发作性或慢性偏头痛患者的年度间接成本节约：加奈珠单抗多项临床试验的事后分析。

Annual indirect cost savings in patients with episodic or chronic migraine: post-hoc analyses from multiple galcanezumab clinical trials.

机构信息

Neurosciences Clinic, Banner University Medical Center, Phoenix, AZ, USA.

Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.

出版信息

J Med Econ. 2022 Jan-Dec;25(1):630-639. doi: 10.1080/13696998.2022.2071528.

DOI:10.1080/13696998.2022.2071528

PMID:35510376

Abstract

AIM

This post-hoc analysis estimated annual indirect cost savings with galcanezumab (GMB) treatment in patients with episodic migraine (EM) or chronic migraine (CM).

METHODS

Data from 4 randomized, Phase 3, double-blind (DB), placebo (PBO)-controlled studies of GMB were analyzed: EVOLVE-1 and EVOLVE-2 (EM, 6-months DB), REGAIN (CM, 3-months DB), and CONQUER (previous failure of 2-4 migraine preventive medication categories, 3-months DB). Indirect costs were calculated at baseline and Month 3 using the first 2 items in Migraine Disability Assessment (MIDAS): (A + B)/60*country specific annual wage (A = days of missed work/school; B = days of reduced productivity at work/school; assuming 60 working days in 3 months). All costs were annualized and expressed in international dollars (Int$) in 2018. ANCOVA models estimated the indirect cost savings as a change from baseline. Secondary analyses determined cost savings by employment and responder status.

RESULTS

Patients (>80% females) from EVOLVE-1 and -2 ( = 1,201; mean age 41.9 years), REGAIN ( = 759; mean age 41.3 years), and CONQUER ( = 453; mean age ∼46.0 years) were analyzed. GMB showed significant indirect cost savings for EM (Int$6256, < .0001) and CM (Int$7129, = .0002), with substantial savings for patients with previous failure of 2-4 migraine preventive medication categories (EM: Int$5664, = .0030; CM: Int$5181, = .1300). Compared with PBO, GMB showed significantly greater indirect cost savings for EM ( = .0156) and patients with previous failure of 2-4 migraine preventive medication categories ( = .0340). Employed patients with CM ( = .0018) and with previous failure of 2-4 migraine preventive medication categories ( < .0001) had significant cost savings after GMB treatment. GMB showed significant indirect cost savings in patients with a reduction in migraine headache days.

CONCLUSION

GMB treatment resulted in annual indirect cost savings in patients with EM, CM, and with previous failure of 2-4 migraine preventive medication categories, with similar observations in the sensitivity analyses.

摘要

目的

本事后分析评估了加奈珠单抗（GMB）治疗发作性偏头痛（EM）或慢性偏头痛（CM）患者的年度间接成本节省。

方法

分析了四项随机、3 期、双盲（DB）、安慰剂（PBO）对照的 GMB 研究的数据：EVOLVE-1 和 EVOLVE-2（EM，6 个月 DB）、REGAIN（CM，3 个月 DB）和 CONQUER（先前偏头痛预防药物治疗失败 2-4 类，3 个月 DB）。使用偏头痛残疾评估（MIDAS）的前两个条目，在基线和第 3 个月计算间接成本：（A+B）/60*国家特定的年度工资（A=旷工/休学天数；B=工作/上学时生产力下降天数；假设 3 个月内有 60 个工作日）。所有成本均按年度计算，并以 2018 年的国际元（Int$）表示。ANCOVA 模型估计了从基线开始的间接成本节省。二次分析确定了按就业和应答者状态的成本节省。

结果

对来自 EVOLVE-1 和 -2（n=1201；平均年龄 41.9 岁）、REGAIN（n=759；平均年龄 41.3 岁）和 CONQUER（n=453；平均年龄约 46.0 岁）的患者进行了分析。GMB 显示 EM（Int$6256，<.0001）和 CM（Int$7129，=0.0002）的间接成本有显著节省，对于先前偏头痛预防药物治疗失败 2-4 类别的患者有较大的节省（EM：Int$5664，=0.0030；CM：Int$5181，=0.1300）。与 PBO 相比，GMB 在 EM（=0.0156）和先前偏头痛预防药物治疗失败 2-4 类别的患者（=0.0340）中显示出显著更大的间接成本节省。CM 在职患者（=0.0018）和先前偏头痛预防药物治疗失败 2-4 类别的患者（<.0001）在接受 GMB 治疗后有显著的成本节省。在偏头痛头痛天数减少的患者中，GMB 显示出显著的间接成本节省。