HTA and Health Care Decisions in Russia: A Perspective from Countries Developing HTA Capacity

1. HTA and Health Care Decisions in Russia: A Perspective from Countries Developing HTA Capacity Oleg Borisenko, MD, PhD Prof. Pavel Vorobyev, MD, PhD, MSc ISPOR Russia Chapter Formulary Committee of Russian Academy of Medical Science 1st Moscow State Medical University named after I.M.Sechenov ISPOR 9th HTA Council Roundtable 9 November 2010 Prague, Czech Republic

2. Agenda • HTA environment (key stakeholders, decision-making, PE and EBM spread, corruption and transparency, policy in health care) • HTA activity and experience • Perspectives of HTA

3. Key stakeholders and decision-making in Russian Health Care

4. Key stakeholders • President • Government • Ministry of Health and Social Development and it’s services (Federal Service on Consumer Protection, Federal Service on Surveillance in Health Care and Social Development, Mandatory Insurance Fund) • Regional Ministries of Health • City (municipal) health administrations • Private insurance companies • Authorities of parallel health care system (about 20)

5. Political environment • Handle management • Decisions made by few people with concentrated power • President and Prime-minister approve all important decisions • Civil society is underdeveloped • Mechanisms of society’s feedback is extremely limited (TV, press are owned by state) • The main source for state budget (up to 90%) is oil and gas trade

6. Decision-makers at macro-level (federal level) • President and Prime-minister approve all significant decisions • MoHSD develop strategy and policy in healthcare, planning health care budget, develop standard or orders of care; Orders of Ministry is not mandatory for regional ministries • Separate projects for number of regions (stroke care equipment procurement, reconstruction of hospitals, building of centers) • MoHSD has several services (for monitoring and control), has no Formulary Committee, consisted of professional; all committees consists of bureaucrats • State Duma approves only federal part of health care budget and Federal Mandatory Insurance Fund’s budget

7. Decision-makers at mezo-level (regional level) • Regional MoH develop strategy of health care, planning regional health care budget, regional programs (drug supply etc.), planning procurement of expensive equipment • Regional governments approve regional health care budget and regional mandatory insurance fund’s budget • Multidirectional projects in different sectors (information of health care, one-channel financing, roadside medical care, medical care for vascular diseases)

8. Decision-makers at micro-level (municipal level) • Main workload lays on municipal health care sector, which is the most underfunded, loss of workforce and equipment • Health administration plans hospital budget, approve list of procured drugs and equipment • Formulary Committees maintain Formularies

9. Role of expert bodies in decision-making • 1990s – continuation of Soviet practice of institute of Chief Specialists of MoH – advisers to MoH • 1900s - set number of Technical Committees on standardization of health technologies in Federal Agency on Technical Regulation and Metrology – in 2009 their activity was stopped due to MoHSD claim • 1998 – establishment of Formulary Committee of MoH – management of Vital and Essential Drug List • 2004 – Formulary Committee was excluded from MoH, since 2005 – in Russian Academy of Medical Science (RAMS) • 2004 – Meetings of MoHSD Assembly was almost stopped (previously consisted of experts, regional authorities, provided recommendations and advises for MoH) • 2006-2010 – MoHSD in conflict with RAMS, several Academic Institutes of RAMS shifted under MoHSD jurisdiction

10. Role of patient organizations • About 80 organizations, effective – about 20 • In late 2009 Union of patient organizations was formed (involves 20 000 patients) • Public Council within Federal Service for Surveillance in HealthCare and Social Development – working effectively • Public Council within MoHSD – doesn’t work • Very effective and growing power • Provide independent and quick feedback to any activity of MoH

11. Professionalsocieties • Several unions of medical specialists, but no effective (National Medical Association, National Medical Palate, Russian Medical Association etc.) • No action in accreditation of specialists, hospitals • No protection for medical specialists • Very common – professional societies by specialty (cardiology, rheumatology, nephrology), developing clinical guidelines, providing education • Professional societies has no independence, because their leaders usually are heads of institutes of MoH or Russian Academy of Medical Sciences

12. HTA environment

13. Key country indicators (official information) World Bank Statistics, 2010

15. High level of corruption in Health Care • Damage all levels of health care • Russia is at 154th placein the world according to Corruption Perception Index prepared by Transparency International • 9-53% of population usually makes informal payment (High School of Economics, 2002, 2006) • Example: according to the Attorney General’s Office prices were doubled during tendersfor procurement computer tomography in 2009 • There are a number of corrupt schemes during tenders for drug procurement for state needs

16. Transparency of decision-making regarding drug policy

17. Pharmacoeconomic research • About 300 studies, quality is different • No state funding for PE studies • No clear state requirements • MoHSD has no specialists in Health Economics within, quality of submitted PE studies is not assessed • There is a formal requirement for submitting PE data within drug dossier during inclusion into Vital and Essential Drug List, quality of studies is not assessed • RSPOR maintains online database of Russian-language PE studies • Several medical journals on PE were issued (RSPOR’s journal – “Clinical Pharmacology and Pharmacoeconomics”) • Branch standard “Clinico-economic studies. General provisions” was established in 2002

18. EBM • Still have low distribution across medical practice • About 5-7 active members of Cochrane Collaboration in Russia • Society for EBM (since 2005) • Number of normative document (protocols of care), formularies (Drug Formulary of Formulary Commission and some other), clinical guidelines include information about level of evidences • Medical journal on EBM closed for second time at 5 years

19. Outcomes research • No state funding • Urgent needs for comparing common generics and follow-on biologics • Clinical trials became essential part of drug registration process • Initiation of new clinical trials was stopped in Aug-Sept 2010 due to changing responsible body for trials registration, ethical approval, changing insurance practice • In Russia 577 new trials (international and local) were registered in state body in 2009 (3,4% of global number of trials)

20. Education of medical specialists • There is an acknowledged gap between education and practice in medicine • Only 1/3 of medical graduates stay in medical profession • PE and EBM still have not implemented on graduate level • RSPOR, 2-3 Post-graduate Departments in medical universities provide education in health economics and EBM

21. HTA activity and experience

22. Formulary Committee of Russian Academy of Medical Sciences • Unique independent body, assessing health technologies • 3-levels process of technology assessment • Secretariat, Commissions by specialty, Presidium - 56 experts • Maintaining: List of Essential Drugs of FC, List of Orphan Medical Technologies, Negative List of Medical Technologies • Maintain Drug Formulary (6 editions) • Public assessment of healthcare policy

23. The Formulary Committee Placing applications at the web-site for 1 month Standard procedure of evaluation Three levels of examination (secretariat, professional group, presidium) Decision-making by consensus  Developing protocols of medical care, clinical guidelines, technology of medical procedures Share of negative decisions decreased from 50% to 11% for the last 10 years

24. Mini-HTA experience • Stavropol Regional Hospital, 2006 • Formal procedure for clinical effectiveness data assessment • Decision-making body – Formulary Commission • 14 reports were prepared • Activity is not continued • Experience is summarized within virtual Institute for Independent HTA at the RSPOR web-site

25. National Standard on HTA • In 2008-2009 National Standard on HTA was developed (available at www.rspor.ru) • Due to prohibition of Technical Committees activities it was not approved

26. Formal HTA There is no any formal service in Ministry of Health and Social Development, both Chambers of Russian Parliament structures There is no any formal service at the regional or city level Parallel Health Care systems (medical services of several Ministries and big enterprises) also lack of HTA activity There is no understanding that such service is necessary

27. Examples of decision-making in Russian Health Care

28. Financing of new effective medicines • Treatment of Gaucher diseases in funded (about 100 patients, about 100 000 euros per patient a year) • Treatment of Mucopolisacharridosis is not (the same class of disease, the same group of drug, the same number of patients, the same annual cost of treatment, the same effects) • 1st line of CML treatment is funded (Glivek), but 2nd is not (Dazatinib, Nilotinib)

29. Implementation of national prophylaxis scheme • Includes procedures with no proved effectiveness: screening with general blood count, general urine count, oncomarkers • In 2008-9 about 500 “Cabinets of Health” were opened across Russia, they used technologies with no evidences of effectiveness (equipment for screening of somatic and psychophysiological disturbances, ECG screening, bioimpedansmetretc.) • Mammography and Prostate-specific antigen screening is wildly used • There was no public assessment of new initiatives • No evidence-based dossier or PE data were used

30. Legislative activity • Adopting the Law “On drug circulation” within record timelines (2 months), just few public discussions without MoHSD participation, public opinion was ignored • Excluded main themes – regulation of orphan drugs and biosimilars; drug registration requires local Russian data, pricing consists of price registration and establishment of mark-ups; no mention of any drug supply programs, principles of financing

31. HTA perspectives in Russia • In the nearest 3-4 years – no opportunity for formal HTA • HTA is closely related to rational decision-making, establishment of civil society

32. HTA environment in some CIS countries Сотрудничающие филиалы

33. ‘There is nothing a government hates more than to be well-informed; for it makes the process of arriving at decisions much more complicated and difficult.’ John Maynard Keynes (1883-1946)