■从美国医疗保健支付者的角度,评估辅助nivolumab与监测治疗高风险肌肉浸润性尿路上皮癌(MIUC)患者的成本效益,并研究替代建模方法对成本效益结果的影响。
■四态,由无病组成的半马尔可夫模型,局部复发,远处复发,和死亡健康状态是为了调查nivolumab在30年时间范围内与监测相比的成本效益.该模型使用来自随机CheckMate274研究(NCT02632409)和已发表文献的数据来告知健康状态之间的过渡。以及成本投入,实用程序,不良事件,和疾病管理。进行了情景分析,以调查模型结构和关键假设对结果的影响。进行了单向确定性和概率敏感性分析,以研究结果的稳健性。
■nivolumab的总预期成本(162,278美元)高于监测(63,027美元)。Nivolumab与改善的生存率(与监测相比增加了1.61个生命年)和0.98个质量调整生命年(QALYs)的增量相关。尽管nivolumab的总治疗费用较高,与观察相比,nivolumab延迟或避免了复发和死亡,因此观察到成本抵消.增量成本效益和成本效用比为61,462美元/生命周期和100,930美元/QALY。
■在分析时,CheckMate274对无病生存率的随访有限,没有总体生存率数据。有限的证据需要对每种类型的复发后的生存建模进行假设。
■对于在美国接受根治性切除术后复发风险高的患者,Nivolumab被认为是一种延长寿命和具有成本效益的辅助治疗MIUC的选择。使用$150,000/QALY的阈值,在所进行的情景和敏感性分析中,成本效益结论保持一致.
UNASSIGNED: To evaluate the cost-effectiveness of adjuvant nivolumab compared with surveillance for the treatment of patients with high-risk muscle-invasive urothelial carcinoma (MIUC) after radical resection from a US healthcare payer perspective and to investigate the impact of alternative modeling approaches on the cost-effectiveness results.
UNASSIGNED: A four-state, semi-Markov model consisting of disease free, local recurrence, distant recurrence, and death health states was developed to investigate the cost-effectiveness of nivolumab compared with surveillance over a 30-year time horizon. The model used data from the randomized CheckMate 274 trial (NCT02632409) and published literature to inform transitions among health states, and inputs on cost, utility, adverse event, and disease management. Scenario analyses were conducted to investigate the impact of model structure and key assumptions on the results. One-way deterministic and probabilistic sensitivity analysis were conducted to investigate the robustness of the results.
UNASSIGNED: Total expected costs were higher with nivolumab ($162,278) compared with surveillance ($63,027). Nivolumab was associated with improved survival (1.61 life-years gained compared with surveillance) and an incremental gain of 0.98 quality-adjusted life-years (QALYs). Although total treatment costs were higher for nivolumab, cost offsets were observed because of delayed or avoided recurrences and deaths experienced with nivolumab compared with observation. The incremental cost-effectiveness and cost-utility ratios were $61,462/life-year and $100,930/QALY.
UNASSIGNED: At the time of analysis, CheckMate 274 had limited follow-up on disease-free survival and no overall survival data. The limited evidence necessitated assumptions on modeling survival after each type of recurrence.
UNASSIGNED: Nivolumab is estimated to be a life-extending and cost-effective option for adjuvant treatment of MIUC for patients who are at high risk of recurrence after undergoing radical resection in the United States. Using a threshold of $150,000/QALY, the cost-effectiveness conclusions remained consistent across the scenario and sensitivity analyses conducted.