Shaping of the evidence-based substitution conceptual framework of the original medicines to generic counterparts in Ukraine
Keywords:bioequivalence, generic drug, therapeutic drug monitoring, narrow therapeutic index, evidence-based medicine, affordable medicines
The aim. To develop conceptual framework of the strategy for a reasonable transition from original to generic medicines by complex implementation of proper bioequivalence studies and sufficient therapeutic drug monitoring management.
Materials and methods. To conduct the study, we used the lists of medicines included in the state reimbursement program “Dostupny Liky” (Affordable Medicines), and materials of reports on medicines public procurement provided on the website of the Ministry of Health of Ukraine and the National Health Service of Ukraine, as well as information data on the results of studies of the quality and effectiveness of these drugs provided by the Rx-Index website. In the course of the study, the methods of logical analysis, SWOT analysis, and statistical evaluation of results, Kingdon’s Policy Streams Approach and the method of flowcharts construction were used. The concept of evidence-based medicine substitution formation in Ukraine was designed applying the Policy Streams Approach.
Results. The analysis of public procurement programs for drugs for the period 2018–2020, as well as the analysis of drugs included in the new list under the “Dostupny Liky” (Affordable Medicines) program, carried out in the course of the study, showed that the level of evidence of data on assessing their effectiveness remains low. At the same time, more than 1.5 billion UAH (~ 50 mln USD) is spent annually on the purchase of such drugs and reimbursement of their cost, and the question of the optimal selection and monitoring of pharmacotherapy with these drugs remains open. A structural model has been developed, in which three basic levels are identified: provision of regulatory and financial components, executive and the level of implementation of the results. The SWOT-analysis of the strengths and weaknesses, as well as external opportunities and threats for the implementation of the conceptual framework made it possible to substantiate the advantages and reveal the possibilities of attracting clinical centers of universities and research institutions to the implementation of the concept. A framework for the interaction of a research center with health care institutions in the implementation of therapeutic drug monitoring was developed for low-income and low-middle income countries on the example of Ukraine. Distribution of responsibilities was proposed and the basic principles of interaction between performers of therapeutic drug monitoring were highlighted.
Conclusions. Based on the results of the analysis of the evidence of the quality and effectiveness of drugs included in public procurement and in reimbursement programs, the key problems of organizing pharmaceutical provision of an appropriate level of quality for a number of chronic diseases requiring lifelong therapy were identified. The conceptual framework of evidence-based original medicines substitution to generic counterparts have been formed; and the ways of its implementation in the conditions of scarce financial resources on the example of Ukraine have been substantiated
- Maxwell, S. R. (2016). Rational prescribing: the principles of drug selection. Clinical Medicine, 16 (5), 459–464. doi: http://doi.org/10.7861/clinmedicine.16-5-459
- Hiemke, C., Bergemann, N., Clement, H., Conca, A., Deckert, J., Domschke, K. et. al. (2017). Consensus Guidelines for Therapeutic Drug Monitoring in Neuropsychopharmacology: Update 2017. Pharmacopsychiatry, 51 (01/02), 9–62. doi: http://doi.org/10.1055/s-0043-116492
- Van Gelder, T. (2011). European Society for Organ Transplantation Advisory Committee Recommendations on Generic Substitution of Immunosuppressive Drugs. Transplant International, 24 (12), 1135–1141. doi: http://doi.org/10.1111/j.1432-2277.2011.01378.x
- Liu, Q., Smith, A. R., Park, J. M., Oguntimein, M., Dutcher, S., Bello, G. et. al. (2018). The adoption of generic immunosuppressant medications in kidney, liver, and heart transplantation among recipients in Colorado or nationally with Medicare part D. American Journal of Transplantation, 18 (7), 1764–1773. doi: http://doi.org/10.1111/ajt.14722
- Evaluation of the Affordable Medicines Programme in Ukraine (2019). WHO Regional office for Europe. Available at: https://www.euro.who.int/en/countries/ukraine/publications/evaluation-of-the-affordable-medicines-programme-in-ukraine-2019
- Wouters, O. J., Kanavos, P. G., McKee, M. (2017). Comparing Generic Drug Markets in Europe and the United States: Prices, Volumes, and Spending. The Milbank Quarterly, 95 (3), 554–601. doi: http://doi.org/10.1111/1468-0009.12279
- Cristofoletti, R., Rowland, M., Lesko, L. J., Blume, H., Rostami-Hodjegan, A., Dressman, J. B. (2018). Past, Present, and Future of Bioequivalence: Improving Assessment and Extrapolation of Therapeutic Equivalence for Oral Drug Products. Journal of Pharmaceutical Sciences, 107 (10), 2519–2530. doi: http://doi.org/10.1016/j.xphs.2018.06.013
- Kaló, Z., Holtorf, A.-P., Alfonso-Cristancho, R., Shen, J., Ágh, T., Inotai, A., Brixner, D. (2015). Need for Multicriteria Evaluation of Generic Drug Policies. Value in Health, 18 (2), 346–351. doi: http://doi.org/10.1016/j.jval.2014.12.012
- Dunne, S., Shannon, B., Dunne, C., Cullen, W. (2013). A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study. BMC Pharmacology and Toxicology, 14 (1). doi: http://doi.org/10.1186/2050-6511-14-1
- Introducing New Strategy on Bioequivalence in Ukraine. (2018). SAFEMed. Available at: https://www.msh.org/sites/default/files/safemed_bioequivalence_tech_report_final.pdf
- Popov, О. S., Kravchenko, І. V., Dоbrоvа, V. Y., Tkachenko, K. M. (2021). The analysis of approaches to conducting bioequivalence studies and the policy of “transparency” of their results in Ukraine, the United States and the European Union. Clinical Pharmacy, 25 (1), 32–40. doi: http://doi.org/10.24959/cphj.21.1548
- Maly, J., Zimcikova, E., Babica, J., Kubena, A. A., Kostriba, J., Mala-Ladova, K. (2019). Representative sample survey on factors determining the Czech physicians’ awareness of generic drugs and substitution. BMC Health Services Research, 19 (1). doi: http://doi.org/10.1186/s12913-019-4631-y
- Zupanets, I. A., Dobrova, V. Y., Shilkina, O. O. (2018). Development of Theoretical Approaches to Pharmaceutical Care Improvement Considering the Modern Requirements of Health-Care System in Ukraine. Asian Journal of Pharmaceutical and Clinical Research, 11 (8), 356. doi: http://doi.org/10.22159/ajpcr.2018.v11i8.26009
- Sweet, C. M. (2017). The Politics and Policies of Regulating Generics in Latin America: A Survey of Seventeen States. Journal of Health Politics, Policy and Law, 42 (3), 485–512. doi: http://doi.org/10.1215/03616878-3802953
- Ferrario, A., Sautenkova, N., Bezverhni, Z., Seicas, R., Habicht, J., Kanavos, P., Safta, V. (2014). An in-depth analysis of pharmaceutical regulation in the Republic of Moldova. Journal of Pharmaceutical Policy and Practice, 7 (1). doi: http://doi.org/10.1186/2052-3211-7-4
- Mansilla, C., Cárdenas, J., Kaplan, W. A., Wirtz, V. J., Kuhn-Barrientos, L., Ortíz de Zárate, M. et. al. (2019). Evaluation of the effects of a generic substitution policy implemented in Chile. BMJ Global Health, 2 (Suppl 3), e000922. doi: http://doi.org/10.1136/bmjgh-2018-000922
- Jones, M. D., Peterson, H. L., Pierce, J. J., Herweg, N., Bernal, A., Lamberta Raney, H., Zahariadis, N. (2015). A River Runs Through It: A Multiple Streams Meta-Review. Policy Studies Journal, 44 (1), 13–36. doi: http://doi.org/10.1111/psj.12115
- Mhazo, A. T., Maponga, C. C. (2021). Agenda setting for essential medicines policy in sub-Saharan Africa: a retrospective policy analysis using Kingdon’s multiple streams model. Health Research Policy and Systems, 19 (1). doi: http://doi.org/10.1186/s12961-021-00724-y
- Rawat, P., Morris, J. C. (2016). Kingdon’s streams model at thirty: Still relevant in the 21st century? Politics and Policy, 44, 608–638. doi: http://doi.org/10.1111/polp.12168
- Giese, K. K. (2020). Coronavirus Disease 2019’s Shake-up of Telehealth Policy: Application of Kingdon’s Multiple Streams Framework. The Journal for Nurse Practitioners, 16 (10), 768–770. doi: http://doi.org/10.1016/j.nurpra.2020.08.015
- Zakupivli Likiv. Informatsiia za Rokamy. MOZ Ukrainy. Available at: https://moz.gov.ua/zakupivli-likiv
- Prohrama «Dostupni Liky»: pidsumky 2020 r. (2021). Apteka, 4 (1275). Available at: https://www.apteka.ua/article/582105
- Pro zatverdzhennia reiestru likarskykh zasobiv yaki pidliahaiut reimbursatsii stanom na 10 liutoho 2021 roku (2021). Nakaz MOZ Ukrainy No. 251. 15.02.2021. Available at: https://moz.gov.ua/article/ministry-mandates/nakaz-moz-ukraini-vid-15022021--251-pro-zatverdzhennja-reestru-likarskih-zasobiv-jaki-pidljagajut-reimbursacii-stanom-na-10-ljutogo-2021-roku
- Detalizatsiia vidpushchenykh likarskykh zasobiv za prohramoiu reimbursatsii «Dostupni liky». Natsionalna sluzhba zdorovia Ukrainy. Available at: https://nszu.gov.ua/e-data/dashboard/reimb-manufacturer-details
- Rx index – dovidnyk ekvivalentnosti likarskykh zasobiv. Available at: https://rx.ua/
- Official Exchange Rate. National Bank of Ukraine. Available at: https://bank.gov.ua/en/markets/exchangerates?date=2021-07-26&period=daily
- Mabilat, C., Gros, M. F., Nicolau, D., Mouton, J. W., Textoris, J., Roberts, J. A. et. al. (2019). Diagnostic and medical needs for therapeutic drug monitoring of antibiotics. European Journal of Clinical Microbiology & Infectious Diseases, 39 (5), 791–797. doi: http://doi.org/10.1007/s10096-019-03769-8
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