Faculty of Medicine, Southampton Health Technology Assessments Centre (SHTAC), University of Southampton, Alpha House, Enterprise Road, Southampton Science Park, Southampton, SO16 7NS, UK.
Pharmacoeconomics. 2018 May;36(5):545-553. doi: 10.1007/s40273-017-0608-z.
As part of the National Institute for Health and Care Excellence (NICE) Single Technology Appraisal (STA) process, the manufacturer of reslizumab (Teva) submitted evidence for its clinical and cost effectiveness for the treatment of eosinophilic asthma inadequately controlled by inhaled corticosteroids. NICE commissioned Southampton Health Technology Assessments Centre (SHTAC) as an independent Evidence Review Group (ERG) to provide a critique of the manufacturer's submitted evidence. Reslizumab is compared with best standard of care and omalizumab, for a small 'overlap' population of patients who have both eosinophilic and IgE-mediated severe asthma. This paper provides a summary of the ERG's review of the manufacturer's submission, and summarises the NICE Appraisal Committee's subsequent guidance (issued in August 2017). The ERG considered that there were limitations in the approach proposed by the manufacturer for the exacerbation rate and the utility for severe exacerbation. The company amended their initial analysis, following comments from the ERG and the NICE committee, whereby the incremental cost effectiveness ratio was £29,870 per QALY gained for reslizumab compared with best standard care. The NICE Appraisal Committee (AC) concluded that reslizumab was recommended as an option for the treatment of severe eosinophilic asthma that is inadequately controlled in adults despite maintenance therapy with high-dose inhaled corticosteroids plus another drug, only if (1) the blood eosinophil count has been recorded as 400 cells per microlitre or more and (2) the patient has had three or more asthma exacerbations in the past 12 months, and (3) the company provides reslizumab with the discount agreed in the patient access scheme.
作为英国国家卫生与临床优化研究所(NICE)单一技术评估(STA)程序的一部分,雷西珠单抗(梯瓦)的制造商提交了其用于治疗吸入皮质类固醇治疗控制不佳的嗜酸性粒细胞性哮喘的临床和成本效益证据。NICE 委托南安普敦健康技术评估中心(SHTAC)作为独立的证据审查小组(ERG),对制造商提交的证据进行评估。雷西珠单抗与最佳标准护理和奥马珠单抗进行比较,适用于同时患有嗜酸性粒细胞和 IgE 介导的严重哮喘的患者的小“重叠”人群。本文总结了 ERG 对制造商提交的文件的审查,并总结了 NICE 评估委员会随后发布的指导意见(2017 年 8 月发布)。ERG 认为,制造商提出的用于加重率和严重加重的效用的方法存在局限性。该公司在 ERG 和 NICE 委员会的评论后修改了他们的初步分析,雷西珠单抗与最佳标准护理相比,增量成本效益比为每增加一个质量调整生命年(QALY)增加 29870 英镑。NICE 评估委员会(AC)得出结论,雷西珠单抗被推荐作为成人重度嗜酸性粒细胞性哮喘的治疗选择,尽管维持治疗采用高剂量吸入皮质类固醇加另一种药物,但仍控制不佳,仅在以下情况下:(1)血嗜酸性粒细胞计数记录为每微升 400 个细胞或更高,(2)患者在过去 12 个月中有 3 次或更多哮喘加重,(3)公司按照患者准入计划提供雷西珠单抗的折扣。