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1.
J Dermatol ; 51(6): 759-771, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38650307

RESUMO

Atopic dermatitis (AD) is a chronic inflammatory skin disease with a significant clinical, economic, and human burden. The JAK1 Atopic Dermatitis Efficacy and Safety (JADE) program's Phase 3 trials demonstrated that as a treatment for moderate-to-severe AD in adults with previous exposure to immunotherapy, abrocitinib showed superior efficacy and safety compared with standard of care (SoC), consisting of topical corticosteroids. This study assessed the cost-effectiveness of abrocitinib with SoC versus SoC alone for this patient population in Japan from a societal perspective. A hybrid decision tree and Markov model were used to capture the initial treatment and long-term maintenance phases. Clinical inputs at 16 weeks were obtained through a Bayesian network meta-analysis of four pivotal trials from the JADE program. Clinical inputs at 52 weeks were derived from the JADE EXTEND trial. Response-specific utility inputs were obtained from published literature. Resource use, costs, and productivity inputs were gathered from Japanese claims analysis, literature, public documents, and expert opinion. Costs and quality-adjusted life years (QALYs) were discounted at 2.0% per year and incremental cost-effectiveness ratios (ICERs) were calculated. Sensitivity and scenario analyses were performed to validate the base case results and explore a payer perspective. Over a lifetime horizon and with the base-case societal perspective, abrocitinib produced a mean gain of 0.75 QALYs, incremental costs of JPY (¥) 2 270 386 (USD [$] 17 265.6), and a resulting ICER of ¥3 034 514 ($23 076.5) per QALY compared with SoC. From a payer perspective, the incremental costs increased to ¥4 476 777 ($34 044.4), with an ICER of ¥5 983 495 ($45 502.6) per QALY. The results were most sensitive to treatment-specific, response-based utility weights, drug costs, and productivity-related inputs. From a Japanese societal perspective, abrocitinib demonstrated superior QALYs and with a willingness-to-pay threshold of ¥5 000 000 ($38 023.4) per QALY, can be considered cost-effective compared with SoC as a treatment for moderate-to-severe AD in adult patients with previous immunosuppressant exposure.


Assuntos
Análise Custo-Benefício , Dermatite Atópica , Pirimidinas , Anos de Vida Ajustados por Qualidade de Vida , Padrão de Cuidado , Humanos , Dermatite Atópica/tratamento farmacológico , Dermatite Atópica/economia , Japão , Adulto , Pirimidinas/economia , Pirimidinas/uso terapêutico , Padrão de Cuidado/economia , Índice de Gravidade de Doença , Sulfonamidas/economia , Sulfonamidas/uso terapêutico , Masculino , Resultado do Tratamento , Feminino , Cadeias de Markov , Corticosteroides/economia , Corticosteroides/uso terapêutico , Corticosteroides/administração & dosagem , Custos de Medicamentos , Análise de Custo-Efetividade
2.
Expert Rev Vaccines ; 23(1): 349-361, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38411109

RESUMO

BACKGROUND: The aim of this study was to evaluate the public health and economic impact of the COVID-19 booster vaccination with BNT162b2 in Japan during an Omicron-dominant period from early 2022. RESEARCH DESIGN AND METHODS: A combined cohort Markov decision tree model estimated the cost-effectiveness of annual or biannual booster vaccination strategies compared to no booster vaccination for those aged 65 years and above, and those aged 60-64 years at high risk as the base case. The societal perspective was primarily considered. We also examined other target populations with different age and risk groups. Sensitivity and scenario analyses with alternative inputs were performed. RESULTS: Annual and biannual vaccination strategies were dominant from the societal perspective in the base case. Incremental Cost Effectiveness Ratios (ICERs) from the payer perspective were JPY 1,752,499/Quality Adjusted Life Year (QALY) for annual vaccination and JPY 2,831,878/QALY for biannual vaccination, both less than the threshold value in Japan (JPY 5 million/QALY). The results were consistent even when examining other target age and risk groups. All sensitivity and scenario analyses indicated that ICERs were below JPY 5 million/QALY. CONCLUSIONS: Booster vaccination with the COVID-19 vaccine BNT162b2 is a dominant strategy and beneficial to public health in Japan.


Assuntos
COVID-19 , Análise de Custo-Efetividade , Humanos , Vacina BNT162 , Japão/epidemiologia , Vacinas contra COVID-19 , Análise Custo-Benefício , COVID-19/epidemiologia , COVID-19/prevenção & controle , Vacinação
3.
Int J Hematol ; 116(4): 500-527, 2022 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-35675024

RESUMO

OBJECTIVES: The Immune Thrombocytopenia (ITP) Life Quality Index (ILQI) is a 10-item patient-reported outcome (PRO) measure developed in US-English to assess health-related quality of life (HRQoL) of adults with ITP. Analysis of ILQI responses indicated differences between Western and non-Western countries. The objective of this study was to translate and linguistically validate the ILQI for Japan and France. METHODS: The ILQI underwent dual forwards/backwards translation with reconciliation and resolution. The translations were reviewed prior to conducting cognitive interviews with ITP patients (n = 5 Japan, n = 5 France). Analysis of interview transcripts highlighted required modifications to the ILQI translations. Japanese and French ITP experts reviewed the final translations for cultural relevance and appropriateness. RESULTS: Most of the Japanese and French forward/backwards translations were reconciled with no revision. The ILQI instructions and items were well understood by Japanese and French participants. Wording in one item of the Japanese version of the ILQI was revised to better align with the source instrument. Three terms/phrases in the French translation were revised due to misunderstanding, being deemed inaccurate or culturally inappropriate. Following review by ITP experts from Japan and France, minor modifications were made. CONCLUSION: Findings confirm the linguistic validity of the ILQI in Japanese and French.


Assuntos
Púrpura Trombocitopênica Idiopática , Qualidade de Vida , Adulto , Humanos , Japão , Linguística , Medidas de Resultados Relatados pelo Paciente , Reprodutibilidade dos Testes , Inquéritos e Questionários
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