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<article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" article-type="research-article" dtd-version="1.1d1" xml:lang="en"><front><journal-meta><journal-id journal-id-type="publisher">REMEDIUM</journal-id><journal-title-group><journal-title>REMEDIUM</journal-title></journal-title-group><issn publication-format="print">1561-5936</issn><issn publication-format="electronic">2658-3534</issn><publisher><publisher-name>Joint-Stock Company Chicot</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="publisher-id">1622</article-id><article-id pub-id-type="doi">10.32687/1561-5936-2023-27-2-105-112</article-id><article-categories><subj-group subj-group-type="heading"><subject>Original Article</subject></subj-group></article-categories><title-group><article-title>Features of modeling the course and outcomes of diseases in the clinical and economic analysis of drugs in oncology — a review of the models used</article-title></title-group><contrib-group><contrib contrib-type="author"><name name-style="western"><surname>Tolkushin</surname><given-names>Alexander G.</given-names></name><bio></bio><email>001</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author"><name name-style="western"><surname>Khabriev</surname><given-names>Ramil U.</given-names></name><bio></bio><email>002</email><xref ref-type="aff" rid="aff-2"/></contrib></contrib-group><aff id="aff-1">Eurasian Academy of Good Practices, Moscow, Russia</aff><aff id="aff-2">N. A. Semashko National Research Institute of Public Health, Moscow, Russia</aff><pub-date date-type="epub" iso-8601-date="2023-12-15" publication-format="electronic"><day>15</day><month>12</month><year>2023</year></pub-date><issue>2</issue><fpage>105</fpage><lpage>112</lpage><history><pub-date date-type="received" iso-8601-date="2025-10-10"><day>10</day><month>10</month><year>2025</year></pub-date></history><permissions><copyright-statement>Copyright © 2023,</copyright-statement><copyright-year>2023</copyright-year></permissions><abstract>Purpose: to determine current trends in modeling the course and outcomes of diseases in the course of clinical and economic studies of drugs in oncology. A review was made of 108 publications presenting the results of clinical and economic (cost-effectiveness) studies of drugs in oncology using simulations published in the first half of 2022 and the second half of 2021. Of the studies reviewed, 98% were performed using a Markov model or a split survival model. Most models include 3 states: no progression (stable state), progression, and death. As a result, 98% of studies calculated the number of quality life years (QALYs) as a measure of effectiveness. Strict preference (reducing costs and increasing efficiency) was found in only 9% of studies. 56% of publications are made in the USA and China. As sources of initial data for modeling, 99% of authors use the results of clinical trials. The current trends in modeling in the framework of clinical and economic studies of drugs in oncology include the consistency of modeling designs and categories of results that allow their comparison, the prevalence of works by authors from China and the United States.</abstract><kwd-group xml:lang="en"><kwd>clinical and economic analysis</kwd><kwd>pharmacoeconomic studies</kwd><kwd>malignant neoplasms</kwd><kwd>oncology</kwd><kwd>cancer</kwd><kwd>modeling</kwd><kwd>drugs</kwd></kwd-group><kwd-group xml:lang="ru"><kwd>клинико-экономический анализ</kwd><kwd>фармакоэкономические исследования</kwd><kwd>злокачественные новообразования</kwd><kwd>онкология</kwd><kwd>рак</kwd><kwd>моделирование</kwd><kwd>лекарственные препараты</kwd></kwd-group></article-meta></front><body></body><back><ref-list><ref id="B1"><label>1.</label><mixed-citation>Yagudina R. I., Skulkova R. S. Fundamentals of pharmacoeconomical analysis. Scientific Centre for Expert Evaluation of Medicinal Products bulletin. 2011;2:56—59. (In Russ.)</mixed-citation></ref><ref id="B2"><label>2.</label><mixed-citation>Zvonarev S. V. Fundamentals of mathematical modeling: textbook. Yekaterinburg; 2019. (In Russ.)</mixed-citation></ref><ref id="B3"><label>3.</label><mixed-citation>Kulikov A. Yu., Nguyen T. T., Tikhomirova A. V. Methodology of modeling in pharmacoeconomics. Pharmacoeconomics. Modern Pharmacoeconomics and Pharmacoepidemiology. 2011;4(4):8—17. (In Russ.)</mixed-citation></ref><ref id="B4"><label>4.</label><mixed-citation>Ichimura T., Nomura H., Shimizu H. et al. Cost-effectiveness of primary prophylaxis of febrile neutropenia with pegfilgrastim in docetaxel, cisplatin and 5-fluorouracil therapy for esophageal cancer. Pharmazie. 2021;76(9):450—454. doi: 10.1691/ph.2021.1031</mixed-citation></ref><ref id="B5"><label>5.</label><mixed-citation>Grau S., Solano C., García-Vidal C. et al. Cost analysis of the use of voriconazole, posaconazole and micafungin in the primary prophylaxis of invasive fungal infections in recipients of allogeneic hematopoietic stem cell transplants. J. Health Econ. Outcomes Res. 2015:3(2):153—161. doi: 10.36469/9832</mixed-citation></ref><ref id="B6"><label>6.</label><mixed-citation>Tolkushin A. G., Moiseeva T. N. Comparison of the original drug filgrastim (Neupogen) with a Russian reproduced drug (Leukostim) for the prevention and treatment of neutropenia against the background of cytostatic polychemotherapy of patients with advanced stages of lymphogranulomatosis: cost-effectiveness analysis and cost minimization. Pharmacoeconomics. Modern Pharmacoeconomics and Pharmacoepidemiology. 2008;(2);22—27. (In Russ.)</mixed-citation></ref><ref id="B7"><label>7.</label><mixed-citation>Kolbin A. S., Kurylev A. A., Proskurin M. A., Balykina Yu. E. The use of everolimus and sorafenib in metastatic kidney cancer: Cost-effectiveness analysis and budget impact analysis. Medical Technologies. Assessment and choice. 2012;(2):72—78. (In Russ.)</mixed-citation></ref><ref id="B8"><label>8.</label><mixed-citation>Omelyanovsky V. V., Avksentieva M. V., Krysanov I. S. et al. Clinical and economic analysis of the use of dasatinib and nilotinib in the second-line therapy of chronic myeloid leukemia in patients resistant to imatinib. Medical Technologies. Assessment and choice. 2011;(2):30—36. (In Russ.)</mixed-citation></ref><ref id="B9"><label>9.</label><mixed-citation>Kosolapov E. G., Kochenkov F. S., Zyryanov S. K., Gladkov O. A. Clinical and economic analysis of the use of pembrolizumab in unresectable and metastatic melanoma compared with targeted therapy. Good clinical practice. 2017;(2):12—24. doi: 10.24411/2588-0519-2017-00011 (In Russ.)</mixed-citation></ref><ref id="B10"><label>10.</label><mixed-citation>Avksentiev N. A., Derkach E. V., Makarov A. S. Pharmacoeconomical study of the use of enzalutamide, abiraterone and kabazitaxel after chemotherapy in patients with metastatic castration-resistant prostate cancer. Medical Technologies. Assessment and choice. 2018;(3):62—74. (In Russ.)</mixed-citation></ref><ref id="B11"><label>11.</label><mixed-citation>Yagudina R. I., Babiy V. V. Survival modeling in pharmacoeconomical research: Markov model and model of divided survival. Pharmacoeconomics. Theory and practice. 2017;5(2):13—17. (In Russ.)</mixed-citation></ref><ref id="B12"><label>12.</label><mixed-citation>Krysanov I. S., Bunyatyan N. D. Basic principles of modeling the «transition of states» in clinical and economic analysis. Bulletin of the Scientific Center for Expertise of Medicinal Products. Regulatory research and examination of medicines. 2013;(1):54—56. (In Russ.)</mixed-citation></ref><ref id="B13"><label>13.</label><mixed-citation>Krysanov I. S. Simulation modeling by the example of the Monte Carlo simulation method. Pharmacoeconomics. Modern Pharmacoeconomics and Pharmacoepidemiology. 2008;(2):3—5. (In Russ.)</mixed-citation></ref><ref id="B14"><label>14.</label><mixed-citation>Kolbin A. S. Pharmacoeconomical research in oncology based on real clinical practice or modeling. Malignant Tumors. 2012;2(2):26-30. (In Russ.)</mixed-citation></ref><ref id="B15"><label>15.</label><mixed-citation>Tolkushin A. G., Zyryanov S. K., Pogudina N. L., Davydovskaya M. V. Methods of conducting clinical and economic studies of drugs for the treatment of malignant neoplasms using modeling. Pharmacoeconomics. Modern Pharmacoeconomics and Pharmacoepidemiology. 2018;11(4):48—60. doi: 10.17749/2070-4909.2018.11.4.048-060. (In Russ.)</mixed-citation></ref><ref id="B16"><label>16.</label><mixed-citation>Blommestein H. M., Franken M. G., van Beurden-Tan C. H.Y. et al. Cost-effectiveness of novel treatment sequences for transplant-ineligible patients with multiple myeloma. JAMA Netw. Open. 2021;4(3):e213497. doi: 10.1001/jamanetworkopen.2021.3497</mixed-citation></ref><ref id="B17"><label>17.</label><mixed-citation>Guyot P., Ades A. E., Ouwens M. J., Welton N. J. Enhanced secondary analysis of survival data: reconstructing the data from published Kaplan—Meier survival curves. BMC Med. Res. Methodol. 2012;12:9. doi: 10.1186/1471-2288-12-9</mixed-citation></ref><ref id="B18"><label>18.</label><mixed-citation>Latimer N. R. Survival analysis for economic evaluations alongside clinical trials — extrapolation with patient-level data: inconsistencies, limitations, and a practical guide. Med. Decis. Making. 2013;33:743—754.</mixed-citation></ref><ref id="B19"><label>19.</label><mixed-citation>Hoyle M. W., Henley W. Improved curve fits to summary survival data: application to economic evaluation of health technologies. BMC Med. Res. Methodol. 2011;11:139. doi: 10.1186/1471-2288-11-139</mixed-citation></ref><ref id="B20"><label>20.</label><mixed-citation>Khaki A. R., Shan Y., Nelson R. E. et al. Cost-effectiveness analysis of neoadjuvant immune checkpoint inhibition vs. cisplatin-based chemotherapy in muscle invasive bladder cancer. Urol. Oncol. 2021;39(10):732.e9—732.e16. doi: 10.1016/j.urolonc.2021.03.004</mixed-citation></ref><ref id="B21"><label>21.</label><mixed-citation>Magalhães Filho M. A.F., Aguiar P. N.Jr., Neves M. B.M. et al. Cost-effectiveness analysis of Ado-trastuzumab emtansine for the treatment of residual invasive HER2-positive breast cancer. Einstein (Sao Paulo). 2022;20:eGS6655. doi: 10.31744/einstein_journal/2022GS6655</mixed-citation></ref><ref id="B22"><label>22.</label><mixed-citation>Meyers B. M., Vogel A., Marotta P. et al. The cost-effectiveness of lenvatinib in the treatment of advanced or unresectable hepatocellular carcinoma from a Canadian perspective. Canad. J. Gastroenterol. Hepatol. 2021;2021:8811018. doi: 10.1155/2021/8811018</mixed-citation></ref><ref id="B23"><label>23.</label><mixed-citation>Liu R., Oluwole O. O., Diakite I. et al. Cost effectiveness of axicabtagene ciloleucel versus tisagenlecleucel for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy in the United States. J. Med. Econom. 2021;24(1):458—468. doi: 10.1080/13696998.2021.1901721</mixed-citation></ref><ref id="B24"><label>24.</label><mixed-citation>Wang X. J., Wang Y. H., Li S. C.T. et al. Cost-effectiveness and budget impact analyses of tisagenlecleucel in adult patients with relapsed or refractory diffuse large B-cell lymphoma from Singapore&amp;apos;s private insurance payer&amp;apos;s perspective. J. Med. Econ. 2021;24(1):637—653. doi: 10.1080/13696998.2021.1922066</mixed-citation></ref><ref id="B25"><label>25.</label><mixed-citation>Sussell J., Singh Jhuti G., Antao V. et al. Cost-effectiveness analysis of ado-trastuzumab emtansine (T-DM1) for the adjuvant treatment of patients with residual invasive HER2+ early breast cancer in the United States. Am. J. Clin. Oncol. 2021;44(7):340—349. doi: 10.1097/COC.0000000000000816</mixed-citation></ref><ref id="B26"><label>26.</label><mixed-citation>Gil-Rojas Y., Lasalvia P., Hernández F. et al. Cost-effectiveness of the dabrafenib schedule in combination with trametinib compared with other targeted therapies, immunotherapy, and dacarbazine for the treatment of unresectable or metastatic melanoma with BRAFV600 mutation in Colombia. Value Health Reg. Issues. 2021;26:182—190. doi: 10.1016/j.vhri.2021.04.008</mixed-citation></ref><ref id="B27"><label>27.</label><mixed-citation>Chatterjee A., Shapouri S., Manzoor B. S. et al. Cost-effectiveness of a 12-month fixed-duration venetoclax treatment in combination with obinutuzumab in first-line, unfit chronic lymphocytic leukemia in the United States. J. Manag. Care Spec. Pharm. 2021;27(11):1532—1544. doi: 10.18553/jmcp.2021.27.11.1532</mixed-citation></ref><ref id="B28"><label>28.</label><mixed-citation>Podkonjak T., Cranmer H., Scarisbrick J. et al. Cost-effectiveness of brentuximab vedotin for the treatment of cutaneous T-cell lymphoma. J. Comp. Eff. Res. 2022;11(3):193—202. doi: 10.2217/cer-2021-0201</mixed-citation></ref><ref id="B29"><label>29.</label><mixed-citation>Braal C. L., Kleijburg A., Jager A. et al. Therapeutic drug monitoring-guided adjuvant tamoxifen dosing in patients with early breast cancer: a cost-effectiveness analysis from the prospective TOTAM trial. Clin. Drug Inv. 2022;42(2):163—175. doi: 10.1007/s40261-021-01114-6</mixed-citation></ref><ref id="B30"><label>30.</label><mixed-citation>Gao T., Liu J., Wu J. Cost-effectiveness analysis of dabrafenib plus trametinib and vemurafenib as first-line treatment in patients with BRAF V600 mutation-positive unresectable or metastatic melanoma in China. Int. J. Environ. Res. Public Health. 2021;18(12):6194. doi: 10.3390/ijerph18126194</mixed-citation></ref><ref id="B31"><label>31.</label><mixed-citation>Zhu J., Wu Q., Wang J., Niu T. Cost-effectiveness analysis of azacitidine maintenance therapy in patients with acute myeloid leukemia. Exp. Rev. Hematol. 2022;15(4):375—382. doi: 10.1080/17474086.2022.2061456</mixed-citation></ref><ref id="B32"><label>32.</label><mixed-citation>Annemans L. Health economics for non-economists: an introduction to the concepts, methods and pitfalls of health economic evaluations. Ghent; 2008.</mixed-citation></ref><ref id="B33"><label>33.</label><mixed-citation>Lemeshko V. A., Musina N. Z., Omelyanovsky V. V. Determination of the therapeutic value of antitumor drugs. Pharmacoeconomics. Modern Pharmacoeconomics and Pharmacoepidemiology. 2020;13(3):262—269. (In Russ.)</mixed-citation></ref><ref id="B34"><label>34.</label><mixed-citation>Tolkushin A. G., Davydovskaya M. V., Yagudina R. I. The concept of determining the equilibrium price of innovative medicines based on their real value — value-based pricing. Remedium. 2017;(12):6—14. (In Russ.)</mixed-citation></ref></ref-list></back></article>
