Yip Chui-Ying, Greystoke Alastair, Abogunrin Seye, Belleli Rossella, Di Maio Danilo, Rouse Peter, Jovanoski Nick
Roche Products Ltd, Welwyn Garden City, United Kingdom.
Northern Centre for Cancer Care, Newcastle upon Tyne, UK, United Kingdom.
Lung Cancer. 2023 May;179:107171. doi: 10.1016/j.lungcan.2023.03.007. Epub 2023 Mar 15.
Atezolizumab monotherapy has marketing authorisation by the Medicines and Healthcare products Regulatory Agency as adjuvant treatment following complete resection for adults with stage II-IIIA non-small cell lung cancer (NSCLC) whose tumours have PD-L1 expression on ≥ 50% of tumour cells and whose disease has not progressed following adjuvant platinum-based chemotherapy. This study evaluated the cost-effectiveness of atezolizumab vs best supportive care (BSC) in the licensed patient population from a UK perspective.
Patient characteristics and clinical inputs were derived from the global, randomised, open-label, phaseIII IMpower010 trial. A Markov model with the following health states was developed: disease-free survival (DFS), locoregional recurrence, first-line metastatic recurrence, second-line metastatic recurrence, and death (all partitioned based on receipt of treatment, excluding death). The base case model used a lifetime time horizon (40 years) and 3.5% discounting annually after the first year. DFS from IMpower010 was analysed with parametric survival models to extrapolate outcomes for time points beyond trial follow-up. The models were adjusted to avoid overestimating results for patients with recurrences in the longer term. Grade ≥ 3 treatment-related adverse events with incidences ≥ 2% were included. Health state utility values were derived from the literature and past NICE appraisals. Sensitivity and scenario analyses assessed uncertainty around assumptions and parameter estimates.
In the base case analysis, atezolizumab therapy resulted in an expected gain of 1.87 quality-adjusted life-years (QALYs) corresponding to an incremental cost-effectiveness ratio of £20,392/QALY for atezolizumab vs BSC, demonstrating cost-effectiveness. Results were most influenced by discount effects and utility in the on-treatment DFS state. Scenario analyses were consistent with the base case results.
Atezolizumab after adjuvant chemotherapy is cost-effective for adults with NSCLC in the UK.
阿替利珠单抗单药疗法已获得药品和保健品监管局的上市许可，用于肿瘤细胞PD-L1表达≥50%、辅助铂类化疗后疾病未进展的II-IIIA期非小细胞肺癌（NSCLC）成年患者在完全切除后的辅助治疗。本研究从英国角度评估了阿替利珠单抗与最佳支持治疗（BSC）在该获批患者群体中的成本效益。
患者特征和临床数据来源于全球随机、开放标签的III期IMpower010试验。构建了一个具有以下健康状态的马尔可夫模型：无病生存（DFS）、局部区域复发、一线转移复发、二线转移复发和死亡（所有状态均根据治疗接受情况划分，死亡除外）。基础病例模型采用终生时间范围（40年），第一年之后每年贴现率为3.5%。使用参数生存模型分析IMpower010试验中的DFS，以推断试验随访期之外时间点的结果。对模型进行调整以避免高估长期复发患者的结果。纳入发生率≥2%的≥3级治疗相关不良事件。健康状态效用值来自文献和过去的英国国家卫生与临床优化研究所（NICE）评估。敏感性分析和情景分析评估了假设和参数估计周围的不确定性。
在基础病例分析中，阿替利珠单抗治疗导致预期获得1.87个质量调整生命年（QALY），阿替利珠单抗与BSC相比的增量成本效益比为20,392英镑/QALY，显示出成本效益。结果受贴现效应和治疗期DFS状态下效用的影响最大。情景分析与基础病例结果一致。
在英国，辅助化疗后使用阿替利珠单抗对NSCLC成年患者具有成本效益。
