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 pharmaceutical 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 decision 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. Reference prices are calculating by the perspectives of payer, seeing in Poland based on the prices in 5 neighboring countries: expenditures only on reimbursement made up Poland, Latvia, Slovakia, Hungary and Czech the value of almost all pharmaceutical expendi- Republic. Marginal wholesale prices are calcu- tures in Ukraine. Meanwhile the total expendi- lating as a median of reference prices for such Pharmaceutical system in Ukraine... PHARMACIA, vol. 65, No. 2/2018 31 medicines in the reference countries with terms marked findings from the literature review DDD as recommended by WHO [16,17]. against 14 basic principles that an optimal ERP The reimbursement program “Affordable system should follow [8]. A number of defined Medicines” has already demonstrated its first endpoints relating to the structural elements of positive results. To determine the quality of ERP ERP were analyzed in this literature review and system implemented by Ukraine we bench- presented in Table 2.

Table 2. Analysis of EPR endpoints in Ukraine

Endpoints Implementation in Ukraine Structural elements Objective and alignment To lower pharmaceutical prices and increase affordability of with health system medicines in reimbursement program Characteristics of ERP implementation relates to reimbursable medicines pharmaceuticals subject to ERP Main role To control reimbursement prices Transparency Fair pricing process due to established legislation framework Competent authorities in Ministry of Health ERP implementation Appeals by stakeholders There is presence of an appeals process for stakeholders to regulator decisions Number of basket 5 countries: Poland, Latvia, Slovakia, Hungary and Czech countries and countries in Republic the basket Criteria for basket Geographical proximity country selection Type of comparator price Price list obtained from official sources of authorized state bodies of reference countries: official prices, ex-factory prices, reference prices Method for calculation of The median of the registered prices for each dosage form of the reference price DDD, in accordance with the WHO recommendations Sources of information Public information sources (e.g. websites) for pricing decisions Inclusion of wealth n/a adjustments Accounting for Fixed exchange rate. The reference prices to the national exchange rate currency (UAH) are transferred at the official exchange rate fluctuations established by the National Bank of Ukraine on the date of the price determination. The recalculation of the register of marginal wholesale prices for medicines is also carried out in case of changes in the official exchange rate (UAH) to the US dollar established by the National Bank of Ukraine by more than 5%per month or 10% per quarter 32 PHARMACIA, vol. 65, No. 2/2018 O. Piniazhko, O. Zaliska, R. Ilyk, Kh.-O. Stasiv

Interaction with other policies Link between price and ERP is aligned with the reimbursement reimbursement processes to contribute to price reduction Interaction with HTA or n/a VBP Alignment with other n/a negotiation tools of reimbursement Link between ERP n/a regulation and patent status

An ideal ERP system would be a trans- property characteristics [8,18]. parent, administratively simple process requir- ing minimal information input based on statu- Reimbursement programs tory pricing rules and regulations [8,9,18]. The reimbursement list includes partially EPR had impact on cost-containment in 2017 in and fully reimbursed drugs (23 INN in total), Ukraine. For the period April-December 2017, approved by the Resolutions of the Cabinet of the average weighted value of 1 DDD of drugs, Ministers of Ukraine No.1080 dated 27.12.2017. the cost of which was reimbursed, decreased by The reimbursement list by trade names include 10.5% compared to the same period last year. It 239 medicines and is approved by the Order of should be noted that the decrease in the weighted MoH No.111 dated 22.01.2018. This list was average value of 1 DDD is due not only to the expanded by 41 items and will be revised twice decrease in prices, but also the redistribution of per year due to the legislation. The cost of 34 consumption in the direction of drugs, the cost of medicines is completely reimbursed and are which is fully or partially reimbursed by the given to patients by prescription free of charge. state, which are much cheaper for drugs, the cost According to other medicines, the patient have to of which is not reimbursed, and the restriction of pay the difference specified in the register surcharges [19]. [20,21]. Generally the use of ERP is limited to The reimbursement list by the country of in-patent medicines but it can be applied to all origin of marketing authorization holder include marketed medicines, or particular categories 24 domestic pharmaceutical companies, 18 – of medicines such as reimbursable, prescrip- EU, 5 – India, 1 – Israel, 1 – Turkey. tion-only or innovative medicines. Interestingly In Table 3 is presented available is that according to the recommendations of evidence on the reimbursement list of medicines EFPIA (2014), ERP should be limited to in-pat- and analysis of copayment. The analysis of ent medicines because: more dynamic and evidence on national level found that the average effective methods can enhance competitive copayment for medicines in the list varies from prices in the off-patent market; price compari- 3.1% on glibenclamide to 57.7% for gliclazide. son between in-patent and off-patent drugs Average copayment for medicines in the list is undermines patent protection and intellectual 30.75%±16,83. Pharmaceutical system in Ukraine... PHARMACIA, vol. 65, No. 2/2018 33

Table 3. Reimbursement list of medicines 2018

INN Dosage form Trade Trade Average names, names 0% copayment, n copayments, % (SD), n min/max Cardiovascular diseases 1 Amiodarone Tablets 200 mg 8 1 31±21,5 (4,8;54,8) 2 Amlodipine Tablets 5/10 mg 36 2 37,6±27,2 (9,1;77,8) 3 Atenolol Tablets 50/100 mg 4 1 31,9±4,8 (26,3;34,7) 4 Bisoprolol Tablets 2,5/5/10 mg 29 3 40,3±21,3 (4,4;67,5) 5 Carvedilol Tablets 6,25/12,5/25 13 3 40,7±17,9 mg (2,5;59,3) 6 Clopidogrel Tablets 75 mg 23 1 26,5 ±13,4 (1;50,3) 7 Digoxin Tablets 0,25 2 1 3,7 8 Enalapril Tablets 5/10/20 mg 18 2 53,3±25,5 (1,9;86) 9 Furosemide Tablets 40 mg 4 1 17,84±18,9 (4,4:39,4) 10 Hydrochlorothiazide Tablets 25 mg 1 1 n/a 11 Isosorbide dinitrate Tablets 5 mg 1 1 n/a 12 Losartan Tablets 50/100 mg 11 1 36,7±18,9 (6,9;58,1) 13 Metoprolol Tablets 25/50/100 8 1 46,4±20,6 mg (12,2; 62,6) 14 Nitroglycerin Tablets 0,5 mg 3 1 13,6 (6;21,2) 15 Simvastatin Tablets 10/20/40 mg 14 2 18,5±10,9 (0,7; 36,5) 16 Spironolactone Tablets 25/50/100 5 2 28,8±25,2 mg (5,8; 55,7) 17 Verapamil Tablets 40/80 mg 4 1 27,5 ±20,2 (8,7;48,9) Asthma 18 Beclometasone aerosol for inhalation 3 1 42,7 100/250 mg (22;63,3) 19 Budesonide suspension for spray 6 2 46,7±3,9 50/200/0,5 mg, (43,6;51,7) powder for inhalation dosed 100/200 mg 34 PHARMACIA, vol. 65, No. 2/2018 O. Piniazhko, O. Zaliska, R. Ilyk, Kh.-O. Stasiv

20 Salbutamol solution for 3 1 18,2 inhalation 100 mg, (14,7;21,6) aerosol for inhalation 100 mg Type 2 diabetes 21 Glibenclamide Tablets 5 mg 3 2 3,1 22 Gliclazide Tablets 30/60/80 mg 8 1 57,7±21,7 (10;72,9) 23 Metformine Tablets 500/850/100 32 2 23,1±14,2 mg (1,8; 45,6) SD standard deviation

The participation is voluntary both by the entered in the Register, the cost of which is reim- pharmaceutical companies and pharmacies. The bursed by the state, this figure is more than 85%, reimbursement decisions are made by the MoH. while for drugs whose value is not reimbursed, Pharmaceutical company have to provide appro- it, by contrast, decreased by 6% [19]. priate application form. Application need to It was found that the change of perspec- include the following information: INN, brand tive of payers of certain categories of medicines name, form, dosage, number of units of a medic- in 2017 comparing with previous years in inal product in consumer packaging, ATC code, Ukraine increased the consumption of medicines manufacturer, country, number of registration in reimbursement program. The growth of certificate in Ukraine, expiration date of the consumption of medicines in the reimbursement registration certificate to the drug, wholesale program indicates an appropriate gap in the price per unit dosage form of a set dose (UAH), unmet medical need of patients before the intro- wholesale price for the package (UAH), about duction of reimbursement. Also ERP generated authorization holder for the medicinal product healthcare savings with the decreasing of price (name, address and full name of the head), infor- levels. It was shown the price elasticity in the mation about the applicant (name, address and growth of demand with decreasing prices. full name of the contact person) [20,21]. At the same time there is reimbursement Meanwhile in money terms, the growth program for type 1diabetes of insulin and its rate of consumption of drugs included in the analogues, which include 70 brand names by reimbursement list of INNs was 27% in 2017 dosage and is approved by separate legislation compared to the same period in 2016. For trade (the Order of MoH No.1025 dated 04.09.2017). names included on the list this indicator has Decree of the Cabinet of Ministers of Ukraine increased by 66%, and for medicines that are not No. 239 “Certain Issues of Insulin Medications reimbursed, decreased by almost 3% [19]. Reimbursement” dated 23.03.2016). Reference The introduction of reimbursement stim- prices are calculating based on the prices in 8 ulated an increase in the consumption of drugs, countries: Bulgaria, Moldova, Poland, Slovakia, the cost of which is reimbursed by the state. In Czech Republic, Latvia, Serbia and Hungary general, during the period April-December [22]. 2017, the amount of DDD consumed of drugs According to official statistical data included in the list of INN, approved by the diabetes mellitus affects 1.2 mn individuals in Resolution of the Cabinet of Ministers of Ukraine and over 232k individuals need insulin Ukraine No. 863 dated 09.11.2016, increased by for the everyday treatment of type 1 diabetes. 58% compared to the same period last year. At The MoH developed National e-registry for the same time, for trade names of medicines insulin-dependent patients, providing a unique Pharmaceutical system in Ukraine... PHARMACIA, vol. 65, No. 2/2018 35 electronic code for drug’s prescription and on NLEM (Order of MOH No.84 dated on allowing to determine an amount of funds, that 12.02.2016, Order of MOH No.885 dated on regions need for insulin reimbursement. The 01.08.2017) [21,24]. registry contains information about patient’s The first edition of NLEM was devel- health condition and insulin prescribed, while oped based on the 19th WHO Essential Medi- the prescription code allows a patient to get the cines Lists. The purpose of the NLEM is to drug in pharmacy. There was set nine patients’ ensure the priority needs of medical care for the groups for 100% reimbursement and two population in health facilities for treatment patients’ groups for partial reimbursement of purpose at the expense of state and local budgets. human insulin and its analogues with co-pay- At the same time, the volume of demand for the ments [23]. procurement of medicines will be determined by It should be noted that innovative and healthcare facilities. In 2018, healthcare institu- generic medicines are included in these reim- tions and facilities financed from state and local bursement program: insulin human, insulin pork, budgets will have to procure drugs in accordance insulin aspart, insulin degludec, insulin detemir, with the new NLEM. From January 1st, 2018, insulin glargine, insulin glusiosine, insulin subject to satisfying 100% need in medicines lispro. 30 brand named are reimbursed without included in the NLEM, customers in the regions copayment, while others are reimbursed with will be able to procure any other drugs registered average copayment 14.3% which ranges from in Ukraine, the need in which they will deter- 10% to 35% (in case of insulin degludеc). We mine independently. identified that 29% of the medicines are Current version of NLEM is approved by produced by the Ukrainian domestic manufac- the Resolution of the Cabinet of Ministers of turers [22, 23]. Ukraine No.1081 dated 13.12.2017 “On Amend- ments to the National List of Essential Medi- Health technology assessment in decision-mak- cines”. The new edition of the NLEM includes ing in Ukraine 427 INNs, and their share in the total drug In 2016-2017 the legislation on HTA was market in the same period is 30% in volumes and implemented in Ukraine. In particular were 25% in values. As of January 1, 2018, 6357 trade approved the main regulatory legal acts cover of names of medicines were registered in Ukraine, patients’ unmet on NLEM and Expert Commit- taking into account the form of release, dosage tee on the Selection and Use of Essential Medi- and quantity in the package, which are included cines of MoH – advisory expert body for the in the NLEM [24]. transparent selection of medicines for inclusion

Figure 1. Market share of medicines in NLEM in the pharmaceutical market

Market share in volumes, % Market share in values, %

30% 25%

70% 75% 36 PHARMACIA, vol. 65, No. 2/2018 O. Piniazhko, O. Zaliska, R. Ilyk, Kh.-O. Stasiv

New medicines can be included on the identified the criteria and assigned them into list based on the mandatory HTA submissions nine groups: economics, disease description, following the main issues: evidence on efficacy, intervention description, health benefits and safety, cost-effectiveness analysis and budget outcomes, feasibility, prevalence, evidence qual- impact analysis. The Expert Committee must ity, social and ethical factors and other criteria. review each submission within 180 calendar Taking into account the results of a HTA Imple- days. mentation Roadmap in Central and Eastern For the first time in Ukraine based on the European (CEE) Countries the most important literature review of international HTA submis- criteria were selected. Special focus was given to sion guidelines (England&Wales, Finland, three sources: an MCDA that was introduced for Poland, Scotland, Spain-Catalonia Region, new hospital technologies in Hungary, a Israel, Thailand, Australia), the EUnetHTA Core published MCDA framework for orphan drugs Model, other methodological guidelines and in Poland and the recently adopted regulation on taking into account the local setting a prelimi- the development of a NLEM in Ukraine. We nary country-specific HTA guideline for looked at MCDAs which are aimed to be used Ukraine was developed by a research team of for reimbursement or investment decisions members of Expert Committee. The initial (86%) and for authorization decisions (14%) version of the HTA guideline includes the [27]. following sections: introduction to HTA, deci- Based on our research the four most sion problem analysis and use of technology in common criteria mentioned in MCDAs used to medical care, analysis of efficacy, effectiveness support reimbursement decisions outside the and safety, pharmacoeconomic analysis and CEE region were: health benefits and outcomes analysis of impact on budget of health care (88%), economics (80%), social and ethical system. The feasibility of the guideline will be factors (76%) and disease description (68%). tested and discussed with various stakeholders in Based on our findings we suggest that the main a structured and transparent way. The imple- clusters of criteria that can be the core of Central mented submission guideline with an economic and Eastern European MCDA models are: health evaluation section will facilitate the appraisal of benefits and outcomes, economics, social and medicines based on objective and transparent ethical factors and disease description, acknowl- information which will allow decision-makers edging that MCDA models should always be and pharmaceutical companies to justify the adapted to the decision problem and the local reimbursement of new medicines based on settings [27]. A new value framework based on cost-effectiveness and budget impact analysis MCDA principles for purposes of HTA could be [25]. used to inform discussions and negotiations on Decision-makers, as well as other stake- coverage and reimbursement decisions, assess- holders, need transparent, comprehensive ways ing the value of new pharmaceuticals, includ- of assessing clinical and economic beneﬁt and ing innovative medicines [26]. the impact those new treatments have, from a wider socio-economic perspective, in order to Budget procurements of medicines make rational decisions about priority setting For the first time in 2015 the MoH for the [26]. Currently from the identified evidence was providing of transparency in state procurements found that application of multiple criteria deci- delegated 60% of the function of state medicines sion analysis (MCDA) in Ukraine is perspective procurements to the international organizations issue in terms of priority settings of diseases and such as UN agencies (the United Nations Devel- selection of medicines. In particular, we opment Program, the United Nations Children's reviewed scientific publications and official Fund) and Crown Agents, British procurement documents of published MCDA models. We agency. Firstly 12 national programs were Pharmaceutical system in Ukraine... PHARMACIA, vol. 65, No. 2/2018 37 approved for approximately USD 88 mn by the the following diseases: diagnostic equipment, Law No. 269-VIII dated 19.03.2015 and the treatment of HIV, hepatitis B and C, tuberculo- Resolution of Cabinet of Ministers of Ukraine sis, adult and childhood oncology, cardiovascu- No.787 dated 08.10.2015. These national lar diseases, childhood hemodialysis, neonatal programs covered vaccines, medicines for the screening for genetic diseases (phenylketonuria TB, HIV, hemophilia, hepatitis B/C and cancer and congenital hypothyroidism), adult nephrolo- treatment, orphan drugs, TB and HIV diagnos- gy assistance, implants and endo-prosthesis, tics. In 2016 the MoH delegated 100% of all the organ transplantation, blood donations, repro- state procurements to these international organi- ductive health, fertility treatment, multiple scle- zations [28]. rosis and hemophilia, diabetes, mucopolysac- In 2017, procurement of medicines for charidosis, substitution maintenance therapy, Ukraine was carried out by the UNDP, the Gaucher's disease, epidermolysis bullosa, UNICEF Children's Fund and the Crown pulmonary arterial hypertension, cerebral palsy, Agents. International organizations purchased juvenile rheumatoid arthritis, mental and behav- medicines in 38 state programs for a total of ioral disorders in the autism spectrum, cystic UAH 5.9 bn. fibrosis, pituitary dwarfism, primary (congeni- Currently there is approved a list of med- tal) immunodeficiency [28]. icines and other health technologies for budget Annually, the MoH approves a list of procurement by the Resolution of the Cabinet of medicines that are purchased for each disease. Ministers of Ukraine No.557 dated 23.08.2016 For example in Table 4 is presented the structure with the amendments dated 27.12.2017. There is of budget program for assisted reproductive approved funding for the national programs for technologies (ART) in 2017 .

Table 4. List of medicines for procurement in budget program for ART Volume, INN Form Dosage form packs Chorionic human chorionic 5000 IU 658 gonadotropin alfa gonadotropin Follitropin alfa ampoules/vials/syringes 75 IU 1 768 Follitropin alfa solution for injection 300 IU (22μg)/0,5 mL 506 Follitropin beta ampoules/vial/syringes 833 IU/mL 705 Triptorelin ampoules/vials/syringes 3,75 mg 248 Menotropin ampoules/vial/syringes 75 IU 5 097 Ganirelix solution for injection 0,25 mg/0,5 mL 571 Propofol ampoules/vial/syringes 10 mg/mL, 20 mL 669

At the first time among former Soviet treatment cycles of ART from public funds countries in Ukraine the state funding of ART (about 600 cycles per year) has appeared. There for population was launched by the Order of is a national program and budget procurement MoH No.579 dated 24.11.2004. Since 2005, in for treatment of infertility which amounts for Ukraine, the possibility of conducting medical USD 227 438 in 2017. 38 PHARMACIA, vol. 65, No. 2/2018 O. Piniazhko, O. Zaliska, R. Ilyk, Kh.-O. Stasiv

Conclusions Health system review. Health Systems in Transi- Our findings showed that there is posi- tion 2015; 17(2): 1-153. tive trend in the growth of pharmaceutical 3. Zalis’ka O, Piniazhko O, Maxi- market in Ukraine for the last years 2015-2017, movych N, Sichkoriz O, Tolubaiev V. Pharma- in particular regarding total expenditures on ceutical system in Ukraine: current and prospec- medicines (private and public) and pharmaceuti- tive issues. Journal of Health Policy&Outcomes cal sales as % of health expenditure. Research 2015; 2: 89-94. Subsequent analysis highlighted that 4. BMI Research (2017). Ukraine Phar- introduction of EPR and reimbursement is of maceuticals & Healthcare Report 2017. benefit to all stakeholders including patients, 5. Wirtz VJ, Hogerzeil HV, Gray AL et manufacturers and government in order to al. Wirtz VJ, Hogerzeil HV, Gray AL, Bigdeli ensure patients’ access to well-priced medi- M, de Joncheere CP, Ewen MA, Gyansa-Lut- cines. Budget holders can spend within their terodt M, Jing S, Luiza VL, Mbindyo RM, means and manufacturers have incentive to Möller H, Moucheraud C, Pécoul B, Rägo L, continue participate in reimbursement programs. Rashidian A, Ross-Degnan D, Stephens PN, Furthermore, MoH of Ukraine expressed the Teerawattananon Y, 'tHoen EF, Wagner AK, intention to expand the list of diseases and Yadav P, Reich MR. Essential medicines for chronic conditions by including new medicines universal health coverage. Lancet 2017; 389: in 2018 in reimbursement programs in order to 403–76. benefit future patient populations. 6. UN. Sustainable Development Goals. Results of this research present that 2015. http://www.un.org/sustainabledevelop- reimbursement program covered unmet need in ment/ sustainable-development-goals/ the essential medicines for high burden diseases [Accessed on: 15th January 2018]. which shows a gap in the pharmaceutical provid- 7. WHO. Global Action Plan for the ing and the need in provide access to affordable Prevention and Control of NCDs. 2013. http://w- pharmaceuticals by public funds. The amount of ww.who.int/nmh/events/ncd_action_plan/en/ DDD consumed of medicines included in the [Accessed on: 15th January 2018]. reimbursement list increased by 85% in 2017. 8. Kanavos P, Fontrier AM, Gill J, The average weighted value of 1 DDD of medi- Kyriopoulos D. The Implementation of External cines, the cost of which was reimbursed, Reference Pricing within and across Country decreased by 10.5% compared to the same Borders. London School of Economics: London: period last year. UK 2017. Consequently one of the main issues in 9. Kanavos P, Fontrier AM, Gill J, Efthy- the development of pharmaceutical system in miadou O, Boekstein N. The Impact of External Ukraine is implementation of HTA for efficient Reference Pricing within and across Countries. allocation of the budget for pharmaceuticals in London School of Economics: London: UK line with the international requirements. Further- 2017. more MCDA use in decision-making is perspec- 10. Inception Impact Assessment tive for more inclusive value-based assessment «Strengthening of the EU cooperation on Health for priority settings and innovative medicines. Technology Assessment (HTA)». 2016. http://ec.europa.eu/smart-regulation/road- References maps/docs/2016_sante_144_health_technology 1. World Bank Open Data. https://da- _assessments_en.pdf [Accessed on: 15th January ta.worldbank.org/country/ukraine [Accessed 2018]. January 2018]. 11. State register of medicines of 2. Lekhan VN, Rudiy VM, Shevchenko Ukraine. http://www.drlz.com.ua/ [Accessed MV, Nitzan Kaluski D, Richardson E. Ukraine: January 2018]. Pharmaceutical system in Ukraine... PHARMACIA, vol. 65, No. 2/2018 39

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Corresponding author: Oresta Piniazhko, PhD, Senior Lecturer Department of Management & Economy of Pharmacy, Drug Technology and Pharmacoeconomics, Postgraduate Faculty, Danylo Halytsky Lviv National Medical University, Lviv, 79010, 69 Pekarska str. e-mail: [email protected] / tel.: +380956063533