Sage Therapeutics, Cambridge, Massachusetts.
Center for the Evaluation of Value and Risk in Health (CEVR), Tufts Medical Center, Boston, Massachusetts.
J Manag Care Spec Pharm. 2020 May;26(5):627-638. doi: 10.18553/jmcp.2020.19306. Epub 2020 Mar 19.
Brexanolone injection (BRX) was approved by the FDA in 2019 for the treatment of adult patients with postpartum depression (PPD), but its cost-effectiveness has not yet been evaluated.
To estimate the cost-effectiveness of BRX compared with treatment with selective serotonin reuptake inhibitors (SSRIs) for PPD.
We projected costs (2018 U.S. dollars) and health (quality-adjusted life-years [QALYs]) for mothers treated with BRX or SSRIs and their children. A health state transition model projected clinical and economic outcomes for mothers based on the Edinburgh Postnatal Depression Scale, from a U.S. payer perspective. The modeled population consisted of adult patients with moderate to severe PPD, similar to BRX clinical trial patients. Short-term efficacy for BRX and SSRIs came from an indirect treatment comparison. Long-term efficacy outcomes over 4 weeks, 11 years (base case), and 18 years were based on results from an 18-year longitudinal study. Maternal health utility values came from analysis of trial-based short-form 6D responses. Other inputs were derived from the literature.
The incremental cost-effectiveness ratio for BRX versus SSRIs was $106,662 per QALY gained over an 11-year time horizon. Drug and administration costs for BRX averaged $38,501, compared with $25 for SSRIs over the studied time horizon. Maternal total direct medical costs averaged $65,908 in the BRX arm, compared with $73,653 in the SSRI arm. BRX-treated women averaged 6.230 QALYs compared with 5.979 QALYs for the SSRI arm. Adding partner costs and utilities in a sensitivity analysis further favored BRX. Results were sensitive to the severity of PPD at baseline and the model time horizon. Probabilistic sensitivity analyses indicated that BRX was cost-effective at the $150,000-per-QALY threshold with 58% probability.
Analysis using a state transition model showed BRX to be a cost-effective therapy compared with SSRIs for treating women with PPD.
This study was funded by Sage Therapeutics, Cambridge, MA. Eldar-Lissai, Gerbasi, and Hodgkins are employees of Sage Therapeutics and own stock or stock options in the company. Gerbasi also reports previous employment with Policy Analysis Inc. Cohen contributed to this work as an independent consultant. Meltzer-Brody has a sponsored clinical research agreement with Sage Therapeutics to the University of North Carolina, as well as a sponsored research agreement from Janssen to the University of North Carolina, unrelated to this work. Meltzer-Brody has also received personal consulting fees from Cala Health and MedScape, unrelated to this work. Johnson, Chertavian, and Bond are employees of Medicus Economics, which was paid fees by Sage to conduct the research for this study. Study findings do not necessarily represent the views of CEVR or Tufts Medical Center.
Brexanolone 注射液(BRX)于 2019 年获得 FDA 批准,用于治疗产后抑郁症(PPD)的成年患者,但尚未评估其成本效益。
评估 BRX 治疗产后抑郁症(PPD)与选择性 5-羟色胺再摄取抑制剂(SSRIs)治疗相比的成本效益。
我们预测了接受 BRX 或 SSRIs 治疗的母亲及其子女的成本(2018 年美元)和健康(质量调整生命年 [QALYs])。基于爱丁堡产后抑郁量表,从美国支付者的角度出发,健康状态转换模型预测了母亲的临床和经济结局。模型人群由患有中重度 PPD 的成年患者组成,与 BRX 临床试验患者相似。BRX 和 SSRIs 的短期疗效来自间接治疗比较。4 周、11 年(基本情况)和 18 年的长期疗效结果基于一项 18 年纵向研究的结果。母亲的健康效用值来自基于试验的短格式 6D 反应分析。其他投入来自文献。
BRX 与 SSRIs 相比,在 11 年的时间范围内,每获得一个质量调整生命年(QALY)的增量成本效益比为 106662 美元。BRX 的药物和管理成本平均为 38501 美元,而在研究期间,SSRIs 的成本为 25 美元。BRX 治疗组的母亲总直接医疗费用平均为 65908 美元,而 SSRI 组为 73653 美元。BRX 治疗组的女性平均获得 6.230 个 QALYs,而 SSRI 组为 5.979 个 QALYs。在敏感性分析中加入伴侣成本和效用值进一步支持了 BRX。结果对基线时 PPD 的严重程度和模型时间范围敏感。概率敏感性分析表明,BRX 在 150000 美元/QALY 的阈值下具有成本效益,概率为 58%。
使用状态转换模型进行的分析表明,BRX 是一种治疗产后抑郁症(PPD)的有效且具有成本效益的疗法,与 SSRIs 相比。
这项研究由马萨诸塞州剑桥的 Sage Therapeutics 公司资助。Eldar-Lissai、Gerbasi 和 Hodgkins 是 Sage Therapeutics 的员工,拥有该公司的股票或股票期权。Gerbasi 还报告了之前在 Policy Analysis Inc. 的工作经历。Cohen 作为独立顾问参与了这项工作。Meltzer-Brody 与 Sage Therapeutics 有一项针对北卡罗来纳大学的赞助临床研究协议,以及一项与 Janssen 针对北卡罗来纳大学的赞助研究协议,与这项工作无关。Meltzer-Brody 还因与 Cala Health 和 MedScape 的个人咨询费而受到影响,与这项工作无关。Johnson、Chertavian 和 Bond 是 Medicus Economics 的员工,该公司受 Sage 委托进行了这项研究。研究结果不一定代表 CEVR 或塔夫茨医疗中心的观点。