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

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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

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
  its 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 societys 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
  Funds 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 funds
  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 doesnt 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)
Indicator Data 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) 10.2
Out-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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(No Transcript)
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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 Generals
  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
  (RSPORs journal Clinical Pharmacology and
  Pharmacoeconomics)
• Branch standard Clinico-economic studies.
  General provisions was established in 2002

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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 countries
Ukraine 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
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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)