The Assessment for Disinvestment of Intramuscular Interferon Beta for Relapsing-Remitting Multiple Sclerosis in Brazil
Autor(a) principal: | |
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Data de Publicação: | 2017 |
Outros Autores: | , , , , , , , , , , , , |
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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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 |
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info:eu-repo/semantics/publishedVersion |
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info:eu-repo/semantics/article |
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article |
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publishedVersion |
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 |
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http://hdl.handle.net/1843/43480 |
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eng |
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eng |
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Pharmacoeconomics |
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info:eu-repo/semantics/openAccess |
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openAccess |
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application/pdf |
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Universidade Federal de Minas Gerais |
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UFMG |
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Brasil |
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FAR - DEPARTAMENTO DE FARMÁCIA SOCIAL |
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Universidade Federal de Minas Gerais |
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