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Aim: To perform a cost-effectiveness analysis comparing axicabtagene ciloleucel (axi-cel) with standard of care (SoC; salvage chemoimmunotherapy, followed by high-dose therapy with autologous stem cell rescue for responders) for second-line (2L) treatment of adults with relapsed or refractory large B-cell lymphoma (r/r LBCL) in the pivotal ZUMA-7 trial data from a Japanese payer perspective.Materials & methods: A three-state partitioned survival model was utilized using population and clinical inputs from the ZUMA-7 trial data over a lifetime horizon.Results: Axi-cel was associated with greater incremental quality-adjusted life-years (2.06) and higher incremental total costs ($48,685.59/¥6.9 million) leading to an incremental cost-effectiveness ratio of $23,590.34/¥3.3 million per quality-adjusted life-years compared with SoC.Conclusion: Axi-cel is a cost-effective treatment alternative to SoC for 2L treatment of adults with r/r LBCL.
[Box: see text].
Asunto(s)
Productos Biológicos , Análisis Costo-Beneficio , Linfoma de Células B Grandes Difuso , Años de Vida Ajustados por Calidad de Vida , Nivel de Atención , Humanos , Japón , Productos Biológicos/economía , Productos Biológicos/uso terapéutico , Linfoma de Células B Grandes Difuso/terapia , Linfoma de Células B Grandes Difuso/economía , Linfoma de Células B Grandes Difuso/tratamiento farmacológico , Inmunoterapia Adoptiva/economía , Inmunoterapia Adoptiva/métodos , Femenino , Masculino , Persona de Mediana Edad , Adulto , Antígenos CD19/economía , Antígenos CD19/uso terapéutico , Antígenos CD19/inmunología , Receptores de Antígenos de Linfocitos T/uso terapéutico , AncianoRESUMEN
Aim: Cost-effectiveness analysis (CEA) was performed to compare axicabtagene ciloleucel (axi-cel) with tisagenlecleucel (tisa-cel) and lisocabtagene (liso-cel) for treatment of relapsed or refractory large B-cell lymphoma in adult patients after ≥2 lines of therapy in Japan. Materials & methods: Cost-effectiveness analysis was conducted using the partition survival mixture cure model based on the ZUMA-1 trial and adjusted to the JULIET and TRANSCEND trials using matching-adjusted indirect comparisons. Results & conclusion: Axi-cel was associated with greater incremental life years (3.13 and 2.85) and incremental quality-adjusted life-years (2.65 and 2.24), thus generated lower incremental direct medical costs (-$976.29 [-¥137,657] and -$242.00 [-¥34,122]), compared with tisa-cel and liso-cel. Axi-cel was cost-effective option compared with tisa-cel and liso-cel from a Japanese payer's perspective.
[Box: see text].
Asunto(s)
Análisis Costo-Beneficio , Años de Vida Ajustados por Calidad de Vida , Humanos , Japón/epidemiología , Masculino , Femenino , Linfoma de Células B Grandes Difuso/tratamiento farmacológico , Linfoma de Células B Grandes Difuso/economía , Linfoma de Células B Grandes Difuso/mortalidad , Antígenos CD19/economía , Antígenos CD19/inmunología , Antígenos CD19/uso terapéutico , Receptores de Antígenos de Linfocitos T/uso terapéutico , Inmunoterapia Adoptiva/economía , Inmunoterapia Adoptiva/métodos , Persona de Mediana Edad , Adulto , Vacunas contra el Cáncer/economía , Vacunas contra el Cáncer/administración & dosificación , Anciano , Productos Biológicos/economía , Productos Biológicos/uso terapéutico , Análisis de Costo-EfectividadRESUMEN
This study aimed to investigate the association between daily sleep duration of <7 hours and lower bone mineral density (BMD) using data from annual health check-ups conducted in Japan between 2020 and 2022. Multivariate regression models were used, where BMD was the objective variable and daily sleep duration (<5 hours, 5 to <7 hours, 7 to <9 hours [reference], ≥9 hours) was the exposure variable adjusted for age, body mass index, physical activity, smoking status, and alcohol intake for men and women and further adjusted for menopausal status for women. The association between insomnia and BMD was also investigated. BMD was determined using calcaneal quantitative ultrasound and expressed as a percentage of the young adult mean (%YAM). In total, 896 men and 821 women were included. Median age was 54 years (interquartile range [IQR]: 46 to 64) for men and 55 years (IQR: 46 to 64) for women). Median BMD for men and women was 79%YAM (IQR: 71 to 89) and 75%YAM (IQR: 68 to 84), respectively. Approximately 80% of men and women slept <7 hours daily. Multivariate regression showed no association between sleep duration and BMD in men. However, women who slept 5 to <7 hours daily had significantly higher BMD by 3.9% compared with those who slept 7 to<9 hours (p = 0.004). No association between insomnia and BMD was found. Overall, a daily sleep duration of <7 hours was not independently associated with lower BMD compared to those who slept 7 to <9 hours in men and women. However, as there is evidence of both shorter and longer sleep durations being associated with an increased risk of adverse events, including cardiovascular events, our result needs to be interpreted with caution. © 2023 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.
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Objective: To describe characteristics of patient with severe stroke (FIM motor score [FIM motor] 20-49 at admission) and examine association between pre-specified factors (age, sex, modified Rankin Scale before stroke onset, body mass index, FIM motor, and FIM cognitive) and time to achieve FIM motor ≥70, that is, self-independent level. Design: Retrospective cohort study using a large database in Japan. Setting: Rehabilitation wards. Participants: Patients with severe stroke (N=1422) who received inpatient rehabilitation were included (median age: 76 years; interquartile range [IQR]: 68.0-84.0). A total of 54.6% were men, and 65.8% were ischemic stroke. Interventions: Not applicable. Main Outcome Measures: Time to achieve FIM motor ≥70. Results: After inpatient rehabilitation, 40.4% (N=575) achieved FIM motor ≥70 (admission FIM motor 20-29, 30-39 and 40-49: 18.6%, 33.6%, and 47.8%, respectively). Patients who achieved FIM motor ≥70 stayed median 81.0 days [IQR, 51.0-120.0]) and received median: 6.94 units per day [IQR, 5.48-7.78], 1 unit=20 minutes). Adjusted Fine-Gray regression revealed that shorter time to achieve FIM motor ≥70 was associated with higher admission FIM motor (hazard ratio [HR] 2.87 [95% confidence interval [CI] 2.27-3.62]: 20-29 vs 40-49), higher admission FIM cognitive (HR 1.81 [95% CI: 1.39-2.35]: 5-14 vs 25-35), and younger (HR 3.20 [95% CI: 2.32-4.42]: ≥85 years vs 20-69 years). Conclusions: Most patients with severe stroke did not achieve FIM motor ≥70 after inpatient rehabilitation. Older patients and patients with lower admission FIM motor require more attention. They should be prioritized for state-of-the-art rehabilitation therapy.