incorporation (CONITEC). A recent Cochrane systematic review demonstrated that intramuscular interferon beta 1a (IFN-β-1a-IM) was inferior to the other beta interferons (IFN-βs) for multiple sclerosis (MS). As a result, CONITEC commissioned an analysis to review possible disinvestment within SUS. The objective of this paper is to describe the disinvestment process for IFN-β-1a-IM in Brazil. The first assessment comprised a literature review and mixed treatment comparison meta-analysis. The outcome of interest was the proportion of relapse-free patients in 2 years. This analysis confirmed the inferiority of IFN-β-1a-IM. Following this, CONITEC recommended disinvestment, with the decision sent for public consultation. More than 3000 contributions were made on CONITEC’s webpage, most of them against the preliminary decision. As a result, CONITEC commissioned a study to assess the effectiveness of IFN-β-1a-IM among Brazilian patients in routine clinical care. The second assessment involved an 11-year follow-up of a non-concurrent cohort of 12,154 MS patients developed by deterministic-probabilistic linkage of SUS administrative databases. The real-world assessment further demonstrated that IFN-β-1a-IM users had a statistically higher risk of treatment failure, defined as treatment switching or relapse treatment or death, with the assessment showing that IFN-β-1a-IM was inferior to the other IFN-βs and to glatiramer acetate in both direct and indirect analysis. In the drug ranking with 40,000 simulations, IFN-β-1a-IM was the worst option, with a success rate of only 152/40,000. Following this, CONITEC decided to exclude the intramuscular presentation of IFN-β from the current MS treatment guidelines, giving patients who are currently on this treatment the option of continuing until treatment failure. In conclusion, we believe this is the first example of this new disinvestment process in action, providing an exemplar for other treatments in Brazil as well as other countries.No Brasil, a inclusão e exclusão de tecnologias em saúde no Sistema Único de Saúde (SUS) é de responsabilidade da Comissão Nacional de Incorporação de Tecnologias em Saúde (CONITEC). Uma revisão sistemática recente da Cochrane demonstrou que o interferon beta 1a intramuscular (IFN-β-1a-IM) foi inferior aos outros interferons beta (IFN-βs) para esclerose múltipla (EM). Como resultado, a CONITEC encomendou uma análise para analisar possíveis desinvestimentos no SUS. O objetivo deste artigo é descrever o processo de desinvestimento do IFN-β-1a-IM no Brasil. A primeira avaliação compreendeu uma revisão da literatura e meta-análise de comparação de tratamento misto. O desfecho de interesse foi a proporção de pacientes sem recidiva em 2 anos. Esta análise confirmou a inferioridade do IFN-β-1a-IM. Em seguida, a CONITEC recomendou o desinvestimento, com a decisão encaminhada para consulta pública. Mais de 3.000 contribuições foram feitas na página da CONITEC, a maioria contra a decisão liminar. Como resultado, a CONITEC encomendou um estudo para avaliar a eficácia do IFN-β-1a-IM entre pacientes brasileiros em atendimento clínico de rotina. A segunda avaliação envolveu um acompanhamento de 11 anos de uma coorte não concorrente de 12.154 pacientes com EM desenvolvida por meio de relacionamento determinístico-probabilístico de bancos de dados administrativos do SUS. A avaliação do mundo real demonstrou ainda que os usuários de IFN-β-1a-IM tiveram um risco estatisticamente maior de falha no tratamento, definido como troca de tratamento ou tratamento de recaída ou morte, com a avaliação mostrando que IFN-β-1a-IM foi inferior a os outros IFN-βs e ao acetato de glatirâmero em análise direta e indireta. No ranking de medicamentos com 40.000 simulações, o IFN-β-1a-IM foi a pior opção, com taxa de sucesso de apenas 152/40.000. A seguir, a CONITEC decidiu excluir a apresentação intramuscular de IFN-β das diretrizes atuais de tratamento da EM, dando aos pacientes que estão atualmente em tratamento com este tratamento a opção de continuar até a falha do tratamento. Concluindo, acreditamos que este é o primeiro exemplo desse novo processo de desinvestimento em ação, dando um exemplo para outros tratamentos no Brasil e em outros países.engUniversidade Federal de Minas GeraisUFMGBrasilFAR - DEPARTAMENTO DE FARMÁCIA SOCIALPharmacoeconomicsSaúde ColetivaSistema Único de Saúde (SUS)DisinvestimentHealth Technology AssessmentThe Assessment for Disinvestment of Intramuscular Interferon Beta for Relapsing-Remitting Multiple Sclerosis in BrazilA Avaliação para Desinvestimento do Interferon Beta Intramuscular para Esclerose Múltipla Remitente-Recorrente no Brasilinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articlehttps://link.springer.com/article/10.1007/s40273-017-0579-0Livia Lovato Pires DelemosMarion BennieIvan Ricardo ZimmermannVânia Crisitna Canuto Dos SantosClarice Alegre PretramaleFrancisco de Assis AcurcioAugusto Afonso Guerra JúniorMarisa SantosCarlos MaglianoIsabela DinizKathiaja SouzaRamon Gonçalves PereiraJuliana AlvaresBrian Godmanapplication/pdfinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da UFMGinstname:Universidade Federal de Minas Gerais (UFMG)instacron:UFMGLICENSELicense.txtLicense.txttext/plain; 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dc.title.pt_BR.fl_str_mv The Assessment for Disinvestment of Intramuscular Interferon Beta for Relapsing-Remitting Multiple Sclerosis in Brazil
dc.title.alternative.pt_BR.fl_str_mv A Avaliação para Desinvestimento do Interferon Beta Intramuscular para Esclerose Múltipla Remitente-Recorrente no Brasil
title The Assessment for Disinvestment of Intramuscular Interferon Beta for Relapsing-Remitting Multiple Sclerosis in Brazil
spellingShingle The Assessment for Disinvestment of Intramuscular Interferon Beta for Relapsing-Remitting Multiple Sclerosis in Brazil
Livia Lovato Pires Delemos
Disinvestiment
Health Technology Assessment
Saúde Coletiva
Sistema Único de Saúde (SUS)
title_short The Assessment for Disinvestment of Intramuscular Interferon Beta for Relapsing-Remitting Multiple Sclerosis in Brazil
title_full The Assessment for Disinvestment of Intramuscular Interferon Beta for Relapsing-Remitting Multiple Sclerosis in Brazil
title_fullStr The Assessment for Disinvestment of Intramuscular Interferon Beta for Relapsing-Remitting Multiple Sclerosis in Brazil
title_full_unstemmed The Assessment for Disinvestment of Intramuscular Interferon Beta for Relapsing-Remitting Multiple Sclerosis in Brazil
title_sort The Assessment for Disinvestment of Intramuscular Interferon Beta for Relapsing-Remitting Multiple Sclerosis in Brazil
author Livia Lovato Pires Delemos
author_facet Livia Lovato Pires Delemos
Marion Bennie
Ivan Ricardo Zimmermann
Vânia Crisitna Canuto Dos Santos
Clarice Alegre Pretramale
Francisco de Assis Acurcio
Augusto Afonso Guerra Júnior
Marisa Santos
Carlos Magliano
Isabela Diniz
Kathiaja Souza
Ramon Gonçalves Pereira
Juliana Alvares
Brian Godman
author_role author
author2 Marion Bennie
Ivan Ricardo Zimmermann
Vânia Crisitna Canuto Dos Santos
Clarice Alegre Pretramale
Francisco de Assis Acurcio
Augusto Afonso Guerra Júnior
Marisa Santos
Carlos Magliano
Isabela Diniz
Kathiaja Souza
Ramon Gonçalves Pereira
Juliana Alvares
Brian Godman
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Livia Lovato Pires Delemos
Marion Bennie
Ivan Ricardo Zimmermann
Vânia Crisitna Canuto Dos Santos
Clarice Alegre Pretramale
Francisco de Assis Acurcio
Augusto Afonso Guerra Júnior
Marisa Santos
Carlos Magliano
Isabela Diniz
Kathiaja Souza
Ramon Gonçalves Pereira
Juliana Alvares
Brian Godman
dc.subject.por.fl_str_mv Disinvestiment
Health Technology Assessment
topic Disinvestiment
Health Technology Assessment
Saúde Coletiva
Sistema Único de Saúde (SUS)
dc.subject.other.pt_BR.fl_str_mv Saúde Coletiva
Sistema Único de Saúde (SUS)
description In Brazil, inclusion and exclusion of health technologies within the Unified Health System (SUS) is the responsibility of the National Committee for Health Technology Incorporation (CONITEC). A recent Cochrane systematic review demonstrated that intramuscular interferon beta 1a (IFN-β-1a-IM) was inferior to the other beta interferons (IFN-βs) for multiple sclerosis (MS). As a result, CONITEC commissioned an analysis to review possible disinvestment within SUS. The objective of this paper is to describe the disinvestment process for IFN-β-1a-IM in Brazil. The first assessment comprised a literature review and mixed treatment comparison meta-analysis. The outcome of interest was the proportion of relapse-free patients in 2 years. This analysis confirmed the inferiority of IFN-β-1a-IM. Following this, CONITEC recommended disinvestment, with the decision sent for public consultation. More than 3000 contributions were made on CONITEC’s webpage, most of them against the preliminary decision. As a result, CONITEC commissioned a study to assess the effectiveness of IFN-β-1a-IM among Brazilian patients in routine clinical care. The second assessment involved an 11-year follow-up of a non-concurrent cohort of 12,154 MS patients developed by deterministic-probabilistic linkage of SUS administrative databases. The real-world assessment further demonstrated that IFN-β-1a-IM users had a statistically higher risk of treatment failure, defined as treatment switching or relapse treatment or death, with the assessment showing that IFN-β-1a-IM was inferior to the other IFN-βs and to glatiramer acetate in both direct and indirect analysis. In the drug ranking with 40,000 simulations, IFN-β-1a-IM was the worst option, with a success rate of only 152/40,000. Following this, CONITEC decided to exclude the intramuscular presentation of IFN-β from the current MS treatment guidelines, giving patients who are currently on this treatment the option of continuing until treatment failure. In conclusion, we believe this is the first example of this new disinvestment process in action, providing an exemplar for other treatments in Brazil as well as other countries.
publishDate 2017
dc.date.issued.fl_str_mv 2017
dc.date.accessioned.fl_str_mv 2022-07-20T18:09:47Z
dc.date.available.fl_str_mv 2022-07-20T18:09:47Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
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dc.identifier.uri.fl_str_mv http://hdl.handle.net/1843/43480
dc.identifier.doi.pt_BR.fl_str_mv 10.1007/s40273-017-0579-0
dc.identifier.issn.pt_BR.fl_str_mv 1170-7690
identifier_str_mv 10.1007/s40273-017-0579-0
1170-7690
url http://hdl.handle.net/1843/43480
dc.language.iso.fl_str_mv eng
language eng
dc.relation.ispartof.pt_BR.fl_str_mv Pharmacoeconomics
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dc.publisher.none.fl_str_mv Universidade Federal de Minas Gerais
dc.publisher.initials.fl_str_mv UFMG
dc.publisher.country.fl_str_mv Brasil
dc.publisher.department.fl_str_mv FAR - DEPARTAMENTO DE FARMÁCIA SOCIAL
publisher.none.fl_str_mv Universidade Federal de Minas Gerais
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