Worldwide Health Economics and Outcomes Research, Bristol Myers Squibb, Princeton, NJ, USA.
Value & Health Economics and Outcomes Research, Bristol Myers Squibb, Solna, Sweden.
J Med Econ. 2021 Jan-Dec;24(1):607-619. doi: 10.1080/13696998.2021.1917139.
Nivolumab has been approved for advanced squamous and non-squamous non-small cell lung cancer (NSCLC) following platinum-based chemotherapy in both Canada and Sweden. We aimed to determine the value-for-money of nivolumab versus docetaxel in a Canadian and Swedish setting based on 5-year data.
These cost effectiveness analyses used partitioned survival models with three mutually exclusive health states: progression-free, progressed disease, and death. All clinical parameters were derived from two registration phase 3 randomized trials, CheckMate 017 and CheckMate 057, with a minimum follow-up of 5 years. Treatment duration was based on time-on-treatment data from the clinical trials. Costs were derived from published sources. The primary outcomes of the analyses were quality-adjusted life-years (QALYs), life-years gained, and incremental cost-effectiveness ratios (ICERs). The model input parameters for each analysis were chosen in line with guidance from the respective HTA authorities.
From a Canadian payer perspective, the ICERs were CAN$140,753 per QALY in the squamous population, and CAN$173,804 per QALY in the non-squamous population, assuming a 10-year time horizon and a 5% discount rate for both costs and outcomes. Sensitivity analyses demonstrated that changes to the discount rates for outcomes had the highest impact on the ICERs. In the Swedish analysis, the ICERs were SEK568,895 per QALY in the squamous population and SEK662,991 per QALY in the non-squamous population, assuming a 15-year time horizon, a 3% discount rate, and a 2-year maximum treatment duration for nivolumab. Sensitivity analyses demonstrated that the ICERs were most sensitive to changes in the discount rate for outcomes.
These updated analyses, based on more mature trial data with a minimum follow-up of 5 years, generate more favorable ICERs versus the previously submitted HTA assessments that resulted in approval of nivolumab for patients with previously treated NSCLC in Canada and Sweden.
在加拿大和瑞典，纳武利尤单抗在铂类化疗后已被批准用于治疗晚期鳞状和非鳞状非小细胞肺癌（NSCLC）。我们旨在根据 5 年数据确定在加拿大和瑞典环境下纳武利尤单抗相对于多西他赛的性价比。
这些成本效益分析使用分区生存模型，有三个相互排斥的健康状态：无进展、疾病进展和死亡。所有临床参数均源自两项注册的 3 期随机试验，CheckMate 017 和 CheckMate 057，随访时间至少 5 年。治疗持续时间基于临床试验中的治疗时间数据。成本源自已发表的资源。分析的主要结果是质量调整生命年（QALY）、生命年获益和增量成本效益比（ICER）。每个分析的模型输入参数均根据各自的 HTA 机构的指导选择。
从加拿大支付者的角度来看，在假设 10 年时间范围和对成本和结果分别采用 5%折扣率的情况下，鳞状人群的 ICER 为每 QALY 140753 加元，非鳞状人群为每 QALY 173804 加元。敏感性分析表明，对结果的折扣率进行更改对 ICER 的影响最大。在瑞典分析中，在假设 15 年时间范围、3%折扣率和纳武利尤单抗的 2 年最大治疗持续时间的情况下，鳞状人群的 ICER 为每 QALY 568895 瑞典克朗，非鳞状人群为每 QALY 662991 瑞典克朗。敏感性分析表明，ICER 对结果的折扣率变化最为敏感。
这些基于至少 5 年随访的更成熟试验数据的更新分析产生了比之前提交的 HTA 评估更有利的 ICER，从而导致纳武利尤单抗在加拿大和瑞典被批准用于治疗先前接受过治疗的 NSCLC 患者。
