Department of Pharmacy, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, 350005, China.
Department of Pharmacy, The First Affiliated Hospital of Fujian Medical University, Fuzhou, 350005, China.
Breast Cancer. 2024 Sep;31(5):917-925. doi: 10.1007/s12282-024-01605-2. Epub 2024 Jun 15.
Tamoxifen (TAM) is recommended as the first-line strategy for men with estrogen receptor (ER)-positive early breast cancer who are candidates for adjuvant endocrine therapy in ASCO guideline. Our study aims to analyze the cost-effectiveness of receiving adjuvant endocrine therapy with TAM compared to no TAM, and to assess the cost-effectiveness of using TAM with high adherence over low adherence for ER-positive early male breast cancer in the USA.
Two Markov models comprising three mutually exclusive health states were constructed: (1) the first Markov model compared the cost-effectiveness of adding TAM with not using TAM (TAM versus Not-TAM); (2) the second model compared the cost-effectiveness of receiving TAM with high adherence and low adherence (High-adherence-TAM versus Low-adherence-TAM). The simulation time horizon for both models was the lifetime of patients. The efficacy and safety data of two models were elicited from the real-world studies. Model inputs were derived from the US website and published literature. The main outcomes of two models both included the total cost, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs).
In the first model, TAM yielded an ICER of $5707.29 per QALY compared to Not-TAM, which was substantially below the WTP threshold of $50,000.00 per QALY in the USA. Probabilistic sensitivity analysis results demonstrated a 100.00% probability of cost-effectiveness for this strategy. In the second model, High-adherence-TAM was dominated absolutely compared to Low-adherence-TAM. The High-adherence-TAM was cost-effective with a 99.70% probability over Low-adherence-TAM when WTP was set as $50,000.00/QALY. All of these parameters within their plausible ranges did not reversely change the results of our models.
Our study will offer valuable guidance for physicians or patients when making treatment decisions and provide an effective reference for decision-making to consider the appropriate allocation of funds to this special group.
在美国临床肿瘤学会（ASCO）指南中，他莫昔芬（TAM）被推荐为雌激素受体（ER）阳性早期乳腺癌患者辅助内分泌治疗的一线策略，这些患者适合接受辅助内分泌治疗。本研究旨在分析与不使用 TAM 相比，接受 TAM 辅助内分泌治疗的成本效益，以及评估在美国，ER 阳性早期男性乳腺癌患者中 TAM 高依从性与低依从性相比的成本效益。
构建了两个包含三个相互排斥健康状态的马尔可夫模型：（1）第一个马尔可夫模型比较了添加 TAM 与不使用 TAM 的成本效益（TAM 与 Not-TAM）；（2）第二个模型比较了接受 TAM 高依从性和低依从性的成本效益（High-adherence-TAM 与 Low-adherence-TAM）。两个模型的模拟时间范围均为患者的终生。两个模型的疗效和安全性数据均来自真实世界研究。模型输入来自美国网站和已发表文献。两个模型的主要结果均包括总成本、质量调整生命年（QALYs）和增量成本效益比（ICERs）。
在第一个模型中，与 Not-TAM 相比，TAM 的每 QALY 成本效益比为 5707.29 美元，远低于美国每 QALY 50000 美元的 WTP 阈值。概率敏感性分析结果表明，该策略的成本效益具有 100.00%的可能性。在第二个模型中，与 Low-adherence-TAM 相比，High-adherence-TAM 绝对占据优势。当 WTP 设置为 50000 美元/QALY 时，High-adherence-TAM 的成本效益比 Low-adherence-TAM 高出 99.70%。当这些参数在其合理范围内变化时，均未改变我们模型的结果。
本研究将为医生或患者在做出治疗决策时提供有价值的指导，并为决策提供有效的参考，以考虑将资金适当地分配给这一特殊群体。
