THE USE OF PHARMACOECONOMIC PRINCIPLES IN LOCAL DRUG POLICY DECISIONS IN POLAND, RUSSIA, AND UKRAINE Presented by: Prof. Olha Zalis ka, the President ISPOR Ukraine Chapter, the Head of Department of Management and Economics of Pharmacy and Drug Technology, Postgraduate Faculty, Danylo Halytsky Lviv National Medical University, Lviv, Ukraine ISPOR 16th European Congress Dublin November 5 2013 Health care in Ukraine Free and beneficial drug providing from state budget Formulary system for inpatient care from 2009 Reimbursement of drugs for hypertension from 2012 In Ukraine the healthcare reforms are harmonized to the European Programme Health -2020
Pharmacoeconomics in Laws The Order of MoH from 13.09.2010 N 769 On Approval of the Concept of Development Pharmaceutical Sector Health of Ukraine during 2011-2020 includes a requirement for the use of pharmacoeconomics Decree of the President from 29.03.2013 539/2013 "On the providing of population of quality and accessible medicines includes the obligatory determination of therapeutic efficacy and pharmacoeconomic rates of drugs Family medicine In four pilot regions - Vinnytsia, Dnipropetrovsk, Donetsk regions and the Kyiv was implemented a healthcare system on the basis of family medicine. During 2011-2013 was formed 167 centers of primary health care.
Are we using HTA in Ukraine? While reviewing a State Formulary of Ukraine During approving regional and local formularies While budget purchases for medical programmes in oncology, diabetes For reimbursement system of medicines for hypertension Formulary system in Ukraine Ministry of Health of Ukraine State expert centre of MoH Central Formulary Committee Regional Formulary Committee 25 regions Pharmacotherapeutic Comission of medical institution
5th State Formulary and Regional Formularies Міністерство охорони здоров я України Центральний формулярний комітет Державний фармакологічний центр ДЕРЖАВНИЙ ФОРМУЛЯР ЛІКАРСЬКИХ ЗАСОБІВ Випуск четвертий Київ 2012 5th State Formulary of medicines of Ukraine Regional Formulary in Lviv 2 nd edition 1140 INN drugs Regional Formulary in Zhytomyr 7 th edition 970 INN drugs 23% non-essential drugs The cooperation of Formulary and Pharmacovigilance systems the Order of MoH from 22.07.2009 529 Мinistry of Health State Expert Centre Administration of post-marketing surveillance Central Formulary Committee Regional departments of administration of postmarketing surveillance The chief therapeutist Regional Formulary Committee The monitoring of in-patient care on effectiveness and safety of drugs Spontaneous message Clinical Pharmacist (or authorized person ) Pharmacotherapeutic commissions of health care facilities
Online side effects card for physicians and patients State Expert Centre of MoH from 2013 There is a card of spontaneous reports about side effects from Patient http://www.dec.gov.ua/ind ex.php?option=com_cont ent&view=article&id=116 &Itemid=260&lang Pilot project of reimbursement for antihypertensive drugs Decree of the Cabinet of Ministry of Ukraine from April 25, 2012 340 On the implementation of the Pilot project on introduction of state regulation of prices for medicine for the patients with arterial hypertension treatment. Calculation of marginal wholesale price the external referencing : - 5 main referent countries (Bulgaria, Moldova, Poland, Slovakia, Check Republic) - 3 additional referent countries (Latvia, Hungary, Serbia) 10
Next steps of reimbursement The Decree of Cabinet of Ministers of Ukraine from 12.06. 2013 N 764 "On improvement of a Pilot project to introduce the state regulation of the drug prices for the treatment of patients with hypertensive disease" List of reimbursement drugs in 2013 Goverment is still funding only the medicines registered in Ukraine, which are manufactured according to Good manufacturing practices- GMP. Therefore, the list of drugs that are reimbursed by the state includes 164 names, even though there are 343 antihypertensive drugs registered in Ukrainian pharmaceutical market.
Pharmacoeconomics and practical health (2002) Zalis ka Olha Methodical recommendations "Using pharmacoeconomic evaluation of drugs in Ukraine" / MoH of Ukraine Ukrmedpatentinform. - Lviv, 2002. - 23 p. Pharmacoeconomics: defended dissertations during 2004-2013 in Ukraine 5 4 3 2 Doctoral Thesis PhD. Thesis 1 0 2004 2006 2008 2010 2012
Pharmacoeconomic results use in practice These results and methods of pharmacoeconomic studies are used in the development and reviewing of regional and local formularies. For example, methods of "cost - benefit" and "risk sharing " for anticancer drugs, that Elena Mаndrik developed and successfully implemented in the National Cancer Institute in Kyiv and other medical institutions which in turn approve them locally Implementation of Information Letter Pharmacoeconomic approach of analysis of oncological disease schemes ( 125-2012) / Mandrik O., Zalis ka O. MoH, Kiyv, 2012.- 4 p. National Institution of Cancer MoH of Ukraine України, м. Київ (the act of implementation from 15.11.2012) ; Institute of Hematology and Blood Transfusion Medical Sciences of Ukraine, Kyiv (Act of 15.10.2012); Ukrainian Institute of Strategic Studies, Ministry of Health of Ukraine, Kyiv (03.09.2012 act accordingly); State Expert Center MoH Ukraine Kyiv (Act of 30.10.2012); State health care «Kharkiv Regional Clinical Oncology Center" (Act of 30.10.2012); Chernivtsi Regional Information and Analytical Center for Health Statistics, engineering and pharmaceutical support of the health care field (Act of 27.09.2012)
Implementation of Information Letter The method of evaluation of direct and indirect medical costs for therapy of COPD in Ukraine ( 126-2012) / Tolubaiev V., Zalis ka O. MoH, Kiyv, 2012.- 4 p. State Scientific Institution "Scientific-Practical Center of Preventive and Clinical Medicine" State Administration, Kyiv Kyiv Regional State Healthcare Government; Chernivtsy Regional Dataanalitical Center of Medical Statistics and Pharmaceutical Engeneering of Helthcare Institutions Volyn Regional Clinical Hospital; Bila Tserkva Municipal Clinical Hospital 2 NGO HTA Ukraine in 2013 was established NGO HTA Ukraine Patient oriented activity Collection and dissemination information of HTA Cooperation with industry Training activity lack of HTA educated experts International cooperation
Prospects training and researches In cooperation with CEESTACH (Poland) training program for Regulatory Authorities Conjoint pharmacoeconomic researches of the universities and the agencies 19 Thank you very much for your attention Danylo Halytsky Lviv National Medical University ISPOR Ukraine Chapter USPOR www.uspor.org olzaliska@ukr.net
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