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Clinical and economic studies on pharmacotherapy of malignant neoplasms: the modeling approach

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The aim is to develop a generalized algorithm and methodology for conducting clinical and economic studies (CeS) on medications used in treatment of malignant neoplasms (MnP). Materials and methods. We conducted a literature search and then reviewed the recent reports on similar CeS. In so doing, we paid special attention to the model type, the modeling methodology, information on the effectiveness and cost, the cost elements, performance criteria, the assessment of the CeS final results, as well as the possibility of applying these results to the national healthcare system. We used the methods of generalization, systematization, as well as visual-graphical and mathematical modeling. Results. A general algorithm for conducting a pharmacoeconomic study has been proposed; this includes an effectiveness analysis, a cost analysis and a comparison of costs and effectiveness (cost-effectiveness). The effectiveness analysis includes selection, digitization, and approximation of overall survival (OS) and progression-free survival (PFS) curves followed by their extrapolation. The choice of extrapolation method is discussed. The cost analysis includes calculating the cost of medications in question, the costs associated with the indicated therapy and with adverse events (Ae), as well the costs associated with disease progression (for certain drugs). The possibility of analyzing indirect and non-medical costs is also discussed. A dynamic version of the Markov model pertaining to the first order course of a disease is proposed; this includes the status before progression (first-line therapy), after progression (second-line therapy) and death. Considering the succession of treatments and the availability of additional data, a similar second-order model (and subsequent orders) can be applied to incorporate additional patient’s condition after the first progression to the second progression (second-line therapy) and after the second progression (third-line therapy). Conclusion. A generalized algorithm has been developed and proposed for carrying out CeS of medications
used in MnP.

About the Authors

A. G. Tolkushin
Research and Practical Center for Clinical Trials and Medical Technology Assessment, Moscow Department of Healthcare
Russian Federation

Aleksandr G. Tolkushin – PhD, Chief Expert, LLC “Smart Choice” Independent Research Company; Leading Researcher, Scientific and Practical Center for Clinical Research and Evaluation of Medical Technologies, Department of Healthcare of the City of Moscow;

12-2 Minskaya Str., Moscow 121096

S. K. Zyryanov
Peoples’ Friendship University of Russia
Russian Federation

Sergej K. Zyryanov – MD, Professor, Head of the Department of General and Clinical Pharmacology, Peoples’ Friendship University of Russia; Deputy Chief Medical Officer, State Clinical Hospital No. 24, Department of Healthcare of the City of Moscow;

Researcher ID: D-8826-2012;

10/3 Miklukho-Maklaya Str., Moscow 117198

N. L. Pogudina
LLC «Independent Research Company «Smart Choice»
Russian Federation

Natalia L. Pogudina – PhD, Director-General;

23/6 Otkrytoe shosse, Moscow 107143

M. V. Davydovskaya
Research and Practical Center for Clinical Trials and Medical Technology Assessment, Moscow Department of Healthcare
Russian Federation

Mariya V. Davydovskaya – MD, PhD, Professor at the Department of Neurology, Neurosurgery and Medical Genetics, Pirogov Russian National Research Medical University; Deputy Chief Consultant in Neurology with the Department of Healthcare of the City of Moscow, Deputy Director for Science, Center for Clinical Research and Evaluation of Medical Technologies;

12-2 Minskaya Str., Moscow 121096


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For citations:

Tolkushin A.G., Zyryanov S.K., Pogudina N.L., Davydovskaya M.V. Clinical and economic studies on pharmacotherapy of malignant neoplasms: the modeling approach. FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology. 2018;11(4):48-60. (In Russ.)

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