1 PRICING & REIMBURSEMENT AGAINST THE BACKGROUND OF HEALTHCARE REFORM IN RUSSIA Omelyanovskiy Vitaly MD, PhD, «Centre for Health technology assessment» RPAPA Positive developments in health care indicators Demographic crisis is not overcome, population continues to shrink. It is currently 141,9 MN vs. 143 MN in 2006 Life expectancy of Russian women has increased to 74,9 years. New born mortality has decreased over the last 10 years by 2 times to 7,5 per 1000 life births. Morbidity and mortality rates are several times higher than in EU Men’s life expectancy (60 years) is one of the lowest in the world Over the last 5-7 years health care sector has become a top government priority. Over 3/4 of all drugs circulated in the country are foreign made Significant government funds are pumped into health care system through 1. drug reimbursement programs 2. national priority project Health 3. regional health care facilities modernization project 4. Pharma 2020 strategy
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1
PRICING & REIMBURSEMENT AGAINST THE
BACKGROUND OF HEALTHCARE REFORM
IN RUSSIA
Omelyanovskiy Vitaly
MD, PhD,
«Centre for Health technology
assessment» RPAPA
Positive developments in health care
indicators
Demographic crisis is not overcome, population continues to shrink. It is
currently 141,9 MN vs. 143 MN in 2006
Life expectancy of Russian women has increased to 74,9 years.
New born mortality has decreased over the last 10 years by 2 times to 7,5 per
1000 life births.
Morbidity and mortality rates are several times higher than in EU
Men’s life expectancy (60 years) is one of the lowest in the world
Over the last 5-7 years health care sector has become a top government priority.
Over 3/4 of all drugs circulated in the country are foreign made
Significant government funds are pumped into health care system through
1. drug reimbursement programs
2. national priority project Health
3. regional health care facilities modernization project
4. Pharma 2020 strategy
2
Price& Reimbursement interactions
DLO VACCINE
7 HCD
HOSPITAL ONLS
Including in EDL
needs price
regulation.
So EDL defines the
price for product.
But entering in EDL is
important for future
reimbursement.
Regional
reimbursement program
Federal reimbursement
program for disable
people
Federal reimbursement
program for 7 High Cost
disease
Limitations of the existing practice of creating reimbursement lists
Existing practice of selecting pharmaceutical drugs for inclusion in reimbursement
lists does not lead to informed decision-making
Decision-makers are not committed to use of HTA reports for making decisions on
funding medical technologies from state funds
Creation of reimbursement lists is not supported by expert evaluation of clinical
efficacy and cost-effectiveness
Key influencers in decision-making process are esteemed chief experts of the MOH.
However they are not familiar with HTA methods.
As a result opinions of these experts are not sufficient for objective decisions taking
into account the results of EBM research and HE evaluations
3
EDL decision making criteria
Product has robust data on
clinical efficacy and safety of the
product including local clinical
data
Product addresses unmet HCS
needs (impact on key indicators,
social significance)
HE data (incl. CEA) versus
comparator
Product presence in treatment
standards and guidelines, incl.
international
Cost saving
Affordability/ budget impact
Locally produced
EDL is “multi-functional” list (mix of products, mix of missions)
No HTA authorized by HCAs in place – no standards of HE evaluation
Medical community, PAGs are not a part of decision making process
Opinion of KOLs is important, but not completely determinative
Presence in local treatment standards
Local experience and demand in place
Local production/ Partnership with local producers
Additional important criteria of decision
making
EDL revision experience 2010
42 new INN included:
6 HIV products + 8 change of registration expired + 25 included into
local treatment standards/ locally produced Gx + 3 innovations
4
Registered prices on ED depend on:
“Original” and previously not supplied in Russia ED
Foreign
Domestic
Minimum prices in reference countries (20
countries are included in basket)
I. Average sale prices of producers
for certain period .
II. Opportunity to increase prices
annually using inflation rate
I. Average import prices (declared at
customs) for certain period (a special
formula for the calculation)
II. No opportunity to increase prices
annually using inflation rate
Executive summary of New launches
pricing
Free pricing at launch. Prices of non-EDL medicines are not regulated
Entering EDL is important for future reimbursement but it leads to price
regulation
Low price won’t guarantee solid volume at launch. Direct contracts with
manufacturers are discussed by officials but legislative platform for
creative pricing models still work in progress
When price regulation is connected with drug insurance system, the new
technology/approaches will be implemented (e.g. internal INN reference
pricing)
5
HC system development: Pharma 2020 program
– focus on local industry and innovation
Imported
80%
Local
20%
Branded
generic
Generic
Original
Imported
50%
Local
50%
Original
Branded
generic
Generic
2007 2020
Cluster push, 2012-2014 hopes
Волгоградская
Область
Препараты из
списка ЖНВЛП
3,5 млрд. рублей
Санкт-Петербург Инновационные препараты
3 млрд. рублей
Ставропольский
край
Госпитальные
растворы
30 млрдрублей
Калужская область
Препараты
ЖНВЛП
1,1 млрд. рублей
Ярославская
область
Препараты ЖНВЛП
10 млрд. рублей
Свердловская
Область
Препараты из
списка ЖНВЛП
14 млрд. рублей
Московская
область
Инновационные
препараты
30 млрд.
рублей
Республика
Татарстан
Препараты
ЖНВЛП
11 млрд
. рублей
Владимирская
область
Инновационные
ЛС
11 млрд
.рублей
Липецкая область
Инновационные
ЛС
3 млрд.
рублей
Алтайский край
Препараты из
списка ЖНВЛП
110 млрд. рублей
Томская область
Препараты
ЖНВЛП, биотех
3 млрд. рублей
более
млрд рублей
About $ billion 8,5
6
Modernization of the drug reimbursement system Current out-patient/in-patient drug supply
$7.6BN = $4.3 BN for reimbursement programs + $0.8BN for Vaccines, Diabetes, TD, Hepatitis B&C + $2.5BN (OMI-outpatient/in-patient
DLO list
Federal Budget
18 INNs Regional
benefit list
$1.6 BN $1.7 BN $1 BN
Region benefit
program, GVRM
Order. 890, 1994
DLO/ONLS
FZ 178,
1998
69% of the drug costs are covered by out-of pocket,
31% – out of public funds, incl.
19% through reimbursement system and 12% - PGG
Regional Budget
7 HCD
Government
regulation
5.5 MN
people 60,000
people
52 social groups and
37 diseases
7.6 MN people
Drugs
under
PGG
EDL
567
INNs
2.5
BN
Insured
population
OMI
Health Care Sector
Changes: summary
Health Care is high in the political
agenda
Standards of care implementation with
free access to treatment guarantee
since 2013
National Drug Insurance system
implementation start in 2013 with full
roll-out in 2016
President’s order “On improvement of
state policy in health care”
Priority diseases area highlighted
New target on 90% of EDL INN
localization by 2025 emphasized
National Strategy of Drug Policy to be
developed by the end of 2013
Reimbursement and
Pricing: summary
More clarity in EDL revision process in
2013
HTA system introduction in 2014-2015
Value of innovation is recognized
Pricing system reforms:
Free pricing on local innovations
External price reference
Internal INN reference pricing
introduction (in 2014?)
15% price preference for local mfrs - till
2015
7
Vitaly Omelyanovskiy
+7 (495) 210 44 80
National Center of Health
Technology Assessment
«Center of Health Technology
Assessment»
Russian Academy of National Economy
and State Services
under President of Russia
THANK YOU FOR YOUR ATTENTION
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