Kashiwa Munenobu, Matsushita Ryo
Faculty of Pharmacy, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kakuma-machi, Kanazawa, 920-1192, Japan.
J Pharm Health Care Sci. 2021 Oct 1;7(1):35. doi: 10.1186/s40780-021-00218-7.
Clinical management of skin-toxicity associated with the use of anti-Epidermal Growth Factor Receptor (EGFR) antibodies to treat colorectal cancer maintains quality of life of patients with colorectal cancer. Results of clinical trials have recommended the efficacy of prophylactic treatment, but the cost-effectiveness is unclear. This study examined the cost-effectiveness of preventive skin care for skin-toxicity caused by panitumumab in third-line therapy for KRAS wild type metastatic colorectal cancer from the perspective of the Japanese healthcare payer.
The data source was J-STEPP trial, which compared preemptive skin treatment with reactive treatment in third-line panitumumab therapy for KRAS wild type metastatic colorectal cancer in Japan. The costs and effectiveness of preemptive treatment was compared with reactive treatment in a 3-year time horizon using a 4-state partitioned survival analysis. The health outcome was quality-adjusted life-years (QALYs). The costs were 2020 revisions to the drug prices. The robustness of the model was verified by one-way sensitivity analysis and a probabilistic sensitivity analysis (PSA). A 2% annual discount was applied to the expenses and QALYs. Willingness-to-pay (WTP) threshold of 5 million JPY was used.
Preemptive treatment had incremental effects of 0.0029 QALYs, incremental costs of 5300 JPY (48.6 USD), and incremental cost-effectiveness ratios (ICER) of 1,843,395 JPY (16,912 USD) per QALY. The variability of preemptive and reactive treatment costs for skin-toxicity and the disutility of skin-toxicity had a large impact on ICER. From PSA, the cost-effectiveness rate of preemptive treatment was 75.0%.
The cost to effectiveness of preemptive treatment to prevent skin-toxicity caused by panitumumab in third-line therapy for KRAS wild type mCRC is not high.
使用抗表皮生长因子受体(EGFR)抗体治疗结直肠癌相关的皮肤毒性临床管理可维持结直肠癌患者的生活质量。临床试验结果推荐了预防性治疗的疗效,但成本效益尚不清楚。本研究从日本医疗支付方的角度,考察了预防性皮肤护理对帕尼单抗所致皮肤毒性在KRAS野生型转移性结直肠癌三线治疗中的成本效益。
数据来源为J-STEPP试验,该试验比较了日本KRAS野生型转移性结直肠癌三线帕尼单抗治疗中先发制人皮肤治疗与反应性治疗。使用四状态分区生存分析在3年时间范围内比较先发制人治疗与反应性治疗的成本和效果。健康结局为质量调整生命年(QALYs)。成本为2020年药品价格修订版。通过单向敏感性分析和概率敏感性分析(PSA)验证模型的稳健性。对费用和QALYs应用2%的年度贴现率。使用500万日元的支付意愿(WTP)阈值。
先发制人治疗的增量效果为0.0029 QALYs,增量成本为5300日元(48.6美元),每QALY的增量成本效益比(ICER)为1,843,395日元(16,912美元)。皮肤毒性先发制人和反应性治疗成本的变异性以及皮肤毒性的负效用对ICER有很大影响。从PSA来看,先发制人治疗的成本效益率为75.0%。
在KRAS野生型mCRC三线治疗中,预防性治疗预防帕尼单抗所致皮肤毒性的成本效益不高。