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Purpose: In this study, we aimed to evaluate the cost-effectiveness of S-1 and oxaliplatin (SOX) plus bevacizumab (Bmab group) compared with SOX plus cetuximab (Cmab group) as a first-line treatment for patients with Kirsten rat sarcoma virus (KRAS) wild-type metastatic colorectal cancer (mCRC) in Japan from the perspective of healthcare payers.
Methods: A partitioned survival model was developed using data from the randomized phase II Osaka Multicenter Study Group on Colorectal Cancer-1107 study, which included overall survival, progression-free survival, and treatment regimens for the Bmab and Cmab groups. Treatment costs were estimated from the Japanese medical claims database and the National Health Insurance drug price list. The utilities were derived from the literature. Outcomes were reported as incremental cost, incremental quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER). The willingness-to-pay (WTP) threshold was set at 7.5 million JPY per QALY. The time horizon of the model was set to 20 years. Sensitivity analyses were conducted to assess the uncertainty of the model for various parameters.
Findings: Compared with the Cmab group, the Bmab group had an incremental cost of 911,373 JPY (6,528 USD), an incremental effectiveness of 0.79 QALY, and an ICER of 1,146,745 JPY (8,215 USD) per QALY. One-way sensitivity analysis showed that the cost of progressive disease treatment in the Bmab group had the greatest impact on the ICER. According to the probabilistic sensitivity analysis, the Bmab group had a 94.9% probability of being cost-effective compared with the Cmab group.
Implications: Considering a WTP threshold of 7.5 million JPY (approximately 53,700 USD) per QALY, Bmab might be a cost-effective treatment option for patients with KRAS wild-type mCRC in Japan. Further studies on economic evaluations based on personalized drugs and patient selection based on clinical and genetic information are warranted.
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http://dx.doi.org/10.1016/j.clinthera.2025.01.019 | DOI Listing |
Expert Opin Biol Ther
July 2025
Clinical Development and Medical Affairs, Biocon Biologics UK Ltd, London, UK.
Background: STELLAR-2 assessed the equivalent efficacy of the ustekinumab biosimilar, Bmab 1200, versus reference ustekinumab in patients with moderate-to-severe chronic plaque psoriasis. Safety, immunogenicity, and pharmacokinetics (PK) were also evaluated.
Research Design And Methods: In this double-blind, parallel-group, Phase 3 study, patients were randomized 1:1 to Bmab 1200 or reference ustekinumab in Treatment Period (TP)1, and at Week 16, those who responded to reference ustekinumab (improvement in Psoriasis Area and Severity Index [PASI] score ≥ 50%) were re-randomized (1:1) to continue reference ustekinumab or switch to Bmab 1200 in TP2.
Expert Opin Investig Drugs
April 2025
Clinical Development and Medical Affairs, Biocon Biologics Limited, Bengaluru, India.
Background: This study assessed the pharmacokinetics (PK) equivalence, safety, tolerability, and immunogenicity of Bmab-1200 versus the reference product ustekinumab (EU-approved and US-licensed Stelara).
Research Design & Methods: This 20-week, randomized, double-blind, three-arm, parallel-design, Phase-1 study enrolled healthy male and female subjects ( = 258; 18-55 years). A single, 45-mg subcutaneous injection of Bmab-1200, EU-approved Stelara, or US-licensed Stelara was administered in a 1:1:1 ratio.
Clin Ther
May 2025
Graduate School of Health Management, Keio University, Fujisawa, Kanagawa, Japan; Graduate School of Business Administration, Keio University, Yokohama, Kanagawa, Japan.
Purpose: In this study, we aimed to evaluate the cost-effectiveness of S-1 and oxaliplatin (SOX) plus bevacizumab (Bmab group) compared with SOX plus cetuximab (Cmab group) as a first-line treatment for patients with Kirsten rat sarcoma virus (KRAS) wild-type metastatic colorectal cancer (mCRC) in Japan from the perspective of healthcare payers.
Methods: A partitioned survival model was developed using data from the randomized phase II Osaka Multicenter Study Group on Colorectal Cancer-1107 study, which included overall survival, progression-free survival, and treatment regimens for the Bmab and Cmab groups. Treatment costs were estimated from the Japanese medical claims database and the National Health Insurance drug price list.
Sci Rep
January 2025
Department of Gastroenterological Surgery, Osaka Metropolitan University Graduate School of Medicine, 1-4-3 Asahi-machi Abeno-ku, Osaka City, 545-8585, Osaka Prefecture, Japan.
Although the phase III SUNLIGHT trial has demonstrated the survival benefit of the addition of bevacizumab (Bmab) to trifluridine/thymidine phosphorylase inhibitor (FTD/TPI), neutropenia, which frequently occurs during FDT/TPI + Bmab therapy, is a concern for clinicians. As TPI is excreted by the kidneys, the risk of adverse events is likely to be high in patients with an impaired renal function. This study aimed to investigate the relationship between renal impairment and the incidence of chemotherapy-induced neutropenia during FTD/TPI + Bmab therapy using real-world data.
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October 2024
Department of Gastroenterological Surgery, Osaka Metropolitan University Graduate School of Medicine, 1-4-3 Asahi-machi Abeno-ku, Osaka City, 545-8585, Osaka Prefecture, Japan.
In later-line treatment of metastatic colorectal cancer (mCRC), there may be large differences in treatment efficacy depending on cancer cachexia. Recently, the cachexia index (CXI), which was calculated from the skeletal muscle mass index (SMI), serum albumin concentration, and neutrophil-to-lymphocyte ratio, was developed to evaluate cancer cachexia. We retrospectively examined the CXI of 80 patients who were treated with trifluridine/thymidine phosphorylase inhibitor (FTD/TPI) + bevacizumab (Bmab) therapy as a later-line treatment for mCRC, and assessed the impact of cancer cachexia on chemotherapeutic efficacy using CXI.
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