Gupta Nidhi, Verma Rohan Kumar, Gupta Sudeep, Prinja Shankar
Department of Radiation Oncology, Government Medical College and Hospital, Chandigarh, India.
Department of Community Medicine and School of Public Health, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
JCO Glob Oncol. 2020 Feb;6:205-216. doi: 10.1200/JGO.19.00293.
We undertook this study to evaluate the incremental cost per quality-adjusted life-year (QALY) gained with use of adjuvant trastuzumab as compared with chemotherapy alone among patients with nonmetastatic breast cancer in India.
We used a Markov model to estimate the incremental cost of using trastuzumab (for 1 year, 6 months, or 9 weeks) as compared with chemotherapy alone using a societal perspective, excluding indirect productivity losses. Although the outcomes (QALYs) in the standard chemotherapy arm were estimated after calibrating the model as per survival data from 2 Indian cancer registries, effectiveness estimates from the HERA trial and a joint analysis of the NSABP B-31 and NCCTG N9831 trials were used to estimate the consequences of 1-year trastuzumab use. The cost of treatment was estimated using national standard treatment guidelines and real-world use estimates for different treatment modalities as per data from Indian cancer registries. Probabilistic sensitivity analysis was undertaken to evaluate parameter uncertainty.
For 1 year of trastuzumab use, the incremental benefit per patient, incremental cost per QALY gained, and probability of being cost effective using HERA trial estimates were 1.29 QALYs, 178,877 Indian national rupees (INRs; US$2,558), and 4%, respectively, whereas the corresponding figures using joint analysis estimates were 1.69 QALYs, INR 134,413 (US$1,922), and 57.3%, respectively.
Use of trastuzumab for 1 year is not cost effective in India at the current price. However, trastuzumab use for 9 weeks is cost effective and should be included in clinical guidelines and reimbursement policies. A price reduction of 15% to 35% increases the probability of 1-year trastuzumab use being cost effective, to 90%.
我们开展这项研究，以评估在印度非转移性乳腺癌患者中，与单纯化疗相比，使用辅助性曲妥珠单抗每获得一个质量调整生命年（QALY）所增加的成本。
我们采用马尔可夫模型，从社会角度估计使用曲妥珠单抗（1年、6个月或9周）与单纯化疗相比的增量成本，不包括间接生产力损失。虽然标准化疗组的结局（QALYs）是根据来自2个印度癌症登记处的生存数据校准模型后估计的，但HERA试验的有效性估计以及NSABP B - 31和NCCTG N9831试验的联合分析被用于估计使用1年曲妥珠单抗的后果。根据印度癌症登记处的数据，使用国家标准治疗指南和不同治疗方式的实际使用估计来估计治疗成本。进行概率敏感性分析以评估参数不确定性。
使用1年曲妥珠单抗时，根据HERA试验估计，每位患者的增量获益、每获得一个QALY的增量成本以及具有成本效益的概率分别为1.29个QALY、178,877印度卢比（INR；2,558美元）和4%，而使用联合分析估计时，相应数字分别为1.69个QALY、134,413印度卢比（1,922美元）和57.3%。
以当前价格，在印度使用1年曲妥珠单抗不具有成本效益。然而，使用9周曲妥珠单抗具有成本效益，应纳入临床指南和报销政策。价格降低15%至35%可使使用1年曲妥珠单抗具有成本效益的概率提高到90%。
