Tratamento farmacológico para Hepatite C: a incorporação dos antivirais de ação direta pelo Sistema Único de Saúde de 2012 a 2021
Autor(a) principal: | |
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Data de Publicação: | 2022 |
Outros Autores: | |
Tipo de documento: | Dissertação |
Idioma: | por |
Título da fonte: | Biblioteca Digital de Teses e Dissertações da UERJ |
Texto Completo: | http://www.bdtd.uerj.br/handle/1/19400 |
Resumo: | Eradication of hepatitis C virus (HCV) through pharmacological treatment is the only intervention that can halt the progression of hepatitis C. Second-generation direct-acting antivirals (DAA) account for high cure rates in safe therapies and fully oral. In Brazil, different DAA have been offered in the Unified Health System (SUS), based on the recommendations of the National Commission for the Incorporation of Technologies in the Unified Health System (CONITEC) and through the inclusion criteria of the Clinical Protocol and Therapeutic Guidelines (PCDT) for hepatitis C. This dissertation aims to analyze the dynamics of incorporation and the effectiveness of the offer of DAA for the treatment of hepatitis C in the SUS, from 2012 to 2021. Documentary analyzes of the CONITEC recommendation reports and the PCDT updates were carried out, in addition to a search in the Ministry of Health databases on federal purchases and on the dispensing of medicines incorporated in he SUS outpatient production. Ten antiviral treatments, comprising fifteen DAA, were incorporated into the SUS and, among them, four antiviral treatments were excluded during the study period. The DAA were quickly requested to CONITEC for analysis of incorporation soon after their registration with the National Agency for Sanitary Surveillance (ANVISA), all of them being very recent global marketing and with little accumulated experience of use. The time taken to complete the CONITEC administrative process was always shorter than the maximum legal deadline, with public consultation time shortened a few times and without a public hearing. This speed, however, comes up against the interval between the incorporation of the DAA and the first dispensation in the SUS, with an average time longer than the legal deadline for offering them in the care network. In several situations, delays in the first regular public purchase made by the Ministry of Health contributed to these deadlines. Incorporated in 2018 and present in the current PCDT, the elbasvir/grazoprevir association does not have purchase or dispensing records, giving a situation in which therapeutic alternatives remain incorporated and could participate in future price negotiations, according to cost-minimization or simplification criteria of treatment by pangenotypic capacity. It is pointed out that the dynamics of incorporation and exclusion of DAA, although based on scientific criteria, can admit other interferences, whether financial or political. Treatment became simpler with pangenotypic treatments and the country was able to start to dispense DAA in the primary care network, improving universal access to treatment. |
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Caetano, RosângelaOsorio-de-Castro, Claudia Garcia SerpaOliveira, Fabiano Saldanha Gomes deElias, Sabrina Calilhttp://lattes.cnpq.br/8920283923288859Motta, Renata Marieiro Naves darmnaves@gmail.com2023-04-14T13:33:46Z2022-10-03MOTTA, Renata Marieiro Naves da. Tratamento farmacológico para Hepatite C: a incorporação dos antivirais de ação direta pelo Sistema Único de Saúde de 2012 a 2021. 2022. 147 f. Dissertação (Mestrado em Saúde Coletiva) - Instituto de Medicina Social Hesio Cordeiro, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, 2022.http://www.bdtd.uerj.br/handle/1/19400Eradication of hepatitis C virus (HCV) through pharmacological treatment is the only intervention that can halt the progression of hepatitis C. Second-generation direct-acting antivirals (DAA) account for high cure rates in safe therapies and fully oral. In Brazil, different DAA have been offered in the Unified Health System (SUS), based on the recommendations of the National Commission for the Incorporation of Technologies in the Unified Health System (CONITEC) and through the inclusion criteria of the Clinical Protocol and Therapeutic Guidelines (PCDT) for hepatitis C. This dissertation aims to analyze the dynamics of incorporation and the effectiveness of the offer of DAA for the treatment of hepatitis C in the SUS, from 2012 to 2021. Documentary analyzes of the CONITEC recommendation reports and the PCDT updates were carried out, in addition to a search in the Ministry of Health databases on federal purchases and on the dispensing of medicines incorporated in he SUS outpatient production. Ten antiviral treatments, comprising fifteen DAA, were incorporated into the SUS and, among them, four antiviral treatments were excluded during the study period. The DAA were quickly requested to CONITEC for analysis of incorporation soon after their registration with the National Agency for Sanitary Surveillance (ANVISA), all of them being very recent global marketing and with little accumulated experience of use. The time taken to complete the CONITEC administrative process was always shorter than the maximum legal deadline, with public consultation time shortened a few times and without a public hearing. This speed, however, comes up against the interval between the incorporation of the DAA and the first dispensation in the SUS, with an average time longer than the legal deadline for offering them in the care network. In several situations, delays in the first regular public purchase made by the Ministry of Health contributed to these deadlines. Incorporated in 2018 and present in the current PCDT, the elbasvir/grazoprevir association does not have purchase or dispensing records, giving a situation in which therapeutic alternatives remain incorporated and could participate in future price negotiations, according to cost-minimization or simplification criteria of treatment by pangenotypic capacity. It is pointed out that the dynamics of incorporation and exclusion of DAA, although based on scientific criteria, can admit other interferences, whether financial or political. Treatment became simpler with pangenotypic treatments and the country was able to start to dispense DAA in the primary care network, improving universal access to treatment.A erradicação do vírus da hepatite C (HCV), por meio de tratamento farmacológico, é a única intervenção que pode deter a progressão dessa doença. Os antivirais de ação direta (AAD) de segunda geração respondem por altas taxas de cura em terapias seguras e totalmente orais. No Brasil, diferentes AAD vêm sendo ofertados no Sistema Único de Saúde (SUS), a partir das recomendações da Comissão Nacional de Incorporação de Tecnologias no Sistema Único de Saúde (CONITEC) e mediante critérios de inclusão do Protocolo Clínico e Diretrizes Terapêuticas (PCDT) para hepatite C. Essa dissertação tem como objetivo analisar a dinâmica de incorporação e a efetividade da oferta dos AAD para tratamento da hepatite C no SUS, de 2012 a 2021. Foram realizadas análises documentais dos relatórios de recomendação da CONITEC e das atualizações de PCDT, além de busca nos bancos de dados do Ministério da Saúde sobre compras federais e sobre a dispensação dos medicamentos incorporados na produção ambulatorial do SUS. Dez tratamentos antivirais, compreendendo quinze AAD, foram incorporados ao SUS e, dentre eles, quatro tratamentos antivirais foram posteriormente excluídos no período estudado. Os AAD foram rapidamente demandados à CONITEC para análise de incorporação logo após seus registros na Agência Nacional de Vigilância Sanitária (ANVISA), sendo todos de comercialização global recente e com pouca experiência acumulada de uso. O tempo de conclusão do processo administrativo da CONITEC foi sempre inferior ao prazo máximo legal, com tempo de consulta pública abreviado algumas vezes e sem audiência pública. Essa celeridade, entretanto, esbarra no intervalo entre a incorporação dos AAD e a primeira dispensação no SUS, com média de tempo maior que o prazo legal para a oferta na rede de atenção. Em diversas situações, atrasos na primeira compra pública regular efetuada pelo Ministério da Saúde contribuíram para esses prazos. Incorporada em 2018 e presente no PCDT vigente, a associação elbasvir/grazoprevir não possui registros de compra ou dispensação, conferindo uma situação em que as alternativas terapêuticas permanecem incorporadas e poderiam participar de futuras negociações de preço, conforme critérios de custo-minimização ou de simplificação do tratamento por capacidade pangenotípica. Sinaliza-se que a dinâmica de incorporação e exclusão dos AAD, embora baseada em critérios científicos, pode admitir outras interferências, sejam financeiras ou políticas. O tratamento tornou-se mais simples a partir dos tratamentos pangenotípicos e o país pôde passar a dispensar os AAD na rede de atenção primária, com vistas a melhorar questões de acesso universal ao tratamento.Submitted by Marcia CB/C (marciagraziadio@yahoo.com.br) on 2023-04-14T13:33:46Z No. of bitstreams: 1 Dissertação - Renata Marieiro Naves da Motta - 2022 - Completa.pdf: 2387503 bytes, checksum: 971d7a70c1e96dc6fc845a9aa2e19749 (MD5)Made available in DSpace on 2023-04-14T13:33:46Z (GMT). No. of bitstreams: 1 Dissertação - Renata Marieiro Naves da Motta - 2022 - Completa.pdf: 2387503 bytes, checksum: 971d7a70c1e96dc6fc845a9aa2e19749 (MD5) Previous issue date: 2022-10-03application/pdfporUniversidade do Estado do Rio de JaneiroPrograma de Pós-Graduação em Saúde ColetivaUERJBrasilCentro Biomédico::Instituto de Medicina Social Hesio CordeiroHepatitis CAntiviral agentsBiomedical technology assessmentUnified Health SystemHepatite CAntiviraisAvaliação da tecnologia biomédicaSistema Único de SaúdeCIENCIAS DA SAUDE::SAUDE COLETIVATratamento farmacológico para Hepatite C: a incorporação dos antivirais de ação direta pelo Sistema Único de Saúde de 2012 a 2021Pharmacological treatment for Hepatitis C: the incorporation of direct-acting by the Unified Health System from 2012 to 2021info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/masterThesisinfo:eu-repo/semantics/openAccessreponame:Biblioteca Digital de Teses e Dissertações da UERJinstname:Universidade do Estado do Rio de Janeiro (UERJ)instacron:UERJORIGINALDissertação - Renata Marieiro Naves da Motta - 2022 - Completa.pdfDissertação - Renata Marieiro Naves da Motta - 2022 - Completa.pdfapplication/pdf2387503http://www.bdtd.uerj.br/bitstream/1/19400/2/Disserta%C3%A7%C3%A3o+-+Renata+Marieiro+Naves+da+Motta+-+2022+-+Completa.pdf971d7a70c1e96dc6fc845a9aa2e19749MD52LICENSElicense.txtlicense.txttext/plain; charset=utf-82123http://www.bdtd.uerj.br/bitstream/1/19400/1/license.txte5502652da718045d7fcd832b79fca29MD511/194002024-02-26 20:29:08.281oai:www.bdtd.uerj.br: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Biblioteca Digital de Teses e Dissertaçõeshttp://www.bdtd.uerj.br/PUBhttps://www.bdtd.uerj.br:8443/oai/requestbdtd.suporte@uerj.bropendoar:29032024-02-26T23:29:08Biblioteca Digital de Teses e Dissertações da UERJ - Universidade do Estado do Rio de Janeiro (UERJ)false |
dc.title.por.fl_str_mv |
Tratamento farmacológico para Hepatite C: a incorporação dos antivirais de ação direta pelo Sistema Único de Saúde de 2012 a 2021 |
dc.title.alternative.eng.fl_str_mv |
Pharmacological treatment for Hepatitis C: the incorporation of direct-acting by the Unified Health System from 2012 to 2021 |
title |
Tratamento farmacológico para Hepatite C: a incorporação dos antivirais de ação direta pelo Sistema Único de Saúde de 2012 a 2021 |
spellingShingle |
Tratamento farmacológico para Hepatite C: a incorporação dos antivirais de ação direta pelo Sistema Único de Saúde de 2012 a 2021 Motta, Renata Marieiro Naves da Hepatitis C Antiviral agents Biomedical technology assessment Unified Health System Hepatite C Antivirais Avaliação da tecnologia biomédica Sistema Único de Saúde CIENCIAS DA SAUDE::SAUDE COLETIVA |
title_short |
Tratamento farmacológico para Hepatite C: a incorporação dos antivirais de ação direta pelo Sistema Único de Saúde de 2012 a 2021 |
title_full |
Tratamento farmacológico para Hepatite C: a incorporação dos antivirais de ação direta pelo Sistema Único de Saúde de 2012 a 2021 |
title_fullStr |
Tratamento farmacológico para Hepatite C: a incorporação dos antivirais de ação direta pelo Sistema Único de Saúde de 2012 a 2021 |
title_full_unstemmed |
Tratamento farmacológico para Hepatite C: a incorporação dos antivirais de ação direta pelo Sistema Único de Saúde de 2012 a 2021 |
title_sort |
Tratamento farmacológico para Hepatite C: a incorporação dos antivirais de ação direta pelo Sistema Único de Saúde de 2012 a 2021 |
author |
Motta, Renata Marieiro Naves da |
author_facet |
Motta, Renata Marieiro Naves da rmnaves@gmail.com |
author_role |
author |
author2 |
rmnaves@gmail.com |
author2_role |
author |
dc.contributor.advisor1.fl_str_mv |
Caetano, Rosângela |
dc.contributor.advisor-co1.fl_str_mv |
Osorio-de-Castro, Claudia Garcia Serpa |
dc.contributor.referee1.fl_str_mv |
Oliveira, Fabiano Saldanha Gomes de |
dc.contributor.referee2.fl_str_mv |
Elias, Sabrina Calil |
dc.contributor.authorLattes.fl_str_mv |
http://lattes.cnpq.br/8920283923288859 |
dc.contributor.author.fl_str_mv |
Motta, Renata Marieiro Naves da rmnaves@gmail.com |
contributor_str_mv |
Caetano, Rosângela Osorio-de-Castro, Claudia Garcia Serpa Oliveira, Fabiano Saldanha Gomes de Elias, Sabrina Calil |
dc.subject.eng.fl_str_mv |
Hepatitis C Antiviral agents Biomedical technology assessment Unified Health System |
topic |
Hepatitis C Antiviral agents Biomedical technology assessment Unified Health System Hepatite C Antivirais Avaliação da tecnologia biomédica Sistema Único de Saúde CIENCIAS DA SAUDE::SAUDE COLETIVA |
dc.subject.por.fl_str_mv |
Hepatite C Antivirais Avaliação da tecnologia biomédica Sistema Único de Saúde |
dc.subject.cnpq.fl_str_mv |
CIENCIAS DA SAUDE::SAUDE COLETIVA |
description |
Eradication of hepatitis C virus (HCV) through pharmacological treatment is the only intervention that can halt the progression of hepatitis C. Second-generation direct-acting antivirals (DAA) account for high cure rates in safe therapies and fully oral. In Brazil, different DAA have been offered in the Unified Health System (SUS), based on the recommendations of the National Commission for the Incorporation of Technologies in the Unified Health System (CONITEC) and through the inclusion criteria of the Clinical Protocol and Therapeutic Guidelines (PCDT) for hepatitis C. This dissertation aims to analyze the dynamics of incorporation and the effectiveness of the offer of DAA for the treatment of hepatitis C in the SUS, from 2012 to 2021. Documentary analyzes of the CONITEC recommendation reports and the PCDT updates were carried out, in addition to a search in the Ministry of Health databases on federal purchases and on the dispensing of medicines incorporated in he SUS outpatient production. Ten antiviral treatments, comprising fifteen DAA, were incorporated into the SUS and, among them, four antiviral treatments were excluded during the study period. The DAA were quickly requested to CONITEC for analysis of incorporation soon after their registration with the National Agency for Sanitary Surveillance (ANVISA), all of them being very recent global marketing and with little accumulated experience of use. The time taken to complete the CONITEC administrative process was always shorter than the maximum legal deadline, with public consultation time shortened a few times and without a public hearing. This speed, however, comes up against the interval between the incorporation of the DAA and the first dispensation in the SUS, with an average time longer than the legal deadline for offering them in the care network. In several situations, delays in the first regular public purchase made by the Ministry of Health contributed to these deadlines. Incorporated in 2018 and present in the current PCDT, the elbasvir/grazoprevir association does not have purchase or dispensing records, giving a situation in which therapeutic alternatives remain incorporated and could participate in future price negotiations, according to cost-minimization or simplification criteria of treatment by pangenotypic capacity. It is pointed out that the dynamics of incorporation and exclusion of DAA, although based on scientific criteria, can admit other interferences, whether financial or political. Treatment became simpler with pangenotypic treatments and the country was able to start to dispense DAA in the primary care network, improving universal access to treatment. |
publishDate |
2022 |
dc.date.issued.fl_str_mv |
2022-10-03 |
dc.date.accessioned.fl_str_mv |
2023-04-14T13:33:46Z |
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dc.identifier.citation.fl_str_mv |
MOTTA, Renata Marieiro Naves da. Tratamento farmacológico para Hepatite C: a incorporação dos antivirais de ação direta pelo Sistema Único de Saúde de 2012 a 2021. 2022. 147 f. Dissertação (Mestrado em Saúde Coletiva) - Instituto de Medicina Social Hesio Cordeiro, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, 2022. |
dc.identifier.uri.fl_str_mv |
http://www.bdtd.uerj.br/handle/1/19400 |
identifier_str_mv |
MOTTA, Renata Marieiro Naves da. Tratamento farmacológico para Hepatite C: a incorporação dos antivirais de ação direta pelo Sistema Único de Saúde de 2012 a 2021. 2022. 147 f. Dissertação (Mestrado em Saúde Coletiva) - Instituto de Medicina Social Hesio Cordeiro, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, 2022. |
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Centro Biomédico::Instituto de Medicina Social Hesio Cordeiro |
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Universidade do Estado do Rio de Janeiro |
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