PDF(Pubmed)
Abstract：
BACKGROUND: Monoclonal antibodies (mAbs) targeting the Calcitonin Gene-Related Peptide (CGRP) pathway are safe and effective treatments for migraine prevention. However, the high cost of these novel therapies has led to reimbursement policies requiring patients to try multiple traditional preventives before access. In Germany, a recent change in insurance policy significantly expanded coverage for the CGRP receptor mAb erenumab, enabling migraine patients who failed just one prior prophylactic medication to receive this mAb. Here, we compare the clinical response to treatment with erenumab in migraine patients treated using the old and new coverage policy.
METHODS: In this retrospective cohort study, we included CGRP-mAb naïve patients with episodic or chronic migraine, who started erenumab at our headache center according to either the old or the new insurance policy and received at least 3 consecutive injections. Headache diaries and electronic documentation were used to evaluate reductions in monthly headache and migraine days (MHD and MMD) and ≥ 50% and ≥ 30% responder rates at month 3 (weeks 9-12) of treatment.
RESULTS: We included 146 patients who received erenumab according to the old policy and 63 patients that were treated using the new policy. At weeks 9-12 of treatment, 37.7% of the old policy group had a 50% or greater reduction in MHD, compared to 63.5% of the new policy group (P < 0.001). Mean reduction in MHD was 5.02 days (SD = 5.46) and 6.67 days (SD = 5.32, P = 0.045) in the old and new policy cohort, respectively. After propensity score matching, the marginal effect of the new policy on treatment outcome was 2.29 days (standard error, SE: 0.715, P = 0.001) more reduction in MHD, and 30.1% (SE: 10.6%, P = 0.005) increase in ≥ 50% response rate for MHD.
CONCLUSIONS: Starting erenumab earlier in the course of migraine progression in a real-world setting may lead to a better response than starting after multiple failed prophylactic attempts. Continually gathering real-world evidence may help policymakers in deciding how readily to cover CGRP-targeted therapies in migraine prevention.
METHODS: In this retrospective cohort study, we included CGRP-mAb naïve patients with episodic or chronic migraine, who started erenumab at our headache center according to either the old or the new insurance policy and received at least 3 consecutive injections. Headache diaries and electronic documentation were used to evaluate reductions in monthly headache and migraine days (MHD and MMD) and ≥ 50% and ≥ 30% responder rates at month 3 (weeks 9-12) of treatment.
RESULTS: We included 146 patients who received erenumab according to the old policy and 63 patients that were treated using the new policy. At weeks 9-12 of treatment, 37.7% of the old policy group had a 50% or greater reduction in MHD, compared to 63.5% of the new policy group (P < 0.001). Mean reduction in MHD was 5.02 days (SD = 5.46) and 6.67 days (SD = 5.32, P = 0.045) in the old and new policy cohort, respectively. After propensity score matching, the marginal effect of the new policy on treatment outcome was 2.29 days (standard error, SE: 0.715, P = 0.001) more reduction in MHD, and 30.1% (SE: 10.6%, P = 0.005) increase in ≥ 50% response rate for MHD.
CONCLUSIONS: Starting erenumab earlier in the course of migraine progression in a real-world setting may lead to a better response than starting after multiple failed prophylactic attempts. Continually gathering real-world evidence may help policymakers in deciding how readily to cover CGRP-targeted therapies in migraine prevention.
摘要：
背景：靶向降钙素基因相关肽（CGRP）途径的单克隆抗体（mAb）是预防偏头痛的安全有效的治疗方法。然而,这些新疗法的高成本导致报销政策要求患者在获得治疗前尝试多种传统的预防措施.在德国,最近保险政策的变化显著扩大了CGRP受体mAberenumab的覆盖范围，使偏头痛患者未能获得一种预防性药物治疗。这里,我们比较了使用新旧覆盖政策治疗的偏头痛患者对erenumab治疗的临床反应.
方法：在这项回顾性队列研究中，我们纳入了CGRP-mAb初治发作性或慢性偏头痛患者，根据旧的或新的保险单，他们在我们的头痛中心开始了erenumab，并接受了至少3次连续注射。使用头痛日记和电子文档来评估每月头痛和偏头痛天数（MHD和MMD）的减少以及治疗第3个月（第9-12周）时≥50％和≥30％的应答率。
结果：我们纳入了146名根据旧政策接受erenumab治疗的患者和63名使用新政策治疗的患者。在治疗的第9-12周，37.7%的旧政策组的MHD减少了50%或更多，与新政策组的63.5%相比(P<0.001)。在新旧政策队列中，MHD的平均减少为5.02天（SD=5.46）和6.67天（SD=5.32，P=0.045），分别。在倾向得分匹配后，新政策对治疗结果的边际效应为2.29天(标准误差，SE：0.715，P=0.001）MHD降低更多，和30.1%(SE：10.6%，P=0.005)增加≥50%的MHD应答率。
结论：在真实世界环境中，在偏头痛进展过程中更早开始使用erenumab可能导致比在多次预防性尝试失败后开始更好的反应。不断收集现实世界的证据可能有助于政策制定者决定如何在偏头痛预防中轻松覆盖CGRP靶向治疗。
方法：在这项回顾性队列研究中，我们纳入了CGRP-mAb初治发作性或慢性偏头痛患者，根据旧的或新的保险单，他们在我们的头痛中心开始了erenumab，并接受了至少3次连续注射。使用头痛日记和电子文档来评估每月头痛和偏头痛天数（MHD和MMD）的减少以及治疗第3个月（第9-12周）时≥50％和≥30％的应答率。
结果：我们纳入了146名根据旧政策接受erenumab治疗的患者和63名使用新政策治疗的患者。在治疗的第9-12周，37.7%的旧政策组的MHD减少了50%或更多，与新政策组的63.5%相比(P<0.001)。在新旧政策队列中，MHD的平均减少为5.02天（SD=5.46）和6.67天（SD=5.32，P=0.045），分别。在倾向得分匹配后，新政策对治疗结果的边际效应为2.29天(标准误差，SE：0.715，P=0.001）MHD降低更多，和30.1%(SE：10.6%，P=0.005)增加≥50%的MHD应答率。
结论：在真实世界环境中，在偏头痛进展过程中更早开始使用erenumab可能导致比在多次预防性尝试失败后开始更好的反应。不断收集现实世界的证据可能有助于政策制定者决定如何在偏头痛预防中轻松覆盖CGRP靶向治疗。
