Análogos de insulina humana versus insulina NPH para o tratamento do diabetes mellitus tipo 1: uma avaliação econômica na perspectiva do Sistema Único de Saúde.

Detalhes bibliográficos
Autor(a) principal: Paulo Henrique Ribeiro Fernandes Almeida
Data de Publicação: 2022
Tipo de documento: Tese
Idioma: por
Título da fonte: Repositório Institucional da UFMG
Texto Completo: http://hdl.handle.net/1843/50799
Resumo: Type 1 diabetes mellitus (T1DM) is a chronic and costly disease both for people who live with it and for governments and society. The economic burden of T1DM is largely due to drug costs and diabetes complications. After the diagnosis of T1DM, treatment must be started immediately, as the lack of endogenous insulin can cause diabetic ketoacidosis. Currently, the Unified Health System (SUS) provides neutral protamine Hagedorn (NPH) as a first-line treatment for patients with T1DM and, as a second-line treatment, the human insulin analogues glargine (IGla U100 and IGla U300), detemir (IDet) and degludec (IDeg). Although some studies show favorable results for insulin analogues, uncertainties remain in terms of health-related quality of life (HRQoL) and cost-utility in relation to NPH insulin, especially in the context of Brazil and SUS. In this sense, the main goal of this thesis was to economically evaluate, from the perspective of SUS, the treatment with human insulin analogues (IGla U100, IGla U300, IDet and IDeg) in comparison to NPH insulin for the treatment of people living with T1DM. In the first stage of the thesis, two cross-sectional studies were carried out that analyzed and measured which factors were associated with the HRQoL of patients treated with IGla U100 (N = 401) and with NPH insulin (N = 179). The results for the two multiple linear regressions of the two cross-sectional studies demonstrated that a higher HRQoL was associated with being young; have higher education; having self-rated health as good or very good; not having been bedridden and having practiced physical activity in the last 15 days; having performed up to three medical consultations in the last year; not having been hospitalized in the last year; have zero to three comorbidities; not having angina, diabetic neuropathy, hearing loss, kidney disease, systemic arterial hypertension or chronic obstructive pulmonary disease; have few, non-severe episodes of hypoglycemia. Additionally, the results of the two studies suggested a barrier to accessing drugs from the Specialized Component of Pharmaceutical Assistance in the SUS, since patients treated with IGla U100 had a higher socioeconomic level when compared to patients treated with NPH insulin. In the second stage of the thesis, two other studies were carried out, one being a systematic review of economic evaluations and a cost-utility analysis (CUA) of the insulins available on SUS (i.e., NPH, IGla U100, IGla U300, IDet and IDeg) for patients with T1DM. The findings of the systematic review demonstrated a low standardization in studies of economic evaluations, lack of transparency of the parameters used to feed the models and the non-use of checklists for the description of the works. Furthermore, incremental cost-effectiveness ratio results generally favored trial sponsors. From the CUA point of view, the effectiveness results, in terms of quality-adjusted life years, pointed to a similarity between the analogues and NPH insulin, with the incremental cost being the main difference between the treatments. This thesis provided theoretical support to deepen knowledge about HRQoL and the cost-utility of insulin therapy for people living with T1DM in Brazil, especially SUS users. Finally, the two cross-sectional studies made it possible to understand which variables had the greatest impact on the HRQoL of patients with T1DM treated with IGla U100 or with NPH insulin in the SUS. In addition, the CUA results pointed to a similarity between the analogues (i.e., IGla U100, IGla U300, IDeg, and IDet) and NPH insulin, with incremental cost being the main difference between the technologies.
id UFMG_06ab7acd574c7bf45f8629234ca5e82e
oai_identifier_str oai:repositorio.ufmg.br:1843/50799
network_acronym_str UFMG
network_name_str Repositório Institucional da UFMG
repository_id_str
spelling Análogos de insulina humana versus insulina NPH para o tratamento do diabetes mellitus tipo 1: uma avaliação econômica na perspectiva do Sistema Único de Saúde.Sistema único de saúdeDiabetes mellitus tipo 1Qualidade de vidaAnálise de custo-benefícioInsulina isófanaInsulina de ação prolongadaType 1 diabetes mellitus (T1DM) is a chronic and costly disease both for people who live with it and for governments and society. The economic burden of T1DM is largely due to drug costs and diabetes complications. After the diagnosis of T1DM, treatment must be started immediately, as the lack of endogenous insulin can cause diabetic ketoacidosis. Currently, the Unified Health System (SUS) provides neutral protamine Hagedorn (NPH) as a first-line treatment for patients with T1DM and, as a second-line treatment, the human insulin analogues glargine (IGla U100 and IGla U300), detemir (IDet) and degludec (IDeg). Although some studies show favorable results for insulin analogues, uncertainties remain in terms of health-related quality of life (HRQoL) and cost-utility in relation to NPH insulin, especially in the context of Brazil and SUS. In this sense, the main goal of this thesis was to economically evaluate, from the perspective of SUS, the treatment with human insulin analogues (IGla U100, IGla U300, IDet and IDeg) in comparison to NPH insulin for the treatment of people living with T1DM. In the first stage of the thesis, two cross-sectional studies were carried out that analyzed and measured which factors were associated with the HRQoL of patients treated with IGla U100 (N = 401) and with NPH insulin (N = 179). The results for the two multiple linear regressions of the two cross-sectional studies demonstrated that a higher HRQoL was associated with being young; have higher education; having self-rated health as good or very good; not having been bedridden and having practiced physical activity in the last 15 days; having performed up to three medical consultations in the last year; not having been hospitalized in the last year; have zero to three comorbidities; not having angina, diabetic neuropathy, hearing loss, kidney disease, systemic arterial hypertension or chronic obstructive pulmonary disease; have few, non-severe episodes of hypoglycemia. Additionally, the results of the two studies suggested a barrier to accessing drugs from the Specialized Component of Pharmaceutical Assistance in the SUS, since patients treated with IGla U100 had a higher socioeconomic level when compared to patients treated with NPH insulin. In the second stage of the thesis, two other studies were carried out, one being a systematic review of economic evaluations and a cost-utility analysis (CUA) of the insulins available on SUS (i.e., NPH, IGla U100, IGla U300, IDet and IDeg) for patients with T1DM. The findings of the systematic review demonstrated a low standardization in studies of economic evaluations, lack of transparency of the parameters used to feed the models and the non-use of checklists for the description of the works. Furthermore, incremental cost-effectiveness ratio results generally favored trial sponsors. From the CUA point of view, the effectiveness results, in terms of quality-adjusted life years, pointed to a similarity between the analogues and NPH insulin, with the incremental cost being the main difference between the treatments. This thesis provided theoretical support to deepen knowledge about HRQoL and the cost-utility of insulin therapy for people living with T1DM in Brazil, especially SUS users. Finally, the two cross-sectional studies made it possible to understand which variables had the greatest impact on the HRQoL of patients with T1DM treated with IGla U100 or with NPH insulin in the SUS. In addition, the CUA results pointed to a similarity between the analogues (i.e., IGla U100, IGla U300, IDeg, and IDet) and NPH insulin, with incremental cost being the main difference between the technologies.O diabetes mellitus tipo 1 (DMT1) é uma doença crônica e onerosa tanto para as pessoas que com ela vivem quanto para os governos e a sociedade. O ônus econômico do DMT1 deve-se, em grande parte, aos custos dos medicamentos e às complicações do diabetes. Após o diagnóstico do DMT1, o tratamento deve ser iniciado imediatamente, pois a falta de insulina endógena pode causar cetoacidose diabética. Atualmente, o Sistema Único de Saúde (SUS) disponibiliza, como primeira linha de tratamento para pacientes com DMT1, a insulina neutral protamine Hagedorn (NPH) e, como segunda linha de tratamento, os análogos de insulina humana glargina (IGla U100 e IGla U300), detemir (IDet) e degludeca (IDeg). Embora alguns estudos demonstrem resultados favoráveis aos análogos de insulina, ainda permanecem incertezas em termos de qualidade de vida relacionada à saúde (QVRS) e de custo-utilidade em relação à insulina NPH, especialmente no contexto do Brasil e do SUS. Assim, o objetivo geral desta tese foi avaliar economicamente, sob a perspectiva do SUS, o tratamento com análogos de insulina humana (IGla U100, IGla U300, IDet e IDeg) em comparação à insulina NPH para o tratamento da pessoa vivendo com DMT1. Na primeira etapa da tese, foram realizados dois estudos transversais que analisaram e mensuraram quais fatores estavam associados à QVRS dos pacientes tratados com IGla U100 (N = 401) e com a insulina NPH (N = 179). Os resultados das duas regressões lineares múltiplas dos dois estudos transversais demonstraram que uma maior QVRS estava associada ao fato de a pessoa ser jovem; ter maior escolaridade; ter autoavaliação de saúde boa ou muito boa; não ter sido acamado e ter praticado exercícios físicos nos últimos 15 dias; ter realizado até três consultas médicas no último ano; não ter sido internado no último ano; ter entre zero e três comorbidades; não ter angina, neuropatia diabética, perda auditiva, doença renal, hipertensão arterial sistêmica ou doença pulmonar obstrutiva crônica; ter poucos episódios de hipoglicemia e não graves. Adicionalmente, os resultados dos dois estudos sugeriram uma barreira de acesso aos medicamentos do Componente Especializado da Assistência Farmacêutica no SUS, uma vez que os pacientes tratados com IGla U100 apresentaram maior nível socioeconômico quando comparados aos pacientes tratados com insulina NPH. Na segunda etapa da tese, foram conduzidos outros dois estudos, sendo uma revisão sistemática de avaliações econômicas e uma análise de custo-utilidade (ACU) das insulinas disponíveis no SUS (ou seja, NPH, IGla U100, IGla U300, IDet e IDeg) em pacientes com DMT1. Os achados da revisão sistemática demonstraram uma baixa padronização nos estudos de avaliações econômicas, falta de transparência dos parâmetros utilizados para alimentar os modelos e o não uso de checklist para a descrição dos trabalhos. Ademais, os resultados da razão de custo-efetividade incremental geralmente favoreceram os patrocinadores dos estudos. Do ponto vista da ACU, os resultados de efetividade, em termos de anos de vida ajustados pela qualidade, apontaram para uma similaridade entre os análogos e a insulina NPH, sendo o custo incremental a principal diferença entre os tratamentos. Esta tese forneceu subsídios teóricos para aprofundar o conhecimento sobre a QVRS e o custo-utilidade da insulinoterapia da pessoa vivendo com DMT1 no Brasil, especialmente os usuários do SUS. Por fim, os dois estudos transversais permitiram entender quais são as variáveis que mais impactaram na QVRS dos pacientes com DMT1 tratados com IGla U100 ou com a insulina NPH no âmbito do SUS. Além disso, os resultados da ACU apontaram para uma similaridade entre os análogos (isto é, IGla U100, IGla U300, IDeg e a IDet) e a insulina NPH, sendo o custo incremental a principal diferença entre as tecnologias.Universidade Federal de Minas GeraisBrasilFARMACIA - FACULDADE DE FARMACIAPrograma de Pós-Graduação em Medicamentos e Assistencia FarmaceuticaUFMGJuliana Alvares Teodorohttp://lattes.cnpq.br/8338204270737352Jéssica Barreto Ribeiro dos SantosGrazielle Dias da SilvaVânia dos Santos Nunes NogueiraPaulo Henrique Ribeiro Fernandes Almeida2023-03-10T15:19:34Z2023-03-10T15:19:34Z2022-06-09info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/doctoralThesisapplication/pdfhttp://hdl.handle.net/1843/50799porhttp://creativecommons.org/licenses/by-nc-nd/3.0/pt/info:eu-repo/semantics/openAccessreponame:Repositório Institucional da UFMGinstname:Universidade Federal de Minas Gerais (UFMG)instacron:UFMG2023-03-10T15:19:35Zoai:repositorio.ufmg.br:1843/50799Repositório InstitucionalPUBhttps://repositorio.ufmg.br/oairepositorio@ufmg.bropendoar:2023-03-10T15:19:35Repositório Institucional da UFMG - Universidade Federal de Minas Gerais (UFMG)false
dc.title.none.fl_str_mv Análogos de insulina humana versus insulina NPH para o tratamento do diabetes mellitus tipo 1: uma avaliação econômica na perspectiva do Sistema Único de Saúde.
title Análogos de insulina humana versus insulina NPH para o tratamento do diabetes mellitus tipo 1: uma avaliação econômica na perspectiva do Sistema Único de Saúde.
spellingShingle Análogos de insulina humana versus insulina NPH para o tratamento do diabetes mellitus tipo 1: uma avaliação econômica na perspectiva do Sistema Único de Saúde.
Paulo Henrique Ribeiro Fernandes Almeida
Sistema único de saúde
Diabetes mellitus tipo 1
Qualidade de vida
Análise de custo-benefício
Insulina isófana
Insulina de ação prolongada
title_short Análogos de insulina humana versus insulina NPH para o tratamento do diabetes mellitus tipo 1: uma avaliação econômica na perspectiva do Sistema Único de Saúde.
title_full Análogos de insulina humana versus insulina NPH para o tratamento do diabetes mellitus tipo 1: uma avaliação econômica na perspectiva do Sistema Único de Saúde.
title_fullStr Análogos de insulina humana versus insulina NPH para o tratamento do diabetes mellitus tipo 1: uma avaliação econômica na perspectiva do Sistema Único de Saúde.
title_full_unstemmed Análogos de insulina humana versus insulina NPH para o tratamento do diabetes mellitus tipo 1: uma avaliação econômica na perspectiva do Sistema Único de Saúde.
title_sort Análogos de insulina humana versus insulina NPH para o tratamento do diabetes mellitus tipo 1: uma avaliação econômica na perspectiva do Sistema Único de Saúde.
author Paulo Henrique Ribeiro Fernandes Almeida
author_facet Paulo Henrique Ribeiro Fernandes Almeida
author_role author
dc.contributor.none.fl_str_mv Juliana Alvares Teodoro
http://lattes.cnpq.br/8338204270737352
Jéssica Barreto Ribeiro dos Santos
Grazielle Dias da Silva
Vânia dos Santos Nunes Nogueira
dc.contributor.author.fl_str_mv Paulo Henrique Ribeiro Fernandes Almeida
dc.subject.por.fl_str_mv Sistema único de saúde
Diabetes mellitus tipo 1
Qualidade de vida
Análise de custo-benefício
Insulina isófana
Insulina de ação prolongada
topic Sistema único de saúde
Diabetes mellitus tipo 1
Qualidade de vida
Análise de custo-benefício
Insulina isófana
Insulina de ação prolongada
description Type 1 diabetes mellitus (T1DM) is a chronic and costly disease both for people who live with it and for governments and society. The economic burden of T1DM is largely due to drug costs and diabetes complications. After the diagnosis of T1DM, treatment must be started immediately, as the lack of endogenous insulin can cause diabetic ketoacidosis. Currently, the Unified Health System (SUS) provides neutral protamine Hagedorn (NPH) as a first-line treatment for patients with T1DM and, as a second-line treatment, the human insulin analogues glargine (IGla U100 and IGla U300), detemir (IDet) and degludec (IDeg). Although some studies show favorable results for insulin analogues, uncertainties remain in terms of health-related quality of life (HRQoL) and cost-utility in relation to NPH insulin, especially in the context of Brazil and SUS. In this sense, the main goal of this thesis was to economically evaluate, from the perspective of SUS, the treatment with human insulin analogues (IGla U100, IGla U300, IDet and IDeg) in comparison to NPH insulin for the treatment of people living with T1DM. In the first stage of the thesis, two cross-sectional studies were carried out that analyzed and measured which factors were associated with the HRQoL of patients treated with IGla U100 (N = 401) and with NPH insulin (N = 179). The results for the two multiple linear regressions of the two cross-sectional studies demonstrated that a higher HRQoL was associated with being young; have higher education; having self-rated health as good or very good; not having been bedridden and having practiced physical activity in the last 15 days; having performed up to three medical consultations in the last year; not having been hospitalized in the last year; have zero to three comorbidities; not having angina, diabetic neuropathy, hearing loss, kidney disease, systemic arterial hypertension or chronic obstructive pulmonary disease; have few, non-severe episodes of hypoglycemia. Additionally, the results of the two studies suggested a barrier to accessing drugs from the Specialized Component of Pharmaceutical Assistance in the SUS, since patients treated with IGla U100 had a higher socioeconomic level when compared to patients treated with NPH insulin. In the second stage of the thesis, two other studies were carried out, one being a systematic review of economic evaluations and a cost-utility analysis (CUA) of the insulins available on SUS (i.e., NPH, IGla U100, IGla U300, IDet and IDeg) for patients with T1DM. The findings of the systematic review demonstrated a low standardization in studies of economic evaluations, lack of transparency of the parameters used to feed the models and the non-use of checklists for the description of the works. Furthermore, incremental cost-effectiveness ratio results generally favored trial sponsors. From the CUA point of view, the effectiveness results, in terms of quality-adjusted life years, pointed to a similarity between the analogues and NPH insulin, with the incremental cost being the main difference between the treatments. This thesis provided theoretical support to deepen knowledge about HRQoL and the cost-utility of insulin therapy for people living with T1DM in Brazil, especially SUS users. Finally, the two cross-sectional studies made it possible to understand which variables had the greatest impact on the HRQoL of patients with T1DM treated with IGla U100 or with NPH insulin in the SUS. In addition, the CUA results pointed to a similarity between the analogues (i.e., IGla U100, IGla U300, IDeg, and IDet) and NPH insulin, with incremental cost being the main difference between the technologies.
publishDate 2022
dc.date.none.fl_str_mv 2022-06-09
2023-03-10T15:19:34Z
2023-03-10T15:19:34Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/doctoralThesis
format doctoralThesis
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://hdl.handle.net/1843/50799
url http://hdl.handle.net/1843/50799
dc.language.iso.fl_str_mv por
language por
dc.rights.driver.fl_str_mv http://creativecommons.org/licenses/by-nc-nd/3.0/pt/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv http://creativecommons.org/licenses/by-nc-nd/3.0/pt/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Universidade Federal de Minas Gerais
Brasil
FARMACIA - FACULDADE DE FARMACIA
Programa de Pós-Graduação em Medicamentos e Assistencia Farmaceutica
UFMG
publisher.none.fl_str_mv Universidade Federal de Minas Gerais
Brasil
FARMACIA - FACULDADE DE FARMACIA
Programa de Pós-Graduação em Medicamentos e Assistencia Farmaceutica
UFMG
dc.source.none.fl_str_mv reponame:Repositório Institucional da UFMG
instname:Universidade Federal de Minas Gerais (UFMG)
instacron:UFMG
instname_str Universidade Federal de Minas Gerais (UFMG)
instacron_str UFMG
institution UFMG
reponame_str Repositório Institucional da UFMG
collection Repositório Institucional da UFMG
repository.name.fl_str_mv Repositório Institucional da UFMG - Universidade Federal de Minas Gerais (UFMG)
repository.mail.fl_str_mv repositorio@ufmg.br
_version_ 1816829815361110016