Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Analysis Group, Inc., Boston, MA, USA.
J Med Econ. 2021 Jan-Dec;24(1):131-139. doi: 10.1080/13696998.2020.1867470.
To estimate the budget impact of adding capmatinib, the first FDA approved MET inhibitor, to a US commercial or Medicare health plan for patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors have a mutation that leads to exon 14 (ex14) skipping.
Target population size was estimated using published epidemiology data. Clinical data were obtained from the GEOMETRY mono-1 capmatinib trial and published trials. Treatments in the market mix included crizotinib, pembrolizumab, ramucirumab, and chemotherapy. Uptake of capmatinib and testing rates were based on market research. All costs (drug acquisition and administration, pre-progression, progression, terminal care, adverse event, and testing) were estimated based on public sources (2020 USD).
The number of patients eligible for capmatinib in the first three years was estimated to be 2-3 in a hypothetical 1 million member commercial plan and 34-44 in a hypothetical 1 million member Medicare plan each year. The estimated total budget impact ranged from $9,695 to $67,725 for a commercial plan and $141,350 to $985,695 for Medicare. With capmatinib included, a marginal per member per month budget impact was estimated (commercial: $0.0008 to $0.0056; Medicare: $0.0118 to $0.0821). Capmatinib inclusion resulted in lower medical costs (commercial: -$0.0003 to -$0.0007; Medicare: -$0.0037 to -$0.0106), partially offsetting increased drug costs ($0.0011 to $0.0064; $0.0154 to $0.0928, respectively), and were primarily driven by reductions in progression and terminal care costs (-$0.0003 to -$0.0009; -$0.0037 to -$0.0125, respectively). The results were most sensitive to capmatinib market share, capmatinib price, and treatment duration.
Certain assumptions were applied to the model to account for inputs with limited evidence.
The estimated budget impact of including capmatinib for mNSCLC with a ex14 skipping mutation is minimal, and the increased drug costs were partially offset by savings in AEs, and progression-related and terminal care costs.
估算将首个获得美国食品药品监督管理局(FDA)批准的 MET 抑制剂卡马替尼(capmatinib)纳入美国商业或医疗保险健康计划,为携带导致外显子 14(exon 14)跳跃突变的非小细胞肺癌(NSCLC)患者治疗的预算影响。该突变导致外显子 14(exon 14)跳跃突变。
使用已发表的流行病学数据估算目标人群规模。临床数据来自于 GEOMETRY mono-1 卡马替尼试验和已发表的试验。市场组合中的治疗方法包括克唑替尼(crizotinib)、派姆单抗(pembrolizumab)、雷莫芦单抗(ramucirumab)和化疗。卡马替尼的采用率和检测率基于市场研究。所有成本(药物获取和管理、疾病进展前、进展期、终末期护理、不良反应和检测)均基于公共资源(2020 年美元)进行估算。
在一个假设的 100 万成员商业计划中,第一年至第三年符合卡马替尼治疗条件的患者人数估计为 2-3 人,在一个假设的 100 万成员医疗保险计划中,每年的人数估计为 34-44 人。商业计划的总预算影响估计为 9695 美元至 67725 美元,医疗保险计划的总预算影响估计为 141350 美元至 985695 美元。纳入卡马替尼后,预计每月每个成员的边际预算影响为(商业:0.0008 美元至 0.0056 美元;医疗保险:0.0118 美元至 0.0821 美元)。纳入卡马替尼可降低医疗成本(商业:-0.0003 美元至-0.0007 美元;医疗保险:-0.0037 美元至-0.0106 美元),部分抵消了药物成本的增加(0.0011 美元至 0.0064 美元;0.0154 美元至 0.0928 美元),主要是由于进展和终末期护理成本的降低(-0.0003 美元至-0.0009 美元;-0.0037 美元至-0.0125 美元)。结果主要取决于卡马替尼的市场份额、卡马替尼的价格和治疗持续时间。
为了说明输入数据证据有限的问题,模型中应用了某些假设。
纳入携带外显子 14 跳跃突变的非小细胞肺癌患者的卡马替尼治疗的预算影响估计很小,药物成本的增加部分被不良反应、进展相关和终末期护理成本的降低所抵消。