Fournier Marie, Chen Chieh-I, Kuznik Andreas, Proudfoot Clare, Mallya Usha G, Michaud Kaleb
Health Economics & Value Assessment, Sanofi France, Chilly-Mazarin, France,
Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Clinicoecon Outcomes Res. 2019 Feb 5;11:117-128. doi: 10.2147/CEOR.S183076. eCollection 2019.
Treatment outcomes and direct medical costs were examined, from a US health payer perspective, of monotherapy with sarilumab 200 mg subcutaneous (SC) every 2 weeks (Q2W) vs adalimumab 40 mg SC Q2W/QW in adult patients with moderately to severely active rheumatoid arthritis who are intolerant of, inadequate responders to, or considered inappropriate candidates for continued methotrexate treatment.
Short-term analysis was based on 24-week wholesale acquisition costs of drugs and treatment response observed in the MONARCH Phase III trial (NCT02332590) per American College of Rheumatology (ACR) 20/50 criteria and European League Against Rheumatism (EULAR) Moderate/Good Disease Activity Score 28-joint count erythrocyte sedimentation rate. Long-term analysis, which also considered drug administration and routine care costs, was conducted via a 6-month decision tree and a 1- to 10-year Markov model with microsimulation of patient profiles from the MOBILITY Phase III trial (NCT01061736). Utilities and quality-adjusted life-years (QALYs) were estimated by mapping 6-month ACR levels to a relative change in Health Assessment Questionnaire - Disability Index score and via published algorithms.
For sarilumab and adalimumab, respectively, 24-week drug costs were $18,954 and $29,232, and costs per responder were $26,435 vs $50,055 on ACR20; $41,475 vs $98,425 on ACR50; and $22,511 vs $41,230 on EULAR Moderate/Good. Base case results at 10 years for total costs and QALYs were $176,977 and 2.75 for sarilumab and $212,136 and 2.61 for adalimumab, respectively. Sarilumab was consistently the more effective and cost-saving treatment across all short-term and long-term incremental analyses.
Sarilumab monotherapy was the economically dominant treatment on incremental cost per responder and incremental cost per QALY compared with adalimumab monotherapy. These results were maintained within the sensitivity analyses.
从美国医疗支付方的角度,研究每2周皮下注射(SC)200mg 沙瑞鲁单抗单药治疗与每2周/每周皮下注射40mg 阿达木单抗治疗中度至重度活动性类风湿性关节炎成年患者的治疗效果和直接医疗成本,这些患者对甲氨蝶呤治疗不耐受、反应不足或被认为不适合继续使用甲氨蝶呤治疗。
短期分析基于在MONARCH III期试验(NCT02332590)中观察到的药物24周批发采购成本以及根据美国风湿病学会(ACR)20/50标准和欧洲抗风湿病联盟(EULAR)28关节计数红细胞沉降率中度/良好疾病活动评分的治疗反应。长期分析还考虑了药物给药和常规护理成本,通过6个月决策树和1至10年马尔可夫模型进行,该模型对MOBILITY III期试验(NCT01061736)中的患者资料进行微观模拟。通过将6个月的ACR水平映射到健康评估问卷-残疾指数评分的相对变化并使用已发表的算法来估计效用和质量调整生命年(QALY)。
沙瑞鲁单抗和阿达木单抗的24周药物成本分别为18,954美元和29,232美元,根据ACR20标准,每个有反应者的成本分别为(26,435美元对50,055美元);根据ACR50标准为(41,475美元对98,425美元);根据EULAR中度/良好标准为(22,511美元对41,230美元)。沙瑞鲁单抗和阿达木单抗10年的总成本和QALY的基础病例结果分别为176,977美元和2.75以及212,136美元和2.61。在所有短期和长期增量分析中,沙瑞鲁单抗始终是更有效且更具成本效益的治疗方法。
与阿达木单抗单药治疗相比,沙瑞鲁单抗单药治疗在每个有反应者的增量成本和每QALY的增量成本方面是经济上占主导地位的治疗方法。这些结果在敏感性分析中得以维持。