IQVIA Institute Biosimilar Shared Savings Programs in Europe 12-22 Forweb

Shared Savings
Programs in
Europe
LESSONS FOR THE UNI TED S TATES
DECEMBER
2022
Introduction
Acceptance and use of biosimilars has been rising in the U.S. Biosimilars can
enhance the sustainability of the overall healthcare system through savings and
increased access. Currently, there are policies under discussion in the U.S. to
improve access to biosimilars, and some of these policies include shared savings
programs (also known as benefit sharing or gain sharing in other countries).
Shared savings programs have been implemented in a number of countries in
Europe. While contexts across countries vary, the experience of such programs in
other countries can provide lessons for the U.S.
In this report, five case studies of shared savings/benefit Find Out More
sharing programs from across Europe are examined
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provided for each case study along with the structure
of the program and results as stated in secondary MURRAY AITKEN
literature and as per IQVIA data. Lessons for the U.S. are Executive Director
summarized based on these case studies. IQVIA Institute for Human Data Science
This report has been developed independently by the

IQVIA Institute for Human Data Science, drawing on
IQVIA proprietary data and published literature across
selected European countries.
Funding for this research and report has been provided

by the Biosimilars Forum.
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Shared Savings Programs in Europe: Lessons for the United States

Table of Contents
Overview 2
Role of biosimilars in healthcare sustainability 4
Biosimilar policies and use of benefit sharing programs 5
Benefit sharing (shared savings) programs: Case studies from Europe 9
Ireland 10
France 13
United Kingdom 16
Germany 20
Italy 24
Lessons for the U.S. 29
Appendix 31
Methodologies 36
References 37
About the authors 39
About the Institute 40

Overview
Biologic drugs have revolutionized treatment of patients Europe has adopted a number of policies to increase
over the past two decades, particularly in the fields of the use of biosimilars, leading to broader availability
serious inflammatory auto-immune diseases. These and uptake compared to the U.S. Acceptance and use of
drugs are products derived from living organisms or biosimilars in the U.S. have risen over the past couple
their components that treat a number of conditions of years, however, availability of biosimilars remains
such as diabetes, cancer, and immune disorders, and lower than in European countries in some cases. While
they constitute some of the most expensive drugs on the context in these countries is different from the U.S.,
the market. Nearly half of all medicine spending (48%) in some of the policies adopted in Europe may hold lessons
the U.S. is on biologics, for a total of $259 billion gross for the U.S. and contribute to optimizing biosimilar use.
expenditure in 2021.
One of the policies to incentivize physician use of
Biosimilars offer the potential to optimize sustainability biosimilars that has been commonly used across
of healthcare systems by reducing costs while ensuring European countries is benefit sharing programs, also
the same quality of care. A biosimilar is a biological referred to as shared savings programs. Such programs
medicine highly similar to another already approved have also been proposed in the U.S. and therefore,
biological medicine (the ‘reference medicine’) and understanding the structure and impact of these
can compete with original biologic products after programs may be helpful to assessing their viability in
the originator’s period of exclusivity is completed. the U.S. context.
Biosimilar entry into the market can drive and stimulate
competition, resulting in reduction of prices, savings for While no consensus definition of benefit sharing
broader access to existing biologics, additional services, programs exists, these generally refer to selective
and innovative drugs, and potentially allowing for earlier contracts at the national/regional/provider level that
treatment of more patients due to reduced costs. incorporate elements of sharing of benefits/savings
to incentivize the use of off-patent biologics and
biosimilars. Based on existing research, such programs
have been used in at least 10 countries at a national or
regional level.
Biosimilars offer the potential Based on selected case studies, benefit sharing
to optimize sustainability of programs have been implemented at a national level in
Ireland and France and at a regional level in Germany,
healthcare systems by reducing Italy, and England (selected case studies, not an
costs while ensuring the same exhaustive list). While it is hard to directly correlate the
use of biosimilars to any one program or policy due to
quality of care.
the presence of several policies and activities, in general,
benefit sharing programs – which have been part of a
comprehensive set of policies for biosimilars - have been
associated with increasing use of lower cost biosimilars,
leading to savings for the health system. For example,
in Ireland, biosimilar use was very low prior to the
implementation of the program and has since risen to
more than 50% (for molecules included in the program),
2 | Shared Savings Programs in Europe: Lessons for the United States

resulting in savings of € 22.7 million in the first year of decision-making is maintained. Physician and patient
implementation (i.e., by July 2020). The program also education to increase comfort with biosimilar use
generated € 3.6 million as savings that were shared and regular communication of the impact of such a
with the specialties to invest back into patient care. policy are important. If the key stakeholders are not
Subsequently, biosimilar use relative to total molecule comfortable with biosimilar use, such a program may
use has increased past 60% in Ireland, leading to not be successful. Government health ministries and
$47 million in savings by end of 2021 (based on IQVIA departments and insurers have generally been the
data and analysis). central driving forces behind benefit sharing programs.
Finally, a shared savings program is one of many
Similarly, increases in biosimilar share and associated other policies that must be considered to optimize an
savings can also be seen in France, England, Germany, appropriate system for biosimilar use.
and Italy. In Germany, the program was piloted in the
Westphalia-Lippe region before being extended to other
regions, and Westphalia-Lippe saw faster biosimilar
uptake in the initial period compared to other regions.
In thCampania region of Italy, a benefit sharing program Benefit sharing programs can
was implemented along with other biosimilar policies, be an approach to increasing
which has been associated with an increase in biosimilar
use; however, comparisons with other regions in Italy are
biosimilar uptake and
mixed as biosimilar uptake is high across regions, and subsequently, increasing savings
many regions have targeted biosimilar uptake policies.
In the UK, many regional benefit sharing programs have
been implemented, resulting in fast uptake/switching
to biosimilars. In the case of the U.S., innovative models As an increasing number of lower-cost biosimilars enter
which promote cost efficient behavior such as the the U.S. market, there is a unique opportunity to reduce
Oncology Care Model have led to slight increases in overall healthcare expenditure while maintaining the
biosimilar use (compared to those not taking part in sustainability of the overall market. Shared savings
these programs), however the difference for biosimilars models hold the potential to align physician incentives
launched more recently is not substantial, which with cost-saving efforts without having an impact on
suggests that a more biosimilar focused approach may overall healthcare quality. Developing such a model will
be needed. likely require leadership from CMS and partnership with
providers, physicians, and patient advocacy groups.
The experiences of these countries offer lessons for While other policies to encourage biosimilar use will be
the U.S. as it considers shared savings programs for needed, developing and accessing pilot shared savings
Medicare Part B. As these examples show, benefit models at this stage may help with ensuring that
sharing programs can be an approach to increasing benefits from biosimilars are optimized moving forward.
biosimilar uptake and subsequently, increasing savings.
Greater biosimilar use can reduce overall costs and
may increase overall patient access. Pilot studies can be
useful in understanding the best approaches to benefit
sharing and can ensure that appropriate incentives
are provided while physician and patient autonomy in
iqviainstitute.org | 3
Role of biosimilars in healthcare sustainability
+ Biologic drugs constitute some of the most on the market and have been a growing contributor to
expensive drugs on the market and have been a the overall drug spending in U.S. and Europe. Nearly half
growing contributor to the overall drug spending of all medicine spending (48%) in the U.S. is on biologics,
in U.S. and Europe, with more than 48% of all drug for a total of $259 billion gross expenditure in 2021 (See
spending in the U.S. coming from biologics Exhibit 1). Biologics constitute a large share of Medicare
spending as some of Medicare Part D’s highest-
+ Biosimilars can play a crucial role in maintaining
expenditure drugs, and all 10 of the highest-expenditure
sustainability of healthcare systems by providing
drugs in Medicare’s Part B program are biologics.2, 3
savings without compromising on the overall quality
of care Interest in the role of biosimilars in maintaining
economic sustainability of the healthcare system has
+ In general, Europe has witnessed broader and faster
been growing. A biosimilar is a biological medicine highly
uptake of biosimilars compared to the U.S. and may
similar to another already approved biological medicine
hold lessons for the U.S. on optimizing biosimilar use
(the ‘reference medicine’) and can compete with
Biologic drugs have revolutionized treatment of patients original biologic products after the originator’s period
over the past two decades, particularly in the fields of of exclusivity is completed.4 Biosimilar entry in the
serious inflammatory auto-immune diseases.1 Biologic market can drive and stimulate competition, resulting
drugs, which are products derived from living organisms in reduction of prices, savings for increased access to
or their components, can treat a number of conditions existing biologics, additional services, and innovative
such as diabetes, cancer, and immune disorders. These drugs, and potentially allowing for earlier treatment of
drugs also constitute some of the most expensive drugs more patients due to reduced costs.
Exhibit 1: Biologic share of overall medicine spending (U.S., EU)

Quarterly medicine spending in EU4+UK and U.S. by product type, US$Bn, Q1 2011–Q2 2022
EU4+UK U.S.
50 160
45 140
40
120
35
30 100
25 80
20
60
15
40
10
5 20
0 0
11
12
13
14
15
16
17
18
19
20
21
22
11
12
13
14
15
16
17
18
19
20
21
22
20
20
20
20
20
20
20
20
20
20
20
20
20
20
20
20
20
20
20
20
20
20
20
20
1
1
Q
Biologic medicines Other medicines
Source: IQVIA MIDAS, Jun 2022.

Exhibit 2: Timeline of biosimilar launches
Biosimilars approved and launched in the U.S.

Launch not
announced
somatropin
filgrastim
infliximab
insulin glargine
insulin lispro
pegfilgrastim
epoetin alfa
bevacizumab
trastuzumab
rituximab
teriparatide
ranibizumab
adalimumab
Jan-07 Jan-13 Jan-14 Jan-15 Jan-16 Jan-17 Jan-18 Jan-19 Jan-20 Jan-21 Jan-22 Jan-23
Launched biosimilars Approved biosimilars not yet launched
Source: IQVIA Institute, Oct 2022.

Notes: Biosimilars approved but not yet launched are placed based on expected launch announced by company. Marketer and manufacturer relationships are
based on information publicly disclosed in the initial FDA approval letter, product label, or company announcements. Approved etanercept (Enbrel) biosimilars
not included as they are not expected to launch until 2029.
The U.S. developed and adopted legislation for Major European countries have also seen faster uptake
regulating and approving biosimilars in 2009 and of some biosimilars compared to the U.S. (Exhibit 3),
expectations at that time were that these biosimilars especially those that launched prior to 2019. Acceptance
would lead to billions of dollars of savings annually. 5
and use of biosimilars in the U.S. has witnessed a rise
In reality, biosimilar pathways have taken some time to over the past couple of years (Exhibit 2, 3). With many
mature as they faced a few issues (such as regulatory additional biologics losing exclusivity over the next
uncertainties, intellectual property issues, coverage and five to ten, it is important that the sustainability of the
reimbursement, patient/provider knowledge, etc.) that healthcare system is considered and approaches to
have impacted their uptake and usage. optimizing the use of biosimilars are explored. While
biosimilar policies in Europe are not directly transferable,
In contrast, many countries across Europe have
they can hold lessons for the U.S. and could help it
adopted various policies to enhance the uptake of
move toward a more optimal ecosystem for biologics
biosimilars, subsequently leading to savings. Overall,
and biosimilar use.7 In particular, policies such as
Europe has seen broader approval, launch and uptake
benefit sharing programs (also known as gain sharing
of biosimilars compared to the U.S. As of September
agreements or shared savings programs) can align
2022, 86 biosimilar medicines have been approved in
incentives across stakeholders and further encourage
Europe (EMA) since 20066 compared to 44 in the U.S. (as
market participation and biosimilar uptake.
of October 2022 based on IQVIA data). The first product
approved as a biosimilar in the U.S. was in 2015, almost
nine years after the first approval in EMA, contributing to
the lag of uptake in biosimilars in the U.S. (Exhibit 2).
Exhibit 3: Uptake of selected biosimilars (France, Germany, Italy, UK, U.S.)
France, Germany, Italy, UK, U.S. biosimilar uptake curves, defined daily doses, quarters since launch
filgrastim pegfilgrastim
100% 100%
Biosimilar share of volume

80% 80%
60% 60%
40% 40%
20% 20%
0% 0%
0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 48 51 54 0 1 2 3 4 5 6 7 8 9 10 11 12 12 14 15
Quarters since launch Quarters since launch
infliximab bevacizumab
100% 100%

80% 80%
60% 60%
40% 40%
20% 20%
0% 0%
0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 48 51 54 0 1 2 3 4 5 6 7 8 9 10 11 12 12 14 15
rituximab trastuzumab
100% 100%
80% 80%
60% 60%
40% 40%
20% 20%
0% 0%
0 2 4 6 8 10 12 14 16 18 20 0 2 4 6 8 10 12 14 16 18 20
France U.S. UK Germany Italy
Source: IQVIA MIDAS, Jun 2022; IQVIA Institute, Nov 2022.

Biosimilar policies and use of benefit sharing programs
+ Europe has adopted a number of supply DEMAND SIDE POLICIES

(e.g., tendering, reference pricing) and demand side
Physician incentives and substitution
(physician incentives, benefit sharing) policies to
Physician incentives to prescribe biosimilars have been
encourage the use of biosimilars
implemented in various forms across Europe. These
+ Benefit sharing programs have been implemented incentives include quotas for share of biosimilars on
in several European countries to incentivize overall prescribing. For example, in Germany, quotas
prescribing of biosimilars exist for some biosimilars within the context of regionally
negotiated economic targets. There can also be quotas
+ While no consensus definition of benefit sharing
for low-cost medicine use, which can include biosimilars,
programs exists, these generally refer to selective
as is the case in Belgium. Pharmacy level substitution for
contracts at the national/regional/provider level
biosimilars remains rare in Europe. In general, physicians
that incorporate elements of the sharing of
are expected to prescribe rationally and to retain final
benefits/savings to incentivize the use of off-patent
decision-making power on therapeutic choices.
biologics and biosimilars
Benefit-sharing programs
+ Discussions around a Medicare part B shared
Another approach to incentivizing rational prescribing
savings program (which is another term for
of biosimilars by physicians and providers is through the
benefit sharing) for biosimilars have been gaining
use of benefit sharing programs (also called gain sharing
increasing attention in the U.S. with legislative bills
or shared savings programs). These benefit sharing
proposing potential pilot models
programs can be set up in several different forms and
SUPPLY SIDE POLICIES 8, 9
there is no clear consensus on their definition. These
Price link programs are a part of a broader biosimilar set of policies.
Many countries have chosen to set the price of the NHS in England refers to them as “Financial arrangements
biosimilar in relation to the reference medicine. In to incentivize the provider to implement processes that
some cases, the price of a biosimilar medicine has to can maximize the early adoption and prescribing of
be set at a certain percentage lower than the reference biosimilars.”10 Other countries do not provide a clear
medicine price. In some other countries, prices are definition, however, these programs generally refer to
fixed upon negotiation based on several factors (such selective contracts at the national/regional/provider level
as any improvements over reference medicine, price that incorporate elements of the sharing of benefits (i.e.,
across Europe, sales-volume forecast in France) but are savings or other benefits such as lack of limits to biologic
generally 10-20% lower than the reference medicine use) to incentivize the use of off-patent biologics and
price. While in some countries, prices are freely set. biosimilars. Based on research published in 2022, benefit
sharing agreements have generally been used to “(i) set
Tendering and reference pricing
prescription objectives for Best Value Biologics [i.e. the
Tendering is commonly used for procurement of
most cost effective option out of the set of biologic and
biosimilars in an inpatient setting. Tendering can also
biosimilars]; (ii) engage prescribers in being compliant
take place in an outpatient setting in a few countries (e.g.,
with the set objectives; (iii) generate and reinvest
Denmark, the Netherlands).
savings according to the needs of the stakeholders who
produced them; and (iv) establish pathways for savings
reinvestment that would fund additional health services through shared savings.12 Prior articles have discussed
and quality-of-care improvements.”11 possible structures for shared savings program for
Medicare Part B.13 Given this background, understanding
Such agreements have been used extensively in Europe.
the experience of European countries with respect to
The UK, Germany and Italy have seen examples of
benefit sharing programs and assessing learnings for
benefit sharing agreements since 2016. In total, based on
the U.S. context is critical. The next section covers a
existing literature, there are more than 10 benefit sharing
set of case studies of benefit sharing programs. The
agreements in Europe at national and regional/provider
existing literature provides an overview of the structure
levels (See Exhibit 4). Experts interviewed in prior research
and impact of these programs, and this background
have also suggested such programs as being an effective
is supplemented with proprietary IQVIA data (where
approach to enhancing the use of biosimilars.9
available) and country expert interviews to understand
the impact of these programs in further detail.
Discussions around a Medicare part B shared savings
program for biosimilars (which would be similar to the
benefit sharing programs) have been gathering increasing
attention in the U.S. In 2021, Senators Cornyn and
Bennet introduced a bill (increasing access to biosimilars
act) which includes a pilot program that encourages
physicians to prescribe less expensive biosimilars
Exhibit 4: Summary table of benefit sharing agreements
COUNTRY LEVEL TARGET MOLECULES
FRANCE National (for selected hospitals) etanercept, adalimumab, insulin glargine
IRELAND National etanercept, adalimumab
PORTUGAL National all hospital-use molecules exposed to biosimilar competition
National Guideline; Regional implementation

ENGLAND TNFαi (etanercept, adalimumab, infliximab), rituximab
(multiple programs)
National Guideline; Regional implementation

SCOTLAND infliximab, adalimumab (IBD patients)
(Lothian, Gramnian)
WALES Cardiff hospital rituximab
Regional-Westfalen-Lippe and sick fund Barmer

GERMANY TNFαi (etanercept, adalimumab, infliximab)
(Subsequently expanded to other regions)
ITALY Regional-Campania Regional Health Service all hospital-use molecules exposed to biosimilar competition
SWEDEN Regional - Skane somatropin, infliximab
NETHERLANDS Insurers and individual hospitals Unknown
Source: Lacosta, Vulto et al, Qualitative Analysis of the Design and Implementation of Benefit-Sharing Programs for Biologics Across Europe, Mar 2022;
available at: https://link.springer.com/article/10.1007/s40259-022-00523-z
8 | Report Title: Strapline – All In Title Case

Benefit sharing (shared savings) programs: Case studies from Europe
+ Benefit sharing programs, which are part of Across Europe, multiple examples of benefit sharing
a holistic set of biosimilar policies, have been programs have been identified. These examples vary
implemented at a national level in Ireland and in terms of the level of implementation (national vs
France and at a regional level in Germany, Italy regional), structure of program (level of benefits shared,
and England (selected case studies, not an voluntary vs. compulsory, etc.) and overall uptake
exhaustive list). objectives. This section summarizes the key available
details regarding a few selected programs. These case
+ In Ireland, biosimilar use was very low prior to the
studies were selected because they represent some of
implementation of the program and for biosimilars
the larger countries where benefit sharing programs
included in the program, use has since risen to
have been implemented as well as countries where
more than 50%, resulting in savings of € 22.7 million
the most information was accessible (a 2022 article by
in the first year of implementation
Lacosta, Vulta et al. provides a comprehensive list of
+ In Germany, the program was piloted in benefit sharing programs).11 While it is hard to directly
Westphalia-Lippe region before being extended link increases in biosimilar use to any one policy, an
to other regions; Westphalia-Lippe saw faster increase in biosimilar uptake was seen in each of these
biosimilar uptake in the initial period compared to case studies. This section aims to provide data from
other regions published literature, government documents, and from
IQVIA MIDAS to better understand the potential impact
+ In the Campania region of Italy, a benefit sharing
of these programs (see appendix for IQVIA Institute
program was implemented which resulted in an
approach to calculating savings).
increase in biosimilar use, however, comparisons
with other regions are mixed as biosimilar uptake
is high across regions, and many regions have
targeted biosimilar uptake policies
+ A number of regional benefit sharing programs

have been implemented in the UK, resulting in fast
uptake/switching to biosimilars
BENEFIT SHARING (SHARED SAVINGS) PROGRAMS: CASE STUDIES FROM EUROPE — IRELAND
Case study: Ireland14

BACKGROUND IMPACT OF THE PROGRAM AND OF BIOSIMILAR USE
Biosimilar uptake had been historically low in Ireland in Published literature

2018, a fact that has been acknowledged and discussed The impact of the first year of the program has been
by the health ministry. 14,15
For example, the biosimilar for assessed through prior published literature. In the case
etanercept (Benepali) had been available since September of adalimumab, 8,163 patients were on the reference
2016, but in its first two years, had only 2% market share. medicine and 166 were on biosimilars in May 2019
Concerns around the sub-optimal use of biosimilars (i.e., prior to the start of the program). By May 2020, more
led the Health Service Executive (i.e., the public health than 3,400 patients were on the BVB for adalimumab.
system in Ireland) to develop a Medicines Management Similarly, in the case of etanercept, 4,208 patients were
Programme (MMP) roadmap for the prescribing of best- on the reference medicine and 104 were on biosimilars
value biological (BVB) medicines in December 2018. The in May 2019. By May 2020, more than 1,800 patients
BVB program assessed the biologic/biosimilars available were on the BVB for adalimumab. By July 2020, the total
for etanercept and adalimumab based on a number patients on BVB across both molecules was more than
of criteria, including costs, and in May 2019, the MMP 8,500 and biosimilars had a 50% market share by Q3 2020.
published its recommendations indicating that Imraldi and The total estimated savings due to the use of BVBs in
Amgevita (should clinicians wish to prescribe a citrate-free this time frame (June 2019 to July 2020) is €22.7 million,
formulation) were the BVBs for adalimumab and Benepali and €3.6 million was provided to specialties as part of the
for etanercept. benefit sharing to be invested back.
STRUCTURE OF BENEFIT SHARING PROGRAM Based on statements by experts, reinvestments

have focused on patient care, such as additional
Based on these BVBs, a benefit sharing program was
equipment (e.g., ultrasound machines, polar machines),
started in June 2019. This program offered the relevant
IT development (e.g., online biologic registry) and
clinical service at a cost of €500 for each patient who
telemedicine. Gain-sharing has also enabled extra
initiated or switched to a BVB medicine. This funding can
clinics and extra clinic time to allow for more infusions.
be invested to further enhance service delivery
Additionally, funding has also been used for hiring local
for patients.
consultants, education programs and infrastructure.
These steps can enhance patient care and lead to more
The program was led by government bodies and the key
prescribers being available for patients, thereby allowing
stakeholders involved were HSE-MMP and HSE-Primary
more patients to be seen and cared for.
Care Reimbursement Service (hospital management and
clinical departments). The program was implemented at a
national level.

IQVIA DATA
Since July 2020, there has been further increase in biosimilar share of the overall adalimumab and etanercept market
(Exhibits 5 and 6), with the biosimilar share based on volume reaching 70% and 63%, respectively.
Adalimumab has seen a volume increase of 50% since introduction of the program while costs have increased at a slower
rate by 19% (at list price level) (Exhibit 5).
Exhibit 5: Uptake of adalimumab biosimilars over time and spending on adalimumab biologics and biosimilars
over time
Quarterly adalimumab defined daily doses in Ireland by product, 2015–2021
Start of the program

Defined daily doses (Millions)
1.2 1.2
1.1
1.0 1.1 1% 2%
0.9 1%
2% 0.9 0.9 1%
0.9 1.0
1% 12% 12% 10% TOTAL
0.9 3% 2% 3% 9% 10% 12%
0.8 4% 4% 7% 13% 12%
0.8 0.8 2% Yuflyma
0.8 1% 8% 13% 15% 14% 14%
0.7 0.8 0.7 14%
0.7 0.7 10%
0.6 0.6 0.6 0.7 17% Idacio
0.5 0.6 0.6 22% 28% 34% 38% 41% 43% 46%
0.5 Hulio
100% 98% 97% 90%
100% 100% 100% Imraldi
100% 100% 100% 100% 100% 100% 100% 100% 100% 79%
67%
100% 100% 100% 59% 50% 42%
37% 34% 31% 30% Amgevita
Humira
Q1 Q1 Q1 Q1 Q1 Q1 Q1
2015 2016 2017 2018 2019 2020 2021
Quarterly adalimumab spending in Ireland by product, US$Mn, 2015–2021

28 34
33
33 33 31 32 1% 33 1%
33 2%
31
32 32 28 28 28 28 1% 1% 10% 1%
2% 29 9%
29 2% 2% 2% 26 8% 9% 11%
28 1% 3% 6%
26 26 26 11% 11% 10%
6% 10% 4% 12% 12% 12% TOTAL
23 24 24 8%
US$Mn
22 11%
21 14% Yuflyma
19% 24% 30% 34% 37% 40% 42%
100% 100% 100% 100% Idacio
100% 100% 99%
100% 100% 98% Hulio
93% 84%
100% 100% 100% 100% 100% 100%
100% 100% 74%
66% 57% Imraldi
50%
45% 41% 38% 37%
Amgevita
Humira
Q1 Q1 Q1 Q1 Q1 Q1 Q1
2015 2016 2017 2018 2019 2020 2021
Source: IQVIA MIDAS, Dec 2021; IQVIA Institute, Nov 2022.
Etanercept’s volume has increased by 14% while costs have increased by 7% (at list price level) (Exhibit 6).
Exhibit 6: Uptake of etanercept biosimilars over time and spending on etanercept biologics and biosimilars over time
Quarterly etanercept defined daily doses in Ireland by product, 2015–2021

0.42 Start of the program
0.41
0.40 1% 0.40 0.40 0.42 0.41 0.42 0.41 0.42
0.41 0.41 0.38 2% 0.37 0.37
0.40 0.40 0.40
0.37 0.38 0.37 0.37
0.39 1% 1%
2% 2% 0.38 0.40 0.38
2% 3% 0.37
0.34 12% 23%
37%
45% 54% 58% 61% 63% 63% 63%
100% 100% 100% 100% 99% 98%

100% 100% 100% 100% 100% 99% 99% 98% 98% 98% 97%
100% 88%
77%
63% TOTAL
55% 46% 42%
39% 37% 37% 37% Benepal
Enbrel
Q1 Q1 Q1 Q1 Q1 Q1 Q1
2015 2016 2017 2018 2019 2020 2021
Quarterly etanercept spending in Ireland by product, US$Mn, 2015–2021
15 15 Start of the program

14 15 13
14 12 12 12 12 12
14
13 12 1% 1% 1% 1% 1%
1% 2% 11 12 12 12
US$Mn
11 11 12 12
11 11 3% 11 11 11 10
10% 21%
34% 54% 58% 60%
100% 100% 100% 42% 51% 59% 60%
100% 100% 100%
100% 100% 99% 99% 99% 99% 99% 99%
100% 100% 98% 97%
90% 79% TOTAL
66% Benepal
58% 49% 46% 42% 40% 41% 40%
Enbrel
Q1 Q1 Q1 Q1 Q1 Q1 Q1
2015 2016 2017 2018 2019 2020 2021
Source: IQVIA MIDAS, Dec 2021; IQVIA Institute, Sep 2022.
Utilizing the IQVIA data to estimate savings between Q2 2019 and Q4 2021, the total savings due to biosimilar use (at a
list price level) for adalimumab and etanercept are estimated at $47 million (Exhibit 7). Although the savings and usage
may not be directly attributable to any one policy, the benefit sharing program has been viewed as a success in Ireland,
especially given the low uptake of biosimilars prior to 2019.
Exhibit 7: Cumulative savings due to increase in adalimumab and etanercept biosimilars uptake after program start
47.0
Cumulative biosimilar savings in Ireland, US$Mn, Q2 2019–Q4 2021
5.7
38.6
32.7 4.8
28.4 4.3
US$Mn
25.0 4.0
21.5 3.7 40.2
17.6 3.4 33.2
11.8 27.5
2.9 22.7 TOTAL
2.9 6.5 2.0
0.8 18.8
0.5 1.1 15.0 etanercept
0.1 11.5
1.7 7.5
0.4 4.0 adalimumab
Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
2019 2019 2019 2020 2020 2020 2020 2021 2021 2021 2021
Note: In Ireland, the total savings are shown from the start of the Benefit Sharing Program. These savings may not be directly attributable to the benesfit
sharing program alone and are driven by a number of biosimilar policies and levers.

BENEFIT SHARING (SHARED SAVINGS) PROGRAMS: CASE STUDIES FROM EUROPE — FRANCE
Case study: France

Similar to Ireland, France also experienced slow biosimilar Published Literature
uptake initially. In the case of etanercept, a biosimilar Published literature has assessed the initial impact of
(Benepali) has been available since Q4 2016, but the overall the programs on uptake of etanercept and adalimumab.
market share of the biosimilar was 10% by Q1 2018 (Exhibit 9). In the case of etanercept, in the first 10 months,18 the
To improve the use of biosimilars in 2018 and again in general program (i.e., main program) saw an increase of
2021, a national benefit sharing program was launched 10.4 percentage points between October 2018 and July
by the French health insurance system in “Plan d’appui à 2019 (21.3% to 31.7%). The experimental program saw an
la transformation du système de santé“ for etanercept, increase of 19.2 percentage points between October 2018
adalimumab and insulin glargine, and an 80% biosimilar and July 2019 (24.7% to 43.8%). Savings for the experimental
uptake target was set for 2022 for biosimilars that have
16
program were estimated at €650,000 after 10 months.
been in the market for past three years. The stakeholders For adalimumab, after 19 months (March 2019 to Oct
involved in the benefit sharing program are the regional 2020),19 the general program saw an increase in biosimilar
health agency, the National Health Service Financial share from 8.3% to 29.8% while the experimental program
Division, and selected hospitals/clinics across France. The saw an increase from 10.3% to 29.8%.
national health insurance (Caisse nationale d’assurance
maladie (CNAM)), and ministry of health (Direction de la IQVIA data
sécurité sociale (DSS) and the Direction générale de l’offre At a national level, there have been further increases in
de soins (DGOS)), and regional health agencies (ARS) biosimilar use through 2020 and 2021, with etanercept
across France are also leading a pilot model (See below). biosimilar use reaching 43% and adalimumab biosimilar
STRUCTURE OF BENEFIT SHARING PROGRAM use reaching 35% by end of 2021 (Exhibits 8 and 9).
There are currently two programs with benefit sharing While the volume of etanercept use has remained
arrangements17 relatively steady, adalimumab use increased by 35%
• Main Program (Started 2018): This program includes all between Q1 2019 and Q4 2021. This increase in biosimilar
hospitals that have a compulsory contract to improve use is at a faster rate compared to the rate in time period
the quality and efficiency of care (CAQES). Hospital preceding biosimilar entry.
prescribers can get 20% of the difference between the

reference drug price and the biosimilar price. This 20%
goes directly to the hospital.
• Experimental Program (Started: October 2018; up to
Jan 1, 2023): 59 NHS hospitals and clinics are voluntarily
participating in this pilot program. Hospital prescribers get
30% of the difference between reference drug price and
the biosimilar price. The difference is given to the specific
clinical department and not the hospital as a whole.
The target molecules in both these programs are
etanercept, insulin glargine, and adalimumab.
More recently, a new program targeting community-based
practitioners was also started. Prescribers can share up
to 30% in 2022 and then 20% in 2023 of savings on use
of biosimilar (for initiation or switching). The molecules
included in this program are etanercept, adalimumab,
follitropin alpha, enoxaparin, and insulin aspart.
Adalimumab has seen a volume increase of 35% since introduction of program while costs have remained stable
(at list price level).
Exhibit 8: Uptake of adalimumab biosimilars over time and spending on adalimumab biologics and biosimilars over time
Quarterly adalimumab defined daily doses in France by product, 2015–2021
Start of the program 6.4 6.6

6.0 6.2
5.6 5.7 6.0 2%
5.3 2% 2%
2% TOTAL
5.3 5.4 1% 2% 2% 3% 3%
5.1 2% 1% 2% 3% 5%
1% 1% 1% 5% 2% 5%
5% Amsparity
4.9 3% 4% 1% 5% 5% 5%
4.9 1% 3% 4% 3% 5% 4% Yuflyma
2% 3%
US$Mn
2% 6% 4% 7% 7%
4.5 4.7 1% 3% 6% 6%
4.3 4.4 4.4 Hyrimoz
3.9 4.0 3.9 4.1 9% 11% 12% 14% 15% 16% 16% 16% 17%
3.6 3.6 3.8 13%
3.4 3.5 Idacio
3.2
Imraldi
100% 100% 99% 95% 90% 86% 81% 78% Hulio
100% 100% 100% 100% 76% 74% 72% 69% 68% 67% 65%
100% 100% 100% 100% 100% 100% 100% 100% 100%
Amgevita
Humira
Q1 Q1 Q1 Q1 Q1 Q1 Q1
2015 2016 2017 2018 2019 2020 2021
Quarterly adalimumab spending in France by product, 2015–2021

138 139 137 TOTAL
130 127 125
118 119121 1% 2% 2%
116 113 1% 4% 5% 5% 2% 2%
Amsparity
114 1% 1% 1% 1% 3%
122 3% 1% 4% 4% 4% 6% 7% Yuflyma
131 134 134 130 131 1% 2% 1% 2% 3% 4% 5% 5%
1% 4%
US$Mn
119 120 116 118 119 117 113 116 3% 3%

110 115 2% 5% 4%
12% 13% 14%
Idacio
7% 8% 10% 11%
10% 15% 15% Hyrimoz
Hulio
100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 99%
100% 100% 96% 92% 89% 85% 82% 79% 77% 75% 73% Imraldi
81% 70% 69%
Amgevita
Humira
Q1 Q1 Q1 Q1 Q1 Q1 Q1
2015 2016 2017 2018 2019 2020 2021

Etanercept’s volume has remained steady while costs have decreased by 30% (at list price level) (Exhibit 9).
Quarterly etanercept defined daily doses in France by product, 2015–2021


2.1 2.1 2.1 2.1 2.1 2.1 2.1
2.2 2.2 2.2 2.2 2.1 2.0 2.1 2.1 2.1 2.1 2.0
2.1 2.1 1% 4% 5% 7% 2.1 1.9 2.1
2.0 2% 1% 2% 3% 5% 6% 6% 7% 7% 2.0 2.0 2.1 2.0
4%
10% 12% 13% 16% 7% 8% 9% 9% 10%
8%
19% 22% 24%
26% 27% 29% 29% 30% 31% 32%
28% 33% TOTAL
100% 100% 100% 100% 100% 100% 100% 99% 98% 96% 95% 93% Nepexto
90% 87% 85%
81% 77%
73% 70% 68% 66% Erelzi
65% 64% 63% 62% 60% 59% 57%
Benepali
Enbrel
Q1 Q1 Q1 Q1 Q1 Q1 Q1
2015 2016 2017 2018 2019 2020 2021
Quarterly etanercept spending in France by product, 2015–2021

68.2 69.7 67.8 60.7 59.9
56.8 5% 6%
59.9 58.1 61.5 60.6 55.8 53.6
1% 2% 3% 56.2 54.4 52.9 52.0
1% 49.0 49.4 48.8
8% 10% 1% 2% 3% 4% 5% 47.8 44.0 45.5 44.4 44.6
11% 13% 5% 44.1
7% 7% 8% 8% 44.3 42.4
US$Mn
6% 39.0
16% 18% 20% 6% 9% 9%
22%
100% 100% 100% 25% 26% 27% 28% 28% 29% TOTAL
100% 100% 100% 100% 25% 30%
99% 98% 97% 95% 94% 92% Nepexto
90% 88%
85%
81% 78% 75% Erelzi
73%
69% 68% 67% 66% 65% 64% 62% 61%
Benepali
Enbrel
Q1 Q1 Q1 Q1 Q1 Q1 Q1
2015 2016 2017 2018 2019 2020 2021

Note: The data shown here is national level data. The Benefit Sharing Program may not apply to all prescribers at a national level. There may also
be additional biosimilar policies being utilized across the country or in specific regions. Hence, a direct correlation of the impact of the policy is
challenging, the data shown above should be considered directional.
Utilizing the IQVIA data to estimate savings since the start of the program (i.e., from Q4 2018 to Q4 2021), the total
savings due to biosimilar use (at a list price level) for adalimumab and etanercept are estimated to be $160 million.
Biosimilar use may be driven by a number of policies, therefore directly attributing the use to any one policy is
challenging, especially since not all hospitals may be a part of the program. However, the benefit sharing program is
viewed as a contributor the increase in biosimilar use. (Exhibit 10)
Exhibit 10: Cumulative savings due to increase in adalimumab and etanercept biosimilars uptake after program start
Cumulative biosimilar savings in France, US$Mn, Q4 2018–Q4 2021 160.3
124.9
59.1
US$Mn
95.5
82.7 51.8
76.8
69.8
60.2 45.9
36.3 41.1
42.6 31.1 101.2 TOTAL
25.0
9.4 16.8 26.7 17.0 73.1
1.4 3.5 6.5 8.5 49.7 etanercept
10.6 35.1 38.7 40.5 41.7
3.5 2.8 8.4 25.5
1.4 16.1 adalimumab
Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
2018 2019 2019 2019 2019 2020 2020 2020 2020 2021 2021 2021 2021

BENEFIT SHARING (SHARED SAVINGS) PROGRAMS: CASE STUDIES FROM EUROPE — UNITED KINGDOM
Case study: United Kingdom

Benefit sharing programs have been commonly used at Published literature and IQVIA data
a regional (Clinical Commissioning Group) level across In the case of North Bristol NHS Trust, a total of 64/65
England with the NHS supporting their development. patients on originator Inflixmab were identified for
A 2018 NHS document reports that that out of the switching. Fifty-two patients were switched to the
incentive schemes allowed for providers, benefit sharing biosimilar resulting in savings of GBP 200,000 over
was used in 75% of the cases. The NHS commissioning three months. In a post switch survey, 97% of patients
framework mentions that these programs should be set were satisfied with the switch process. The share of
up for a short timeframe and utilized to achieve best value savings provided to the trust were reinvested into
biologic targets of 80-90% (90% uptake for treatment- gastroenterology services and an additional pharmacist
naïve patients within three months of biosimilar market was funded for closer monitoring and funding of
entry; 80% uptake for established patients within biologic treatments.
12 months of biosimilar entry). 20
A number of these benefit sharing programs have been

reported publicly. In this case study, we cover the details
of one such program as an example.
STRUCTURE OF BENEFIT SHARING PROGRAM
In general, the benefit sharing programs have utilized a

50:50 split of the savings between the CCG and providers.
As an example, North Bristol NHS Trust, set up a benefit
sharing program with the North Somerset and South
Gloucestershire CCG in July 2015 to manage the switch of
originator infliximab to biosimilar.21

In general, and across the UK as a whole, there has been a high uptake of biosimilars, with more than 80% uptake for
each of the Anti-TNF (Tumor Necrosis Factor) biologics (adalimumab, infliximab and etanercept). Adalimumab has seen
a volume increase of 55% since the introduction of biosimilars, while costs have increased at a slower rate of 42% (at list
price level) (Exhibit 11).
Exhibit 11: Uptake of adalimumab biosimilars over time and spending on adalimumab biologics and biosimilars over time
Quarterly adalimumab defined daily doses in UK by product, 2015–2021 8.1

7.9 8.7
8.4
2% 7%
7.5 4% 7%
7.4 6.9
7.0 1%
8% 8% 6% 7%
6.5 10% 10%
5.8 6.4 9%
5.9 5.6 9%
5.5 5.7 5.7 5.8
2%
5% 7% 8% 32% 30% 29% TOTAL
5.4 5.3 31% 32% 31%
5.2
5.0 32% 32%
4.5 4.6 4.6 4.6 4.5 4.6 13%
25% 31% 34% Hulio
3.9 11%
Hyrimoz
23% 41% Idacio
100% 100% 100% 100% 100%100%
100% 99% 31% 35% 36% 37% 36% 39% 38% 40%
100% 34%
100% 100% 100%100% 100% 100% 75% Imraldi
100%
46% Amgevita
30% 24% 24% 23% 21% 23% 19%
19% 17% 16%
Humira
Q1 Q1 Q1 Q1 Q1 Q1 Q1
2015 2016 2017 2018 2019 2020 2021
Quarterly adalimumab spending in UK by product, 2015–2021

239
232 229
241
2% 2% 4% 6%
7%
193 197 189 8%
186 1% 8% 7% 7% TOTAL
176 174 170 159 165 172
164 169 158 9% 9% 31%
161 155 155 154 2% 5% 9% 10% 30% 29% 28% Idacio
153 147 144 7% 8%
144
134 134 138 12% 30% 32% Hulio
31% 31%
10% 24% 30% 33%
Hyrimoz
100% 100% 100% 99% 22% 38% 38% 39% 40%
100% 100% 100% 100% 100% 100% 30% 33% 34% 35% 36% 35% Imraldi
100% 100% 100% 100% 100% 100% 77%
49% Amgevita
33% 26% 26% 25% 23% 24% 21% 20% 18% 18%
Humira
Q1 Q1 Q1 Q1 Q1 Q1 Q1
2015 2016 2017 2018 2019 2020 2021

Notes: Benefit-sharing program start date varied across regions.
Etanercept has seen a volume increase of 25% while costs have remained stable (at list price level) (Exhibit 12).
Quarterly etanercept defined daily doses in UK by product, 2015-2021
3.0 3.1 3.2
2.9 2.9 3.1 3.1 3.1 3.1
2.8 3.0 3.0 3.0 3.0 3.0 3.0

3% 5% 7% 9% 8%
1% 8% 9% 9% 2.8 8%
2.7 2.7 2.7 8% 9% 9% 9% 9% 9%
2.6 2.3 2.6 2.6 10%
2.5 2.4 2.5
4% 2.3
12%
28% 42% 50% 56% 64%
69%
70% 70% 72% 73% 72% 73% 76% 75% 78%
74% 74% 74% 77% 77% 77%
100% 100% 100% 100%
100% 96% TOTAL
88%
72% 58% Erelzi
50%
44% 35%
28% 25% 23% Benepali
19% 19% 19% 18% 17% 18% 16% 16% 17% 14%
14% 15% 14%
Enbrel
Q1 Q1 Q1 Q1 Q1 Q1 Q1
2015 2016 2017 2018 2019 2020 2021
Quarterly etanercept spending in UK by product, 2015-2021
91 88 91
85 86 87
US$Mn
83 83 82 81 82
76 73 73 77 80 79 79 79 77 78 77 80 76 8% 9% 8%
70 67 71 3% 5% 7% 8% 8% 8% 9% 8%
4% 1% 9% 9% 9% 8% 9%
61
12%
TOTAL
26% 40% 48% 54% 62% 67% 68% 77% 76% 76%
69% 71% 72% 71% 72% 73% 73% 75% 74% 76%
100% 100% 100% 100% 73% Erelzi
100% 96%
88%
74% 60% 52% Benepali
46% 37% 30% 27%
25% 21% 20% 21% 19% 18% 19% 17% 17% 18% 15% 15% 16% 16%
Enbrel
Q1 Q1 Q1 Q1 Q1 Q1 Q1
2015 2016 2017 2018 2019 2020 2021


Infliximab’s volume of use has doubled while costs have increased at a slower rate of 65% (at list price level) (Exhibit 13).
Exhibit 13: Uptake of infliximab biosimilars over time and spending on infliximab biologics and biosimilars over time
Quarterly infliximab defined daily doses in UK by product, 2015–2021 6.2 6.3

5.9 4% 4%
5.2 5.2 5.7 5.7
5.3 4% 7% 7%
1% 4% 4% 4%
4.7 4.8 5.1 5% 7% 7%
4.5 4.7 5.0 6% 6% 8% 8% 9%
4.4 5% 8% 8%
4.3 4.3 3% 4% 5% 7% 8% 8%
2% 3% 7% 9% 9%
1% 1% 9%
4.1 4.2 30%
27% 7%
3.3
3.4 3.5 3.7 3.8 3.8 3.9 35%
3.5 TOTAL
3%2% 6% 14% 16% 23% 36% 39% 36%
3.1 8% 14% 19% 18% 18% 16% 40% 41% 43% 45% 46% 47% 47% 46% 43%
42% 42% Flixabi
11% 23%
36% 45% 56%
61% 58%
Zessly
49% 47% 51% 55% Inflectra
100% 97% 90% 80% 45% 45% 43% 42% 46%
70% 41% 39% 40% 39% 37% 37% 39% 44%
59% Remsima
46% 39%
29% 23%
19% 15% 13% 11% 9%
8% 7% 7% 7% Remicade
Q1 Q1 Q1 Q1 Q1 Q1 Q1
2015 2016 2017 2018 2019 2020 2021
Quarterly infliximab spending in UK by product, 2015–2021
103 106 106
93 97 5% 4% 4%
82 5% 7%
83 4%
86 5% 8% 9%
78 8% 7%
72 72 71 75 75 73 75 76 76
1% 6%
5% 9% 7% 7%
68 4% 76 5% 9% 8%
2% 6% 1% 2% 3% 3% 5% 7% 8%
67 70 64 69 1% 8% 7% TOTAL
US$Mn
64 3% 66 7% 8%
8% 61 62 9%
13% 10% 21% 40% 39% 46% 50% 55% Zessly
45% 44% 43% 42% 41% 39% 39% 43%
18% 35% 48% 46% 37%
36%
17% 43% 54% 60% 57% Flixabi
90% 17% Remsima
100% 97% 81% 16%
72% 61% 14% 15% 39% 41% 43% 45% 46% 46% 47% 45%
22% 35% 43% 42% 42% 39% 36% 34% 30% Inflectra
49% 41% 27%
32% 25% 21% 16% 14% 12% 10% 9%
8% 8% 7% 7% Remicade
Q1 Q1 Q1 Q1 Q1 Q1 Q1
2015 2016 2017 2018 2019 2020 2021
Utilizing IQVIA data to estimate savings since the entry of biosimilars, the total savings due to biosimilar use (at a list
price level) for infliximab, adalimumab and etanercept are estimated to be $998 million. The biosimilar use may be
driven by a number of policies, therefore directly attributing the use to any one policy is challenging, however the
benefit sharing program is viewed as a contributor to the increase in biosimilar use. (Exhibit 14)
Exhibit 14: Cumulative savings due to entry of biosimilars (anti-TNF)
Cumulative biosimilar savings in UK, US$Mn, Q1 2015–Q4 2021 998

950
866 905
823
776
724
668
US$Mn
617 559.5 590.9

567 505.9 531.3
464
511 450.4 480.3
418 420.3
388.8
371 359.3 TOTAL
327 330.4
187 292 299.1
70 261 272.4 infliximab
147 220.9 247.0
26 41 49.4 107 70.7 223 196.8
8 12 21.6
32.0 35.5 53.4 158.5 176.5 343.1 359.7 374.1 390.1
407.3 etanercept
3 5
8.9 20.5
94.0 116.0 137.4 191.3 212.2 236.9 257.6 278.8 303.8 325.3
4.6 171.4
2.9 5.4 7.7 12.3 71.1 85.9 102.0 115.3 130.4 149.7 adalimumab
Q1 Q3 Q1 Q3 Q1 Q3 Q1 Q3 Q1 Q3 Q1 Q3 Q1 Q3
2015 2015 2016 2016 2017 2017 2018 2018 2019 2019 2020 2020 2021 2021

Note: In UK, the total savings are shown from biosimilar entry as benefit sharing program dates varied by region and were generally started around
the tsime of biosimilar entry. These savings may not be directly attributable to the benefit sharing program alone and are driven by a number of
biosimilar policies and levers.
BENEFIT SHARING (SHARED SAVINGS) PROGRAMS: CASE STUDIES FROM EUROPE
Case study: Germany22,23

Health insurance companies (‘Krankenkassen; KKs) and Published literature

regional associations of health insurance accredited
While the results of the program have not been publicly
companies (Kassenärztliche Vereinigungen; KVs) represent
released, the impact can be assessed by analyzing
payers and providers in Germany and many biosimilar
biosimilar uptake data. The pilot program started in
related decisions take place at a regional level. For example,
Westphalia-Lippe in 2015 for infliximab and as Exhibit
different regions and insurance companies can establish
15 shows, this region saw faster uptake of the biosimilar
varying biosimilar quota levels. In 2015, around the time of
compared to other regions between 2015 and 2018.
the launch of infliximab biosimilar, a pilot benefit sharing
program was started for the region of Westphalia-Lippe by The pilot program was also viewed as a success, leading
BARMER, a health insurance company in Germany. to it being replicated with other KVs and BARMER;
however, the details of these programs vary in terms
of the prescription objectives, remuneration etc. The
This program was set up as voluntary with providers details of the programs are not publicly available, making
opting in. Prescription objectives were set in consultation comparisons across regions challenging.
between insurance companies and providers. The Anti-
IQVIA data
TNF biologics/biosimilars were included in the program.
If providers were able to meet the prescription objectives, Based on IQVIA data at a national level in Germany, the
they received financial remuneration (amount not Anti-TNFs have witnessed strong biosimilar uptake with
specified) and were exempted from adhering to budget biosimilars comprising 70–80% of the market. This level of
caps concerning prescription of biologics, which is likely to uptake is likely driven by a mix of policies such as prescription
increase patient access to biologics in general. quotas, benefit sharing, physician education, etc.
Exhibit 15: Regional uptake of biosimilars over time (infliximab and etanercept)
infliximab etanercept
100% 90%
90% 80%
80% 70%
70% 60%
60%
50%
50%
40%
40%
30% 30%
20% 20%
10% 10%
0% 0%
Q2 15
Q3 15
Q4 15
Q1 15
Q2 16
Q3 16
Q4 16
Q1 16
Q2 17
Q3 17
Q4 17
Q1 17
Q2 18
Q3 18
Q4 18
18
Q2 15
Q3 15
Q4 15
Q1 15
Q2 16
Q3 16
Q4 16
Q1 16
Q2 17
Q3 17
Q4 17
Q1 17
Q2 18
Q3 18
Q4 18
18
20
20
20
20
20
20
20
20
20
20
20
20
20
20
20
20
20
20
20
20
20
20
20
20
20
20
20
20
20
20
20
20
Q1
Q1
Westphalia-Lippe Westphalia-Lippe
Source: Moorkens et al., Learnings from Regional Market Dynamics of Originator and Biosimilar Infliximab and Etanercept in Germany, 2020.
Notes: Other regions may have seen benefit sharing programs as well. However, the details may vary and are not publicly available. Additionally,
Westphalia-Lippe was the pilot model and provides the earliest example of such a program.

BENEFIT SHARING (SHARED SAVINGS) PROGRAMS: CASE STUDIES FROM EUROPE — GERMANY
Adalimumab has seen a volume increase of 47% since the introduction of biosimilars, while costs have decreased by
20% (at list price level) (Exhibit 16).
over time
Quarterly adalimumab defined daily doses in Germany by product, 2015–2021 7.8

1%
7.2
7.0 4%
6.7 6.8 3%
5.3 6.4 2%
6.1 6.3 2% 3% TOTAL
3% 1% 5.8 2% 15%
1% 5.3 5.5 5.9 1% 1% 17% 17% 16% 16% Yuflyma
5%
4.8 4.9 5.0 2% 3% 16% 17% 17% 17% 16%
4.6 4.4 4.6 4.7 4.7 7% 13% 15% 18% 14% 15% 15% 16% Idacio
4.2 4.3 4.3 11% 12% 13% 14%
3.7 3.8 4.0 3.9 7% 9% 7% 14% 18% Imraldi
9% 11%
8% 11% 15% 16% 17% 18% 18%
14% 16% 13%
16% Hyrimoz
17% 18% 19% 20% 20% 19% 19%
100% 100% 88% Hulio
100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100%
69% 59% 52%
46% 41% Amgevita
37% 34% 31% 28% 28% 27% 26%
Humira
Q1 Q1 Q1 Q1 Q1 Q1 Q1
2015 2016 2017 2018 2019 2020 2021

Notes: In Germany, the total savings are shown from biosimilar entry as benefit sharing program dates varied by region and were generally started
around the time of biosimilar entry. These savings may not be directly attributable to the benefit sharing program alone and are driven by a number
of biosimilar policies and levers. Benefit-sharing program start date varied across regions.
Quarterly adalimumab spending in Germany by product, 2015–2021

301 270
4% 5%
279 TOTAL
292 294 297 299 1% 2% 271 276
260 2% 261
279 5% 268 254
258 5% 4% 1% 2% 239 Yuflyma
236 246 248 252 240 9% 11% 12% 12%
1% 226
14% 221 229 4%
2%
US$Mn
216 217
227 223 7% 8% 9% 12% 1% 13% 14% 3% 3% Idacio
11% 16%
8% 9% 13% 10% 12% 16% 16%
10% 8% 8% 10% 11% 13% Imraldi
11% 14% 16%
12% 10% 15% 15%
100% 100% 100% 100% 100% 92% 14% 15% Hyrimoz
100% 100% 100% 100% 100% 13% 16% 18% 18% 18%
100% 100% 100% 100% 78%
100% 70% 64% Hulio
60% 57% 20% 19% 19%
53% 50% 46% 41% Amgevita
28% 28% 27%
Humira
Q1 Q1 Q1 Q1 Q1 Q1 Q1
2015 2016 2017 2018 2019 2020 2021

Etanercept has seen a volume increase of 50% while costs have been reduced by 16% (at list price level) (Exhibit 17).
Exhibit 17: Uptake of etanercept biosimilars over time and spending on etanercept biologics and biosimilars
over time
Quarterly etanercept defined daily doses in Germany by product, 2015–2021

3.4 3.6
3.3 3.3 3.4 2%
3.1 1% 2%
3.0 3.3 3.3 3.2 3.2 1% 1%
3.0 3.1 3.2 3.1 3.2
1% 4% 6% 3.0 3.0
2.9 9% 10% 22% 24%
2.7 2.7 7% 17% 18%
2.5 2.6 12% 13% 15% 20% 23% 24% 24%
2.5 5% 19%
2.3 2.4 2.4 10% 16% 26% 32% 35% 37%
2.3
40% 43% 44% 45%
47% 50% 51% 52% TOTAL
53% 54%
54% 55% 54% 54% 53% 54%
Nepexto
100% 100% 95% 90%
100% 100% 100% 84%
74% 68% 64% 59% Erelzi
53% 50% 47% 44%
41% 37% 34% 32% Benepali
29% 27% 25% 23%
21% 21% 21% 20%
Enbrel
Q1 Q1 Q1 Q1 Q1 Q1 Q1
2015 2016 2017 2018 2019 2020 2021
Quarterly etanercept spending in Germany by product, 2015–2021
160 163 162 163

1% 3% 5% 6% 162 164
138 146 8% 9% 148 147 145 131
135 128 4% 139 138 134 124
130 10% 11% 11%
126 126 9% 13% 30% 32% 121 119 122 1% 1%
28% 36% 38% 103 105 108
US$Mn
22% 40% 41% 110 18% 2%

15% 16% 18% 19% 1% 2%
43% 46% 48% 18%
23% 23% 23% TOTAL
48% 49% 53% 53% Nepexto
100% 100% 100% 100% 100% 96% 91% 87% 50% 51%
78% 72% 69% 54% 54% 54% Erelzi
65% 59%
56% 53% 50%
47% 43% 41%
37% 35% Benepali
32% 30% 29% 27%
22% 21% 21%
Enbrel
Q1 Q1 Q1 Q1 Q1 Q1 Q1
2015 2016 2017 2018 2019 2020 2021


Infliximab’s volume of use has doubled while costs have remained relatively stable (at list price level) (Exhibit 18).
Exhibit 18: Uptake of infliximab biosimilars over time and spending on infliximab biologics and biosimilars over time
Quarterly infliximab defined daily doses in Germany by product, 2015–2021

6.2 6.3
5.8 5.9 6% 6%
5.0 5.2 5.6
6%
4.8 4.7 4.8 4.9 4.9 5% 6% 6% 11% 10%
4% 12% 12%
4.7 4.7 2% 3% 4% 4% 5%
4.2 4.3 4.5 4.5 4.6 12%
16% 15%
3.5 4.2 6% 13%
3.3 3.4
6% 4.0 4.0 4% 8% 8% 11% 13% 15% 12% 10% 11% 12% 13% 13% 20% 17%
1% 4% 3.6 3.6 3.8 7% 23% TOTAL
6% 14% 15% 20%
1% 4% 8% 10% 12% 23% 24% 24% 25% 25% 24% 24% 24% 24% 24% 24% 25% 27% 25%
8% 9% 10% 11% 12% 40% Zessly
15% 34% 37%
15% 16% 17% 18% 17% 17% 17% 16% 16% 17% 23% 28%
17% 17% 17% 19% Flixabi
98% Inflectra
91% 87% 84% 81% 78% 75% 72% 62%
55% 55% 51% 49% 47% 45% 44% 46% 46% 44% 42% 41% 39% 38% 36% 35% 32% 30% 30% Remsima
Remicade
Q1 Q1 Q1 Q1 Q1 Q1 Q1
2015 2016 2017 2018 2019 2020 2021
Quarterly infliximab spending in Germany by product, 2015–2021

91 102 101 105 103
91 88 102 99 98 95 100
1% 4% 6% 98 94 95 95
3% 5% 5% 90 3% 3% 3% 3%
92 92 2% 4% 83 83 87 4%
1% 4% 6% 12% 88 7% 79 79 79 77
US$Mn
9% 11% 84 1% 3% 13% 13% 12% 12% TOTAL

7% 14% 18% 27% 9% 2% 2% 2% 2% 3% 14%
9% 10% 11%
8% 22% 24% 25% 10% 10% 14% 22% 20%
13% 29% 10% 10% 11% 12% 14% 26% 23% Zessly
15% 16% 29% 30%
17% 19% 20% 30% 31% 31% 29%
31% 33% 33% Flixabi
22% 35%
98% 22% 45% 49%
92% 88% 85% 82% 79% 77%
73%
22% 22% 22% 23% 23% 23% 30% 36% 42% Inflectra
65% 59% 55%
51% 48% 22% 25%
42% 40% 37% 38% Remsima
36% 34% 32% 30% 26% 25% 23% 21% 20% 18%
16%
Remicade
Q1 Q1 Q1 Q1 Q1 Q1 Q1
2015 2016 2017 2018 2019 2020 2021

Utilizing IQVIA data to estimate savings since the entry of biosimilars, the total savings due to biosimilar use (at a list price level)
for infliximab, adalimumab and etanercept are estimated to be $3.6 billion. Given the variation in biosimilar policies across
regions in Germany (different quota levels, different incentives), it is challenging to attribute this saving to any one specific
policy, but discussions around benefit sharing policies suggest that they have played a role in the overall use (Exhibit 19).

Cumulative biosimilar savings in Germany, US$Mn, Q1 2015–Q4 2021 3,682
1,426.6
3,274 1,594.5
1,333.6
2,903 1,365.4
1,246.5
2,559 1,159.1
2,281 1,164.8
US$Mn
2,008 1,085.3
1,007.3
1,758 660.7
1,511 575.0
858 1,035 1,259 TOTAL
711 84.0 497.1
585 109.0 932.8 424.8
65.2 130.3 858.8 372.2 infliximab
163 209 490 50.5 67.6 785.8 318.2
333 368 424 21.3
87 104 128 160.4 195.6 255 291 26.3 23.8 28.2 37.2 643.7
715.9
217.2
268.8
etanercept
12 28 46 67 24.3 577.9 682.5 823.5
969.2
131.4 2.9 13.8 23.4 452.8 513.2
162.4
11.9 27.9 46.2 67.5 88.0 108.0 231.9 266.9 306.5 343.8 395.8 209.6 311.0
435.2 556.8
adalimumab
Q1 Q3 Q1 Q3 Q1 Q3 Q1 Q3 Q1 Q3 Q1 Q3 Q1 Q3
2015 2015 2016 2016 2017 2017 2018 2018 2019 2019 2020 2020 2021 2021
Notes: In Germany, the total savings are shown from biosimilar entry as benefit sharing program dates varied by region and were generally started around the time
of biosimilar entry. These savings may not be directly attributable to the benefit sharing program alone and are driven by a number of biosimilar policies and levers.
BENEFIT SHARING (SHARED SAVINGS) PROGRAMS: CASE STUDIES FROM EUROPE — ITALY
Case study: Italy

In Italy, policies related to biosimilars are often made Published literature

at a regional level. In general, there has been a push to In general, Italy has witnessed high uptake of biosimilars
increase biosimilar uptake through the use of various across most regions. It is challenging to estimate the
affordability measures such as prescribing targets, impact of the benefit sharing program in Campania given
purchasing framework agreements, and related. There is a the prevalence of a number of other policies to promote
degree of regional variability in the choice of policies that biosimilar uptake in Campania and across regions. On the
are adopted. Campania is the only region in Italy that has whole, Campania has witnessed higher biosimilar uptake
adopted a benefit sharing program to encourage use than the national average in some cases (bevacizumab,
of biosimilars. 24
rituximab and infliximab) while it has been lower than the
national average in other cases (adalimumab, etanercept
and somatropin) (Exhibit 20).25 The reinvestment of
From 2016 onward, a benefit sharing program was savings in innovative therapies would be important to
established by the regional health ministry in Campania consider as well, but data to assess this is limited.
that covered all hospital use molecules that have
biosimilar competition. Fifty percent of the savings from
biosimilars is retained by the hospital administration with
5% meant for clinical departments. The aim is to utilize
these savings to fund innovative drugs. The regional
health ministry retains the remaining 50%.
Other regions in Italy may have financial incentives for

use of biosimilars as well, however, these have not been
captured in publicly available literature.
Exhibit 20: Level of biosimilar uptake — Campania vs average across Italy
100% 98% 99% 98% 100% 99% 100%

94% 98%
93%
84% 84%
77% 79%
24%
20%
adalimumab bevacizumab etanercept filgrastim infliximab rituximab somatropin trastuzumab

Italy Campania
Source: AIFA Regional Biosimilar Data May 2022 (accessed Oct 2022).
Notse: Benefit sharing program start date varied across regions.

IQVIA data
Adalimumab has seen a volume increase of 25% since the introduction of biosimilars while costs have remained stable
(at list price level) (Exhibit 21).
over time
Quarterly adalimumab defined daily doses in Italy by product, 2015–2021

3.0 3.0
2.8 2.9 2.9
2.4 2.6 2.7 2.6 2.6 4% 5%
2% 2% 3%
2% 2.4 2.6 2.5 1% 2% 5% 1%
2.4 2.5 2.4
2.3 2.3 2.4 2% 7% 21% 20% 20% 20% 19%
2.1 2.1 2.1 2.0 25% 29%
TOTAL
1.9 2.0 15% 33% 33% 31% 27%
1.9 1.9 1.9 10% 13% 16% 19% 24% Idacio
10% 8%
12%
14% 18%
20% 24% 31% 33% 33%
Amgevita
30% 26%
100% 100% 100% 100% 100% 100% 100% 100% 100% 96% Hyrimoz
100% 100% 100% 100% 100% 100% 77% 66%
59% 52% 46%
43% 39% 36% 32% Imraldi
28% 27% 25%
Humira
Q1 Q1 Q1 Q1 Q1 Q1 Q1
2015 2016 2017 2018 2019 2020 2021
Quarterly adalimumab spending in Italy by product, 2015–2021
87 94 95 96 95
92
93 94 2% 87 83 88 2% 2% 3% 4%
89 90 91 83 88 5%
85 84
1% 6% 9% 12% 14%
2% 5% 1%
82 17% 7%
75 74
70 70 71 72 70 72 14% 23% 22%
69 27%
US$Mn
21% 20% 20%

31% 32% 27% TOTAL
8% 30% 20%
10% 19% Idacio
12% 16% 27% 30%
17% 21% 30%
100% 100% 100% 100% 97% 27% Hyrimoz
100% 100% 24%
100% 100% 100% 100% 100% 100% 100% 100% 100% 80% 70% Amgevita
63% 56%
51% 48% 44% 41%
37% 33% 31% Imraldi
30%
Humira
Q1 Q1 Q1 Q1 Q1 Q1 Q1
2015 2016 2017 2018 2019 2020 2021
Note: Benefit-sharing program start date varied across regions.
Etanercept has seen a marginal volume decrease while costs have been reduced by 29% (at list price level) (Exhibit 22).
Exhibit 22: Uptake of etanercept biosimilars over time and spending on etanercept biologics and biosimilars
over time
Quarterly etanercept defined daily doses in Italy by product, 2015–2021

1.5 1.6 1.7 1.7 1.6

1.6 1.6 1.7 1.6 1.5
1.6 1.6 1.6 1.6 1.6 1.6 1% 1%
1.5 4% 4% 1.5 1.5 1.5
8%
15% 20% 24% 1.5 1.4 1.5 1.4 1.5 1.5 1.5 1.4
32% 9% 13%
40% 10% 12% 12% 13% 13% 15% 15% 17%
42% 19%
42%
43%
46%
46% 49% 50% 51% 53%
54% 55%
53% 53%
100% 100% 100% 100% 100% 100% 100% 99% 96% 92% TOTAL
85% 80% 76%
68% Erelzi
60% 57%
54% 48%
44% 42% 39% 37% 36% Benepali
34% 31% 30% 29% 28%
Enbrel
Q1 Q1 Q1 Q1 Q1 Q1 Q1
2015 2016 2017 2018 2019 2020 2021
Quarterly etanercept spending in Italy by product, 2015–2021
60 55 60
59 58 57 53 58 58 57
55 56 52
55 1% 6% 53 50
3% 11% 15% 18% 47
1% 45 43
3% 46 45
US$Mn
25% 7% 44 44 43
32% 8%
41 42 41 40
33% 11% 11% 12% 13%
10% 9% 11% 15%
34% 16%
36% 38%
39% 42% 43% 44% 46% 48% 49% TOTAL
100% 100% 100% 100% 48% 48%
100% 100% 100% 99% 97% 94% 89% 85% 82%
75% Erelzi
68% 66%
63% 58% Benepali
54% 51% 48% 46% 45% 43% 40%
39% 38% 36%
Enbrel
Q1 Q1 Q1 Q1 Q1 Q1 Q1
2015 2016 2017 2018 2019 2020 2021


Infliximab’s volume of use has increased marginally while costs have remained relatively stable (at list price level)
(Exhibit 23).
Quarterly infliximab defined daily doses in Italy by product, 2015-2021

2.1 2.1
1.8 1.9 1.8 2.0 2.0
1.6 1.8 1.9 1.9 1.9 1.9 1.9
1.9
1.9 1.9
1.7 1.7 1.8 1.8
1.9
2%
1.8 12% 11% 1% 1% 3%
1.7 1.7
1.7 2% 5% 1.7 1.7 16% 14% 14% 14%
4% 12% 15% 18% 19% 23% 27% 30% 26% 26% 27% 27% 27% 23% 20% 21% 12%
7% 9% 11% 18% 22%
8% 14% 13% 9%
14% 18% 23% 15% 17% TOTAL
27% 19% 8% 11% 13%
30% 33% 35% 23% 24% Inflectra
36% 37% 35% 34% 29% 28% 26% 25% 24% 23% 7%
Remsima
7%
100% 94% 87% 10% 18% 24% 30% 33% 34% 37% 42% 44% 44% 54% 55% 57% 55% 52% Zessly
79% 74% 66%
61% 55% 49%
46% 45% Flixabi
39% 35% 29%
23% 22% 19%
16% 14% 13% 10% 9% 8% 8% 7% 7% 6%
6% Remicade
Q1 Q1 Q1 Q1 Q1 Q1 Q1
2015 2016 2017 2018 2019 2020 2021
Quarterly infliximab spending in Italy by product, 2015–2021
29 32 35 34 35 35 35
30 33 34
3% 29 31 31 32 2% 32 31 30 32 33
31 31 7% 31 31 29
5% 6% 30 29 30 9% 29 8% 11% 15% 17%
2% 17% 1% 1% 3% 7% 13%
7%
US$Mn
12% 16% 21% 25% 24% 29%

33% 34% 35% 33% 33% 34% TOTAL
8% 10% 28% 31% 32% 36% 42%
11% 28% 44% 44% 54% 54% Inflectra
14% 17% 18% 27% 56% 55% 52%
17% 20% 22% 25%
26%
24% 24%
23%
Remsima
100% 29% 23% 24% 18%
95% 88% 82% 25%
76% 69% 64% 26% 27% 14% 13% Zessly
58% 52% 49% 49% 27% 27% 9% 12% 14%
43% 38% 32% 23% 20% 21% Flixabi
26% 24% 21% 15% 14% 14% 12% 11%
16% 15% 13% 10% 9% 9% 8% 7% 8% 6% 6% Remicade
Q1 Q1 Q1 Q1 Q1 Q1 Q1
2015 2016 2017 2018 2019 2020 2021
Utilizing the IQVIA data to estimate savings since the entry of biosimilars, the total savings due to biosimilar use (at a list price
level) for infliximab, adalimumab and etanercept are estimated to be $439 million. Given the variation in biosimilar policies
across regions (different quota levels, different incentives), it is challenging to attribute this saving to any one specific policy,
but discussions around benefit sharing policies suggest that they have played a role in the overall use in Campagnia.

Cumulative biosimilar savings in Italy, US$Mn, Q1 2015–Q4 2021 439
401
369
344
317 178.3
291 169.3
US$Mn
265 161.6
231 156.0
149.3
118 198 142.5
99 142 169 135.3 115.1
18.6 126.5 104.9 TOTAL
85 12.3 15.4 95.9
7.4 117.4 88.3
60 65 67 74 80.5 infliximab
48 57 6.5
2.3 108.9 72.5
22 0.5 2.1 100.2 64.4
7 12 17 3.3 2.4 2.3 92.0 54.1 145.9 etanercept
3 39 1.8 111.1 126.9
27 32 84.8 43.9
3.3 7.3 11.7 16.7 21.8 46.5 53.4 57.8 62.7 66.5 71.6 78.0 26.3
34.7
50.7 65.0 75.9 87.1 99.4
26.8 32.3 39.0 25.0 36.5 adalimumab
Q1 Q3 Q1 Q3 Q1 Q3 Q1 Q3 Q1 Q3 Q1 Q3 Q1 Q3
2015 2015 2016 2016 2017 2017 2018 2018 2019 2019 2020 2020 2021 2021

Notes: In Italy, the total savings are shown from biosimilar entry as benefit sharing program dates varied by region and were generally started
around the time of biosimilar entry. These savings may not be directly attributable to the benefit sharing program alone and are driven by a number
of biosimilar policies and levers.
Oncology Care Model in United States
While a shared savings or benefit sharing program for (Exhibit 30). This difference may be driven by the pressure
biosimilars has not been implemented in the U.S., the to reduce costs, however, given the affordability benefits
Oncology Care Model (OCM) can offer insights into the that the use of biosimilars can provide, the difference is
impact of programs that are based on incentivizing not large for biosimilars launched in 2019. This suggests
affordability. that a greater focus on incentivizing biosimilars may be
OCM ran from 2016 to 2021 and participants covered one- required to actively enhance biosimilar uptake.
fourth of Medicare FFS chemotherapy-related cancer care Overall across Europe, benefit sharing programs have
practices. The goal of OCM was to utilize appropriately been used extensively. While data on the impact of these
aligned financial incentives to enable improved care programs is not always readily available, in countries
coordination, appropriateness of care, and access to where such data is provided (e.g., Ireland, England,
care for beneficiaries undergoing chemotherapy. OCM France), an increase in biosimilar use leading to savings
encouraged participating practices to improve care and for the health system can be observed. Cases such as the
lower costs through an episode-based payment model one in Ireland suggest that a benefit sharing program
that financially incentivized high-quality, coordinated had a large impact. Prior research on these programs has
care. Performance-based payment are used to incentivize also highlighted the importance of educating physicians
practices to lower the total cost of care and improve care and patients on biosimilars, and establishing a regular
for beneficiaries during treatment episodes. As such, line of communication across patients, physicians and
OCM providers may have greater financial incentive to health bodies leading the program are important for its
administer biosimilar products compared to providers not successful implementation. Communicating the savings
taking part in the OCM. However, there were no direct
26
achieved and the impact of reinvestment have also been
incentives for incentivizing the use of biosimilars. identified as useful for generating greater engagement
Based on a 2021 IQVIA study,27 OCM participants had a from physicians. These aspects will be important to reflect
slightly higher level of uptake for biosimilars launched on in the U.S. context as shared savings programs
in 2019 compared to those that did not take part in OCM are considered.
Exhibit 25: Comparison of oncology biosimilar share trend by provider OCM status
OCM participant (2%) Other (98%)
OCM participant (2%) Other (98%)
% of new-to-brand patients
% of new-to-brand patients
50%
44% 45%
42% 43% 43% 43%
38%
30% 30% 30% 32% 34%
29% 31% 28% 30%
28% 31%
18%
16% 17% 19% 18%
12% 16%
13% 11%
11% 13% 14% 15%
1% 8% 9%
5% 5%
Pre 2019 launches Avg (n=3) Pre 2019 launches Avg (n=3)
Source: IQVIA LAAD Medical Procedure Claims, US Market Access Strategy Consulting analysis.

Lessons for the U.S.
+ As European examples show, benefit sharing BENEFIT SHARING PROGRAMS CAN HELP INCREASE
programs, as part of an overall set of biosimilar BIOSIMILAR UPTAKE
policies, can be an approach to increasing biosimilar Benefit sharing programs can be an approach to
uptake and subsequently, increasing savings increasing biosimilar uptake and subsequently,
increasing savings. They can also allow for enhanced
+ Shared savings programs can also allow for
patient care through reinvestments. Across the case
enhanced patient care through reinvestment of
studies, the use of benefit sharing has been associated
savings by specialties/clinical teams
with an increase in use of biosimilars. While other
+ Increased biosimilar use can reduce overall costs policies may impact biosimilar uptake, the Ireland
and may increase overall patient access example is of particular interest as the use of biosimilars
was substantially low prior to the program and
+ Government health ministries and insurers have
biosimilars saw substantial increase in uptake once the
generally been the central driving forces behind
program was implemented. Ireland has also seen the
benefit sharing programs
savings that were shared with the specialties be used to
+ Pilot studies can be useful in understanding the improve patient care. France also witnessed increases
best approaches to benefit sharing and can ensure in biosimilar use after the implementation of benefit
that appropriate incentives are provided while sharing programs. Regional examples in Germany and
physician and patient autonomy in decision-making the UK point to a similar dynamic.
is maintained
INCREASED BIOSIMILAR USE CAN REDUCE OVERALL COSTS
+ Physician and patient education to increase Increasing use of biosimilars which are generally lower
comfort with biosimilar use and regular in cost has led to savings in each of the case studies
communication of the impact of such a policy can discussed earlier. While policies related to incentivizing
be important affordability overall are in place in a number of
European countries/regions, a specific policy targeted at
Health policies applied in Europe have a different context biosimilars may provide more impetus to increase use
from the U.S.; however, a number of lessons can be of biosimilars. In the U.S., the Oncology Care Model has
taken from the experiences of biosimilars in European led to some preference for biosimilars due to their cost
countries. With many biosimilars expected to launch in advantages, however, a more targeted approach toward
the U.S. in the next five to ten years, it is important that incentivizing biosimilars could prove more effective.
the use of biosimilars is optimized.
In a number of countries, the increasing use of
The case studies researched for this report offer biosimilars has not only led to reduced costs but also to
insights that could potentially be considered as the U.S. an increase in overall use. This increase in use suggests
evaluates legislation to improve access to biosimilars, that lower cost of biosimilars may have allowed for
which include proposals for shared savings programs for greater use due to overall affordability. However, it is
Medicare part B. important to note that this increase in overall use of the
molecule is not seen in all cases. For example, in most
countries, the use of etanercept molecule remained
steady or declined slightly upon biosimilar entry.
GOVERNMENT HEALTH MINISTRIES HAVE DRIVEN PHYSICIAN EDUCATION AND COMMUNICATION
DEVELOPMENT OF BENEFIT SHARING PROGRAMS MATTERS
Government health ministries and departments and Physician education to increase comfort with biosimilar
insurers have generally been central driving forces use and regular communication of the impact of such
behind benefit sharing programs. The benefit sharing a policy can be important. Optimal biosimilar use
programs have been led by government bodies in most will require participation and alignment of multiple
countries; for example, in Ireland, the Health Services stakeholders and factors across the healthcare
Executive developed the program, while in France, both system. As part of the benefit sharing programs, most
the general program and the pilot study were led by the countries had programs to increase the understanding
health ministry and the National Health Insurance Fund. of biosimilars among physicians so that they had
Similarly, regional health ministries and departments in increased comfort with their use. While there is growing
Italy and the UK have led benefit sharing programs. acceptance of biosimilars globally ( e.g., the recent
statement on interchangeability of reference medicines
In the U.S., given the large potential for savings for
and biologics by the European Medicines Association),
Medicare, CMS Innovation Center may be well suited
education efforts can help overcome any concerns from
to test potential innovative approaches to enhancing
patients or physicians.
biosimilar use.
CONCLUSION
PILOT STUDIES CAN HELP IN UNDERSTANDING
As an increasing number of lower-cost biosimilars enter
BEST APPROACHES
the U.S. market, there is an important opportunity
Pilot studies can be useful in understanding the best
to capitalize on potential savings they could provide,
approaches to benefit sharing and can ensure that
thereby reducing overall healthcare expenditure while
appropriate incentives are provided while physician and
maintaining the sustainability of the overall market.
patient autonomy in decision-making is maintained.
Shared savings models hold the potential to align
physician incentives with cost saving efforts without
Several countries (such as France, Germany, UK) initially
having an impact on overall healthcare quality. Examples
implemented benefit sharing programs at a pilot level
from Europe suggest that such models, along with other
before expanding it more broadly. These pilot models
biosimilar policies, can increase savings due to greater
allowed the countries to experiment with different
biosimilar use. As such models are considered, it will
models and approaches.
be important to ensure that physicians and patients
A similar approach may be suited for the U.S., as a pilot feel comfortable with biosimilars and have autonomy
study would allow for experimentation on aspects such to make decisions. Developing such a model will likely
as level of incentive, voluntary vs compulsory, targets, require leadership from CMS and partnership with
etc., while ensuring physician and patient comfort with providers, physicians, and patient advocacy groups.
such policies. This will also help ensure that the policy is While other policies to encourage biosimilar use will
effective before broader use. It is crucial that patients and also be needed, developing, and assessing pilot shared
physicians feel comfortable with such policies and that savings models at this stage can help with ensuring that
these pilot models ensure that prescribing decisions are benefits from biosimilars are optimized moving forward.
being made with clinical factors as the driving criteria.

APPENDIX: BENEFIT SHARING (SHARED SAVINGS) PROGRAMS: CASE STUDY SUMMARIES FROM EUROPE
Case study summary: Ireland

BACKGROUND
• Biosimilar uptake was low (2%) for etanercept despite two years on the market
• Health Services Executive designed a ‘Best Value Biologic (BVB)’ program to promote use of BVBs
(selected based on cost and other factors) in 2018–19
• Time frame: June 2019
• Stakeholders: Health Services Executive (public healthcare system), local clinics/hospitals departments
• Molecules: adalimumab and etanercept
• Note: Benefit Sharing is a component of biosimilar related policies
STRUCTURE OF PROGRAM
• EUR 500 provided to clinical department for every patient initiated or switched to best value biologic
• Savings must be reinvested into the department (monitored by HSE-Primary Care Reimbursement)
IMPACT OF THE PROGRAM AND OF BIOSIMILAR USE
Uptake
• Adalimumab: patients on biosimilars increased from 166 in May 2019 to over 3400 on BVB in May 2020
• Etanercept: patients on biosimilars increased from 104 in May 2019 to over 1800 by May 2020
• B
y July 2020, the total patients on BVB across both molecules was over 8500 and biosimilars had 50%
market share by Q3 2020 and over 60% by Q4 2021
Change in volume of use and cost since start of the program
• Adalimumab: Volume increased by 50% since introduction of program while costs have increased by 19%
(at list price level)
• Etanercept: Volume has increased by 14% while costs have increased by 7% (at list price level)
Savings
• Total estimated savings due to the use of BVBs between Jun 2019 to July 2020 is EUR 22.7 million
(based on available literature)
• E
stimated Savings from Q2 2019 and Q4 2021 (on list price level) due to increase in biosimilar use across all
of Ireland (For adalimumab and etanercept) – $47 Mn (based on IQVIA Institute calculations)*
Reinvestment
• EUR 3.6 million was provided to specialties as part of the benefit sharing to be invested back between
July 2019 and July 2020
Reinvestments have focused on patient care such as additional equipment (e.g. ultrasound machines,
polar machines), IT development (e.g. online biologic registry); gain-sharing has also enabled extra clinics
and extra clinic time to allow for more infusions; funding has also been used for hiring local consultants,
education programs and infrastructure.
Source: Duggan et al,, Uptake of biosimilars for TNF-α inhibitors adalimumab and etanercept following the best-value biological medicine initiative in
Ireland, Oct 2021, IQVIA MIDAS and IQVIA Institute Analysis.
Notes: * In Ireland, the total savings are shown from the start of the Benefit Sharing Program. These savings may not be directly attributable to the
benefit sharing program alone and are driven by a number of biosimilar policies and levers.
Case study summary: France

BACKGROUND
• Biosimilar uptake was low (<10%) for etanercept despite one year on the market
• T
o improve the use of biosimilars, a national benefit-sharing program was launched by the French health
insurance system and an 80% biosimilar uptake target was set for 2022
• Time frame: General: 2018–22; Pilot: 2018–23
• S
takeholders: Clinics/hospitals departments, the National Health Service Financial Division, the regional
health agency (ARS); Pilot: national health insurance (CNAM), ministry of health (DSS and DGOS), and regional
health agencies (ARS)
• Molecules: adalimumab, etanercept, insulin glargine
• G
eneral program: 20% of the price difference between the reference product and its biosimilar goes to
the hospital financial department for each unit of biosimilar product hospital prescribed and dispensed at
community pharmacy
• P
ilot (59 NHS hospitals) up to Jan 2023: 30% of the price difference between the reference product and its
biosimilar goes to the clinical units that were involved in the generation of savings

Uptake
Published Literature
Etanercept
• General program: increase of 10.4 percentage points between October 2018 and July 2019 (21.3% to 31.7%)
• E
xperimental Pilot program: increase of 19.2 percentage points between October 2018 and July 2019
(24.7% to 43.8%)
Adalimumab
• General program: increase in biosimilar share from 8.3% to 29.8%
• Experimental Pilot program: an increase in biosimilar share from 10.3% to 29.8%
IQVIA Data
• Etanercept: Biosimilar uptake has reached 43% by end of 2021
• Adalimumab: Biosimilar uptake has reached 35% by end of 2021
Change in volume of use and costs since start of the program
• Adalimumab: Volume increased by 40% since introduction of program while costs have remained stable
(at list price level)
• Etanercept: Volume has remained steady while costs have decreased by 23% (at list price level)
Savings
• Savings after 10 months due to etanercept biosimilar uptake in experimental program: EUR 650k
• E
stimated Savings from Q4 2018 to Q4 2021 (on list price level) due to increase in biosimilar use across all of
France (For adalimumab and etanercept) – $160 Million (based on IQVIA Institute calculations)*
Source: Incentives promoting use of biosimilar medicines in France, Oct 2022; Paubel et al., Impact of French experiment for incentivizing Etanercept
biosimilar use after 10 months, Mar 2020; Tano et al., Assessment of the French National Experimentation for Incentivising Hospital Prescriptions of
Adalimumab Biosimilars Delivered in Retail Pharmacies, July 2022; IQVIA MIDAS and IQVIA Institute Analysis.
Notes: * In France, the total savings are shown from the start of the Benefit Sharing Program. These savings may not be directly attributable to the
benefit sharing program alone as not all hospitals may have taken part in the program and are driven by a number of biosimilar policies and levers.

Case study summary: United Kingdom

BACKGROUND
• B
enefit sharing programs have been commonly used at regional (Clinical Commissioning Group, CCG) level
across England
• N
HS report states that that out of the incentive schemes allowed for providers, benefit-sharing was used in
75% of the cases
• T
hese programs have been set up to achieve 90% uptake for treatment-naïve patients within 3 months of
biosimilar market entry; 80% uptake for established patients within 12 months of biosimilar entry
• One example of such a program is covered below (many other examples are also available in literature)
• Time frame: 2015
• Stakeholders: North Somerset and South Gloucestershire CCG, North Bristol NHS Trust
• Molecules: infliximab
• N
ote: Benefit Sharing is a component of biosimilar related policies
• 5
0:50 split of the savings between the CCG and providers
• Managed switch of infliximab to biosimilars with >80% switch to biosimilars

Uptake
North Bristol Example
• Infliximab: 52 patients were switched to the biosimilar out of 64/65 (>80%). 97% patients satisfied with
switching process.
National
• O
verall, based on IQVIA data at a national level, the anti-TNFs have witnessed strong biosimilar uptake with
biosimilars comprising of >80% of the market
Change in volume of use and costs since biosimilar entry
National
• A
dalimumab: Volume increased by 55% while costs have increased by 42% (at list price level)
• Etanercept: Volume has increased by 25% while costs have remained stable (at list price level)
• Infliximab: Volume has doubled while costs have increased by 65% (at list price level)
Savings
• G
BP 200,000 in savings from switching to biosimilars
National
• T
otal estimated savings due to the use of anti-tnf biosimilars at a national level (at a list price level based on
IQVIA Institute calculations) = $998 Mn
• N
ote: These savings may not be directly attributable to the benefit sharing program alone and are driven
by a number of biosimilar policies and levers
Reinvestment
• The share of savings provided to the trust were reinvested into gastroenterology services and an
additional pharmacist was funded for closer monitoring and funding of biologic treatments
Source: Lacosta, Vulto et al, Qualitative Analysis of the Design and Implementation of Benefit-Sharing Programs for Biologics Across Europe, Mar 2022;
available at: https://link.springer.com/article/10.1007/s40259-022-00523-z; Chung et al., Making The Change: Switching to Infliximab Biosimilars for
IBD at North Bristol NHS Trust, 2016; IQVIA MIDAS and IQVIA Institute Analysis.
Case study summary: Germany

BACKGROUND
• B
iosimilar policies are developed by Health insurance companies (‘Krankenkassen; KKs) and regional
associations of health insurance accredited companies (Kassenärztliche Vereinigungen; KVs)
• Different regions and insurance companies can establish varying biosimilar quota levels
• I n 2015, a pilot benefit sharing program was started for the region of Westphalia-Lippe by BARMER, a
health insurance company
• H
ealth Services Executive designed a ‘Best Value Biologic (BVB)’ program to promote use of BVBs (selected
based on cost and other factors) in 2018–19
• Time frame: 2015 onwards
• Stakeholders: BARMER, Westphalia-Lippe providers
• M
olecules: Anti-TNFs (infliximab, etanercept, adalimumab)
• Voluntary program that providers can opt-in
• Prescription objectives set in consultation between BARMER and providers
• P
roviders meeting objectives given financial remuneration (amount not specified) and were exempted
from adhering to budget caps

Uptake
Westphalia-Lippe
• Infliximab: Westphalia-Lippe witnessed faster uptake of biosimilar compared to other regions reaching
over 80% by 2018
• E
tanercept: Westphalia-Lippe witnessed faster uptake of biosimilar compared to other regions reaching
over 70% by 2018
• T
he benefit sharing program has been extended to other regions since the initial pilot but details of the
program vary and are not publicly available
National
• Overall, based on IQVIA data at a national level, the anti-TNFs have witnessed strong biosimilar uptake with
biosimilars comprising of 70-80% of the market likely driven by a mix of biosimilar policies
National
• Adalimumab: Volume increased by 47% while costs have decreased by 20% (at list price level)
• Etanercept: Volume has increased by 50% while costs have reduced by 16% (at list price level)
• Infliximab: Volume has doubled while costs have remained relatively stable (at list price level)
Savings
National
• While it is challenging to estimate savings at a regional level, total estimated savings due to the use of anti-
tnf biosimilars at a national level (at a list price level based on IQVIA Institute calculations) = $3,682 Mn
• N
Reinvestment
• Details on reinvestment are not available, exemption form budget caps likely to increase access to biologics
Source: Lacosta, Vulto et al, Qualitative Analysis of the Design and Implementation of Benefit-Sharing Programs for Biologics Across Europe, Mar
2022; available at: https://link.springer.com/article/10.1007/s40259-022-00523-z; Moorkens et al., Learnings from Regional Market Dynamics of
Originator and Biosimilar Infliximab and Etanercept in Germany, 2020; IQVIA MIDAS and IQVIA Institute Analysis.

Case study summary: Italy

BACKGROUND
• Biosimilar policies are made at regional level by regional health ministries in consultation with providers
• C
ampania region established a benefit sharing program; Other regions in Italy may have financial
incentives for use of biosimilars, however, these have not been captured in publicly available literature
• Time frame: 2016 onwards
• Stakeholders: Campania Ministry of Health, Regional providers (Hospitals/Clinics)
• Molecules: all hospital use molecules that have biosimilar competition
• 5
0% of the savings from biosimilars is retained by the hospital administration with aim to fund innovative
drugs with 5% meant for clinical departments
• The regional health ministry retains the remaining 50%
Uptake
Campania
• Campania has witnessed higher biosimilar uptake than the national average in some cases (bevacizumab,
rituximab and infliximab)
• H
owever, it has been lower than the national average in other cases (adalimumab, etanercept and
somatropin)
National
• In general, biosimilar uptake in Italy has been high nationally with each of the anti tnfs
(adalimumab, etanercept and inflixmab) achieving over 70% uptake
• A
variety of regional biosimilar policies are being used making an assessment of relative impact of benefit
sharing program difficult
National
• Adalimumab: Volume increased by 25% since biosimilar entry while costs have remained stable (at list price level)
• Etanercept: Volume has seen a marginal decline while costs have reduced by 29% (at list price level)
• Infliximab: Volume has seen a marginal increase while costs have remained relatively stable (at list price level)
Savings
National
• While it is challenging to estimate savings at a regional level, total estimated savings due to the use of
anti-tnf biosimilars at a national level (at a list price level based on IQVIA Institute calculations) = $439 Mn
• N
Reinvestment
• Details on reinvestment are not available
Source: Lacosta, Vulto et al, Qualitative Analysis of the Design and Implementation of Benefit-Sharing Programs for Biologics Across Europe,
Mar 2022; available at: https://link.springer.com/article/10.1007/s40259-022-00523-z; AIFA Regional Biosimilar Data May 2022 (accessed Oct 2022);
IQVIA MIDAS and IQVIA Institute Analysis.
Methodologies
METHODOLOGY FOR CALCULATING SAVINGS The following dataset was utilized to conduct this
To estimate the savings associated with the entry of the analysis
biosimilar, we compare the actual sales that took place
IQVIA MIDAS® is a unique platform for assessing
with the hypothetical scenario where the biosimilar is
worldwide healthcare markets. It integrates IQVIA’s
not available in the market (or the program was not
national audits into a globally consistent view of the
started) and therefore, the molecule price per DDD
pharmaceutical market, tracking virtually every product
stays constant at pre-expiry (or pre-start of program)
in hundreds of therapeutic classes, and provides
prices across the time period. This approach to calculate
estimated product volumes, trends and market share
the savings has been previously adopted in studies
through retail and non-retail channels. MIDAS data are
which assessed savings from biosimilars in individual
updated quarterly and retain 12 years of data. Historic
countries.28 This approach allows U.S. to account for
archives of MIDAS were used to extend analyses to the
savings due to the lower price of the biosimilar as well
full time period analyzed, 2005 to 2021.
as the potentially lower price of the other somatropin
products due to the increased price competition from
the biosimilar.

References
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Toxicol. 2015;34(12):1279-85.
2. Nguyen NX, Sheingold S. Medicare Part B Drugs: Trends in Spending and Utilization, 2006-2017: Department of Health and
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pdf.
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July 2022 Data Book: Health Care Spending and the Medicare Program [Internet]. [cited Accessed October 30,2022]. Available
from: https://www.medpac.gov/wp-content/uploads/2022/07/July2022_MedPAC_DataBook_Sec10_v2_SEC.pdf.
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Available from: https://www.ema.europa.eu/en/human-regulatory/overview/biosimilar-medicines-overview.
5. Arad N, Lopez MH, Ray R, Dentzer S, Kroetsch A, McClellan M, et al. Realizing the Benefits of Biosimilars: What the U.S. Can
Learn from Europe: Duke Margolis Center for Health Policy. Available from: https://healthpolicy.duke.edu/sites/default/
files/2021-04/Realizing%20the%20Benefits%20of%20Biosimilars.pdf.
6. Biosimilar medicines can be interchanged [press release]. European Medicines Agency (EMA). 2022 Sep 19.
7. The IQVIA Institute. Spotlight on Biosimilars. Available from: https://www.iqvia.com/locations/united-states/library/white-
papers/biosimilars-in-the-us-reimbursement-and-impacts-to-uptake.
8. Vogler S, Schneider P, Zuba M, Busse R, Panteli D. Policies to Encourage the Use of Biosimilars in European Countries and Their
Potential Impact on Pharmaceutical Expenditure,. Frontiers in Pharmacology. 2021;12.
9. Moorkens E, Vulto AG, Huys I, Dylst P, Godman B, Keuerleber S, et al. Policies for biosimilar uptake in Europe: An overview. PLOS
ONE. 2017;12(12):e0190147.
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Available from: https://www.england.nhs.uk/wp-content/uploads/2017/09/biosimilar-medicines-commissioning-framework.
pdf.
11. Barcina Lacosta T, Vulto AG, Turcu-Stiolica A, Huys I, Simoens S. Qualitative Analysis of the Design and Implementation of
Benefit-Sharing Programs for Biologics Across Europe. BioDrugs. 2022;36(2):217-29.
12. Senator John Cornyn. Cornyn, Bennet Introduce Bipartisan Bill to Increase Access to Generic Drugs,Accessed October 30,
2022. Available from: https://www.cornyn.senate.gov/content/news/cornyn-bennet-introduce-bipartisan-bill-increase-access-
generic-drugs.
13. Brill A. Shared Savings Demonstration for Biosimilars in Medicare: An Opportunity to Promote Biologic Drug Competition:
Matrix Global Advisors. Available from: https://getmga.com/wp-content/uploads/2022/04/Biosimilar_Shared_Savings.pdf.
14. Duggan B, Smith A, Barry M. Uptake of biosimilars for TNF-α inhibitors adalimumab and etanercept following the best-value
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Review-2021.pdf.
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documents/202201271725260.PNGDRESS_2021-2022.pdf.
17. Generics and Biosimilars Initiative (GaBI). Incentives promoting use of biosimilar medicines in FranceAccessed October 30,
2022. Available from: https://www.gabionline.net/reports/incentives-promoting-use-of-biosimilar-medicines-in-france.
18. Paubel P, Degrassat-Theas A, Bocquet F. Impact of French Experiment for Incentivising Etanercept Biosimilar Use Afte 10
MonthsAccessed October 30, 2022. Available from: https://www.eahp.eu/sites/default/files/2spd-008_0.pdf.
19. Tano M, Degrassat Theas A, Ribault M, Paubel P. HPR12 Assessment of the French National Experimentation for
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Supplement):S468-S9.
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Bristol NHS Trust. Gut. 2016;65(Suppl 1):A22-A3.
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Handbuch-Biosimilars_Oktober-2019.pdf.
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Pharmaceuticals (Basel). 2021;14(3).
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https://www.aifa.gov.it/en/monitoraggio-consumi-e-spesa-biosimilari.
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innovation.cms.gov/innovation-models/oncology-care.
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insights/the-iqvia-institute/reports/spotlight-on-biosimilars.
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About the authors
MURRAY AITKEN VIBHU TEWARY
Executive Director, Project Director, IQVIA Institute for
IQVIA Institute for Human Human Data Science
Data Science
Murray Aitken is Executive Director, IQVIA Institute Vibhu Tewary is a Project Director at the IQVIA Institute
for Human Data Science, which provides policy setters for Human Data Science and is based out of New York,
and decisionmakers in the global health sector with NY. His key areas of interest include healthcare policy,
objective insights into healthcare dynamics. He led global market access, and economic modeling. Vibhu has
the IMS Institute for Healthcare Informatics, now the authored multiple reports on global healthcare policy
IQVIA Institute, since its inception in January 2011. and market access. Prior to joining IQVIA, he worked as
Murray previously was Senior Vice President, Healthcare a researcher in a policy think tank in India. Vibhu did his
Insight, leading IMS Health’s thought leadership undergraduate studies at the Indian Institute
initiatives worldwide. Before that, he served as Senior of Technology, Madras, and holds an MBA from
Vice President, Corporate Strategy, from 2004 to 2007.
Duke University.
Murray joined IMS Health in 2001 with responsibility
for developing the company’s consulting and services
businesses. Prior to IMS Health, Murray had a 14-year
career with McKinsey & Company, where he was a leader
in the Pharmaceutical and Medical Products practice
from 1997 to 2001. Murray writes and speaks regularly
on the challenges facing the healthcare industry. He is
editor of Health IQ, a publication focused on the value
of information in advancing evidence-based healthcare,
and also serves on the editorial advisory board of
Pharmaceutical Executive. Murray holds a Master of
Commerce degree from the University of Auckland
in New Zealand, and received an M.B.A. degree with
distinction from Harvard University.
About the Institute
The IQVIA Institute for Human Data Science • Understanding the future role for biopharmaceuticals
contributes to the advancement of human health in human health, market dynamics, and implications
globally through timely research, insightful analysis and for manufacturers, public and private payers,
scientific expertise applied to granular non-identified providers, patients, pharmacists and distributors.
patient-level data.
• Researching the role of technology in health system
Fulfilling an essential need within healthcare, the products, processes and delivery systems and the
Institute delivers objective, relevant insights and business and policy systems that drive innovation.
research that accelerate understanding and innovation
Guiding principles
critical to sound decision making and improved
The Institute operates from a set of guiding principles:
human outcomes. With access to IQVIA’s institutional
knowledge, advanced analytics, technology and • Healthcare solutions of the future require fact based
unparalleled data the Institute works in tandem with a scientific evidence, expert analysis of information,
broad set of healthcare stakeholders to drive a research technology, ingenuity and a focus on individuals.
agenda focused on Human Data Science including
• Rigorous analysis must be applied to vast amounts of
government agencies, academic institutions, the life
timely, high quality and relevant data to provide value
sciences industry, and payers.
and move healthcare forward.
Research agenda
• Collaboration across all stakeholders in the
The research agenda for the Institute centers on
public and private sectors is critical to advancing
five areas considered vital to contributing to the
healthcare solutions.
advancement of human health globally:
• Insights gained from information and analysis should
• Improving decision-making across health systems
be made widely available to healthcare stakeholders.
through the effective use of advanced analytics and
methodologies applied to timely, relevant data. • Protecting individual privacy is essential, so research will
be based on the use of non-identified patient information
• Addressing opportunities to improve clinical
and provider information will be aggregated.
development productivity focused on innovative
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research, inform discourse, achieve better healthcare
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and improve the health of all people.
focusing on patient centricity, precision medicine
and better understanding disease causes, treatment
consequences and measures to improve quality and
cost of healthcare delivered to patients.

The IQVIA Institute for Human Data Science
is committed to using human data science to
provide timely, fact-based perspectives on the
dynamics of health systems and human health
around the world. The cover artwork is a visual
representation of this mission. Using algorithms
and data from the report itself, the final image
presents a new perspective on the complexity,
beauty and mathematics of human data
science and the insights within the pages.
The algorithmic art on this report was

generated from data that captures the shifts
in biosimilar use in selected case studies
before and after the introduction of the
benefit sharing program.
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Shared Savings

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Funding for this research and report has been provided

Shared Savings Programs in Europe: Lessons for the United States

Role of biosimilars in healthcare sustainability 4

Biosimilar policies and use of benefit sharing programs 5

Benefit sharing (shared savings) programs: Case studies from Europe 9

Lessons for the U.S. 29

About the authors 39

About the Institute 40

2 | Shared Savings Programs in Europe: Lessons for the United States

Exhibit 1: Biologic share of overall medicine spending (U.S., EU)

Biologic medicines Other medicines

Source: IQVIA MIDAS, Jun 2022.

4 | Shared Savings Programs in Europe: Lessons for the United States

Biosimilars approved and launched in the U.S.

Launched biosimilars Approved biosimilars not yet launched

Source: IQVIA Institute, Oct 2022.

Biosimilar share of volume

Biosimilar share of volume

Biosimilar share of volume

France U.S. UK Germany Italy

Source: IQVIA MIDAS, Jun 2022; IQVIA Institute, Nov 2022.

6 | Shared Savings Programs in Europe: Lessons for the United States

+ Europe has adopted a number of supply DEMAND SIDE POLICIES

Exhibit 4: Summary table of benefit sharing agreements

COUNTRY LEVEL TARGET MOLECULES

FRANCE National (for selected hospitals) etanercept, adalimumab, insulin glargine

IRELAND National etanercept, adalimumab

PORTUGAL National all hospital-use molecules exposed to biosimilar competition

National Guideline; Regional implementation

National Guideline; Regional implementation

WALES Cardiff hospital rituximab

Regional-Westfalen-Lippe and sick fund Barmer

SWEDEN Regional - Skane somatropin, infliximab

NETHERLANDS Insurers and individual hospitals Unknown

8 | Report Title: Strapline – All In Title Case

+ A number of regional benefit sharing programs

Case study: Ireland14

Biosimilar uptake had been historically low in Ireland in Published literature

STRUCTURE OF BENEFIT SHARING PROGRAM Based on statements by experts, reinvestments

10 | Shared Savings Programs in Europe: Lessons for the United States

Quarterly adalimumab defined daily doses in Ireland by product, 2015–2021

Start of the program

Quarterly adalimumab spending in Ireland by product, US$Mn, 2015–2021

Source: IQVIA MIDAS, Dec 2021; IQVIA Institute, Nov 2022.

Quarterly etanercept defined daily doses in Ireland by product, 2015–2021

100% 100% 100% 100% 99% 98%

Quarterly etanercept spending in Ireland by product, US$Mn, 2015–2021

15 15 Start of the program

12 | Shared Savings Programs in Europe: Lessons for the United States

Case study: France

arrangements17 relatively steady, adalimumab use increased by 35%

prescribers can get 20% of the difference between the

Quarterly adalimumab defined daily doses in France by product, 2015–2021

Start of the program 6.4 6.6

Quarterly adalimumab spending in France by product, 2015–2021

Start of the program

119 120 116 118 119 117 113 116 3% 3%

Source: IQVIA MIDAS, Dec 2021; IQVIA Institute, Sep 2022.

14 | Shared Savings Programs in Europe: Lessons for the United States

Quarterly etanercept defined daily doses in France by product, 2015–2021

Start of the program