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      Cost-effectiveness analysis of rezvilutamide versus bicalutamide in the treatment of metastatic hormone-sensitive prostate cancer

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          Abstract

          Abstract
          Objectives

          The economic implications of combining rezvilutamide with androgen deprivation therapy (ADT) remain uncertain, despite the observed survival advantages compared with bicalutamide plus ADT. Therefore, this study evaluates the cost-effectiveness of rezvilutamide plus ADT as the first-line treatment of metastatic hormone-sensitive prostate cancer (mHSPC) from the perspective of the Chinese healthcare system.

          Design

          A partitioned survival model was developed to assess the cost-effectiveness of rezvilutamide combined with ADT. Clinical data were obtained from the CHART trial. Costs and utility values were obtained from local estimate and published literature. Only direct medical costs were included in the model.

          Interventions

          Rezvilutamide was administered at 240 mg daily or bicalutamide at 50 mg daily until progression.

          Outcome measures

          The main outputs of the model included costs and quality-adjusted life years (QALYs), which were used to determine the incremental cost-effectiveness ratio (ICER). One-way and probabilistic sensitivity analysis (PSA) were used to explore model uncertainties.

          Results

          The rezvilutamide group showed an expected gain of 2.28 QALYs and an incremental cost of US$60 758.82 compared with the bicalutamide group. The ICER for rezvilutamide group versus bicalutamide group was US$26 656.94 per QALY. The variables with the greatest impact on the model results were the utility for progression-free survival state and the price of rezvilutamide. PSA revealed that rezvilutamide group had 100% probability of being cost-effective at a willingness-to-pay threshold of US$35707.5 per QALY.

          Conclusion

          Rezvilutamide in combination with ADT is more cost-effective compared with bicalutamide plus ADT as the first-line treatment of mHSPC from the perspective of the Chinese healthcare system.

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          Most cited references23

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          Global Cancer Statistics 2018: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries

          This article provides a status report on the global burden of cancer worldwide using the GLOBOCAN 2018 estimates of cancer incidence and mortality produced by the International Agency for Research on Cancer, with a focus on geographic variability across 20 world regions. There will be an estimated 18.1 million new cancer cases (17.0 million excluding nonmelanoma skin cancer) and 9.6 million cancer deaths (9.5 million excluding nonmelanoma skin cancer) in 2018. In both sexes combined, lung cancer is the most commonly diagnosed cancer (11.6% of the total cases) and the leading cause of cancer death (18.4% of the total cancer deaths), closely followed by female breast cancer (11.6%), prostate cancer (7.1%), and colorectal cancer (6.1%) for incidence and colorectal cancer (9.2%), stomach cancer (8.2%), and liver cancer (8.2%) for mortality. Lung cancer is the most frequent cancer and the leading cause of cancer death among males, followed by prostate and colorectal cancer (for incidence) and liver and stomach cancer (for mortality). Among females, breast cancer is the most commonly diagnosed cancer and the leading cause of cancer death, followed by colorectal and lung cancer (for incidence), and vice versa (for mortality); cervical cancer ranks fourth for both incidence and mortality. The most frequently diagnosed cancer and the leading cause of cancer death, however, substantially vary across countries and within each country depending on the degree of economic development and associated social and life style factors. It is noteworthy that high-quality cancer registry data, the basis for planning and implementing evidence-based cancer control programs, are not available in most low- and middle-income countries. The Global Initiative for Cancer Registry Development is an international partnership that supports better estimation, as well as the collection and use of local data, to prioritize and evaluate national cancer control efforts. CA: A Cancer Journal for Clinicians 2018;0:1-31. © 2018 American Cancer Society.
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            Survival analysis for economic evaluations alongside clinical trials--extrapolation with patient-level data: inconsistencies, limitations, and a practical guide.

            N Latimer (2013)
            In health technology assessments (HTAs) of interventions that affect survival, it is essential to accurately estimate the survival benefit associated with the new treatment. Generally, trial data must be extrapolated, and many models are available for this purpose. The choice of extrapolation model is critical because different models can lead to very different cost-effectiveness results. A failure to systematically justify the chosen model creates the possibility of bias and inconsistency between HTAs. To demonstrate the limitations and inconsistencies associated with the survival analysis component of HTAs and to propose a process guide that will help exclude these from future analyses. We reviewed the survival analysis component of 45 HTAs undertaken for the National Institute for Health and Clinical Excellence (NICE) in the cancer disease area. We drew upon our findings to identify common limitations and to develop a process guide. The chosen survival models were not systematically justified in any of the HTAs reviewed. The range of models considered was usually insufficient, and the rationale for the chosen model was universally limited: In particular, the plausibility of the extrapolated portion of fitted survival curves was very rarely explicitly considered. Limitations. We do not seek to describe and review all methods available for performing survival analysis-several approaches exist that are not mentioned in this article. Instead we seek to analyze methods commonly used in HTAs and limitations associated with their application. Survival analysis has not been conducted systematically in HTAs. A systematic approach such as the one proposed here is required to reduce the possibility of bias in cost-effectiveness results and inconsistency between technology assessments.
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              Hormonal Therapy for Prostate Cancer

              Huggins and Hodges demonstrated the therapeutic effect of gonadal testosterone deprivation in the 1940s and therefore firmly established the concept that prostate cancer is a highly androgen-dependent disease. Since that time, hormonal therapy has undergone iterative advancement, from the types of gonadal testosterone deprivation to modalities that block the generation of adrenal and other extragonadal androgens, to those that directly bind and inhibit the androgen receptor (AR). The clinical states of prostate cancer are the product of a superimposition of these therapies with nonmetastatic advanced prostate cancer, as well as frankly metastatic disease. Today’s standard of care for advanced prostate cancer includes gonadotropin-releasing hormone agonists (e.g., leuprolide), second-generation nonsteroidal AR antagonists (enzalutamide, apalutamide, and darolutamide) and the androgen biosynthesis inhibitor abiraterone. The purpose of this review is to provide an assessment of hormonal therapies for the various clinical states of prostate cancer. The advancement of today’s standard of care will require an accounting of an individual’s androgen physiology that also has recently recognized germline determinants of peripheral androgen metabolism, which include HSD3B1 inheritance.
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                Author and article information

                Contributors
                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2024
                12 July 2024
                : 14
                : 7
                : e073170
                Affiliations
                [1 ]departmentDepartment of Pharmacy , Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences , Hangzhou, China
                [2 ]College of Pharmaceutical Sciences, Zhejiang University , Hangzhou, China
                [3 ]Zhejiang University of Technology , Hangzhou, China
                Author notes

                Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

                None declared.

                HD and SL contributed equally.

                Author information
                http://orcid.org/0000-0001-5491-4930
                http://orcid.org/0000-0001-7865-5435
                http://orcid.org/0000-0002-8070-5662
                Article
                bmjopen-2023-073170
                10.1136/bmjopen-2023-073170
                11253765
                39002960
                5a7e9f89-b854-416d-872f-f8bf819e4aa6
                Copyright © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 27 February 2023
                : 17 June 2024
                Funding
                Funded by: Key Laboratory of Clinical Cancer Pharmacology and Toxicology Research of Zhejiang Province;
                Award ID: 2020E10021
                Categories
                Original Research
                Oncology
                1717
                1506

                Medicine
                prostatic neoplasms,health economics,public health
                Medicine
                prostatic neoplasms, health economics, public health

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