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While attending the ISPOR Europe 2019 meeting in Copenhagen, I
came across an interesting discussion of the unique challenges that
payers in Central and Eastern European (CEE) countries face when
trying to devise risk sharing agreement (RSA) schemes. Speakers
shared their experience with RSA implementation in Russia, Poland
and the CEE region as a whole.
Russia's tender requirements threaten RSA
design
In Russia, one of the main challenges with RSA implementation
lies in regulatory requirements that treat medicines as a type of
goods whose procurement by public institutions should take place
only via electronic tender, according to Malwina Holownia-Voloskova
from the State Budgetary Institution, Research Institute for
Healthcare Organization and Medical Management for the Moscow
Healthcare Department. This requirement means that public payers
have to come up with creative solutions to apply risk sharing for
drugs whose price and quantity have already been agreed in a
tender. One of the ways to circumvent this difficulty being
considered by payers in the Moscow region, according to her, is to
include conditions in the tender win documents that allow the payer
to evaluate the drug's cost-effectiveness at specific points in
time. If the drug is found to be cost-effective, it will continue
being supplied at the price agreed in the tender. However, if its
cost-effectiveness assessment is negative, the payer would require
the tender terms to be re-negotiated.
Meanwhile, Vitaly Omelyanovskiy, Director of the Centre for HTA,
Russian Presidential Academy of National Economy & Public
Administration, and President of the ISPOR Russia HTA Chapter
discussed some of the challenges with implementation of the
country's RSA pilot project. In particular, use of RSA has been
limited to the private sector. Evidence of a successful RSA deal
with a private hospital will be required before the public sector
would start broad implementation of RSA. One obvious disadvantage
with this approach, in my view, is that pharmaceutical companies
may be unwilling to provide favorable terms for an RSA with an
individual hospital compared to what they would be prepared to
negotiate with a large public sector payer: thus, the lack of
success in the private sector would not necessarily translate into
similar outcomes in the public healthcare provision sector.
Another difficulty with RS implementation is that quality
criteria currently apply only in the inpatient sector, making it
more difficult to evaluate drug performance in an outpatient
setting, according to Omelyanovskiy. Risk sharing implementation in
Russia is seen as part of a paradigm change from traditional
healthcare to value-based health care (VBHC). Currently, VBHC
implementation is being tested in Russia in a cataract project,
with 1,727 patients enrolled so far out of planned enrolment of
2,500 patients. In 2020, Russian authorities plan to run similar
VBHC projects for inflammatory bowel disease, diabetes and coronary
artery disease.
Poland's success story
In contrast to Russia, Poland has extensive experience with risk
sharing schemes which it started implementing in 2011. In 2018,
100% of applications for financing within the country's Drug
Programs (comprising the most expensive drugs on the market) had an
RS proposal, according to data presented by Roman Topór-Mądry from
Poland's Agency for Health Technology Assessment (AOTM). The
corresponding share was 80% of applications for all drugs and 50%
of applications for financing of outpatient care drugs. The data
presented further indicated that manufacturers increasingly favor
simple discounts or payback types of RS deals in Poland due to
their ease of administration and management. Despite the success of
RSA schemes in Poland, challenges remain with cooperation between
the Ministry of Health, payers and the AoTM, as well as access to
real world data, according to Topór-Mądry.
The broad CEE picture
Zoltan Kalo, Professor of Health Economics at Hungary's
Semmelweis University, considered the regional trends with RS
implementation and the reasons why RS agreements are increasingly
popular in CEE countries. In his view, Eastern European countries
view RS agreements as a solution to the problem of high drug prices
in the region. "In Eastern Europe we do risk sharing as we can't
accept that we pay drug prices as high as payers in Western
Europe," he stated. As Western European countries now frequently
reference drug prices in Eastern European countries under
International Reference Pricing (IRP), CEE payers often find that
drug price levels in their markets are not in fact lower than
prices in the higher-income countries of Western Europe, according
to Kalo.
Is IRP use encouraging RSA?
The view that Risk Sharing is somehow a response to IRP is an
interesting one and is, to a large extent, confirmed by
our own analysis of pricing and reimbursement trends. We track
IRP regulations across the world on a daily basis, while our IRP
matrix currently contains 64 referrer and 81 reference countries.
Meanwhile, our risk sharing database currently includes 864 RSA
deals from around the world. While IRP works very well in reducing
prices, its unintended consequences include potential launch delays
in low-price countries, price convergence, a decline in price
transparency, and drug shortages in low-price countries due to
parallel exports to higher-price markets. A look at our IRP
analyses and data from our risk sharing database suggests that as
IRP has become more widely used around the world, the number of
risk sharing agreements (particularly those with confidential price
discounts) has surged. Unlike performance-based RSAs, which were
more popular in the infancy of RSA, payers and pharma companies
increasingly opt for discount-based RSAs, which have the advantage
of easier administration and ability to keep the agreed discount
confidential (whereas performance-based or price-volume RSAs allow
the level of discount to be calculated in some cases). Maintaining
RSA discounts confidentiality is essential if lower-income
countries as to secure de facto drug price levels which more
accurately reflect their ability to pay.
My colleagues and I are at the ISPOR Europe meeting until
Wednesday evening. Please come visit us at booth C3-065.
Posted 04 November 2019 by Milena Izmirlieva, Director, Life Sciences Research, IHS Markit