Cost-Effectiveness Analysis of Pembrolizumab Plus Chemotherapy Compared with Chemotherapy as First-Line Treatment for Advanced PD-L1-Positive Triple-Negative Breast Cancer from a Japanese Healthcare Perspective.

IF 2.9 3区医学 Q2 PHARMACOLOGY & PHARMACY

Clinical Drug Investigation Pub Date : 2025-06-01 Epub Date: 2025-05-03 DOI:10.1007/s40261-025-01445-8

Yugo Chisaki, Nobuhiko Nakamura, Takako Komuro, Hirokatsu Nyuji, Mai Harano, Noriaki Kitada

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引用次数: 0

Abstract

Background and objectives: Pembrolizumab has been approved for the immunotherapy of programmed death ligand 1 (PD-L1)-positive triple-negative breast cancer (TNBC) based on the KEYNOTE-355 trial. However, cost-effectiveness evidence is limited. The purpose of this study was to evaluate the cost-effectiveness of pembrolizumab plus chemotherapy compared with chemotherapy alone for patients with PD-L1-positive inoperable or metastatic TNBC from a Japanese healthcare perspective.

Methods: The cost-effectiveness analysis was performed for pembrolizumab, of which the drug price was determined at 214,498 Japanese yen (JPY), or 1631 US dollars (USD) (1 USD = 131.5 JPY) for KEYTRUDA^® (100 mg), using a partition survival model based on the KEYNOTE-355 trial subgroup analysis in Japan. The comparison was made using quality-adjusted life years (QALYs) and the incremental cost-effectiveness ratio (ICER). One-way deterministic and probabilistic sensitivity analyses (PSA), which evaluate the impact of parameter uncertainty, were performed to assess the robustness and calculate the acceptable probability, defined as the probability of the ICER being below the willingness-to-pay (WTP).

Results: Pembrolizumab plus chemotherapy provided an additional 0.676 QALYs at an incremental cost of 8,503,072 JPY. The ICER for pembrolizumab plus chemotherapy compared with conventional chemotherapy was 12,577,178 JPY (95,644 USD) per QALY. The ICER per QALY was below the willingness-to-pay threshold of 15,000,000 JPY. PSAs revealed that the acceptable probability was 83.9% at 15,000,000 JPY.

Conclusions: The pembrolizumab plus chemotherapy is likely to be a cost-effective option compared with conventional chemotherapy for patients with PD-L1-positive inoperable or metastatic TNBC in a Japanese medical environment from a healthcare system.

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从日本医疗保健角度分析派姆单抗联合化疗与化疗作为一线治疗晚期pd - l1阳性三阴性乳腺癌的成本-效果分析

背景和目的：基于KEYNOTE-355试验，派姆单抗已被批准用于程序性死亡配体1 （PD-L1）阳性三阴性乳腺癌（TNBC）的免疫治疗。然而，成本效益证据有限。本研究的目的是从日本医疗保健的角度评估派姆单抗联合化疗与单独化疗相比，对pd - l1阳性不能手术或转移性TNBC患者的成本效益。方法：采用基于KEYNOTE-355试验亚组分析的分区生存模型，对派姆单抗进行成本-效果分析，其中KEYTRUDA®（100 mg）的药物价格确定为214,498日元（JPY），或1631美元（USD）（1美元= 131.5日元）。采用质量调整寿命年（QALYs）和增量成本-效果比（ICER）进行比较。通过评估参数不确定性影响的单向确定性和概率敏感性分析（PSA）来评估稳健性并计算可接受概率，可接受概率定义为ICER低于支付意愿（WTP）的概率。结果：派姆单抗加化疗提供了额外的0.676个qaly，增量成本为8,503,072日元。与常规化疗相比，派姆单抗联合化疗的ICER为每QALY 12,577,178日元（95,644美元）。每个QALY的ICER低于1500万日元的支付意愿阈值。psa显示，在15,000,000日元上的可接受概率为83.9%。结论：在日本的医疗环境中，与传统化疗相比，派姆单抗加化疗可能是一种具有成本效益的选择，用于pd - l1阳性不能手术或转移性TNBC患者。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical Drug Investigation 医学-药学

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.