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Pharmaceutical System in Ukraine: Implementation of External Reference Pricing, Reimbursement Programs and Health Technology Assessment

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Pharmaceutical System in Ukraine: Implementation of External Reference Pricing, Reimbursement Programs and Health Technology Assessment 28 PHARMACIA, vol. 65, No. 2/2018 O. Piniazhko, O. Zaliska, R. Ilyk, Kh.-O. Stasiv PHARMACEUTICAL SYSTEM IN UKRAINE: IMPLEMENTATION OF EXTERNAL REFERENCE PRICING, REIMBURSEMENT PROGRAMS AND HEALTH TECHNOLOGY ASSESSMENT O. Piniazhko1, O. Zaliska1, R. Ilyk2, Kh.-O. Stasiv1 Danylo Halytsky Lviv National Medical University, 1Department of Management&Economy of Pharmacy, Drug Technology and Pharmacoeconomics, Postgraduate Faculty; 2Department of Prosthetic Dentistry Abstract. The introduction of new regulatory framework regarding pharmaceuti- cal pricing and reimbursement policies, health technology assessment leads to fair pricing and equitable access to health technologies, including innovative medicines, whilst improving the sustainability of pharmaceutical system in Ukraine. It was observed the growth of pharmaceutical market in Ukraine by 12.4% in US dollar terms in 2017 and increased medicines consumption in the reimbursement list by 85%. Introduction of external reference pricing in the new reimbursement programs have shown benefit to all stakeholders in order to provide access to medicines and cover unmet need. Ensuring affordable medicines requires functioning regulatory and procurement systems, legal provisions governance and efficient management. The results of review highlights that HTA use in the development of National List of Essential Medicines leads to efficient allocation of the budget in line with the international practice and multiple criteria deci- sion analysis is perspective tool in the decision-making in Ukraine. Key words: external reference pricing, reimbursement, health technology assessment, medicines, multiple criteria decision analysis Introduction in USD per capita it was accounted for USD 203 The dynamic development of reforming in 2014 [1]. process in healthcare system recently took place The country’s health system consists of a in Ukraine in 2016-2017. In particular was public and private sectors. 50.8% of total health adopted legislation framework, which regulates expenditure was public in 2014 [1]. This has pharmaceutical pricing and reimbursement poli- significant implications for equity in health cies, introduction of health technology assess- system financing as private spending on health ment (HTA), development of the National List makes up the rest, dominated by out-of-pocket of Essential Medicines (NLEM) following inter- payments. Most health financing comes from national requirements. general government revenues raised through In 2017, Ukraine had a population of taxation (value added taxes, business income about 42.4 mn. Life expectancy at birth is 71 taxes, international trade and excise taxes). years. A gross domestic product (GDP) was of Out-of-pocket payments account for most other about USD 2185.7 per capita in 2016. Due to the health expenditure [2,3]. 46.2 % of total health results of 2017, GDP growth is about 2%.Total expenditure were out-of-pocket in 2014 [1]. health expenditure was about 7.1% of GDP and This indicator is high on account of the Pharmaceutical system in Ukraine... PHARMACIA, vol. 65, No. 2/2018 29 expensive medicines, which are generally of evidence was conducted examining legisla- purchased at full cost price by patients. The total tion database, scientific publications and reports pharmaceutical sales made up 2.34% of GDP in on the study issues: pharmaceutical market, 2017[4]. external reference pricing and reimbursement, Access to medicines, including their HTA implementation in the decision-making in availability and affordability, is a major public Ukraine. We analyzed the volume of pharma- health challenge worldwide. Countries have ceutical market in Ukraine comparing with committed to improving access to medicines neighboring countries, reimbursement programs through universal health coverage, the Sustain- and quality of ERP system implemented by able Development Goals and, in the context of Ukraine. We benchmarked findings from the the growing non-communicable disease burden, literature review against 14 basic principles via the Global Action Plan for the Prevention that an optimal ERP system should follow [8]. and Control [5-7]. In the international practice In addition reimbursement list of medicines, external reference pricing (ERP) is a powerful structure of copayments, market share of NLEM tool implemented by government policy and future direction of HTA use in Ukraine were makers that is used extensively across the analyzed and outlined in this review article. world, either to inform or set pharmaceutical prices in a given country [8,9]. HTA is a key Results and Discussion tool for developed countries to ensure the acces- Overview of pharmaceutical market in Ukraine sibility, quality and sustainability of health care According to the official data the State [10]. There is a need to assess the added value of register of medicines of Ukraine includes 13152 health technologies in Ukraine and help to medicines (including substances and in bulk allocate national resources to effective health forms), among them 30.5% are of domestic man- interventions. It should be noted that a number of ufacturers and 69.5% – foreign (January 2018) major developments have occurred in Ukraine [11]. regarding above mentioned issues. As in most European countries in This study aims to outline and analyze Ukraine pharmacies can also sell cosmetics, pharmaceutical market structure, pharmaceutical food supplements, medical products and pricing and reimbursement policies, HTA homeopathic products. There are 17650 pharma- implementation in Ukraine in 2015-2018 in line cies and 4773 pharmacy points in Ukraine [12]. with the international requirements and future We analysed the dynamics of retail sales on directions. pharmaceutical market of Ukraine during 2015-2017 in values (USD/UAH) and in natural Materials and Methods units (Table 1) [13]. Literature review of secondary sources Table 1. Analysis of retail sales for medicines, medical products, cosmetics, food supplements in Ukraine in the period 2015-2017 Year Medicines Medical products Cosmetics Food supplements Total market UAH / Share in UAH / Share in UAH / Share UAH / Share UAH/ USD mn pharm. USD mn/ pharm. USD in USD mn in USD cort, % cort, % mn pharm. pharm. mn cort, % cort,% Monetary units 2015 41460.1/ 84.2 4161.7 8.5 1897.5 3.9 1696 3.4 50501 1898.4 190.5 86.8 77.7 2312.3 30 PHARMACIA, vol. 65, No. 2/2018 O. Piniazhko, O. Zaliska, R. Ilyk, Kh.-O. Stasiv 2016 50619.6/ 84.4 4709.8 7.9 2219.6 3.7 2420.5 4.0 60002 1981.1 184.3 86.9 94.7 2349.1 2017 61152.5/ 84.1 5481 7.5 2663.1 3.7 3385.4 4.7 72682 2299.8 206,1 100.2 127.3 2733.4 Natural units, packs 2015 973.3 64.5 454.6 30.2 42.4 2.8 37.7 2.5 1505 2016 1046.2 65.6 457 28.6 42.7 2.7 49.3 3.1 1611 2017 1114.5 66.2 462 27.4 46.1 2.7 62.4 3.7 1702 The total volume of retail sales of medi- tures on medicines in Ukraine increased by cines, medical products, cosmetics and food 15.2% in local currency terms and 12.4% in US supplements increased in values in USD by dollar terms comparing with Poland – only by 16.5% in 2017, in volumes – 5.6% comparing to 4%. This shows the perspective of market access 2016 and amounted to USD 2.7bn (UAH of new medicines, coverage of patients’ unmet 72.7bn). The total volume of retail sales of medi- need and growth of demand factors of access to cines in particular increased in values in USD by medicines. 16.1% in 2017, in volumes – 6.5 % comparing to 2016 and was USD 2.3bn (UAH 61.2bn).By External reference pricing ATC-classification the volume of pharmacy The reimbursement program “Affordable sales in values increased by the group A “Ali- Medicines” was launched in April 2017 for mentary tract and metabolism”, C “Cardiovascu- cardiovascular diseases, type 2 diabetes and lar system” and “Respiratory system” in 2017 asthma. We found the high burden of these [4,13]. diseases based on the disability-adjusted life Total expenditures on medicines (private years (DALY) in 2016 in Ukraine. Burden of and public) were USD 2.57bn (UAH 67.6bn) in ischemic heart disease, cerebrovascular disease, 2017 in Ukraine (+15.2% in local currency terms stroke was 33.55% of DALY, diabetes – 1.15%, and +12.4% in US dollar terms). Pharmaceuti- asthma – 0.65% due to the World bank data cals represent large budget components for [15]. health systems, and pharmaceutical cost contain- According to Resolutions of the Cabinet ment is in focus in many countries. Pharmaceuti- of Ministers of Ukraine No.862 “On state regula- cal sales were 47% of health expenditure in tion of prices on medicines” dated 09.11.2016 2017. Pharmaceutical sales as % of GDP and No.863 “On implementation of reimburse- decreased from 2015 to 2017, but it should be ment” dated 09.11.2016 was started implemen- noted that the forecast predicts the growth of tation of the new state price regulation on the expenditure till 2019 [4]. medicines. According to the bylaws such medi- Comparing with other neighboring coun- cines have to be registered and included on the tries for example in Poland, where the total regulatory list – NLEM [16,17]. volume of sales of medicines was USD 11.68bn The state budget funding was approved in 2017 (including USD 2.4bn for reimburse- in the amount of USD 24.6mn for this reim- ment), expenditures on medicines in Ukraine are bursement program in 2017. The government lower by almost five times [14]. Meanwhile in has already approved increased funding of this Poland pharmaceutical sales of health expendi- program on the 30% – USD 35.1mn for 2018. ture were on 12.6% lower than in Ukraine and There is ERP for the medicines in the reimburse- amounted 34.4% in 2017. This is substantiated ment program.
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