Mwamburi Mkaya, Liebler Eric J, Staats Peter S
profecyINTEL, LLC, Bridgewater, NJ. Email:
Am J Manag Care. 2020 Feb;26(1 Suppl):S15-S19. doi: 10.37765/ajmc.2020.42545.
gammaCore is cleared by the FDA for acute and preventive treatment of cluster headache and the acute treatment of migraine in adults. Previously, only 2 treatments were approved for acute treatment of cluster headache while none were approved for preventive treatment. Following the initial FDA clearance, based on the ACT-1 and ACT-2 studies, a gammaCore Patient Registry (GPR) was designed to provide insights on the use of gammaCore and prescription patterns in the real-world setting and to characterize respective benefits and challenges during the acute treatment of episodic cluster headache. GPR was a prospective observational registry in which patients with episodic cluster headache (3rd edition of the International Classification of Headache Disorders criteria) who were prescribed gammaCore were invited to voluntarily enroll and provide information on their experiences between July 2017 and June 2018. Participants provided baseline information and were trained to self-administer treatment with gammaCore for cluster pain. Participants were also requested to record information for each cluster attack. Of the 182 patients who provided baseline demographic and cluster headache characteristics, 152 provided health index baseline data using EuroQol Health Index tool, 5-level format (EQ5D-5L) and 17 patients provided attack data on a total of 192 cluster headache attacks. The mean age was 49 years; 65% were male and 82% were white; the mean number of months of known diagnosis of cluster headache was 57; the mean number of attacks per cluster headache 4-week period was 14; and the mean pain score was 3.7 (0-4 scale) with a mean attack duration of 74 minutes. Sixty-seven percent of patients had used preventive treatments and 83% had used abortive treatments for cluster headaches; 25% of participants reported at least 1 comorbidity. The mean EQ5D-5L score (scale 0-1) was 0.83. Of the 192 cluster headache attacks reported, gammaCore was used in 116 (60%) attacks. Within this group, the mean pain score at the start of the attacks was 2.7, the mean number of stimulations used was 3.6, and the pain score after 30 minutes was 1.3. At 30 minutes, the pain of 81 (70%) attacks was reduced to none (27%) or mild (43%) (a pain score of 0 or 1) and in 94 (81%) attacks, patients experienced a reduction of at least 1 point in the pain score. This real-world observational evidence suggests that gammaCore adds clinically meaningful value to patients with episodic cluster headache by providing rapid pain relief and confirms that there is significant interest among prescribers in providing this new treatment and technology. This evidence further supports the need to redefine gammaCore as no longer investigational or experimental during considerations for reimbursement.
伽马刀已获得美国食品药品监督管理局（FDA）批准，用于成人丛集性头痛的急性和预防性治疗以及偏头痛的急性治疗。此前，仅有两种治疗方法被批准用于丛集性头痛的急性治疗，而没有一种被批准用于预防性治疗。在获得FDA的初步批准后，基于ACT - 1和ACT - 2研究，设计了伽马刀患者登记处（GPR），以了解伽马刀在现实环境中的使用情况和处方模式，并确定发作性丛集性头痛急性治疗期间的各自益处和挑战。GPR是一项前瞻性观察性登记研究，邀请被处方使用伽马刀的发作性丛集性头痛患者（符合《国际头痛疾病分类》第3版标准）在2017年7月至2018年6月期间自愿登记并提供其治疗经历的信息。参与者提供了基线信息，并接受了使用伽马刀自我治疗丛集性疼痛的培训。参与者还被要求记录每次丛集性发作的信息。在提供基线人口统计学和丛集性头痛特征的182名患者中，152名使用欧洲生活质量健康指数工具（5级格式，EQ5D - 5L）提供了健康指数基线数据，17名患者提供了总共192次丛集性头痛发作的发作数据。平均年龄为49岁；65%为男性，82%为白人；已知丛集性头痛诊断的平均月数为57个月；每4周丛集性头痛发作的平均次数为14次；平均疼痛评分为3.7（0 - 4分制），平均发作持续时间为74分钟。67%的患者曾使用预防性治疗，83%的患者曾使用丛集性头痛的终止性治疗；25%的参与者报告至少有一种合并症。平均EQ5D - 5L评分（0 - 1分制）为0.83。在报告的192次丛集性头痛发作中，116次（60%）发作使用了伽马刀。在这组发作中，发作开始时的平均疼痛评分为2.7，平均使用的刺激次数为3.6，30分钟后的疼痛评分为1.3。在30分钟时，81次（70%）发作的疼痛减轻至无（27%）或轻度（43%）（疼痛评分为0或1），在94次（81%）发作中，患者的疼痛评分至少降低了1分。这一现实世界的观察证据表明，伽马刀通过提供快速的疼痛缓解为发作性丛集性头痛患者增加了临床有意义的价值，并证实了开处方者对提供这种新治疗方法和技术有浓厚兴趣。这一证据进一步支持了在考虑报销时将伽马刀重新定义为不再是研究性或实验性的必要性。
