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
1
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
2
Key stakeholders and
decision-making in
Russian Health Care
3
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)
4
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
5
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
6
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)
7
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
8
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
9
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
10
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
11
HTA environment
12
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
13
World Bank Statistics, 2010
14
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
15
Transparency of decision-making regarding drug policy
Programs
Responsible bodies
Transparency of
decision-making



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
+, -/+
Federal
level
-/+
-/+
-/+
16
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 Russianlanguage 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
17
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
18
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 AugSept 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)
19
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
20
HTA activity and
experience
21
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
22
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
23
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
24
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
25
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
26
Examples of decision-making
in Russian Health Care
27
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)
28
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
29
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
30
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
31
HTA environment in some CIS countries
Ukraine
Kazakhstan
Armenia
Georgia
Azerbaijan
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
Spending of health care (%,
GDP)
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 markups, registration of
price for state
procurement
Free
Free
Free
32
Сотрудничающие филиалы
‘There is nothing a
government hates more
than to be wellinformed; for it makes
the process of arriving
at decisions much more
complicated and
difficult.’
John Maynard Keynes
(1883-1946)
33