RECOMMENDATIONS CONCERNING DEVELOPMENT OF THE SCALE OF BUDGET IMPACT RATE IN THE EVALUATION OF THE PURCHASE OF MEDICINES IN UKRAINE

Authors

DOI:

https://doi.org/10.11603/2312-0967.2019.3.10402

Keywords:

health technology assessment, budget impact rate, national list of essential medicines, medicines

Abstract

The aim of the work. Development of a rate of budget impact when evaluating the inclusion of a medicines on the National List of Essential Medicines (National List) in the analysis of the economic efficiency.

Materials and methods. ABC analysis used for developed of this recommendations. The aim is assessing of the potential impact on the budget of medicines in case of its inclusion on the National List. The study used data provided by the Pharmexsplorer market research system, Support in Market Development (SMD) for 2018.

Results and discussion. The developed of scale of rate of budget impact is recommended to be used to assess the financial consequences of using medical technology over an appropriate time horizon of 1 year or more to ensure an adequate level of functioning in the healthcare sector.  In the case of procurement by state budget and local budgets, if expenses per one INN exceeds 40 million UAH per year, the budget impact rate is excessive. If the expenses for one INN are in the range from 20 million to 40 million, the budget impact rate is big, if the costs range from 10 to 20 million UAH, then the impact is moderate, if expenses are less than 10 million, then the impact is insignificant.

Subject to the inclusion of a medicinal product in the National List, in the case of procurement by health care institutions that are financed from the local budget, the scale of budget impact levels has the following gradation: if the cost per INN exceeds 17 million UAH per year, the budget impact rate is excessive. If the expenses for one INN are in the range from 6 to 17 million UAH, the budget impact rate is big, if the expenses for one INN are in the range from 3 to 6 million UAH, the impact is moderate; if the expenses are less than 3 million, the impact is insignificant.

Conclusion. A scale for determining of rate of budget impact was developed based on the analysis of the procurement of medicines from the National List for 2018. It has such a gradation in four levels of influence: excessive, big, moderate and insignificant. It is promising to use a rate of budget impact for HTA with the aim of future financing by the expenses of state and local budgets in Ukraine.

Author Biographies

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

MD, PhD, DS (Medicine), Professor, Head of Expert Committee on Selection and Use of Essential Medicines MoH of Ukraine, Head of Pharmacology and Clinical Pharmacology Department

T. M. Dumenko, State Expert Center MoH of Ukraine

MD, PhD (Medicine), Director

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

PhD (Pharmacy), Director of the Health Technology Assessment Department, Member of the Expert Committee on Selection and Use of Essential Medicines MoH of Ukraine, Kyiv

I. M. Romanenko, State Expert Center of the MoH of Ukraine

Member Expert Committee on Selection and Use of Essential Medicines MoH of Ukraine, Head of the Department for Evaluation of the Economic Efficiency of Medicines of the Medical Technology Evaluation Department, Kyiv

M. M. Klimenko, State Expert Center of the MoH of Ukraine

member of the Expert Committee on the Selection and Use of Essential Medicines MoH of Ukraine, Deputy Head of the Department for Evaluation of the Economic Efficiency of Medicines of the Department of Medical Technology Evaluation, Kyiv

O. A. Topachevsky, State Expert Center of the MoH of Ukraine

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

M. B. Leleka, State Expert Center MoH of Ukraine

PhD (Pharmacy), expert of the department of evaluation of the economic efficiency of medicinal products of the Department of Medical Technology Assessment, Kyiv

References

Decree of the Cabinet of Ministers 12/05/2018 р. № 1022. On Approval of the State Strategy for the Implementation of the State Policy of Providing the Population with Medicines for the period up to 2025 [Про затвердження Державної стратегії реалізації державної політики забезпечення населення лікарськими засобами на період до 2025 року]. Available from: [https://zakon.rada.gov.ua/laws/show/1022-2018-%D0%BFhttps://zakon.rada.gov.ua/laws/show/z0258-16]

Order of the Ministry of Health of Ukraine 02/11/2016 № 84. On Approval of the Regulation on the National List of Essential Medicines and the Regulation of the Expert Committee of Selection and Use of Essential Medicines [Про затвердження Положення про Національний перелік основних лікарських засобів та Положення про експертний комітет з відбору та використання основних лікарських засобів] Available from: [ https://zakon.rada.gov.ua/laws/show/z0258-16]

Guidelines for the health technology assessment, Expert Committee on the selection and use of essential medicines of the Ministry of Health of Ukraine, Version 1.1., Kyiv 2018. [Керівна настанова із оцінки технологій охорони здоров’я, Експертний комітет з відбору та використання основних лікарських засобів МОЗ України, Версія 1.1.] Київ 2018.

Order of the Ministry of Health of Ukraine on 04/03/2017. № 275-р. On approval of the medium-term plan of the Government's priority actions by 2020 and the plan of the Government's priority actions for 2017. [Про затвердження середньострокового плану пріоритетних дій Уряду до 2020 року та плану пріоритетних дій Уряду на 2017 рік] Available from: [https://zakon.rada.gov.ua/laws/show/275-2017-%D1%80#n10]

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

Sean D. Sullivan, Josephine A. Mauskopf, Federico Augustovski, J. Jaime Caro, Karen M. Lee, Mark Minchin, et al. - Budget Impact Analysis—Principles of Good Practice: Report of the ISPOR 2012 Budget Impact Analysis Good Practice II Task Force. Value in Health. 2014; Vol.17, Issue 1: 5–14. Available from: [https://doi.org/10.1016/j.jval.2013.08.2291] DOI: https://doi.org/10.1016/j.jval.2013.08.2291

Josephine A. Mauskopf, Sean D. Sullivan, Lieven Annemans, Jaime Caro, C. Daniel Mullins, Mark Nuijten, at al. Principles of Good Practice for Budget Impact Analysis: Report of the ISPOR Task Force on Good Research Practices— Budget Impact Analysis. Value in Health. 2007; Vol.10, № 5: 336-347. Available from: [https://doi.org/10.1111/j.1524-4733.2007.00187.x] DOI: https://doi.org/10.1111/j.1524-4733.2007.00187.x

Drug and Therapeutics Committees - A Practical Guide. World Health Organization. 2003; Available from: [ http://apps.who.int/medicinedocs/es/d/Js4882e/12.html]

Management Sciences for Health and World Health Organization. 2007. Drug and Therapeutics Committee Training Course. Submitted to the U.S. Agency for International Development by the Rational Pharmaceutical Management Plus Program. Arlington, VA: Management Sciences for Health.

Pariy VD, Safonov YuM, Zakharova NM, Dumenko TM, Zhula AV, Taran VV., Borus VM, Vezhnovets TA, Matukova DG, Prus NV. Economichnuy analis vukorustannia resursiv v sustemi okhoronu zdorovia [Economic analysis of the use of resources in the health system] Zhutomur: «Polissia»; 2015. 142 p.

Morozov A. M.., Yakovleva L. V.., Besditko N. V. et al. Metoduchni recomendacii z ocincuclinichnoi ta economichnoi docilnosti vucorustannia likarskukh zasobiv v licuvalno-profilactuchnomu zacladi (suprovid formularnoi sustemu) [Methodical recommendations for assessing the clinical and economic feasibility of the use of drugs in the health care institution (support of the formular system)]. – Kharkiv: NPhU, 2012. – 59 s.

Bidiuk PI, Terentiev OM, Prosiankina-Zharova TI. Prukladna statistika [Applied statistics] Vinnutsia: "Edelveis &K"; 2013.

Gerasumenko SS, Golovach AV, Jerina AM, Kozuriev OV, Palian ZO, Shustiko AA. Statistika 2-Ed, К.: КNЕU; 2000. 467 p.

Published

2019-09-09

How to Cite

Oleschuk, O. ., Dumenko, T. M., Pinyazhko, O. B., Romanenko, I. M., Klimenko, M. M., Topachevsky, O. A., & Leleka, M. B. (2019). RECOMMENDATIONS CONCERNING DEVELOPMENT OF THE SCALE OF BUDGET IMPACT RATE IN THE EVALUATION OF THE PURCHASE OF MEDICINES IN UKRAINE. Pharmaceutical Review Farmacevtičnij časopis, (3), 92–101. https://doi.org/10.11603/2312-0967.2019.3.10402

Issue

Section

Pharmacoeconomics