College of Pharmacy, Jinan University, Guangzhou, People's Republic of China.
Department of Pharmacy, General Hospital of Guangzhou Military Command of PLA, Guangzhou, People's Republic of China.
Clin Ther. 2018 Jul;40(7):1122-1139. doi: 10.1016/j.clinthera.2018.05.012. Epub 2018 Jul 11.
The prominent efficacy of the addition of daratumumab to lenalidomide and dexamethasone (DRd) or the addition to bortezomib and dexamethasone (DVd) was proven previously for patients with relapsed or refractory multiple myeloma (RRMM). However, the cost-effectiveness of adding daratumumab to traditional doublet regimens versus doublet regimens alone (DRd vs Rd; DVd vs Vd) was unknown.
We developed a semi-Markov model by using a US payer perspective and 10-year time horizon to estimate the cost and quality-adjusted life years (QALYs) for treatments. Clinical data were obtained from the POLLUX (Phase 3 Study Comparing DRd Versus Rd in Subjects with Relapsed or Refractory Multiple Myeloma [RRMM]) and CASTOR (Phase 3 Study Comparing DVd Versus Vd in Subjects with RRMM) trials. Deterministic and probabilistic sensitivity analyses were conducted to evaluate model uncertainty.
The incremental cost-effectiveness ratio (ICER) for DVd compared with Vd was $284,180 per QALY; the ICER for DRd compared with Rd was $1,369,062 per QALY. Only when the price of daratumumab was reduced to 37% (US $702/vial) of the current price could the addition of daratumumab to Vd be cost-effective under the US willingness-to-pay (WTP) of $50,000/QALY. However, under no discount level of the daratumumab price is the addition of daratumumab to Rd acceptable. When the WTP increased to $300,000/QALY, the addition of DVd had a 56.7% probability of being cost-effective compared with the Vd regimen.
Due to the high price of daratumumab, neither the addition of daratumumab to Rd nor Vd proved to be cost-effective under US WTP. However, if the daratumumab price fell to a certain discount level, the DVd regimen might be cost-effective.
先前已证明,对于复发或难治性多发性骨髓瘤(RRMM)患者,添加达雷妥尤单抗至来那度胺和地塞米松(DRd)或添加至硼替佐米和地塞米松(DVd)的方案具有明显疗效。然而,添加达雷妥尤单抗至传统双联方案与双联方案单用(DRd 与 Rd;DVd 与 Vd)的成本效益尚不清楚。
我们采用美国支付者视角和 10 年时间范围,通过半马尔可夫模型来估算治疗的成本和质量调整生命年(QALYs)。临床数据来自 POLLUX(DRd 对比 Rd 治疗复发或难治性多发性骨髓瘤受试者的 3 期研究)和 CASTOR(DVd 对比 Vd 治疗复发或难治性多发性骨髓瘤受试者的 3 期研究)试验。进行了确定性和概率敏感性分析以评估模型不确定性。
与 Vd 相比,DVd 的增量成本效果比(ICER)为每 QALY 284,180 美元;与 Rd 相比,DRd 的 ICER 为每 QALY 1,369,062 美元。只有当达雷妥尤单抗的价格降至当前价格的 37%(每支 702 美元)时,在 WTP 为 50,000 美元/QALY 的情况下,添加达雷妥尤单抗至 Vd 才具有成本效益。然而,在达雷妥尤单抗价格不打折的情况下,添加达雷妥尤单抗至 Rd 是不可接受的。当 WTP 增加到 300,000 美元/QALY 时,与 Vd 方案相比,添加 DVd 有 56.7%的概率具有成本效益。
由于达雷妥尤单抗价格高昂,在美国 WTP 下,添加达雷妥尤单抗至 Rd 或 Vd 均不具有成本效益。然而,如果达雷妥尤单抗价格降至一定折扣水平,DVd 方案可能具有成本效益。