J Am Pharm Assoc (2003). 2023 May-Jun;63(3):817-824.e3. doi: 10.1016/j.japh.2022.12.019. Epub 2022 Dec 20.
Relugolix treatment of advanced prostate cancer (APC), like other gonadotropin-releasing hormone-antagonists, results in rapid decrease in testosterone concentrations without the risk of flare, as seen in leuprolide. Despite this benefit over leuprolide, no economic evaluation assessment to ascertain the cost-effectiveness of relugolix has been conducted. Therefore, this study aims to assess the cost-effectiveness of androgen deprivation therapy (ADT) with 120 mg relugolix against 7.5 mg leuprolide for the treatment of APC.
A Markov model was used to assess and compare the costs of APC treatment from a health care payer's perspective and the effectiveness of ADT with relugolix and leuprolide at the 3 lines of APC treatment among modified intent-to-treat patients. Relative progression-free (PFS) and overall survival (OS) rates were estimated. Outcomes measured in the analyses included costs of the drugs and therapies, quality-adjusted life-years (QALYs), incremental cost-effectiveness ratios (ICERs), cost-effectiveness acceptability, and probability curves.
The cost-effectiveness analysis showed the ICER for ADT with relugolix to be US $49,571.1 per QALY. At the ICER value, the sensitivity analysis indicated that ADT with leuprolide was dominant in 100% of the simulations. ADT acceptance with relugolix was 100% when a willingness-to-pay threshold was set at US $100,000/QALY. At 5-years, the relative PFS and OS rates for relugolix at the first line of therapy were 72.7% and 86.0%, respectively, compared to 61.0% and 85.90% for leuprolide.
Though the influence of adverse events was not considered in the analysis, ADT with relugolix was not a cost-effective choice for APC management. While the analysis revealed a slight chance of sustaining testosterone suppression with relugolix, ADT with relugolix provided no significant survival advantages over ADT with leuprolide. Therefore, this analysis confirms no need for further assessment of APC interventions to make informed decisions beneficial to the APC patients, oncologists, and other stakeholders.
与其他促性腺激素释放激素拮抗剂一样，瑞戈非尼治疗晚期前列腺癌（APC）会导致睾酮浓度迅速下降，而不会像亮丙瑞林那样出现flare 现象。尽管与亮丙瑞林相比有这种优势，但尚未进行经济评估以确定瑞戈非尼的成本效益。因此，本研究旨在评估 120mg 瑞戈非林与 7.5mg 亮丙瑞林治疗 APC 的雄激素剥夺疗法（ADT）的成本效益。
使用 Markov 模型从医疗保健支付者的角度评估和比较 APC 治疗的成本，并在 APC 治疗的 3 线治疗中对接受瑞戈非尼和亮丙瑞林治疗的患者进行修改后的意向治疗。相对无进展生存期（PFS）和总生存期（OS）率进行了估计。分析中测量的结果包括药物和治疗的成本、质量调整生命年（QALYs）、增量成本效益比（ICER）、成本效益可接受性和概率曲线。
成本效益分析显示，瑞戈非尼 ADT 的 ICER 为每 QALY 49571.1 美元。在 ICER 值处，敏感性分析表明，在 100%的模拟中，亮丙瑞林 ADT 具有优势。当设定愿意支付的阈值为 100000 美元/QALY 时，瑞戈非林 ADT 的接受率为 100%。在第 1 线治疗中，瑞戈非林的相对 PFS 和 OS 率分别为 72.7%和 86.0%，而亮丙瑞林分别为 61.0%和 85.90%。
尽管在分析中没有考虑不良事件的影响，但瑞戈非尼 ADT 并不是 APC 管理的一种具有成本效益的选择。虽然分析显示瑞戈非林维持睾酮抑制的可能性略低，但瑞戈非林 ADT 并没有比亮丙瑞林 ADT 提供显著的生存优势。因此，该分析证实无需进一步评估 APC 干预措施，以做出有利于 APC 患者、肿瘤学家和其他利益相关者的知情决策。
