Number Needed to Treat and Cost Per Responder Analysis of Anti-CGRP Monoclonal Antibodies for Migraine Prevention in Adults for Whom Prior Preventive Treatments have Failed.

IF 4 3区 医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL
Dimos D Mitsikostas, Susanne F Awad, Rikke Kongerslev, Line Pickering Boserup, Xin Ying Lee, Ravinder Phul, Simona Sacco
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引用次数: 0

Abstract

Introduction: Four monoclonal antibodies (mAbs) targeting calcitonin gene-related peptide (CGRP) signaling are approved for migraine prevention and commonly prescribed/reimbursed after the failure of repurposed anti-migraine medications. Participants achieving clinical response [e.g., ≥ 50% monthly migraine days (MMDs) reduction] during an anti-CGRP mAb trial are likely to continue treatment. We calculated number needed to treat (NNT) and quarterly cost per responder (CPR) across four anti-CGRP mAbs.

Methods: Data were from randomized, double-blind, placebo-controlled phase 3b clinical trials that evaluated anti-CGRP mAbs (eptinezumab, fremanezumab, galcanezumab, erenumab) for migraine prevention in adults with episodic or chronic migraine for whom 2-4 prior preventive treatments have failed. NNT was calculated as 1 divided by absolute risk reduction (difference between active treatment and placebo in the proportion of participants with ≥ 50% or ≥ 75% MMD reduction over Weeks 1-12). CPR was calculated by multiplying NNT by the quarterly (3-month) drug acquisition CPR (£), based on the reimbursed list price in the United Kingdom (CPR could not be calculated for eptinezumab 300 mg). Statistical comparisons were not made.

Results: All anti-CGRP mAbs demonstrated higher rates of ≥ 50% and ≥ 75% MMD reduction than their respective placebo (p < 0.05). The NNT to achieve ≥ 50% MMD reduction ranged from 2.7 (eptinezumab 300 mg) to 6.0 (erenumab 140 mg), and for ≥ 75%, 6.0 (eptinezumab 300 mg) to 16.2 (fremanezumab 675 mg/q). The cost per ≥ 50% responder ranged from £4647 (eptinezumab 100 mg) to £7009 (erenumab 140 mg), and for ≥ 75%, £9850 (eptinezumab 100 mg) to £21,862 (fremanezumab 675 mg/q).

Conclusions: These results show that, for most anti-CGRP mAbs, a low number of participants (< 10) with migraine need to be treated to achieve one person with a ≥ 50% or ≥ 75% reduction in MMDs over Weeks 1-12, with CPR ranging from £4647 (eptinezumab 100 mg) to £21,862 (fremanezumab 675 mg/q).

抗cgrp单克隆抗体预防既往预防治疗失败的成人偏头痛所需治疗数量和每个应答者的成本分析
四种靶向降钙素基因相关肽(CGRP)信号传导的单克隆抗体(mab)被批准用于偏头痛预防,并在重新使用抗偏头痛药物失败后经常处方/报销。在抗cgrp单抗试验中达到临床缓解的参与者(例如,每月偏头痛天数减少≥50%)可能会继续治疗。我们计算了四种抗cgrp单克隆抗体所需治疗的数量(NNT)和每个应答者的季度成本(CPR)。方法:数据来自随机、双盲、安慰剂对照的3b期临床试验,这些临床试验评估了抗cgrp单克隆抗体(eptinezumab、fremanezumab、galcanezumab、erenumab)对2-4例既往预防治疗失败的成人发作性或慢性偏头痛的预防作用。NNT计算为1除以绝对风险降低(1-12周内,积极治疗与安慰剂治疗中MMD降低≥50%或≥75%的参与者比例的差异)。CPR是通过NNT乘以季度(3个月)药物获取CPR(£)来计算的,基于英国的报销目录价格(eptinezumab 300 mg无法计算CPR)。没有进行统计比较。结果:所有抗cgrp单克隆抗体均比相应的安慰剂显示出更高的MMD降低率≥50%和≥75% (p)。结论:这些结果表明,对于大多数抗cgrp单克隆抗体,参与者(
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来源期刊
Advances in Therapy
Advances in Therapy 医学-药学
CiteScore
7.20
自引率
2.60%
发文量
353
审稿时长
6-12 weeks
期刊介绍: Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
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