日本人表皮生长因子受体 2 阳性早期乳腺癌患者使用帕妥珠单抗和曲妥珠单抗辅助治疗的成本效益分析。

IF 2.9 3区 医学 Q2 PHARMACOLOGY & PHARMACY Clinical Drug Investigation Pub Date : 2024-11-07 DOI:10.1007/s40261-024-01399-3
Chanon Nusawat, So Sato, Hideaki Watanabe, Takaaki Konishi, Hayato Yamana, Hideo Yasunaga
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引用次数: 0

摘要

背景和目的:人表皮生长因子受体 2(HER2)阳性乳腺癌因其侵袭性而给治疗带来了相当大的挑战。全球指南已批准对早期乳腺癌进行全年的 HER2 靶向治疗。然而,以往对 HER2 双靶向疗法的成本效益分析非常有限。本研究旨在考察日本医疗体系中早期乳腺癌双 HER2 靶向疗法的成本效益:在基于马尔可夫模型的研究中,评估了与曲妥珠单抗单一疗法相比,联合使用百妥珠单抗和曲妥珠单抗的双重抗 HER2 疗法的成本效益。研究纳入了中位年龄为 51 岁、开始接受治疗的患者。研究采用质量调整生命年(QALYs)和增量成本效益比(ICERs)作为比较单位。研究还针对结节阳性和结节阴性患者进行了分组分析,以探讨成本效益的差异。从日本医疗支付方的角度出发,采用蒙特卡罗模拟法对 10,000 个样本进行了单向确定性分析和更广泛的概率敏感性分析:HER2 双靶向治疗可增加 0.17 QALYs,额外费用为 15,289 美元,因此每 QALY 的 ICER 为 92,232 美元。在结节阳性患者亚组中,HER2 双靶向疗法的获益更为显著,可增加 0.64 QALYs,每 QALY 的 ICER 为 24,561 美元。敏感性分析表明,该模型易受从侵袭性无病生存期到死亡、从侵袭性无病生存期到一线转移性乳腺癌以及与培妥珠单抗相关的成本等过渡概率变化的影响。概率敏感性分析表明,对于结节阳性患者,HER2 双靶向治疗可能是一种具有成本效益的选择:结论:HER2 双靶向疗法的经济可行性在结节阳性的高危早期乳腺癌患者中最为明显。这项研究强调了双重HER2靶向疗法作为一种具有成本效益的附加疗法在这些病例中的潜力。
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Cost-Effectiveness Analysis of Adjuvant Pertuzumab and Trastuzumab in Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer in Japan.

Background and objective: Human epidermal growth factor receptor 2 (HER2)-positive breast cancer presents considerable treatment challenges owing to its aggressive nature. Global guidelines have endorsed a full year of HER2-targeted therapy for early-stage breast cancer. However, previous cost-effectiveness analyses of dual HER2-targeted therapies have been limited. This study aimed to examine the cost effectiveness of dual HER2-targeted therapy for early-stage breast cancer within the Japanese healthcare system context.

Methods: In the Markov model-based study, the cost effectiveness of dual anti-HER2 therapy, combining pertuzumab and trastuzumab, was assessed in comparison to trastuzumab monotherapy. Patients in whom treatment was initiated at a median age of 51 years were included. The study utilized quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs) as comparison units. Subgroup analyses were conducted to explore variations in cost effectiveness, focusing on node-positive and node-negative patients. Both one-way deterministic and broader probabilistic sensitivity analyses using Monte Carlo simulations with 10,000 samples were performed from the Japanese healthcare payers perspective.

Results: Dual HER2-targeted therapy led to 0.17 QALYs increment at an additional cost of $US15,289, resulting in an ICER of $US92,232 per QALY. In the subgroup of node-positive patients, the benefit of the dual HER2-targeted therapy was more pronounced, with an increase of 0.64 QALYs and an ICER of $US24,561 per QALY. Sensitivity analyses revealed the model's susceptibility to changes in the transition probabilities from invasive disease-free survival to death, from invasive disease-free survival to first-line metastatic breast cancer, and to costs associated with pertuzumab. Probabilistic sensitivity analysis suggests that for node-positive patients, dual HER2-targeted therapy may be a cost-effective option.

Conclusions: The economic viability of dual HER2-targeted therapy was most pronounced in patients with node-positive high-risk early breast cancer. This study highlights the potential of dual HER2-targeted therapy as a cost-effective addition for these cases.

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来源期刊
CiteScore
5.90
自引率
3.10%
发文量
108
审稿时长
6-12 weeks
期刊介绍: Clinical Drug Investigation provides rapid publication of original research covering all phases of clinical drug development and therapeutic use of drugs. The Journal includes: -Clinical trials, outcomes research, clinical pharmacoeconomic studies and pharmacoepidemiology studies with a strong link to optimum prescribing practice for a drug or group of drugs. -Clinical pharmacodynamic and clinical pharmacokinetic studies with a strong link to clinical practice. -Pharmacodynamic and pharmacokinetic studies in healthy volunteers in which significant implications for clinical prescribing are discussed. -Studies focusing on the application of drug delivery technology in healthcare. -Short communications and case study reports that meet the above criteria will also be considered. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Clinical Drug Investigation may be accompanied by plain language summaries to assist readers who have some knowledge, but non in-depth expertise in, the area to understand important medical advances.
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