Eli Lilly and Company, Indianapolis, IN, USA.
TechData Services Company, King of Prussia, PA, USA.
J Med Econ. 2023 Jan-Dec;26(1):149-157. doi: 10.1080/13696998.2023.2165365.
Galcanezumab (GMB) improved quality-of-life and reduced disability of patients with episodic (EM) and chronic migraine (CM) in Phase 3 trials.
To estimate indirect cost savings associated with GMB treatment in patients with migraine in the United States (US).
We analyzed data of patients from the US from three randomized, Phase 3, double-blind, placebo (PBO)-controlled GMB studies: EVOLVE-1 and EVOLVE-2 (EM patients), REGAIN (CM patients). Annual indirect costs were calculated using items of the Migraine Disability Assessment (MIDAS) questionnaire: lost time/productivity at work/school, household work, and leisure time. All costs were annualized and expressed in 2019 US dollars. While the main analysis considered lost time/productivity at work/school and household work as a full day, a sensitivity analysis was performed by discounting them by half. For EM, annual indirect costs savings were estimated using mixed model repeated measures analysis. For CM, ANCOVA models were used to estimate annual indirect costs savings as change from baseline.
The analysis included 805 patients with EM (mean age = 41.4 years; PBO = 534; GMB = 271) and 423 patients with CM (mean age = 38.9 years; PBO = 279; GMB = 144). Compared to PBO, GMB significantly reduced annual indirect costs among patients with EM at 3 months (least square mean [95% confidence interval] work/school = $1,883.6 [603.64-3,163.65], = .0040, household work = $628.9 [352.95-904.88], <.0001, and leisure activity = $499.17 [42.36-955.98], = .0323) and 6 months (work/school = $2,382.29 [1,065.48-3,699.10], = .0004, household work = $559.45 [268.99-849.90], = .0002, and leisure activity = $753.81 [334.35-1,173.27], = .0004), whereas a significant difference was not observed among patients with CM. Sensitivity analysis results were similar to primary analysis results.
GMB treatment versus PBO resulted in significantly greater indirect cost savings in patients with EM through improved productivity at work/school, household work, and leisure days. Patients with CM receiving GMB versus PBO attained greater cost savings, although not statistically significant, through reduced lost productivity at work/school.
加奈珠单抗（GMB）在 3 期临床试验中改善了发作性偏头痛（EM）和慢性偏头痛（CM）患者的生活质量并降低了残疾程度。
评估 GMB 治疗偏头痛患者在美国（US）的间接成本节约。
我们分析了来自美国的三项随机、3 期、双盲、安慰剂（PBO）对照 GMB 研究（EVOLVE-1 和 EVOLVE-2 [EM 患者]、REGAIN [CM 患者]）中患者的数据。使用偏头痛残疾评估（MIDAS）问卷中的项目计算年度间接成本：工作/学校的损失时间/生产力、家务劳动和休闲时间。所有成本均按年计算，并以 2019 年美元表示。主要分析将工作/学校和家务劳动中的损失时间/生产力视为一整天，然后进行敏感性分析，将其折半。对于 EM，使用混合模型重复测量分析估算年度间接成本节约。对于 CM，使用协方差分析模型来估计从基线开始的年度间接成本节约。
分析包括 805 名 EM 患者（平均年龄=41.4 岁；PBO=534；GMB=271）和 423 名 CM 患者（平均年龄=38.9 岁；PBO=279；GMB=144）。与 PBO 相比，GMB 在 3 个月（最小二乘均值[95%置信区间]工作/学校=1883.6[603.64-3163.65]， = .0040，家务劳动=628.9[352.95-904.88]， <.0001，休闲活动=499.17[42.36-955.98]， = .0323）和 6 个月（工作/学校=2382.29[1065.48-3699.10]， = .0004，家务劳动=559.45[268.99-849.90]， = .0002，休闲活动=753.81[334.35-1173.27]， = .0004）时，GMB 显著降低了间接成本，而在 CM 患者中未观察到显著差异。敏感性分析结果与主要分析结果相似。
与 PBO 相比，GMB 治疗可通过提高工作/学校、家务劳动和休闲时间的生产力，使 EM 患者的间接成本显著节约。与 PBO 相比，接受 GMB 治疗的 CM 患者虽然未达到统计学意义，但工作/学校的生产力损失有所减少，从而节省了更多的成本。
