阿托格潘与利美昔康预防性治疗发作性偏头痛的每次治疗应答成本分析。

IF 5.4 2区 医学 Q1 CLINICAL NEUROLOGY Headache Pub Date : 2024-11-01 Epub Date: 2024-09-09 DOI:10.1111/head.14824
Jessica Ailani, Pranav Gandhi, Anjana Lalla, Rashmi Halker Singh, Peter McAllister, Jonathan H Smith, Brett Dabruzzo, Natty Chalermpalanupap, Kari Kelton, Stephanie J Nahas
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引用次数: 0

摘要

目的估算在美国阿托格潘和利美昔康与安慰剂相比用于发作性偏头痛(EM)预防性治疗的治疗人数和每名额外应答者的成本:背景:偏头痛对患者的日常活动和生活质量产生巨大影响,并给个人和社会带来严重的临床和经济负担。了解口服降钙素基因相关肽受体拮抗剂(gepants)在预防治疗偏头痛方面的疗效比较和经济价值非常重要。目前,美国食品和药物管理局已批准阿托吉潘和利美昔班用于偏头痛的预防性治疗(利美昔班用于偏头痛,阿托吉潘用于偏头痛和慢性偏头痛)。由于缺乏头对头试验,我们采用了间接治疗比较的方法,对预防性治疗偏头痛的临床试验中的疗效数据进行比较。我们估算了需要治疗的人数(这是临床实践中用于比较治疗效果的重要指标)和每增加一名应答者的成本(这可用于确定治疗的成本效益):利用阿托吉潘(ADVANCE)和利美昔康(BHV3000-305)注册试验的公开数据,对阿托吉潘60毫克、每日一次和利美昔康75毫克、隔日一次作为EM预防性治疗的疗效进行了间接治疗比较。关注的疗效结果是每月偏头痛/头痛的平均天数比基线减少≥50%(应答率≥50%),基本情况分析和两种情况分析对这一结果的定义各不相同。计算并比较了两种治疗方法(在基础病例分析中为第9-12周;在情景分析中为阿托吉潘的第1-12周和第9-12周,以及利美君的第9-12周)的治疗所需人数和每额外应答者相对于安慰剂的成本:在基础病例分析中,阿托格班的≥50%应答率为64.9%(95%置信区间[CI],53.9-74.5),利美君的≥50%应答率为51.8%(95%置信区间,42.9-60.6),而安慰剂的≥50%应答率为44.1%(95%置信区间,39.4-49.0)。在基础方案中,阿托格潘与安慰剂相比所需的治疗人数中位数为 4.8(95% CI,3.1-9.0),而利美昔康为 13.0(95% CI,5.9-75.1)。在基础方案中,与安慰剂相比,阿托吉潘每增加一名应答者的成本估计为15,823美元(95% CI,11,079-29,516美元),而利美昔康为73,029美元(95% CI,32,901-422,104美元)。两种情况分析的结果与基础病例分析一致:在所有评估方案中,阿托格潘与安慰剂相比,在预防性治疗急性心肌梗死方面,阿托格潘的治疗人数和每名额外应答者的成本均大大低于利美君。这些分析表明,在预防性治疗EM方面,阿托格潘可能比利美昔班更具成本效益。局限性包括纳入/排除标准的差异以及不同试验之间≥50%应答率报告的差异。
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Cost per treatment responder analysis of atogepant compared to rimegepant for the preventive treatment of episodic migraine.

Objective: To estimate the number needed to treat and cost per additional responder for atogepant and rimegepant versus placebo for the preventive treatment of episodic migraine (EM) in the United States.

Background: Migraine has an enormous impact on a person's daily activities and quality of life, and results in significant clinical and economic burden to both individuals and society. It is important to understand the comparative efficacy and economic value of oral calcitonin gene-related peptide receptor antagonists (gepants) for preventive treatment of EM. Currently, atogepant and rimegepant are US Food and Drug Administration approved for preventive treatment of migraine (rimegepant for EM and atogepant for EM and for chronic migraine). In the absence of head-to-head trials, we utilized an indirect treatment comparison on efficacy data from clinical trials conducted for the preventive treatment of EM. We estimated number needed to treat, a valuable metric used in clinical practice to compare treatment efficacy, and cost per additional responder, which can be used to establish the cost effectiveness of a treatment.

Methods: An indirect treatment comparison was conducted to compare the efficacy of atogepant 60 mg once daily and rimegepant 75 mg once every other day as preventive treatments for EM using published data from the registrational trials of atogepant (ADVANCE) and rimegepant (BHV3000-305). The efficacy outcome of interest was ≥50% reduction from baseline in mean monthly migraine/headache days (≥50% responder rate), which was variably defined for a base case and two scenario analyses. Number needed to treat and cost per additional responder versus placebo were calculated and compared between both treatments (weeks 9-12 in the base case analysis; weeks 1-12 and 9-12 for atogepant and during weeks 9-12 for rimegepant in the scenario analyses).

Results: In the base case analysis, ≥50% responder rates were 64.9% (95% confidence interval [CI], 53.9-74.5) for atogepant and 51.8% (95% CI, 42.9-60.6) for rimegepant, compared to 44.1% (95% CI, 39.4-49.0) for placebo. The median number needed to treat versus placebo in the base case scenario was 4.8 (95% CI, 3.1-9.0) for atogepant compared to 13.0 (95% CI, 5.9-75.1) for rimegepant. The cost per additional responder versus placebo in the base case scenario was estimated to be $15,823 (95% CI, $11,079-$29,516) for atogepant compared to $73,029 (95% CI, $32,901-$422,104) for rimegepant. Results of the two scenario analyses were consistent with the base case analysis.

Conclusions: Atogepant had substantially lower numbers needed to treat and costs per additional responder versus placebo than rimegepant for the preventive treatment of EM across all evaluated scenarios. These analyses suggest that atogepant may be more cost effective than rimegepant for the preventive treatment of EM. Limitations include differences in inclusion/exclusion criteria and in reporting of the ≥50% responder rates between trials.

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来源期刊
Headache
Headache 医学-临床神经学
CiteScore
9.40
自引率
10.00%
发文量
172
审稿时长
3-8 weeks
期刊介绍: Headache publishes original articles on all aspects of head and face pain including communications on clinical and basic research, diagnosis and management, epidemiology, genetics, and pathophysiology of primary and secondary headaches, cranial neuralgias, and pains referred to the head and face. Monthly issues feature case reports, short communications, review articles, letters to the editor, and news items regarding AHS plus medicolegal and socioeconomic aspects of head pain. This is the official journal of the American Headache Society.
期刊最新文献
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