University of Houston College of Pharmacy, Houston, TX.
Mayo Clinic Cancer Center, Phoenix, AZ.
Clin Colorectal Cancer. 2022 Dec;21(4):277-284. doi: 10.1016/j.clcc.2022.09.003. Epub 2022 Sep 17.
Recent phase 2 trials have provided data supporting regorafenib dose optimization (ReDO) and trifluridine/tipiracil (TAS-102) with bevacizumab (TAS-BEV) as treatment options in refractory metastatic colorectal cancer (mCRC). Historically, regorafenib standard dose (RSD) and TAS-102 have been utilized as third-line options in mCRC. Given the incorporation of ReDO and TAS-BEV as treatment options, we sought to evaluate relative cost-effectiveness of ReDO vs. RSD, TAS-102, and TAS-BEV for mCRC from a payer perspective.
A Markov model was constructed to estimate total costs and quality-adjusted life-years (QALYs) for ReDO, RSD, TAS-102, and TAS-BEV. Clinical parameters were obtained from phase 2 and 3 trials for comparators. Health state utility values were from the RSD phase 3 clinical trial. Incremental cost-effectiveness ratios (ICERs) were utilized to compare treatments. Model robustness was checked with one-way and probabilistic sensitivity analyses.
In the base case, ReDO was dominant over TAS-BEV (ie provided a higher QALY at a lower cost). ReDO produced an ICER of $104,308 per QALY relative to RSD and $37,966 relative to TAS-102. In one-way sensitivity analyses, monthly drug cost of TAS-BEV was the most influential parameter determining relative cost-effectiveness between TAS-BEV and ReDO. When TAS-102 and RSD were independently compared to ReDO, the most influential parameters were related to duration of OS and PFS and costs of managing AEs.
The optimum dosing strategy for regorafenib has improved its benefit-to-toxicity ratio and relative cost-effectiveness compared to RSD, TAS-102, and TAS-BEV.
最近的 2 期临床试验提供的数据支持regorafenib 剂量优化(ReDO)和 trifluridine/tipiracil(TAS-102)联合 bevacizumab(TAS-BEV)作为难治性转移性结直肠癌(mCRC)的治疗选择。在历史上,regorafenib 标准剂量(RSD)和 TAS-102 一直被用作 mCRC 的三线治疗选择。鉴于 ReDO 和 TAS-BEV 被纳入治疗选择,我们从支付者的角度评估了 ReDO 与 RSD、TAS-102 和 TAS-BEV 治疗 mCRC 的相对成本效益。
构建了一个马尔可夫模型,以从支付者的角度估计 ReDO、RSD、TAS-102 和 TAS-BEV 的总费用和质量调整生命年(QALYs)。比较剂的临床参数来自 2 期和 3 期试验。健康状态效用值来自 RSD 3 期临床试验。使用增量成本效益比(ICER)比较治疗方法。通过单因素和概率敏感性分析检查模型的稳健性。
在基线情况下,ReDO 优于 TAS-BEV(即提供更高的 QALY 且成本更低)。与 RSD 相比,ReDO 的 ICER 为每 QALY 104308 美元,与 TAS-102 相比为 37966 美元。在单因素敏感性分析中,TAS-BEV 的每月药物成本是决定 TAS-BEV 和 ReDO 相对成本效益的最关键参数。当 TAS-102 和 RSD 分别与 ReDO 进行比较时,最关键的参数与 OS 和 PFS 持续时间以及 AE 管理成本有关。
与 RSD、TAS-102 和 TAS-BEV 相比,regorafenib 的最佳剂量策略提高了其获益-毒性比和相对成本效益。