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Transcript of 1 HTA and Health Care Decisions in Russia: A Perspective from Countries Developing HTA Capacity Oleg...
1
HTA and Health Care Decisions in Russia: A Perspective from
Countries Developing HTA Capacity
Oleg Borisenko, MD, PhDProf. Pavel Vorobyev, MD, PhD, MSc
ISPOR Russia ChapterFormulary Committee of Russian Academy of Medical Science
ISPOR 9th HTA Council Roundtable 9 November 2010
Prague, Czech Republic
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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
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Key stakeholders and decision-making in
Russian Health Care
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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)
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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
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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
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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)
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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
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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
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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
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Professional societies• 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
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HTA environment
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Key country indicators (official information)
IndicatorData on 2007
Health expenditure, total (% of GDP) 5.4
Health expenditure, public (% of GDP) 3.5
Health expenditure, private (% of GDP) 1.9
Health expenditure, public (% of total health expenditure) 64.2
Health expenditure, private (% of total health expenditure) 35.8
Health expenditure, public (% of government expenditure) 10.2Out-of-pocket health expenditure (% of private expenditure on
health) 83.0
External resources for health (% of total expenditure on health) 0.0
Health expenditure per capita (current US$) 493
World Bank Statistics, 2010
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High level of corruption in Health Care
• Damage all levels of health care• Russia is at 154th place in 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 tenders for procurement computer tomography in 2009
• There are a number of corrupt schemes during tenders for drug procurement for state needs
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Transparency of decision-making regarding drug policy
Programs Responsible bodies Transparency of decision-making
Federal level
ONLS/DLO “7 nosologies” program Supply of Army
Russian Academy of Medical Sciences
HIV/AIDS
TB Diabetes Vaccines
MoH + regionsl MoH MoH Formulary Commission of
Ministry of Defense Administration of RAMS Federal Service for
Surveillance in Consumers Protection and Human Wellfare
MoH MoH Federal Service for
Surveillance in Consumers Protection and Human Wellfare
++/--/+
--/+
-/+-/+
Regional level
Regional benefit Centralized procurement for
hospitals
Regional MoH Regional MoH
+/-+/-
Hospital level
Drug procurement Administration + formulary commission
+, -/+
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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
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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)
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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
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HTA activity and experience
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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
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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
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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
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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
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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
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Examples of decision-making in Russian Health Care
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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)
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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, bioimpedansmetr etc.)
• 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
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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
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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
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HTA environment in some CIS countriesUkraine Kazakhstan Armenia Georgia Azerbaijan
Spending of health care (%, GDP)
7.0 (2005) 3.9 (2005) 3.8 (2008) 8.6 (2005) 4.0 (2007)
Public spending on health care (% of total)
52.8 64.2 43.7 19.5 29.3
Corruption perception index (place in the list of 178 countries)
134th 105th 123rd 68th 134th
National HTA body No Developing stage No No No
Per capita spending on pharmaceuticals (US doll.)
46 67 16 35 24
Reimbursement Certain socially valued diseases
Certain socially valued diseases, certain categories
Certain socially valued diseases, certain categories
Under insurance schemes, expensive drugs – from international donors
Certain socially valued diseases
Key stakeholders Formulary Commission
Formulary Commission
Chief specialists Chief specialists Chief specialists
Pricing Wholesale, retail mark-ups
Wholesale mark-ups, registration of price for state procurement
Free Free Free
Сотрудничающие филиалы
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‘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)