Modelling in economic evaluations of medicines
Economic evaluation in health (also known as pharmacoeconomic in case of medicines) identifies, measures, and values costs and outcomes of alternative healthcare technologies, and can be performed alongside controlled clinical trials, but analytical modelling is usually used. Decision trees and Markov models are the two most common approaches used in economic evaluation. The biggest advantages of a decision tree are clarity, simplicity, and straightforwardness. On the other hand, the main advantage of the Markov model is its ability to incorporate complex events into the simulation, which is practically impossible to do with a decision tree. Reimbursement policy in Serbia mandatorily incorporates economic evaluations to promote availability and accessibility of the prescription medicines. To show pharmacoeconomic value of a medicine, budget impact analysis and the cost-effectiveness analysis should be included. The latter should be conducted using appropriate modelling techniques. However, since no official methodological guidelines about the modelling and economic analysis exist, the submissions by marketing authorization holders vary greatly. The future of pharmacoeconomic modelling depends on the research area of interest, with new frameworks and approaches being developed.
Drummond MF, Sculpher MJ, Torrance GW, O’Brien BJ, Stoddart G. Methods for the economic evaluation of health care programmes. 3rd Ed. New York: Oxford University Press; 2005; p. 65-9.
Bootman JL, Townsend RJ, McGhan WF, editors. Principles of Pharmacoeconomics. 3rd Ed. Cincinnati: Harvey Whitney Books; 2005; p. 1-18.
Rascati KL. Essentials of Pharmacoeconomics. 2nd Ed. Philadelphia: Lippincott Williams & Wilkins; 2013; p. 3-6.
Petrou S, Gray A. Economic evaluation alongside randomised clinical trials: design, conduct, analysis, and reporting. BMJ. 2011;342:d1548.
Brennan A, Chick SE, Davies R. A taxonomy of model structures for economic evaluation of health technologies. Health Econ. 2006;15(12):1295-310.
Barton P, Bryan S, Robinson S. Modelling in the economic evaluation of health care: selecting the appropriate approach. J Health Serv Res Policy. 2004;9(2):110-8.
Petrou S, Gray A. Economic evaluation using decision analytical modelling: design, conduct, analysis, and reporting. BMJ. 2011;342:d1766.
Ademi Z, Kim H, Reid CM, Hollingsworth B, Liew D. Overview of pharmacoeconomic modelling methods. Br J Clin Pharmacol. 2012;75(4):944-50.
Whitehead SJ, Ali S. Health outcomes in economic evaluation: the QALY and utilities. Br Med Bull. 2010;96(1):5–21.
Gray A, Clarke P, Wolstenholme J, Wordsworth S. Applied methods of cost-effectiveness analysis in health care. New York: Oxford University Press; 2010; p. 179-210.
Briggs A, Claxton C, Sculpher M. Decision modelling for health economic evaluation. New York: Oxford University Press; 2006; p. 27-44
Bogavac-Stanojevic N, Dopsaj V, Jelic-Ivanovic Z, Lakić D, Vasić D, Petrova G. Economic evaluation of different screening alternatives for patients with clinically suspected acute deep vein thrombosis. Biochemia Medica 2013;23(1): 96-106.
Živković M, Lakić D, Tadić I, Odalović M, Bogavac Stanojević N. Farmakoekonomska evaluacija primene rastvora za infuziju kaspofungina i amfotericina B u terapiji teških sistemskih mikoza. Arh Farm 2015;65(1):33-46.
Lakić D, Tadić I, Odalović M, Kolundžić S. Upotreba antibakterijskih lekova u lečenju infekcija urinarnog trakta – farmakoekonomski aspekt. Arh Farm 2015;65(1):47-57.
Lakić D, Petrović B, Petrova G. A cost-effectiveness analysis of different types of labor for singleton pregnancy – real life data. Srp Arh Celok Lek 2014;142(11-12):688-94.
Stojković T, Marinković V, Lakić D, Bogavac-Stanojević N. Pharmacoeconomic Evaluation of Providing Pharmacist-Managed Anticoagulation Service to Patients on Warfarin. Arh farm 2016;66(2):103-17.
Basu S. Modelling Public Health and Healthcare Systems. New York: Oxford University Press; 2018; p. 125-45.
Cookson R, Griffin S, Norheim OF, Culyer A. Distributional Cost-Effectiveness Analysis. New York: Oxford University Press; 2021; p. 137-8.
Lakic D, Petrova G, Bogavac-Stanojevic N, Jelic-Ivanovic Z, Kos M. The cost-effectiveness of hypertension pharmacotherapy in Serbia: A Markov Model. Biotechnol & Biotechnol Eq. 2012;26(3):3066-72.
Kostić M, Jovanović S, Tomović M, Milenković MP, Janković SM. Cost-effectiveness analysis of tocilizumab in combination with methotrexate for rheumatoid arthritis: a Markov model based on data from Serbia, country in socioeconomic transition. Vojnosanit Pregl. 2014;71(2):144-8.
Kostić M, Milosavljević MN, Stefanović S, Ranković G, Janković SM. Cost-utility of tafenoquine vs. primaquine for the radical cure (prevention of relapse) of Plasmodium vivaxmalaria. J Chemother. 2020;32(1):21-9.
Dutina A, Stašević-Karličić I, Pandrc N, Prokić A, Janković SM. Cost-effectiveness of aripiprazole vs. olanzapine in the long-term treatment of schizophrenia. Srp Arh Celok Lek. 2019;147(7-8):468-74.
Lakic D, Bogavac-Stanojevic N, Jelic-Ivanovic Z, Kotur-Stevuljevic J, Spasic S, Kos M. A Multimarker Approach for the Prediction of Coronary Artery Disease: Cost-Effectiveness Analysis. Value Health. 2010;13(6):770-7.
Petrovic S, Bogavac-Stanojevic N, Lakic D, Peco-Antic AE, Vulicevic I, Ivanisevic I, et al. Cost-effectiveness analysis of acute kidney injury biomarkers in pediatric cardiac surgery. Biochemia Medica. 2015;25(2):262-71.
Uredba o kriterijumima za formiranje cena lekova za upotrebu u humanoj medicine čiji je režim izdavanja na recept. Službeni glasnik RS 86/15, 8/16, 15/18 and 18/19.
Pravilnik o uslovima, kriterijumima, načinu i postupku za stavljanje leka na listu lekova, izmene i dopune liste lekova, odnosno za skidanje leka sa Liste lekova. Službeni glasnik RS 41/14, 125/14, 48/15, and 14/18.
Cleemput I, Van Wilder P, Huybrechts M, Vrijens F. Belgian Methodological Guidelines for Pharmacoeconomic Evaluations: Toward Standardization of Drug Reimbursement Requests. Value Health. 2009;12:441-9.
Piniazhko O, Zaliska O, Nemeth B. Development of Pharmacoeconomic Guidelines In Ukraine: Methodological Issues And Policy Implications. Value Health. 2017;20(9):A669-A700.
Squires H, Boyd K. The use of modelling approaches for the economic evaluation of public health intervention. In: Rhiannon T. Edwards, McIntosh E, editors. Applied health economics for public health practise and research. New York: Oxford University Press; 2019; p. 248-73.
Squirres, H, Chilcott J, Akehurst R, Burr J, Kelly MP. A framework for developing the structure of public health economic models. Value Health. 2016;19(5):588-601.
Boyd KA, Fenwick E, Briggs A. Using an Iterative Approach to Economic Evaluation in the Drug Development Process. Drug Develop Res. 2010;71(8):470–7.