Avaliação económica de Fidaxomicina no tratamento de infeções por Clostridium difficile graves ou recorrentes
Autor(a) principal: | |
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Data de Publicação: | 2013 |
Outros Autores: | , , |
Tipo de documento: | Artigo |
Idioma: | por |
Título da fonte: | Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
Texto Completo: | http://hdl.handle.net/10451/33477 |
Resumo: | Objectives: Fidaxomicin is a macrocyclic antibiotic drug indicated for the treatment of Clostridium difficile infections (CDI). The purpose of this study was to evaluate from a societal perspective the cost-effectiveness and cost-utility of fidaxomicin in the treatment of severe or recurrent CDI compared to the recommended alternative therapy, vancomycin. Methods: The effectiveness estimates of fidaxomicin and vancomycin, provided by two clinical trials in addition to other studies, were extrapolated to 10 days cycles and a time horizon of 1 year using a Markov model. The costs considered in the study included medication, hospitalization, complications and outpatient visits. Estimates of the indirect costs generated by productivity losses due to absenteeism were not included, for lack of relevant evidence for the Portuguese reality and because the population affected by CDI tends to be no longer active in the labor market. Results: Over a one year horizon and compared to vancomycin treatment, in the base case, fidaxomicin treatment in patients with severe ICD is associated with a gain of 0.010 QALY and a cost increase of 138 €. The treatment of patients with recurrent CDI with fidaxomicin is associated with a gain of 0.019 QALYs and a cost reduction of 626 €. Fidaxomicin treatment has an acceptable incremental cost-utility ratio in patients with severe CDI (ICUR: 13,245 €/ QALY) and dominates in patients with recurrent CDI (ICUR: -33,701 €/ QALY). Fidaxomicin treatment in patients with severe and recurrent CDI is also associated with a reduction in the number of recurrences (ICER: 321 €/ recurrence avoided in patients with severe CDI and ICER: -828 €/ recurrence avoided in patients with recurrent CDI). These results are sensitive to the cost of hospitalization, decreasing with a rising cost of hospitalization. In the probabilistic sensitivity analysis the model predicts that the probability of cost-effectiveness of fidaxomicin is 44,9% in the case of severe CDI and 58% for recurrent CDI for a willingness to pay threshold of 30.000 €. Conclusions: In the Portuguese health system context, fidaxomicin presents good cost-effectiveness and cost-utility results, representing a valuable addition to the therapeutic arsenal for the treatment of CDI. |
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Avaliação económica de Fidaxomicina no tratamento de infeções por Clostridium difficile graves ou recorrentesClostridium difficile Infections (CDI)DiarrheaCost-utilityCost-effectivenessFidaxomicinObjectives: Fidaxomicin is a macrocyclic antibiotic drug indicated for the treatment of Clostridium difficile infections (CDI). The purpose of this study was to evaluate from a societal perspective the cost-effectiveness and cost-utility of fidaxomicin in the treatment of severe or recurrent CDI compared to the recommended alternative therapy, vancomycin. Methods: The effectiveness estimates of fidaxomicin and vancomycin, provided by two clinical trials in addition to other studies, were extrapolated to 10 days cycles and a time horizon of 1 year using a Markov model. The costs considered in the study included medication, hospitalization, complications and outpatient visits. Estimates of the indirect costs generated by productivity losses due to absenteeism were not included, for lack of relevant evidence for the Portuguese reality and because the population affected by CDI tends to be no longer active in the labor market. Results: Over a one year horizon and compared to vancomycin treatment, in the base case, fidaxomicin treatment in patients with severe ICD is associated with a gain of 0.010 QALY and a cost increase of 138 €. The treatment of patients with recurrent CDI with fidaxomicin is associated with a gain of 0.019 QALYs and a cost reduction of 626 €. Fidaxomicin treatment has an acceptable incremental cost-utility ratio in patients with severe CDI (ICUR: 13,245 €/ QALY) and dominates in patients with recurrent CDI (ICUR: -33,701 €/ QALY). Fidaxomicin treatment in patients with severe and recurrent CDI is also associated with a reduction in the number of recurrences (ICER: 321 €/ recurrence avoided in patients with severe CDI and ICER: -828 €/ recurrence avoided in patients with recurrent CDI). These results are sensitive to the cost of hospitalization, decreasing with a rising cost of hospitalization. In the probabilistic sensitivity analysis the model predicts that the probability of cost-effectiveness of fidaxomicin is 44,9% in the case of severe CDI and 58% for recurrent CDI for a willingness to pay threshold of 30.000 €. Conclusions: In the Portuguese health system context, fidaxomicin presents good cost-effectiveness and cost-utility results, representing a valuable addition to the therapeutic arsenal for the treatment of CDI.Objetivos: A fidaxomicina é um antibiótico pertencente à classe macrocíclica de antibacterianos, com indicação para o tratamento de infeções por Clostridium difficile (ICD). O objetivo deste estudo foi avaliar, na perspetiva da sociedade, o custo-efetividade e o custo-utilidade da fidaxomicina no tratamento de ICD graves ou recorrentes, comparativamente à alternativa terapêutica recomendada, a vancomicina. Métodos: As estimativas de eficácia da fidaxomicina e vancomicina, provenientes de dois ensaios clínicos em conjunto com dados de outros estudos, foram extrapoladas para ciclos de dez dias e um horizonte temporal de um ano, recorrendo a um modelo de Markov. Os custos considerados no estudo incluem os custos da medicação, do internamento, das complicações e das consultas. Não foram considerados os custos indiretos derivados da perda da produtividade por absentismo, quer por falta de evidência direta relevante para a realidade portuguesa quer porque a população afetada pelas ICD tende maioritariamente a já não estar ativa no mercado de trabalho. Resultados: Ao longo de um ano, e comparativamente com tratamento com vancomicina, no cená- rio de base o tratamento com fidaxomicina em doentes com ICD grave está associado a um ganho de 0,010 AVAQ e a um incremento dos custos em € 138. No tratamento de doentes com ICD recorrente, a fidaxomicina está associada a um ganho de 0,019 AVAQ e a um decréscimo de custos de € 626. O tratamento com fidaxomicina corresponde assim a um valor aceitável de custo-efetividade em doentes com ICD grave (ICUR: € 13,245/AVAQ) e é dominante em doentes com ICD recorrente (ICUR: -€ 33,701/AVAQ). O tratamento com fidaxomicina em doentes com ICD grave e doentes com ICD recorrente está também associado a uma redução do número de recorrências (ICER: € 321/recorrência evitada em doentes com ICD grave e ICER: -€ 828/ recorrência evitada em doentes com ICD recorrente). Estes resultados são sensíveis ao custo do internamento, diminuindo com o aumento do custo do internamento. Na análise de sensibilidade probabilística, o modelo prevê que, para um limiar de aceitabilidade de € 30 mil, a probabilidade da fidaxomicina ser custo-efetiva é de 44,9 por cento no caso de ICD grave e de 58 por cento no caso de ICD recorrente. Conclusões: A fidaxomicina tem uma boa relação custo-utilidade no contexto do sistema de saúde português, representando um adicionamento importante ao arsenal terapêutico para o tratamento das ICD.FormifarmaRepositório da Universidade de LisboaGouveia, MiguelCosta, JoãoAlarcão, JoanaBorges, Margarida2018-05-18T10:12:19Z20132013-01-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10451/33477porRev Port Farmacoter. 2013;5:264-2731647-354Xinfo:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2023-11-08T16:28:21Zoai:repositorio.ul.pt:10451/33477Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T21:48:30.141299Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse |
dc.title.none.fl_str_mv |
Avaliação económica de Fidaxomicina no tratamento de infeções por Clostridium difficile graves ou recorrentes |
title |
Avaliação económica de Fidaxomicina no tratamento de infeções por Clostridium difficile graves ou recorrentes |
spellingShingle |
Avaliação económica de Fidaxomicina no tratamento de infeções por Clostridium difficile graves ou recorrentes Gouveia, Miguel Clostridium difficile Infections (CDI) Diarrhea Cost-utility Cost-effectiveness Fidaxomicin |
title_short |
Avaliação económica de Fidaxomicina no tratamento de infeções por Clostridium difficile graves ou recorrentes |
title_full |
Avaliação económica de Fidaxomicina no tratamento de infeções por Clostridium difficile graves ou recorrentes |
title_fullStr |
Avaliação económica de Fidaxomicina no tratamento de infeções por Clostridium difficile graves ou recorrentes |
title_full_unstemmed |
Avaliação económica de Fidaxomicina no tratamento de infeções por Clostridium difficile graves ou recorrentes |
title_sort |
Avaliação económica de Fidaxomicina no tratamento de infeções por Clostridium difficile graves ou recorrentes |
author |
Gouveia, Miguel |
author_facet |
Gouveia, Miguel Costa, João Alarcão, Joana Borges, Margarida |
author_role |
author |
author2 |
Costa, João Alarcão, Joana Borges, Margarida |
author2_role |
author author author |
dc.contributor.none.fl_str_mv |
Repositório da Universidade de Lisboa |
dc.contributor.author.fl_str_mv |
Gouveia, Miguel Costa, João Alarcão, Joana Borges, Margarida |
dc.subject.por.fl_str_mv |
Clostridium difficile Infections (CDI) Diarrhea Cost-utility Cost-effectiveness Fidaxomicin |
topic |
Clostridium difficile Infections (CDI) Diarrhea Cost-utility Cost-effectiveness Fidaxomicin |
description |
Objectives: Fidaxomicin is a macrocyclic antibiotic drug indicated for the treatment of Clostridium difficile infections (CDI). The purpose of this study was to evaluate from a societal perspective the cost-effectiveness and cost-utility of fidaxomicin in the treatment of severe or recurrent CDI compared to the recommended alternative therapy, vancomycin. Methods: The effectiveness estimates of fidaxomicin and vancomycin, provided by two clinical trials in addition to other studies, were extrapolated to 10 days cycles and a time horizon of 1 year using a Markov model. The costs considered in the study included medication, hospitalization, complications and outpatient visits. Estimates of the indirect costs generated by productivity losses due to absenteeism were not included, for lack of relevant evidence for the Portuguese reality and because the population affected by CDI tends to be no longer active in the labor market. Results: Over a one year horizon and compared to vancomycin treatment, in the base case, fidaxomicin treatment in patients with severe ICD is associated with a gain of 0.010 QALY and a cost increase of 138 €. The treatment of patients with recurrent CDI with fidaxomicin is associated with a gain of 0.019 QALYs and a cost reduction of 626 €. Fidaxomicin treatment has an acceptable incremental cost-utility ratio in patients with severe CDI (ICUR: 13,245 €/ QALY) and dominates in patients with recurrent CDI (ICUR: -33,701 €/ QALY). Fidaxomicin treatment in patients with severe and recurrent CDI is also associated with a reduction in the number of recurrences (ICER: 321 €/ recurrence avoided in patients with severe CDI and ICER: -828 €/ recurrence avoided in patients with recurrent CDI). These results are sensitive to the cost of hospitalization, decreasing with a rising cost of hospitalization. In the probabilistic sensitivity analysis the model predicts that the probability of cost-effectiveness of fidaxomicin is 44,9% in the case of severe CDI and 58% for recurrent CDI for a willingness to pay threshold of 30.000 €. Conclusions: In the Portuguese health system context, fidaxomicin presents good cost-effectiveness and cost-utility results, representing a valuable addition to the therapeutic arsenal for the treatment of CDI. |
publishDate |
2013 |
dc.date.none.fl_str_mv |
2013 2013-01-01T00:00:00Z 2018-05-18T10:12:19Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://hdl.handle.net/10451/33477 |
url |
http://hdl.handle.net/10451/33477 |
dc.language.iso.fl_str_mv |
por |
language |
por |
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Rev Port Farmacoter. 2013;5:264-273 1647-354X |
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info:eu-repo/semantics/openAccess |
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openAccess |
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application/pdf |
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Formifarma |
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Formifarma |
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Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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