UPDATE OF RECOMMENDATIONS CONCERNING DEVELOPMENT OF THE SCALE OF BUDGET IMPACT RATE IN THE EVALUATION OF THE PURCHASE OF MEDICINES IN UKRAINE AS FOR 2019 DATA

Authors

DOI:

https://doi.org/10.11603/2312-0967.2020.2.11256

Keywords:

health technology assessment, budget impact analysis, National list of essential medicines, central procurement programs, medicines

Abstract

The aim of the work. To update the budget impact scale when assessing the inclusion of medicines on the National List of Essential Medicines (National List) and central procurement programs at the expense of state and local budgets during the analysis of economic feasibility of medicines in assessing health technologies in 2019.

Materials and Methods. The analysis was updated using the published methodological recommendations for assessing the budget impact scale of medicines in the case of their inclusion on the National List or central programs, which were developed using ABC-analysis. The study used data provided by the Pharmexplorer market research system and open data of the National Health Service of Ukraine as for 2019.

Results and Discussion. The budget impact scale for the purchase of medicines is an important tool designed to assess the financial burden caused by the inclusion of medicines on the National List or central programs. According to the results of the study, we established that if the cost of one medicine, which is evaluated during the health technology assessment with the aim of inclusion on the National List, when purchased at the expense of state and local budgets, exceeds 44 million UAH per year, the budget impact will be excessive. If the costs per one INN are in the range of 21 to 44 million UAH, the impact on the budget will be large, if the costs are from UAH 13 to 21 million - moderate, and less than UAH 13 million - insignificant. Provided that medicines are included in the central procurement programs, the budget impact scale has the following gradation: if the costs per one INN exceed 55 million UAH per year, the impact on the budget will be excessive, within 29-55 million UAH - large, in the range from 16 to 29 million UAH - moderate, less than 16 million - insignificant.

Comparing the obtained results with the indicators calculated according to the results of 2018, it was found that in 2019 the threshold values of the budget impact scale for the purchase of medicines included on the National List increased by an average of 15%.

Conclusions. Based on the analysis of procurement data of medicines from the National List and central programs, we updated the recommendations of the levels of budget impact as for 2019 in Ukraine and identified two scenarios, depending on the level of procurement and regulatory list. We found that the budget impact is excessive when yearly costs per INN exceed 44 million UAH in the case of inclusion of a new medicine on the National List and more than 55 million UAH in the case of inclusion in central programs. This scale is recommended for use in the health technology assessment and as an additional tool for the decision-making process in the inclusion of new drugs on the regulatory lists in Ukraine - the National List and Central Procurement Programs.

Author Biographies

O. M. Oleshchuk, I. Horbachevsky Ternopil National Medical University

DS, Professor, Head of Expert Committee on Selection and Use of Essential Medicines MoH of Ukraine, Head of Pharmacology and Clinical Pharmacology Department

O. B. Piniazhko, State Expert Center MoH of Ukraine

PhD (Pharmacy), Director of the Health Technology Assessment Department

L. І. Kovtun, State Expert Center MoH of Ukraine

PhD (Medicine), Deputy Director on Clinical Issues

V. V. Serediuk, State Expert Center MoH of Ukraine

expert of the division of economic evaluation of medicines of the Health Technology Assessment Department

А. М. Masheiko, State Expert Center MoH of Ukraine

PhD (Pharmacy), Head of the division of economic evaluation of medicines of the Health Technology Assessment Department

O. A. Topachevskyi, Digital Health Outcomes

member of the Expert Committee on the Selection and Use of Essential Medicines MoH of Ukraine

References

Mills M, Kanavos P. Do pharmaceutical budgets deliver financial sustainability in healthcare? Evidence from Europe. Health Policy. 2020;124(3):239-51. DOI:10.1016/j.healthpol.2019.12.002 DOI: https://doi.org/10.1016/j.healthpol.2019.12.002

Budget impact test (NICE). Available from: [https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-technology-appraisal-guidance/budget-impact-test].

ICER Updates to Methods and Public Meeting Procedures for Value Assessment Framework, 2020 [Оновлення ICER до методів та процедур публічних зустрічей для рамкової структури оцінки вартості, 2020 рік]. Available from: [https://icer-review.org/announcements/2020_vaf_update/].

Resolution of the Cabinet of Ministers of Ukraine dated March 25, 2009, No. 333 “Some issues of governmental price regulation for medicines and products of medical appointment” (in the redaction of the Resolution of the Cabinet of Ministers No. 1081 as of December 13th, 2017 “On Amendments to the National List of Essential Medicines”) [Деякі питання державного регулювання цін на лікарські засоби і вироби медичного призначення (в редакції постанови КМУ від 13 грудня 2017 р. № 1081 “Про внесення змін до Національного переліку основних лікарських засобів”)] Available from: [https://zakon.rada.gov.ua/laws/show/333-2009-п].

Resolution of the Cabinet of Ministers of Ukraine of March 17, 2017, No. 152 On Ensuring Availability of Medicinal Products [Про забезпечення доступності лікарських засобів] Available from: [https://zakon.rada.gov.ua/laws/show/152-2017-%D0%BF].

Resolution of the Cabinet of Ministers No. 255 of the Cabinet of Ministers of Ukraine of March 13, 2019 Resolution of the Cabinet of Ministers of Ukraine of March 13, 2019 No. 255 “On Approving the List of Medicines and Medical Devices Purchased under Purchase Agreements with Specialized Organizations Performing Procurement by Budget Purposes in 2019 under the Provision Program medical measures of individual state programs and complex measures of a programmatic character ” [Про затвердження переліку лікарських засобів та медичних виробів, які закуповуються на підставі угод щодо закупівлі із спеціалізованими організаціями, які здійснюють закупівлі за напрямами використання бюджетних коштів у 2019 році за програмою «Забезпечення медичних заходів окремих державних програм та комплексних заходів програмного характеру]. Available from: https://zakon.rada.gov.ua/laws/show/255-2020-%D0%BF. Ukrainian.

Oleschuk O, Dumenko TM, Pinyazhko OB, Romanenko IM, Klimenko MM, Topachevsky OA et al. Recommendations concerning development of the scale of budget impact rate in the evaluation of the purchase of medicines in Ukraine [Рекомендації щодо розробки шкали рівнів впливу на бюджет при оцінці закупівлі лікарських засобів в Україні]. Farm chasop. 2019;3:92-101. DOI: 10.11603/2312-0967.2019.3.10402. DOI: https://doi.org/10.11603/2312-0967.2019.3.10402

Published

2020-07-13

How to Cite

Oleshchuk, O. M., Piniazhko, O. B., Kovtun L. І., Serediuk, V. V. ., Masheiko А. М., & Topachevskyi, O. A. (2020). UPDATE OF RECOMMENDATIONS CONCERNING DEVELOPMENT OF THE SCALE OF BUDGET IMPACT RATE IN THE EVALUATION OF THE PURCHASE OF MEDICINES IN UKRAINE AS FOR 2019 DATA. Pharmaceutical Review Farmacevtičnij časopis, (2), 76–83. https://doi.org/10.11603/2312-0967.2020.2.11256

Issue

Section

Pharmacoeconomics