New rules of government drug in Russia

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Prepared By:
New rules of government drug in Russia
Listing’s Gotta Give
Aston Consulting
FEBRUARY 2015
www.pharmaboardroom.com
White Paper
Listing’s
druglisting
listingininRussia.
Russia.
Listing'sGotta
GottaGive.
Give. New
New rules
rules of
of government
government drug
A government decree that defines new rules for compilation of reimbursable drug lists entered into force
September 1 of this
year [1].
This defines
document is
meant
to accomplish
two importantof
things:
unify the
Aongovernment
decree
that
new
rules
for compilation
reimbursable
existing lists and introduce the transparent criteria for inclusion of essential medicines in them (the bulk
drug
lists entered into force on September 1 of this year [1]. This document is
of public drug procurement in Russia is based on the nomenclature of pharmaceutical products specified
in the respective
lists).
meant
to accomplish
two important things: unify the existing lists and
introduce
the transparent criteria for inclusion of essential medicines in
The key to understanding the government policy with regards to drug lists lies in the fact that the universal drug reimthem
(the
bulk
public
drugunequivocally
procurement
in Russia
isisbased
bursement
system
has of
not been
established
in this country.
Whatever
termed ason
drugthe
reimbursement
today covers just a small number of those who seek medical attention. According to the current arrangements, only the
nomenclature of pharmaceutical products specified in the respective lists).
selected categories of outpatients with specific conditions are entitled to free or discounted medicines (as part of the
so called drug reimbursement programs).
The key to understanding the government policy with regards to drug lists lies
Figure 1. Reimbursement programs and lists of essential drugs
in Drug
the fact that the universal drug reimbursement system has not been estabEligible
recent
lished
unequivocally
in this country.
isFunding
termed
as drugMost
reimbursereimbursement
List ofWhatever
drugs
source
beneficiaries
update
program
ment
today covers just a small number of those who seek medical attention.
ONLS
6 Social groups
354 INNs
Federal budget
2011
According
to
the
current
arrangements,
only
the
selected
categories
of outpa7 costly nosologies
Patients with any of
18 INNS
Federal budget
2008
tients with specific
conditions
these
conditions are entitled to free or discounted medicines (as
Government
9 Social
groups
(31
Determined atprograms).
the
Regional budget
At the discretion of
part
of theDecree
so called
drug
reimbursement
№890 (GD)
disease groups)
regional level
Orphan diseases
24 orphan diseases
None
each region
Regional budget
2013
We will not address the issue of how the eligibility of different types of benefiThe abovementioned
programs but
and drug
serve important
social
providing
ciaries
is determined,
thelistsoverall
efforts
offunctions
the state
toreimbursement
reimburseforatmuch
least
needed pharmaceuticals. The drugs stipulated under ONLS and GD №890 are supplied free of charge to the vulnerable
some
patients
forasthe
drugs
they cannot
affordofisseniors,
to bewarwelcomed.
On the
population
groups such
people
with disabilities,
certain categories
veterans and children.
And the
better
access
to
high-cost
medications
is
secured
through
two
other
programs:
“7
costly
nosologies”
and
“Orphan
other hand, many experts point to the lack of flexibility and ability to factor in
diseases”. The responsibility for financing these services is shared between federal and regional governments.
subtler nuances when it comes to drawing up these lists. For instance, it’s a
We will not address
issue ofeligible
how the eligibility
of different
types
of beneficiaries
determined,
but the overall
efcommon
thingthewhen
patients
don’t
get
the full isrange
of required
mediforts of the state to reimburse at least some patients for the drugs they cannot afford is to be welcomed. On the other
cations,
because the particular item they need for treatment of their condition
hand, many experts point to the lack of flexibility and ability to factor in subtler nuances when it comes to drawing up
have
notForbeen
approved
and
the don’t
reimbursement
At the
these lists.
instance,
it’s a common
thingincluded
when eligiblein
patients
get the full range ofprogram.
required medications,
because the particular item they need for treatment of their condition have not been approved and included in the
same
time, the principles for inclusion remain vague and unclear. Until recentreimbursement program. At the same time, the principles for inclusion remain vague and unclear. Until recently there
lywere
there
were no
appropriate
legal/regulatory
mechanisms
forand
revision
and
no appropriate
legal/regulatory
mechanisms
for revision and updating
of these rosters,
the approaches
offered by the
of Health
often did
notthe
hold water.
This has led to
health authorities
off the revision
updating
ofMinistry
these
rosters,
and
approaches
offered
by theputting
Ministry
of of
some federal drug lists for a long time.
Health often did not hold water. This has led to health authorities putting off
the revision of some federal drug lists for a long time.
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For example, when preparing the list of medicines to be supplied under ONLS program they relied solely on “the international Anatomical Therapeutic Chemical Classification System (ATC) recommended by the WHO, in which the drugs are
divided into different groups according to the organ or system on which they act and their chemical, pharmacological
and therapeutic properties.” Unfortunately, this was the only criteria presented to the medical community. [2].
Listing's Gotta Give. New rules of government drug listing in Russia.
A government decree that defines new rules for compilation of reimbursable
We have
beenentered
faced with the
paradoxical
in which all the 1
players
of the year
health care
that updat- is
drug
lists
into
forcesituation
on September
of this
[1].industry
Thisagree
document
ing reimbursable lists is desirable, but not a whole lot could be done under the existing regulatory framework.
meant to accomplish two important things: unify the existing lists and
The new approach
the compilation ofcriteria
drug lists is for
goinginclusion
to rest on three
pillars:
introduce
thetotransparent
offundamental
essential
medicines in
- identical methodology (uniform criteria used for all existing lists)
them
(the (clear
bulkandofunambiguous
public drug
procurement
in Russia is based on the
- transparency
basis for
evaluation)
- “single authority” (one
list to serve as a model
for all others) specified in the respective lists).
nomenclature
ofmain
pharmaceutical
products
The List of Vital and Essential Drugs (known as ZhNVLP in Russia) was selected to provide the foundation for all other
lists. key to understanding the government policy with regards to drug lists lies
The
inZhNVLP
the fact
that the universal drug reimbursement system has not been estabList: evolution
lished unequivocally in this country. Whatever is termed as drug reimburseZhNVLP – a federal list of free drug products for medicinal use, guaranteed by the government to ensure prevention
ment
today covers just a small number of those who seek medical attention.
and treatment of illnesses, including those with the highest prevalence rate in Russia [3].
According to the current arrangements, only the selected categories of outpaZhNVLPwith
plays anspecific
essential role
in the state regulation
of prices forto
thefree
drugs or
included
in it through mandatory
registratients
conditions
are entitled
discounted
medicines
(as
tion of manufacturer’s maximum selling price and enforcement of controls on wholesale and retail markups for medipart
the soin allcalled
drug
programs).
cines of
distributed
segments
of thereimbursement
Russian pharmaceutical market
[4].
Figure 2. ZhNVLP Sales (2013) US$ (million)
We will not address the
issue of how theZhNVLP
eligibility of different types of benefiTotal Market [5]
ciaries is determined, but the overall efforts
(%) [6]of the state to reimburse at least
Retail Sector
811
623 (52%)is to be welcomed. On the
some
patients for the10drugs
they cannot5afford
Reimbursement
3 461 point to the lack
2 247of
(66%)
other
hand, many experts
flexibility and ability to factor in
Hospital Sector
3 128
3 042 (97%)
subtler
nuances when17 it
comes to drawing
up these lists. For instance, it’s a
Total Market
400
10 939 (63%
common thing when eligible patients don’t get the full range of required medications, because the particular item they need for treatment of their condition
Despite the fact that the state regulation of prices concerns the medicines that occupy a significant market share (about
have
not2),been
approved
andreimbursement
included in
the reimbursement
program.
Atofthe
63%, Fig.
the prices
in the government
segment
are regulated for not more
than two thirds
the
drugs. time, the principles for inclusion remain vague and unclear. Until recentsame
lyWhile
there
were ofnocosts
appropriate
legal/regulatory
mechanisms
for itrevision
and
streamlining
and price controls
are the strategic goals of
the government policy,
seems strange
that
regulation does
apply rosters,
to all products
purchased
at the expense of the
state budget
or does
not cover allof
drugs
updating
of not
these
and
the approaches
offered
by the
Ministry
from the minimum range of products for pharmacies, i.e. most vital medicines (Fig. 3)
Health
often did not hold water. This has led to health authorities putting off
the revision of some federal drug lists for a long time.
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Figure 3. Share of drug products from ZhNVLP List
Listing's Gotta Give. New rules of government drug listing in Russia.
A government decree that defines new rules for compilation of reimbursable
drug lists entered into force on September 1 of this year [1]. This document is
meant to accomplish two important things: unify the existing lists and
introduce the transparent criteria for inclusion of essential medicines in
them (the bulk of public drug procurement in Russia is based on the
nomenclature
pharmaceutical
products
the respective
lists).
To a great extent, theof
answer
to that is found in a poor
definition ofspecified
the principles in
for inclusion
of drugs in ZhNVLP
and
other reimbursable lists and lack of assessment criteria for this inclusion. Another aspect that played a part was the
origins and evolution of this list.
The key to understanding the government policy with regards to drug lists lies
initial
workthat
to create
ZhNVLP
was started
in 1992.
Over the past 19 yearssystem
the list washas
reviewed
least tenestabtimes.
inThethe
fact
the
universal
drug
reimbursement
notatbeen
Different approaches were explored for updating it. ZhNVLP was approved and finalized at various levels (Ministry of
lished
unequivocally
in this
country.
Whatever
is termed
astherein
drug(from
reimburseHealth, Government
of the Russian
Federation),
while the
number of drugs
incorporated
344 to 1000
names) today
and classification
varied
significantlyof
at different
ment
coversmethodologies
just a small
number
thosetimes.
who seek medical attention.
According
the ofcurrent
only
categories
outpaThe scope andto
purpose
the list hasarrangements,
also changed more than
once the
and atselected
different periods
was defined of
as follows:
n production
and procurement
of vital andare
essential
drugs to free or discounted medicines (as
tients
with specific
conditions
entitled
preferential tax treatment (income tax not levied)
partnn of
the so called drug reimbursement programs).
purchase of drugs for state needs on a competitive basis (through tender system)
n government regulation of drug prices
n basis for compilation of reimbursable drug lists in the regions of Russia [3].
We will not address the issue of how the eligibility of different types of beneficiaries
issince
determined,
butrecent
the changes
overall(2011),
efforts
ofwas
the
to than
reimburse
least
As a result,
the time of the most
ZhNVLP
notstate
much more
a collection at
of incongruous functions,
none offor
which
could
be performed
in full: some
patients
the
drugs
they cannot
afford is to be welcomed. On the
n Did not determine which drugs should be considered vital for meeting the priority health needs of the populaothertionhand,
many
experts larger
point
to the
lack
ofrecommended
flexibilitybyand
ability
in
(ZhNVLP
holds considerably
number
of drugs
than
WHO,
has itemsto
thatfactor
are efficient
for limited
categories
of patients,
but at the
time lacksup
somethese
other medicines
that target
wider patient
subtler
nuances
when
it comes
tosame
drawing
lists. For
instance,
it’s and
a
therapeutic segments)
common
when
eligible
patients
don’t
get theof drugs
full range
of required
medin Did notthing
determine
the scope
of government
guarantees
for provision
to the population
(some of the
medicines
effectively
supplied
to beneficiaries
different
reimbursement
programsof
are their
excluded
from it)
cations,
because
the
particular
itemunder
they
need
for treatment
condition
n Did not ensure regulation of public spending on drug procurement
have not been approved and included in the reimbursement program. At the
The procedure
drawing
up the ZhNVLP
[8] was spelled
out in detail
in the and
previous
edition of the
document,
same
time,for
the
principles
for List
inclusion
remain
vague
unclear.
Until
recentcriteria for inclusion and/ or exclusion of particular drugs. However, the provisions for drug evaluation,
lyincluding
therethe
were
no appropriate legal/regulatory mechanisms for revision and
as well as the requirements for submitting clinical and other explanatory data on pharmaceuticals being added to the
updating
of these
and the approaches
offered
the
Ministry
list were lacking.
Also, the rosters,
criteria for decision-making
on inclusion / rejection
of theby
drug
products
were notof
clearly defined
and
provided
no
detail
as
to
the
expected
requirements.
In
addition
to
that,
there
were
no
precise
regulations
Health often did not hold water. This has led to health authorities putting offfor
drug evaluation process involving independent experts well-versed in evidence-based medicine and health economthe
revision
of some
federal
drug lists for a long time.
ics, which
diminished
the quality
of appraisal.
43
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Listing's Gotta Give. New rules of government drug listing in Russia.
It should be noted separately, that since 2010, the Russian Ministry of Health could not apply this Provision, because
it did not comply with the applicable Federal laws, whereas the legal act that it stemmed from was no longer in force.
The list was not updated over the past 4 years due to the lack of the legal act establishing the procedure for its compiAlation
government
decree
that
defines
newagency
rulesempowered
for compilation
of not
reimbursable
by the Ministry of
Health and
any other
governmental
to approve it was
legally determined.
drug lists entered into force on September 1 of this year [1]. This document is
meant
to accomplish
two important things: unify the existing lists and
ZhNVLP List:
our Alpha and Omega
introduce the transparent criteria for inclusion of essential medicines in
The hurdles described above notwithstanding, ZhNVLP continues to be the fundamental basis for implementation of
them
(the bulk of public drug procurement in Russia is based on the
the state policy of drug supply, especially following the improvements made recently.
nomenclature of pharmaceutical products specified in the respective lists).
Figure 4. Improved coordination between drug lists in Russia
The key to understanding the government policy with regards to drug lists lies
in the fact that the universal drug reimbursement system has not been established unequivocally in this country. Whatever is termed as drug reimbursement today covers just a small number of those who seek medical attention.
According to the current arrangements, only the selected categories of outpatients with specific conditions are entitled to free or discounted medicines (as
part of the so called drug reimbursement programs).
According to the Government Decree that defines new rules for the compilation of drug lists, ZhNVLP has become a
foundation for other lists, including:
We
will not address the issue of how the eligibility of different types of benefin List of costly drugs (7 nosologies)
ciaries
isdrugs
determined,
but the
overall
efforts of the state to reimburse at least
n List of
for separate categories
of patients
(ONLS)
n Minimum
range for
of drug
products
for they
pharmacies
(MAA) afford is to be welcomed. On the
some
patients
the
drugs
cannot
other
hand,
many
experts
to the lack
flexibility
and
ability
factor
One of the
innovations
of this
documentpoint
is the requirement
for theof
particular
drug to be
present
in the to
ZhNVLP
be- in
fore it can nuances
be added to other
lists.it
Also,
from now
the key prerequisite
for placing
on the list
willa
be
subtler
when
comes
toondrawing
up these
lists.a new
Forproduct
instance,
it’s
its therapeutic and clinical benefits for treatment of indicated health conditions as opposed to similar products. This
common
thing
patients
don’t
the fullevaluation
rangeparameters
of required
criterion is going
to bewhen
assessedeligible
using a scale
of integrated
clinicalget
and economic
(reportsmediform
clinical trials,
efficacy andthe
safetyparticular
data, additionalitem
therapeutic
etc.)for
and atreatment
final score in points
will be calculated
for
cations,
because
theyvalue,
need
of their
condition
each of them. Based on the results of the clinical and economic evaluation the experts will form their recommendations
have
not been approved and included in the reimbursement program. At the
for inclusion of the particular drug on the list. Above all the focus will be placed on reducing the overall health costs
under the
Government
Guarantees Program
of free medical
care (impact
on the healthcare
budget) and
/ or potentially
same
time,
the principles
for inclusion
remain
vague
and unclear.
Until
recenttreatment costs as compared with regimens using other drugs of the same therapeutic group.
lylower
there
were no appropriate legal/regulatory mechanisms for revision and
updating
of these
rosters,
and the
approaches
bypossibility
the Ministry
of for
When evaluating
the additional
data presented
for consideration,
suchoffered
factors as the
to use the drug
treatmentoften
of prevalent
and its
local production
in Russia
2 or 3 extra
points to theputting
final score. off
Health
didconditions
not hold
water.
This has
ledmay
to add
health
authorities
the
of some
federal
drug
lists and
forappointed
a long the
time.
The revision
Ministry of Health
has already
approved
a regulation
expert panels to tackle the issues of inclusion/exclusion of drug products to the different lists (Fig. 5).
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Figure 5. Agencies involved in approving drug lists
Listing's Gotta Give. New rules of government drug listing in Russia.
A government decree that defines new rules for compilation of reimbursable
drug lists entered into force on September 1 of this year [1]. This document is
meant to accomplish two important things: unify the existing lists and
introduce the transparent criteria for inclusion of essential medicines in
them (the bulk of public drug procurement in Russia is based on the
nomenclature of pharmaceutical products specified in the respective lists).
The key to understanding the government policy with regards to drug lists lies
in the fact that the universal drug reimbursement system has not been established unequivocally in this country. Whatever is termed as drug reimbursement today covers just a small number of those who seek medical attention.
Starting this year, the ZhNVLP List will be adjusted on an annual basis, whereas other lists will be revised at least once
According
to(this
thehascurrent
arrangements,
only the
selected
categories
of outpaevery three years
to do with the
need to prepare expenditure
accounts
for the budget
planning period).
tients with specific conditions are entitled to free or discounted medicines (as
The ZhNVLP List is a centerpiece of the Strategy for “Development of pharmaceutical and medical industry in Russia”
part
of the so
drug reimbursement
programs).
for 2013-2020.
The called
strategy highlights
the fact that 90% of the drugs
from the ZhNVLP List should be produced domestically in the near future. The priority in majority of cases will be given to local pharmaceutical products or the drugs
whose production was localized (See our previous article «Support of domestic production in Russia as one of the
We
will not address the issue of how the eligibility of different types of benefikey elements in development of local pharmaceutical industry: opportunities and risks for international players»). The
ciaries
is determined,
but theproduction,
overallwill
efforts
ofinternational
the statepharmaceutical
to reimburse
at least
government,
striving to support domestic
encourage
companies
whose
drugs are added to ZhNVLP List to localize their manufacturing. In some cases the lack of local production lines could
some
patients for the drugs they cannot afford is to be welcomed. On the
be used as a pretext to deny the inclusion of the company products to the list.
other hand, many experts point to the lack of flexibility and ability to factor in
Benefactanuances
male locata malefacta
subtler
when itarbitror*
comes to drawing up these lists. For instance, it’s a
common
thingthewhen
patients
don’t
therequests
full range
of requiredof mediAs of this moment,
Ministry eligible
of Health has
received more
than aget
thousand
for inclusion/exclusion
particular
drugs
in
the
ZhNVLP
List
in
2015.
Analyzing
the
inclusion
criteria,
one
may
conclude
that
things
like
the
established
cations, because the particular item they need for treatment of their condition
domestic production and indications for treatment of prevailing conditions, though considered as important factors,
have
been
approved
and included
inand
the
reimbursement
program.
At the
do notnot
play the
key role
in decision-making.
Instead, clinical
economic
efficiency becomes
a decisive criterion,
as
the authorities
reimburse the drugs
proven efficacy
offeredvague
at the most
reasonable
price.Until
If the evidence
same
time,seek
theto principles
for with
inclusion
remain
and
unclear.
recentbase for the drugs under consideration is viewed insufficient, or if they have lesser therapeutic value compared to other
lyreference
theremedications,
were nothey
appropriate
legal/regulatory mechanisms for revision and
will be excluded from the lists.
updating of these rosters, and the approaches offered by the Ministry of
Making sure that the company products make it to the updated ZhNVLP List should be one of the top priorities for
Health
often did not hold water. This has led to health authorities putting off
any pharmaceutical manufacturer involved in the system of government drug procurement. Following the introduced
the
revision
some
federal
lists for
time.
amendments,
theof
market
players
have nowdrug
got an effective
toolatolong
estimate
the possibilities for their brands to be
approved and added on the respective drug list and build their further strategy accordingly. Under these new circumstances the decision of the Ministry of Health becomes easier to predict.
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According to our forecasts, the ZhNVLP List will be adopted as a benchmark for the regional lists of essential drugs (as
well as hospital formularies), which are currently divergent from it in many ways. The efforts to improve and align the
quality of care will inevitably make the ZhNVLP a single source for all inpatient facilities in Russia and in the mid-term all
drug reimbursement
in Russia
will defines
be based onnew
it.
Apublic
government
decree
that
rules for compilation of reimbursable
Listing's Gotta Give. New rules of government drug listing in Russia.
drug lists entered into force on September 1 of this year [1]. This document is
meant to accomplish two important things: unify the existing lists and
REFERENCES
introduce
the oftransparent
criteria
inclusion
of essential
medicines
1.Decree #871
the Government of
the Russianfor
Federation
dated August
28, 2014 “On
Approval of thein
Rules for
Forming
the
Lists
of
Drugs
for
Medical
Use
and
Minimum
Range
of
Drugs
Required
for
Medical
Care
Delivery”.
them (the bulk of public drug procurement in Russia is based on the
http://government.ru/media/files/myBXVUxYbiU.pdf
nomenclature of pharmaceutical products specified in the respective lists).
2.Explanatory note to the draft orderof the Ministry of Health of the Russian Federation “On Approval of the List of
Drugs Prescribed by Physicians (Nurse Practitioners) to Secure the Medical Care Delivery for Particular Categories of
Eligible for State Social
Aid” dated April 8, 2011.
The key
toCitizens
understanding
the government
policy with regards to drug lists lies
№61 dated April
12, 2010
(edited on March 12, system
2014) “On Circulation
Medicines”.
in3.theRussian
fact Federation
that theLawuniversal
drug
reimbursement
has notofbeen
estab4.Government
Executive Order
#1938-r
dated November
11, 2010is“On
Approval as
of the
List of reimburseEssential and the
lished
unequivocally
in this
country.
Whatever
termed
drug
Most Important Medications for 2011”.
ment today covers just a small number of those who seek medical attention.
5. IMS Data
According to the current arrangements, only the selected categories of outpa6.Data provided by the Ministry of Industry and Trade of the Russian Federation http://minpromtorg.gov.ru/presstientscentre/all/#!ogranicheniya_po_zakupkam_importnyh_lekarstv_ne_zatronut_apteki
with specific conditions are entitled to free or discounted medicines (as
part
of
the so called
drug reimbursement
programs).
7.
V. Omelyanovsky,
M. Avxentyeva,
I. Soldatova, M. Sura, N.
Zorin, I. Krysanov: “Clinical and economic evaluation
used to form lists of medical products.” Medical technologies. Assessment and selection. 2010; 1: 28—31.
8.
Order
#276n
of the Ministry
Health of
of the
Russian
Federation
dated May
27, 2009 “Concerning
the benefiWe
will
not
address
the ofissue
how
the
eligibility
of different
types of
Procedure for Compilation of the List of Vital and Essential Medicines”. http://www.rosminzdrav.ru/
ciariesdocuments/7647-prikaz-minzdravsotsrazvitiya-rossii-276n-ot-27-maya-2009-g
is determined, but the overall efforts of the state to reimburse at least
some patients for the drugs they cannot afford is to be welcomed. On the
other hand, many experts point to the lack of flexibility and ability to factor in
subtler nuances when it comes to drawing up these lists. For instance, it’s a
common thing when eligible patients don’t get the full range of required medications, because the particular item they need for treatment of their condition
have not been approved and included in the reimbursement program. At the
same time, the principles for inclusion remain vague and unclear. Until recently there were no appropriate legal/regulatory mechanisms for revision and
updating of these rosters, and the approaches offered by the Ministry of
Health often did not hold water. This has led to health authorities putting off
the revision of some federal drug lists for a long time.
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