Insinga Ralph P, Vanness David J, Feliciano Josephine L, Vandormael Kristel, Traore Sory, Burke Thomas
a Merck Sharp & Dohme Corp. , Center for Observational and Real-World Evidence , North Wales , PA , USA.
b Department of Health Policy and Administration , Pennsylvania State University, State College , PA , USA.
J Med Econ. 2018 Dec;21(12):1191-1205. doi: 10.1080/13696998.2018.1521416. Epub 2018 Sep 21.
To describe cost-effectiveness of pembrolizumab plus platinum and pemetrexed chemotherapy in metastatic, non-squamous, NSCLC patients in the US.
A model is developed utilizing partitioned survival analysis to estimate the cost-effectiveness of KEYNOTE-189 trial comparators pembrolizumab + chemotherapy (carboplatin/cisplatin + pemetrexed) vs chemotherapy alone. Clinical efficacy, treatment utilization, health utility, and safety data are derived from the trial and projected over 20 years. For extrapolating survival beyond the trial, a novel SEER population-data approach is applied (primary analysis), with separate estimation via traditional parametric extrapolation methods. Costs for drugs and non-drug disease management are also incorporated. Based on an indirect treatment comparison, cost-effectiveness of pembrolizumab + chemotherapy vs pembrolizumab monotherapy is evaluated for patients with programmed death-ligand 1 (PD-L1) ≥ 50%.
In the full non-squamous population, pembrolizumab + chemotherapy is projected to increase life expectancy by 2.04 years vs chemotherapy (3.96 vs 1.92), for an approximate doubling of life years. Resultant incremental cost-effectiveness ratios (ICERs) are $104,823/QALY and $87,242/life year. In patients with PD-L1 ≥ 50% and 1-49%, life expectancy is more than doubled (4.53 vs 1.88 years) and (4.87 vs 2.01 years), with a 32% (2.60 vs 1.97 years) increase in PD-L1 < 1% patients. Corresponding incremental costs/quality-adjusted life year (QALY) are $103,402, $66,837, and $183,529 for PD-L1 ≥ 50%, 1-49%, and <1% groups, respectively. Versus pembrolizumab monotherapy in PD-L1 ≥ 50% patients, representing current standard of care, pembrolizumab + chemotherapy increases life expectancy by 65% (4.53 vs 2.74 years) at an ICER of $147,365/QALY.
The addition of pembrolizumab to chemotherapy is projected to extend life expectancy to a point not previously seen in previously untreated metastatic non-squamous NSCLC. Although ICERs vary by sub-group and comparator, results suggest pembrolizumab + chemotherapy yields ICERs near, or in most cases, well below a 3-times US per capita GDP threshold of $180,000/QALY, and may be a cost-effective first-line treatment for metastatic non-squamous NSCLC patients.
描述帕博利珠单抗联合铂类和培美曲塞化疗在美国转移性非鳞状非小细胞肺癌(NSCLC)患者中的成本效益。
利用分区生存分析开发一个模型,以评估KEYNOTE-189试验的比较组,即帕博利珠单抗联合化疗(卡铂/顺铂联合培美曲塞)与单纯化疗的成本效益。临床疗效、治疗利用率、健康效用和安全性数据均来自该试验,并预测20年的情况。为了推断试验之外的生存期,采用了一种新颖的监测、流行病学和最终结果(SEER)人群数据方法(主要分析),并通过传统参数外推法进行单独估计。还纳入了药物和非药物疾病管理的成本。基于间接治疗比较,评估程序性死亡配体1(PD-L1)≥50%的患者中帕博利珠单抗联合化疗与帕博利珠单抗单药治疗的成本效益。
在整个非鳞状人群中,预计帕博利珠单抗联合化疗与化疗相比可使预期寿命延长2.04年(3.96年对1.92年),生命年数几乎翻倍。由此产生的增量成本效益比(ICER)为每质量调整生命年(QALY)104,823美元和每生命年87,242美元。在PD-L1≥50%和1%-49%的患者中,预期寿命增加了一倍多(4.53年对1.88年)和(4.87年对2.01年),PD-L1<1%的患者增加了32%(2.60年对1.97年)。PD-L1≥50%、1%-49%和<1%组对应的增量成本/QALY分别为103,402美元、66,837美元和183,529美元。与目前作为护理标准的PD-L1≥50%患者的帕博利珠单抗单药治疗相比,帕博利珠单抗联合化疗使预期寿命增加了65%(4.53年对2.74年),ICER为每QALY 147,365美元。
预计在化疗中添加帕博利珠单抗可将预期寿命延长至先前未治疗的转移性非鳞状NSCLC患者中未曾见过的水平。尽管ICER因亚组和比较组而异,但结果表明,帕博利珠单抗联合化疗产生的ICER接近或在大多数情况下远低于美国人均GDP阈值180,000美元/QALY的3倍,可能是转移性非鳞状NSCLC患者具有成本效益的一线治疗方法。