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1、Shared Savings Programs in Europe LESSONS FOR THE UNITED STATESDECEMBER202 2Acceptance 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 t

2、he 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

3、 such programs in other countries can provide lessons for the U.S.In this report,five case studies of shared savings/benefit sharing programs from across Europe are examined using secondary research,expert interviews and IQVIA data.The background to setting up a program is provided for each case stu

4、dy along with the structure of the program and results as stated in secondary literature and as per IQVIA data.Lessons for the U.S.are summarized based on these case studies.This report has been developed independently by the IQVIA Institute for Human Data Science,drawing on IQVIA proprietary data a

5、nd published literature across selected European countries.Funding for this research and report has been provided by the Biosimilars Forum.Find Out MoreIf you wish to receive future reports from the IQVIA Institute for Human Data Science or join our mailing list,visit iqviainstitute.org.MURRAY AITKE

6、NExecutive Director IQVIA Institute for Human Data Science2022 IQVIA and its affiliates.All reproduction rights,quotations,broadcasting,publications reserved.No part of this publication may be reproduced or transmitted in any form or by any means,electronic or mechanical,including photocopy,recordin

7、g,or any information storage and retrieval system,without express written consent of IQVIA and the IQVIA Institute.IntroductionShared Savings Programs in Europe:Lessons for the United StatesTable of ContentsOverview 2Role of biosimilars in healthcare sustainability 4Biosimilar policies and use of be

8、nefit sharing programs 5Benefit sharing(shared savings)programs:Case studies from Europe 9Ireland 10France 13United Kingdom 16Germany 20Italy 24Lessons for the U.S.29Appendix 31Methodologies 36References 37About the authors 39About the Institute 40Biologic drugs have revolutionized treatment of pati

9、ents over the past two decades,particularly in the fields of serious inflammatory auto-immune diseases.These drugs are products derived from living organisms or their components that treat a number of conditions such as diabetes,cancer,and immune disorders,and they constitute some of the most expens

10、ive drugs on the market.Nearly half of all medicine spending(48%)in the U.S.is on biologics,for a total of$259 billion gross expenditure in 2021.Biosimilars offer the potential to optimize sustainability of healthcare systems by reducing costs while ensuring the same quality of care.A biosimilar is

11、a biological medicine highly similar to another already approved biological medicine(the reference medicine)and can compete with original biologic products after the originators period of exclusivity is completed.Biosimilar entry into the market can drive and stimulate competition,resulting in reduc

12、tion of prices,savings for broader access to existing biologics,additional services,and innovative drugs,and potentially allowing for earlier treatment of more patients due to reduced costs.Europe has adopted a number of policies to increase the use of biosimilars,leading to broader availability and

13、 uptake compared to the U.S.Acceptance and use of biosimilars in the U.S.have risen over the past couple of years,however,availability of biosimilars remains lower than in European countries in some cases.While the context in these countries is different from the U.S.,some of the policies adopted in

14、 Europe may hold lessons for the U.S.and contribute to optimizing biosimilar use.One of the policies to incentivize physician use of biosimilars that has been commonly used across European countries is benefit sharing programs,also referred to as shared savings programs.Such programs have also been

15、proposed in the U.S.and therefore,understanding the structure and impact of these programs may be helpful to assessing their viability in the U.S.context.While no consensus definition of benefit sharing programs exists,these generally refer to selective contracts at the national/regional/provider le

16、vel that 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.Based on selected case studies,benefit sharing programs have be

17、en implemented at a national level in Ireland and France and at a regional level in Germany,Italy,and England(selected case studies,not an exhaustive list).While it is hard to directly correlate the use of biosimilars to any one program or policy due to the presence of several policies and activitie

18、s,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

19、the program and has since risen to more than 50%(for molecules included in the program),Biosimilars offer the potential to optimize sustainability of healthcare systems by reducing costs while ensuring the same quality of care.2|Shared Savings Programs in Europe:Lessons for the United StatesOverview

20、resulting in savings of 22.7 million in the first year of implementation(i.e.,by July 2020).The program also generated 3.6 million as savings that were shared with the specialties to invest back into patient care.Subsequently,biosimilar use relative to total molecule use has increased past 60%in Ire

21、land,leading to$47 million in savings by end of 2021(based on IQVIA data and analysis).Similarly,increases in biosimilar share and associated savings can also be seen in France,England,Germany,and Italy.In Germany,the program was piloted in the Westphalia-Lippe region before being extended to other

22、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 was implemented along with other biosimilar policies,which has been associated with an increase in biosimilar use;however,comparisons with

23、 other regions in Italy are mixed as biosimilar uptake is high across regions,and 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 w

24、hich promote cost efficient behavior such as the Oncology Care Model have led to slight increases in biosimilar use(compared to those not taking part in these programs),however the difference for biosimilars launched more recently is not substantial,which suggests that a more biosimilar focused appr

25、oach may be needed.The experiences of these countries offer lessons for the U.S.as it considers shared savings programs for Medicare Part B.As these examples show,benefit sharing programs can be an approach to increasing biosimilar uptake and subsequently,increasing savings.Greater biosimilar use ca

26、n 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 decision-making is maintained.Physician and patient educa

27、tion to increase comfort with biosimilar use and regular communication of the impact of such a policy are important.If the key stakeholders are not comfortable with biosimilar use,such a program may not be successful.Government health ministries and departments and insurers have generally been the c

28、entral driving forces behind benefit sharing programs.Finally,a shared savings program is one of many other policies that must be considered to optimize an appropriate system for biosimilar use.As an increasing number of lower-cost biosimilars enter the U.S.market,there is a unique opportunity to re

29、duce overall healthcare expenditure while maintaining the sustainability of the overall market.Shared savings models hold the potential to align physician incentives with cost-saving efforts without having an impact on overall healthcare quality.Developing such a model will likely require leadership

30、 from CMS and partnership with providers,physicians,and patient advocacy groups.While other policies to encourage biosimilar use will be needed,developing and accessing pilot shared savings models at this stage may help with ensuring that benefits from biosimilars are optimized moving forward.Benefi

31、t sharing programs can be an approach to increasing biosimilar uptake and subsequently,increasing savingsiqviainstitute.org|34|Shared Savings Programs in Europe:Lessons for the United StatesRole of biosimilars in healthcare sustainability +Biologic drugs constitute some of the most expensive drugs o

32、n the market and have been a growing contributor to the overall drug spending in U.S.and Europe,with more than 48%of all drug spending in the U.S.coming from biologics +Biosimilars can play a crucial role in maintaining sustainability of healthcare systems by providing savings without compromising o

33、n the overall quality of care+In general,Europe has witnessed broader and faster uptake of biosimilars compared to the U.S.and may hold lessons for the U.S.on optimizing biosimilar useBiologic drugs have revolutionized treatment of patients over the past two decades,particularly in the fields of ser

34、ious inflammatory auto-immune diseases.1 Biologic drugs,which are products derived from living organisms or their components,can treat a number of conditions such as diabetes,cancer,and immune disorders.These drugs also constitute some of the most expensive drugs on the market and have been a growin

35、g contributor to the overall drug spending in U.S.and Europe.Nearly half of all medicine spending(48%)in the U.S.is on biologics,for a total of$259 billion gross expenditure in 2021(See Exhibit 1).Biologics constitute a large share of Medicare spending as some of Medicare Part Ds highest-expenditure

36、 drugs,and all 10 of the highest-expenditure drugs in Medicares Part B program are biologics.2,3Interest in the role of biosimilars in maintaining economic sustainability of the healthcare system has been growing.A biosimilar is a biological medicine highly similar to another already approved biolog

37、ical medicine(the reference medicine)and can compete with original biologic products after the originators period of exclusivity is completed.4 Biosimilar entry in the market can drive and stimulate competition,resulting in reduction of prices,savings for increased access to existing biologics,addit

38、ional services,and innovative drugs,and potentially allowing for earlier treatment of more patients due to reduced costs.Exhibit 1:Biologic share of overall medicine spending(U.S.,EU)Source:IQVIA MIDAS,Jun 2022.Biologic medicinesOther medicinesEU4+UKQuarterly medicine spending in EU4+UK and U.S.by p

39、roduct type,US$Bn,Q1 2011Q2 2022U.S.50454035302520151050Q1 2017Q1 2011Q1 2012Q1 2013Q1 2014Q1 2022Q1 2015Q1 2016Q1 2018Q1 2019Q1 2020Q1 20200806040200Q1 2017Q1 2011Q1 2012Q1 2013Q1 2014Q1 2022Q1 2015Q1 2016Q1 2018Q1 2019Q1 2020Q1 2021iqviainstitute.org|5The U.S.developed and adopted legis

40、lation for regulating and approving biosimilars in 2009 and expectations at that time were that these biosimilars would lead to billions of dollars of savings annually.5 In reality,biosimilar pathways have taken some time to mature as they faced a few issues(such as regulatory uncertainties,intellec

41、tual property issues,coverage and reimbursement,patient/provider knowledge,etc.)that have impacted their uptake and usage.In contrast,many countries across Europe have adopted various policies to enhance the uptake of biosimilars,subsequently leading to savings.Overall,Europe has seen broader approv

42、al,launch and uptake of biosimilars compared to the U.S.As of September 2022,86 biosimilar medicines have been approved in Europe(EMA)since 20066 compared to 44 in the U.S.(as of October 2022 based on IQVIA data).The first product approved as a biosimilar in the U.S.was in 2015,almost nine years aft

43、er the first approval in EMA,contributing to the lag of uptake in biosimilars in the U.S.(Exhibit 2).Major European countries have also seen faster uptake of some biosimilars compared to the U.S.(Exhibit 3),especially those that launched prior to 2019.Acceptance and use of biosimilars in the U.S.has

44、 witnessed a rise over the past couple of years(Exhibit 2,3).With many additional biologics losing exclusivity over the next five to ten,it is important that the sustainability of the healthcare system is considered and approaches to optimizing the use of biosimilars are explored.While biosimilar po

45、licies in Europe are not directly transferable,they can hold lessons for the U.S.and could help it move toward a more optimal ecosystem for biologics and biosimilar use.7 In particular,policies such as benefit sharing programs(also known as gain sharing agreements or shared savings programs)can alig

46、n incentives across stakeholders and further encourage market participation and biosimilar uptake.Exhibit 2:Timeline of biosimilar launches Source:IQVIA Institute,Oct 2022.Notes:Biosimilars approved but not yet launched are placed based on expected launch announced by company.Marketer and manufactur

47、er 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.Launched biosimilarsApproved biosimilars not yet launchedLaunch not

48、announcedBiosimilars approved and launched in the U.S.somatropinfilgrastiminfliximabinsulin glargineinsulin lispropegfilgrastimepoetin alfabevacizumabtrastuzumabrituximabteriparatideranibizumabadalimumabJan-07Jan-13Jan-14Jan-15Jan-16Jan-17Jan-18Jan-19Jan-20Jan-21Jan-22Jan-236|Shared Savings Programs

49、 in Europe:Lessons for the United StatesExhibit 3:Uptake of selected biosimilars(France,Germany,Italy,UK,U.S.)Biosimilar share of volumeSource:IQVIA MIDAS,Jun 2022;IQVIA Institute,Nov 2022.filgrastimFrance,Germany,Italy,UK,U.S.biosimilar uptake curves,defined daily doses,quarters since launchpegfilg

50、rastim100%80%60%40%20%0%0369 12 15 18 21 24 27 30 33 36 39 42 45 48 51 54Biosimilar share of volume100%80%60%40%20%0%02468111215Biosimilar share of volumeinfliximabbevacizumab100%80%60%40%20%0%0369 12 15 18 21 24 27 30 33 36 39 42 45 48 51 54Biosimilar share of volume100%80%60%40%20%0%024

51、68111215Biosimilar share of volumeFrancerituximabtrastuzumab100%80%60%40%20%0%024680Biosimilar share of volume100%80%60%40%20%0%024680U.S.UKGermanyItalyQuarters since launchQuarters since launchQuarters since launchQuarters since launchQuarters since launchQuarters s

52、ince launchiqviainstitute.org|7Biosimilar policies and use of benefit sharing programs+Europe has adopted a number of supply (e.g.,tendering,reference pricing)and demand side(physician incentives,benefit sharing)policies to encourage the use of biosimilars+Benefit sharing programs have been implemen

53、ted in several European countries to incentivize prescribing of biosimilars+While no consensus definition of benefit sharing programs exists,these generally refer to selective contracts at the national/regional/provider level that incorporate elements of the sharing of benefits/savings to incentiviz

54、e the use of off-patent biologics and biosimilars+Discussions around a Medicare part B shared savings program(which is another term for benefit sharing)for biosimilars have been gaining increasing attention in the U.S.with legislative bills proposing potential pilot modelsSUPPLY SIDE POLICIES8,9Pric

55、e link Many countries have chosen to set the price of the biosimilar in relation to the reference medicine.In some cases,the price of a biosimilar medicine has to be set at a certain percentage lower than the reference medicine price.In some other countries,prices are fixed upon negotiation based on

56、 several factors(such as any improvements over reference medicine,price across Europe,sales-volume forecast in France)but are generally 10-20%lower than the reference medicine price.While in some countries,prices are freely set.Tendering and reference pricingTendering is commonly used for procuremen

57、t of biosimilars in an inpatient setting.Tendering can also take place in an outpatient setting in a few countries(e.g.,Denmark,the Netherlands).DEMAND SIDE POLICIESPhysician incentives and substitutionPhysician incentives to prescribe biosimilars have been implemented in various forms across Europe

58、.These incentives include quotas for share of biosimilars on overall prescribing.For example,in Germany,quotas exist for some biosimilars within the context of regionally negotiated economic targets.There can also be quotas for low-cost medicine use,which can include biosimilars,as is the case in Be

59、lgium.Pharmacy level substitution for biosimilars remains rare in Europe.In general,physicians are expected to prescribe rationally and to retain final decision-making power on therapeutic choices.Benefit-sharing programsAnother approach to incentivizing rational prescribing of biosimilars by physic

60、ians and providers is through the use of benefit sharing programs(also called gain sharing or shared savings programs).These benefit sharing programs can be set up in several different forms and there is no clear consensus on their definition.These programs are a part of a broader biosimilar set of

61、policies.NHS in England refers to them as“Financial arrangements to incentivize the provider to implement processes that can maximize the early adoption and prescribing of biosimilars.”10 Other countries do not provide a clear definition,however,these programs generally refer to selective contracts

62、at the national/regional/provider level that incorporate elements of the sharing of benefits(i.e.,savings or other benefits such as lack of limits to biologic use)to incentivize the use of off-patent biologics and biosimilars.Based on research published in 2022,benefit sharing agreements have genera

63、lly been used to“(i)set prescription objectives for Best Value Biologics i.e.the most cost effective option out of the set of biologic and biosimilars;(ii)engage prescribers in being compliant with the set objectives;(iii)generate and reinvest savings according to the needs of the stakeholders who p

64、roduced them;and(iv)establish pathways for savings 8|Report Title:Strapline All In Title Casereinvestment that would fund additional health services and quality-of-care improvements.”11Such agreements have been used extensively in Europe.The UK,Germany and Italy have seen examples of benefit sharing

65、 agreements since 2016.In total,based on existing literature,there are more than 10 benefit sharing agreements in Europe at national and regional/provider levels(See Exhibit 4).Experts interviewed in prior research have also suggested such programs as being an effective approach to enhancing the use

66、 of biosimilars.9 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 inc

67、ludes a pilot program that encourages physicians to prescribe less expensive biosimilars through shared savings.12 Prior articles have discussed possible structures for shared savings program for Medicare Part B.13 Given this background,understanding the experience of European countries with respect

68、 to benefit sharing programs and assessing learnings for the U.S.context is critical.The next section covers a set of case studies of benefit sharing programs.The existing literature provides an overview of the structure and impact of these programs,and this background is supplemented with proprieta

69、ry IQVIA data(where available)and country expert interviews to understand the impact of these programs in further detail.Exhibit 4:Summary table of benefit sharing agreements COUNTRYLEVELTARGET MOLECULESFRANCENational(for selected hospitals)etanercept,adalimumab,insulin glargineIRELANDNationaletaner

70、cept,adalimumabPORTUGALNationalall hospital-use molecules exposed to biosimilar competitionENGLANDNational Guideline;Regional implementation(multiple programs)TNFi(etanercept,adalimumab,infliximab),rituximabSCOTLANDNational Guideline;Regional implementation(Lothian,Gramnian)infliximab,adalimumab(IBD

71、 patients)WALESCardiff hospitalrituximabGERMANYRegional-Westfalen-Lippe and sick fund Barmer(Subsequently expanded to other regions)TNFi(etanercept,adalimumab,infliximab)ITALYRegional-Campania Regional Health Serviceall hospital-use molecules exposed to biosimilar competitionSWEDENRegional-Skanesoma

72、tropin,infliximabNETHERLANDSInsurers and individual hospitalsUnknown 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:/ sharing(shared savings)programs:Case studies from Europe+Benefit

73、 sharing programs,which are part of a holistic set of biosimilar policies,have been implemented at a national level in Ireland and France and at a regional level in Germany,Italy and England(selected case studies,not an exhaustive list).+In Ireland,biosimilar use was very low prior to the implementa

74、tion of the program and for biosimilars included in the program,use has since risen to more than 50%,resulting in savings of 22.7 million in the first year of implementation+In Germany,the program was piloted in Westphalia-Lippe region before being extended to other regions;Westphalia-Lippe saw fast

75、er biosimilar uptake in the initial period compared to other regions+In the Campania region of Italy,a benefit sharing program was implemented which resulted in an increase in biosimilar use,however,comparisons with other regions are mixed as biosimilar uptake is high across regions,and many regions

76、 have targeted biosimilar uptake policies+A number of regional benefit sharing programs have been implemented in the UK,resulting in fast uptake/switching to biosimilarsAcross Europe,multiple examples of benefit sharing programs have been identified.These examples vary in terms of the level of imple

77、mentation(national vs regional),structure of program(level of benefits shared,voluntary pulsory,etc.)and overall uptake objectives.This section summarizes the key available details regarding a few selected programs.These case studies were selected because they represent some of the larger countries

78、where benefit sharing programs have been implemented as well as countries where the most information was accessible(a 2022 article by Lacosta,Vulta et al.provides a comprehensive list of benefit sharing programs).11 While it is hard to directly link increases in biosimilar use to any one policy,an i

79、ncrease in biosimilar uptake was seen in each of these case studies.This section aims to provide data from published literature,government documents,and from IQVIA MIDAS to better understand the potential impact of these programs(see appendix for IQVIA Institute approach to calculating savings).10|S

80、hared Savings Programs in Europe:Lessons for the United StatesCase study:Ireland14 BACKGROUNDBiosimilar uptake had been historically low in Ireland in 2018,a fact that has been acknowledged and discussed by the health ministry.14,15 For example,the biosimilar for etanercept(Benepali)had been availab

81、le since September 2016,but in its first two years,had only 2%market share.Concerns around the sub-optimal use of biosimilars led the Health Service Executive(i.e.,the public health system in Ireland)to develop a Medicines Management Programme(MMP)roadmap for the prescribing of best-value biological

82、(BVB)medicines in December 2018.The BVB program assessed the biologic/biosimilars available for etanercept and adalimumab based on a number of criteria,including costs,and in May 2019,the MMP published its recommendations indicating that Imraldi and Amgevita(should clinicians wish to prescribe a cit

83、rate-free formulation)were the BVBs for adalimumab and Benepali for etanercept.STRUCTURE OF BENEFIT SHARING PROGRAMBased on these BVBs,a benefit sharing program was started in June 2019.This program offered the relevant clinical service at a cost of 500 for each patient who initiated or switched to

84、a BVB medicine.This funding can be invested to further enhance service delivery for patients.The program was led by government bodies and the key stakeholders involved were HSE-MMP and HSE-Primary Care Reimbursement Service(hospital management and clinical departments).The program was implemented at

85、 a national level.IMPACT OF THE PROGRAM AND OF BIOSIMILAR USEPublished literature The impact of the first year of the program has been assessed through prior published literature.In the case of adalimumab,8,163 patients were on the reference medicine and 166 were on biosimilars in May 2019 (i.e.,pri

86、or to the start of the program).By May 2020,more than 3,400 patients were on the BVB for adalimumab.Similarly,in the case of etanercept,4,208 patients were on the reference medicine and 104 were on biosimilars in May 2019.By May 2020,more than 1,800 patients were on the BVB for adalimumab.By July 20

87、20,the total patients on BVB across both molecules was more than 8,500 and biosimilars had a 50%market share by Q3 2020.The total estimated savings due to the use of BVBs in this time frame(June 2019 to July 2020)is 22.7 million,and 3.6 million was provided to specialties as part of the benefit shar

88、ing to be invested back.Based on statements by experts,reinvestments have focused on patient care,such as additional equipment(e.g.,ultrasound machines,polar machines),IT development(e.g.,online biologic registry)and telemedicine.Gain-sharing has also enabled extra clinics and extra clinic time to a

89、llow for more infusions.Additionally,funding has also been used for hiring local consultants,education programs and infrastructure.These steps can enhance patient care and lead to more prescribers being available for patients,thereby allowing more patients to be seen and cared for.BENEFIT SHARING(SH

90、ARED SAVINGS)PROGRAMS:CASE STUDIES FROM EUROPE IRELANDiqviainstitute.org|11IQVIA DATASince 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.Adalim

91、umab 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).Quarterly adalimumab defined daily doses in Ireland by product,20152021Exhibit 5:Uptake of adalimumab biosimilars over time and spending on adali

92、mumab biologics and biosimilars over timeYuflymaTOTALIdacioHulioImraldiAmgevitaHumiraDefined daily doses(Millions)Q12015Q12016Q12017Q12018Q12019Q12020Q12021Start of the program0.5 0.5 0.6 0.6 0.6 0.6 0.6 0.7 0.7 0.7 0.7 0.8 0.7 0.8 0.8 0.8 0.8 0.9 0.9 0.9 0.9 0.9 1.0 1.0 1.1 1.2 1.1 1.2 100%100%100%

93、100%100%100%100%100%100%100%100%100%100%100%100%100%98%97%90%79%67%59%50%42%37%34%31%30%4%10%17%22%28%34%38%41%43%46%3%8%13%14%15%14%14%13%12%12%1%2%2%2%3%4%7%9%10%12%12%10%1%1%1%1%2%BENEFIT SHARING(SHARED SAVINGS)PROGRAMS:CASE STUDIES FROM EUROPE IRELANDSource:IQVIA MIDAS,Dec 2021;IQVIA Institute,N

94、ov 2022.Quarterly adalimumab spending in Ireland by product,US$Mn,2015202133 21 22 23 24 24 26 26 28 26 29 31 32 33 33 33 32 28 28 28 28 28 26 29 31 32 34 33 YuflymaTOTALIdacioHulioImraldiAmgevitaHumiraUS$MnQ12015Q12016Q12017Q12018Q12019Q12020Q12021Start of the program100%100%100%100%100%100%100%100

95、%100%100%100%100%100%100%100%100%99%98%93%84%74%66%57%50%45%41%38%37%3%8%14%19%24%30%34%37%40%42%2%6%10%11%12%12%12%11%11%10%1%2%2%2%2%4%6%8%9%10%11%9%1%1%1%1%1%12|Shared Savings Programs in Europe:Lessons for the United StatesCumulative biosimilar savings in Ireland,US$Mn,Q2 2019Q4 2021Source:IQVIA

96、 MIDAS,Dec 2021;IQVIA Institute,Nov 2022.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.TOTALetanerceptadalimum

97、abUS$MnQ22019Q32019Q42019Q12020Q22020Q32020Q42020Q12021Q22021Q32021Q420210.8 2.9 6.5 11.8 17.6 21.5 25.0 28.4 32.7 38.6 47.0 0.1 0.51.12.02.93.43.74.04.34.85.70.4 1.74.07.511.515.018.822.727.533.240.2BENEFIT SHARING(SHARED SAVINGS)PROGRAMS:CASE STUDIES FROM EUROPE IRELANDExhibit 6:Uptake of etanerce

98、pt biosimilars over time and spending on etanercept biologics and biosimilars over timeExhibit 7:Cumulative savings due to increase in adalimumab and etanercept biosimilars uptake after program start 0.34 0.37 0.38 0.41 0.37 0.41 0.40 0.40 0.37 0.39 0.40 0.42 0.38 0.40 0.40 0.41 0.37 0.37 0.37 0.38

99、0.40 0.38 0.40 0.42 0.41 0.42 0.41 0.42 BenepalTOTALEnbrelDefined daily doses(Millions)Q12015Q12016Q12017Q12018Q12019Q12020Q12021Start of the program100%100%100%100%100%100%100%100%100%100%99%99%99%98%98%98%98%97%88%77%63%55%46%42%39%37%37%37%1%1%1%2%2%2%2%3%12%23%37%45%54%58%61%63%63%63%Source:IQVI

100、A MIDAS,Dec 2021;IQVIA Institute,Sep 2022.Quarterly etanercept defined daily doses in Ireland by product,2015202114 14 15 14 15 15 12 13 12 12 12 12 13 12 11 11 11 11 11 11 11 10 11 12 12 12 12 12 BenepalTOTALEnbrelUS$MnQ12015Q12016Q12017Q12018Q12019Q12020Q12021Start of the program1%1%1%1%1%1%2%3%10

101、%21%34%42%51%54%58%60%59%60%58%49%46%42%40%41%40%100%100%100%100%100%100%100%100%100%100%99%99%99%99%99%99%98%97%90%79%66%Etanercepts volume has increased by 14%while costs have increased by 7%(at list price level)(Exhibit 6).Utilizing the IQVIA data to estimate savings between Q2 2019 and Q4 2021,t

102、he 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

103、 low uptake of biosimilars prior to 2019.Quarterly etanercept spending in Ireland by product,US$Mn,20152021iqviainstitute.org|13Case study:France BACKGROUNDSimilar to Ireland,France also experienced slow biosimilar uptake initially.In the case of etanercept,a biosimilar(Benepali)has been available s

104、ince Q4 2016,but the overall market share of the biosimilar was 10%by Q1 2018(Exhibit 9).To improve the use of biosimilars in 2018 and again in 2021,a national benefit sharing program was launched by the French health insurance system in“Plan dappui la transformation du systme de sant“for etanercept

105、,adalimumab and insulin glargine,and an 80%biosimilar uptake target was set for 202216 for biosimilars that have been in the market for past three years.The stakeholders involved in the benefit sharing program are the regional health agency,the National Health Service Financial Division,and selected

106、 hospitals/clinics across France.The national health insurance(Caisse nationale dassurance maladie(CNAM),and ministry of health(Direction de la scurit sociale(DSS)and the Direction gnrale de loffre de soins(DGOS),and regional health agencies(ARS)across France are also leading a pilot model(See below

107、).STRUCTURE OF BENEFIT SHARING PROGRAMThere are currently two programs with benefit sharing arrangements17 Main Program(Started 2018):This program includes all hospitals that have a compulsory contract to improve the quality and efficiency of care(CAQES).Hospital prescribers can get 20%of the differ

108、ence 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 refe

109、rence 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 als

110、o 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.IMPACT OF THE PROGRAM AND OF BIOSIMILAR USEPublished Lite

111、raturePublished literature has assessed the initial impact of the programs on uptake of etanercept and adalimumab.In the case of etanercept,in the first 10 months,18 the general program(i.e.,main program)saw an increase of 10.4 percentage points between October 2018 and July 2019(21.3%to 31.7%).The

112、experimental program saw an increase of 19.2 percentage points between October 2018 and July 2019(24.7%to 43.8%).Savings for the experimental program were estimated at 650,000 after 10 months.For adalimumab,after 19 months(March 2019 to Oct 2020),19 the general program saw an increase in biosimilar

113、share from 8.3%to 29.8%while the experimental program saw an increase from 10.3%to 29.8%.IQVIA dataAt a national level,there have been further increases in biosimilar use through 2020 and 2021,with etanercept biosimilar use reaching 43%and adalimumab biosimilar use reaching 35%by end of 2021(Exhibit

114、s 8 and 9).While the volume of etanercept use has remained relatively steady,adalimumab use increased by 35%between Q1 2019 and Q4 2021.This increase in biosimilar use is at a faster rate compared to the rate in time period preceding biosimilar entry.BENEFIT SHARING(SHARED SAVINGS)PROGRAMS:CASE STUD

115、IES FROM EUROPE FRANCE14|Shared Savings Programs in Europe:Lessons for the United StatesSource:IQVIA MIDAS,Dec 2021;IQVIA Institute,Sep 2022.BENEFIT SHARING(SHARED SAVINGS)PROGRAMS:CASE STUDIES FROM EUROPE FRANCEQuarterly adalimumab spending in France by product,20152021Exhibit 8:Uptake of adalimuma

116、b biosimilars over time and spending on adalimumab biologics and biosimilars over timeYuflymaAmsparityTOTALHyrimozIdacioHulioImraldiAmgevitaHumiraUS$MnQ12015Q12016Q12017Q12018Q12019Q12020Q12021Start of the program110 115 119 120 116 118 119 117 113 116 131 134 134 130 131 122 114 116 118 119 121 113

117、 130 138 139 137 127 125 100%100%100%100%100%100%100%100%100%100%100%100%100%100%100%99%96%92%89%85%82%81%79%77%75%73%70%69%1%2%5%7%8%10%10%11%12%13%14%15%15%1%2%3%3%4%4%4%4%4%4%5%5%1%1%2%3%3%3%4%5%5%6%7%1%1%1%1%1%1%2%2%2%2%YuflymaAmsparityTOTALHyrimozIdacioImraldiHulioAmgevitaHumiraUS$MnQ12015Q1201

118、6Q12017Q12018Q12019Q12020Q12021100%100%100%100%100%100%100%100%100%100%100%100%100%100%100%99%95%90%86%81%78%76%74%72%69%68%67%65%1%3%6%9%11%12%13%14%15%16%16%16%17%1%2%3%3%4%4%5%6%6%7%7%2%3%3%4%4%5%5%5%5%5%5%5%1%1%1%2%2%3%3%3%1%1%1%2%2%2%2%2%2%2%3.23.43.53.63.63.83.94.03.94.14.34.44.44.54.74.94.95.

119、15.35.45.65.35.76.06.06.26.46.6Start of the programAdalimumab has seen a volume increase of 35%since introduction of program while costs have remained stable (at list price level).Quarterly adalimumab defined daily doses in France by product,20152021iqviainstitute.org|15Source:IQVIA MIDAS,Dec 2021;I

120、QVIA Institute,Sep 2022.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

121、of the policy is challenging,the data shown above should be considered directional.Quarterly etanercept spending in France by product,20152021TOTALNepextoErelziBenepaliEnbrelDefined daily doses(Millions)Q12015Q12016Q12017Q12018Q12019Q12020Q12021Start of the program2.0 2.1 2.2 2.2 2.1 2.2 2.2 2.1 2.1

122、 2.1 2.1 2.1 2.1 2.1 2.1 2.1 2.0 2.1 2.1 2.1 2.1 1.9 2.0 2.1 2.0 2.0 2.1 2.0 100%100%100%100%100%100%100%99%98%96%95%93%90%87%85%81%77%73%70%68%66%65%64%63%62%60%59%57%1%2%4%5%7%10%12%13%16%19%22%24%26%27%28%29%29%30%31%32%33%1%2%3%4%5%6%6%7%7%7%8%8%9%9%10%TOTALNepextoErelziBenepaliEnbrelUS$MnQ12015

123、Q12016Q12017Q12018Q12019Q12020Q1202168.2 69.7 67.8 59.9 58.1 61.5 60.6 55.8 53.6 56.8 60.7 59.9 56.2 54.4 52.9 52.0 49.0 49.4 48.8 47.8 44.1 39.0 44.0 45.5 44.4 44.6 44.3 42.4 100%100%100%100%100%100%100%99%98%97%95%94%92%90%88%85%81%78%75%73%69%68%67%66%65%64%62%61%1%2%3%5%6%8%10%11%13%16%18%20%22%

124、25%25%26%27%28%28%29%30%1%1%2%3%4%5%5%6%6%7%7%8%8%9%9%Source:IQVIA MIDAS,Dec 2021;IQVIA Institute,Nov 2022.Exhibit 10:Cumulative savings due to increase in adalimumab and etanercept biosimilars uptake after program startCumulative biosimilar savings in France,US$Mn,Q4 2018Q4 2021TOTALetanerceptadali

125、mumabUS$MnQ22019Q12019Q42018Q32019Q42019Q12020Q22020Q32020Q42020Q12021Q22021Q32021Q420212.8 8.5 16.1 25.5 35.1 38.7 40.5 41.7 49.7 73.1 101.2 1.4 3.5 9.4 16.8 26.7 42.6 60.2 69.8 76.8 82.7 95.5 124.9 160.3 1.4 3.5 6.5 8.4 10.6 17.0 25.0 31.1 36.3 41.1 45.9 51.8 59.1 BENEFIT SHARING(SHARED SAVINGS)PR

126、OGRAMS:CASE STUDIES FROM EUROPE FRANCEEtanercepts volume has remained steady while costs have decreased by 30%(at list price level)(Exhibit 9).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 p

127、rice 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

128、 viewed as a contributor the increase in biosimilar use.(Exhibit 10)Exhibit 9:Uptake of etanercept biosimilars over time and spending on etanercept biologics and biosimilars over timeQuarterly etanercept defined daily doses in France by product,2015202116|Shared Savings Programs in Europe:Lessons fo

129、r the United StatesBENEFIT SHARING(SHARED SAVINGS)PROGRAMS:CASE STUDIES FROM EUROPE UNITED KINGDOMCase study:United Kingdom BACKGROUNDBenefit sharing programs have been commonly used at a regional(Clinical Commissioning Group)level across England with the NHS supporting their development.A 2018 NHS

130、document reports that that out of the incentive schemes allowed for providers,benefit sharing was used in 75%of the cases.The NHS commissioning framework mentions that these programs should be set up for a short timeframe and utilized to achieve best value biologic targets of 80-90%(90%uptake for tr

131、eatment-nave patients within three months of biosimilar market entry;80%uptake for established patients within 12 months of biosimilar entry).20A 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 O

132、F BENEFIT SHARING PROGRAMIn 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

133、originator infliximab to biosimilar.21 IMPACT OF THE PROGRAM AND OF BIOSIMILAR USEPublished literature and IQVIA data In the case of North Bristol NHS Trust,a total of 64/65 patients on originator Inflixmab were identified for switching.Fifty-two patients were switched to the biosimilar resulting in

134、 savings of GBP 200,000 over three months.In a post switch survey,97%of patients were satisfied with the switch process.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 trea

135、tments.iqviainstitute.org|17Exhibit 11:Uptake of adalimumab biosimilars over time and spending on adalimumab biologics and biosimilars over timeHulioTOTALHyrimozIdacioImraldiAmgevitaHumiraDefined daily doses(Millions)Q12015Q12016Q12017Q12018Q12019Q12020Q120213.9 4.5 4.6 4.6 4.6 4.5 4.6 5.0 5.2 5.4 5

136、.3 5.5 5.7 5.7 5.8 5.9 5.6 5.8 6.4 6.5 7.0 7.5 7.4 6.9 8.1 7.9 8.4 8.7 100%100%100%100%100%100%100%100%100%100%100%100%100%100%100%99%75%46%30%24%24%23%21%23%19%19%17%16%11%23%31%34%35%36%37%36%39%38%40%41%13%25%31%34%32%31%32%32%32%31%30%29%2%1%4%6%7%2%5%7%8%9%10%10%9%8%8%7%7%BENEFIT SHARING(SHARED

137、 SAVINGS)PROGRAMS:CASE STUDIES FROM EUROPE UNITED KINGDOMSource:IQVIA MIDAS,Dec 2021;IQVIA Institute,Nov 2022.Notes:Benefit-sharing program start date varied across regions.Quarterly adalimumab spending in UK by product,20152021IdacioTOTALHulioHyrimozImraldiAmgevitaHumiraDefined daily doses(Millions

138、)Q12015Q12016Q12017Q12018Q12019Q12020Q12021134 153 161 155 147 144 134 138 144 155 154 164 176 174 170 169 158 159 165 172 186 193 197 189 232 229 239 241 100%100%100%100%100%100%100%100%100%100%100%100%100%100%100%99%77%49%33%26%26%25%23%24%21%20%18%18%10%22%30%33%34%35%36%35%38%38%39%40%12%24%30%3

139、3%31%30%32%31%31%30%29%28%2%5%2%7%8%9%10%9%9%8%8%7%7%1%2%4%6%7%Quarterly adalimumab defined daily doses in UK by product,20152021In 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(adali

140、mumab,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).18|Shared Savings Programs in Europe:Lessons for the United StatesSource:IQVIA MIDAS,Dec 2021;IQVIA I

141、nstitute,Nov 2022.Notes:Benefit-sharing program start date varied across regions.Exhibit 12:Uptake of etanercept biosimilars over time and spending on etanercept biologics and biosimilars over timeQuarterly etanercept spending in UK by product,2015-2021TOTALErelziBenepaliEnbrelDefined daily doses(Mi

142、llions)Q12015Q12016Q12017Q12018Q12019Q12020Q120212.6 2.5 2.7 2.7 2.4 2.3 2.5 2.3 2.6 2.7 2.6 2.8 2.9 2.9 3.0 3.1 3.0 3.0 3.1 3.0 3.0 3.1 3.1 2.8 3.2 3.0 3.1 3.0 100%100%100%100%100%96%88%72%58%50%44%35%28%25%23%19%19%19%18%17%18%16%16%17%14%14%15%14%4%12%28%42%50%56%64%69%70%70%72%73%72%73%74%74%76%

143、75%74%78%77%77%77%1%3%5%7%8%8%9%9%9%9%9%9%10%8%9%8%9%TOTALErelziBenepaliEnbrelUS$MnQ12015Q12016Q12017Q12018Q12019Q12020Q1202185 83 91 88 76 73 70 61 67 73 71 77 83 80 79 82 79 79 77 78 77 80 81 76 91 86 87 82 100%100%100%100%100%96%88%74%60%52%46%37%30%27%25%21%20%21%19%18%19%17%17%18%15%15%16%16%4%

144、12%26%40%48%54%62%67%68%69%71%72%71%72%73%73%75%74%73%77%76%76%76%1%3%5%7%8%8%9%9%9%8%8%9%9%8%9%8%8%BENEFIT SHARING(SHARED SAVINGS)PROGRAMS:CASE STUDIES FROM EUROPE UNITED KINGDOMEtanercept has seen a volume increase of 25%while costs have remained stable(at list price level)(Exhibit 12).Quarterly e

145、tanercept defined daily doses in UK by product,2015-2021iqviainstitute.org|19Source:IQVIA MIDAS,Dec 2021;IQVIA Institute,Nov 2022.Notes:Benefit-sharing program start date varied across regions.Exhibit 13:Uptake of infliximab biosimilars over time and spending on infliximab biologics and biosimilars

146、over timeTOTALFlixabiZesslyInflectraRemsimaRemicadeDefined daily doses(Millions)Q12015Q12016Q12017Q12018Q12019Q12020Q120213.1 3.3 3.4 3.5 3.5 3.7 3.8 3.8 3.9 4.1 4.2 4.3 4.3 4.4 4.5 4.7 4.7 4.8 5.0 5.2 5.2 5.1 5.3 5.7 5.7 5.9 6.2 6.3 100%97%90%80%70%59%46%39%29%23%19%15%13%11%9%8%7%7%7%6%6%5%5%4%4%4

147、%4%4%8%14%19%18%18%16%14%16%23%36%40%41%43%45%46%47%47%46%43%42%42%39%36%35%30%27%1%4%7%9%9%8%8%9%7%1%1%2%3%3%4%5%7%7%8%9%8%8%8%7%7%7%2%6%11%23%36%45%56%61%58%49%47%45%45%43%42%41%39%40%39%37%37%39%44%46%51%55%3%TOTALZesslyFlixabiRemsimaInflectraRemicadeUS$MnQ12015Q12016Q12017Q12018Q12019Q12020Q1202

148、164 68 72 72 67 70 64 61 62 66 69 71 75 75 73 75 76 76 76 83 82 78 86 93 97 103 106 106 100%97%90%81%72%61%49%41%32%25%21%16%14%12%10%9%8%8%7%7%6%5%5%5%5%5%4%4%3%8%13%18%17%17%16%14%15%22%35%39%41%43%45%46%46%47%45%43%42%42%39%36%34%30%27%2%6%10%21%35%43%54%60%57%48%46%45%44%43%42%41%39%40%39%37%36%

149、39%43%46%50%55%1%1%2%3%3%4%5%7%7%8%9%8%8%8%7%7%7%1%4%7%9%9%8%8%9%7%Source:IQVIA MIDAS,Dec 2021;IQVIA Institute,Nov 2022.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

150、 savings may not be directly attributable to the benefit sharing program alone and are driven by a number of biosimilar policies and levers.Exhibit 14:Cumulative savings due to entry of biosimilars(anti-TNF)etanerceptinfliximabTOTALadalimumabUS$MnQ12015Q32015Q12016Q32016Q12017Q32017Q12018Q32018Q1201

151、9Q32019Q12020Q32020Q12021Q320214.6 8.9 20.5 35.5 53.4 70.7 85.9 102.0 115.3 130.4 149.7 171.4 191.3 212.2 236.9 257.6 278.8 303.8 325.3 343.1 359.7 374.1 390.1 407.3 2.9 5.4 7.7 12.3 21.6 32.0 49.4 71.1 94.0 116.0 137.4 158.5 176.5 196.8 220.9 247.0 272.4 299.1 330.4 359.3 388.8 420.3 450.4 480.3 50

152、5.9 531.3 559.5 590.9 3 5 8 12 26 41 70 107 147 187 223 261 292 327 371 418 464 511 567 617 668 724 776 823 866 905 950 998 Quarterly infliximab spending in UK by product,20152021Quarterly infliximab defined daily doses in UK by product,20152021BENEFIT SHARING(SHARED SAVINGS)PROGRAMS:CASE STUDIES FR

153、OM EUROPE UNITED KINGDOMInfliximabs volume of use has doubled while costs have increased at a slower rate of 65%(at list price level)(Exhibit 13).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,adali

154、mumab 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)Cumulativ

155、e biosimilar savings in UK,US$Mn,Q1 2015Q4 202120|Shared Savings Programs in Europe:Lessons for the United StatesCase study:Germany22,23 BACKGROUNDHealth insurance companies(Krankenkassen;KKs)and regional associations of health insurance accredited companies(Kassenrztliche Vereinigungen;KVs)represen

156、t payers and providers in Germany and many biosimilar related decisions take place at a regional level.For example,different regions and insurance companies can establish varying biosimilar quota levels.In 2015,around the time of the launch of infliximab biosimilar,a pilot benefit sharing program wa

157、s started for the region of Westphalia-Lippe by BARMER,a health insurance company in Germany.STRUCTURE OF BENEFIT SHARING PROGRAMThis program was set up as voluntary with providers opting in.Prescription objectives were set in consultation between insurance companies and providers.The Anti-TNF biolo

158、gics/biosimilars were included in the program.If providers were able to meet the prescription objectives,they received financial remuneration(amount not specified)and were exempted from adhering to budget caps concerning prescription of biologics,which is likely to increase patient access to biologi

159、cs in general.IMPACT OF THE PROGRAM AND OF BIOSIMILAR USEPublished literatureWhile the results of the program have not been publicly released,the impact can be assessed by analyzing biosimilar uptake data.The pilot program started in Westphalia-Lippe in 2015 for infliximab and as Exhibit 15 shows,th

160、is region saw faster uptake of the biosimilar compared to other regions between 2015 and 2018.The pilot program was also viewed as a success,leading to it being replicated with other KVs and BARMER;however,the details of these programs vary in terms of the prescription objectives,remuneration etc.Th

161、e details of the programs are not publicly available,making comparisons across regions challenging.IQVIA dataBased on IQVIA data at a national level in Germany,the Anti-TNFs have witnessed strong biosimilar uptake with biosimilars comprising 7080%of the market.This level of uptake is likely driven b

162、y a mix of policies such as prescription quotas,benefit sharing,physician education,etc.BENEFIT SHARING(SHARED SAVINGS)PROGRAMS:CASE STUDIES FROM EUROPESource:Moorkens et al.,Learnings from Regional Market Dynamics of Originator and Biosimilar Infliximab and Etanercept in Germany,2020.Notes:Other re

163、gions 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.Exhibit 15:Regional uptake of biosimilars over time(infliximab and etanercept)100%90%

164、80%70%60%50%40%30%20%10%0%Q1 2015Q2 2015Q3 2015Q4 2015Q1 2016Q2 2016Q3 2016Q4 2016Q1 2017Q2 2017Q3 2017Q4 2017Q1 2018Q2 2018Q3 2018Q4 2018Westphalia-Lippe90%80%70%60%50%40%30%20%10%0%Q1 2015Q2 2015Q3 2015Q4 2015Q1 2016Q2 2016Q3 2016Q4 2016Q1 2017Q2 2017Q3 2017Q4 2017Q1 2018Q2 2018Q3 2018Q4 2018Westp

165、halia-Lippeinfliximabetanerceptiqviainstitute.org|21BENEFIT SHARING(SHARED SAVINGS)PROGRAMS:CASE STUDIES FROM EUROPE GERMANYAdalimumab has seen a volume increase of 47%since the introduction of biosimilars,while costs have decreased by 20%(at list price level)(Exhibit 16).Exhibit 16:Uptake of adalim

166、umab biosimilars over time and spending on adalimumab biologics and biosimilars over timeSource:IQVIA MIDAS,Dec 2021;IQVIA Institute,Nov 2022.Notes:Benefit-sharing program start date varied across regions.YuflymaTOTALImraldi IdacioHyrimozHulioAmgevitaHumiraUS$MnQ12015Q12016Q12017Q12018Q12019Q12020Q1

167、2021216 217 227 236 223 246 248 252 240 258 279 292 294 297 299 301 270 271 276 268 254 226 260 279 261 221 229 239 100%100%100%100%100%100%100%100%100%100%100%100%100%100%100%92%78%70%64%60%57%53%50%46%41%28%28%27%1%5%8%10%11%12%13%14%15%16%20%19%19%2%4%5%8%8%10%11%13%14%18%18%18%2%5%7%8%9%9%10%10%

168、11%12%15%15%16%4%9%11%12%12%12%13%13%14%14%16%16%16%1%1%1%2%2%3%3%4%Quarterly adalimumab spending in Germany by product,20152021Source:IQVIA MIDAS,Dec 2021;IQVIA Institute,Nov 2022.Notes:In Germany,the total savings are shown from biosimilar entry as benefit sharing program dates varied by region an

169、d 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.YuflymaTOTALImraldi IdacioHyrimozHuli

170、oAmgevitaHumiraDefined daily doses(Millions)Q12015Q12016Q12017Q12018Q12019Q12020Q120213.7 3.8 4.0 4.2 3.9 4.3 4.3 4.6 4.4 4.6 4.7 4.8 4.7 4.9 5.0 5.3 5.3 5.5 5.9 6.1 6.3 5.8 6.4 7.0 6.7 6.8 7.2 7.8 100%100%100%100%100%100%100%100%100%100%100%100%100%100%100%88%69%59%52%46%41%37%34%31%28%28%27%26%2%8

171、%11%14%16%16%17%18%19%20%20%19%19%1%3%5%7%9%11%13%15%16%17%18%18%18%3%7%9%11%12%13%14%14%14%15%15%16%16%7%13%15%16%17%17%18%17%17%17%16%16%15%1%1%1%2%2%2%3%3%4%1%Quarterly adalimumab defined daily doses in Germany by product,2015202122|Shared Savings Programs in Europe:Lessons for the United StatesB

172、ENEFIT SHARING(SHARED SAVINGS)PROGRAMS:CASE STUDIES FROM EUROPE GERMANYSource:IQVIA MIDAS,Dec 2021;IQVIA Institute,Nov 2022.Notes:Benefit-sharing program start date varied across regions.Exhibit 17:Uptake of etanercept biosimilars over time and spending on etanercept biologics and biosimilars over t

173、imeQuarterly etanercept spending in Germany by product,20152021TOTALNepextoErelziBenepaliEnbrelDefined daily doses(Millions)Q12015Q12016Q12017Q12018Q12019Q12020Q120212.3 2.3 2.4 2.5 2.4 2.5 2.6 2.7 2.7 2.9 3.0 3.1 3.0 3.1 3.2 3.3 3.0 3.1 3.2 3.3 3.2 3.0 3.2 3.4 3.3 3.3 3.4 3.6 100%100%100%100%100%95

174、%90%84%74%68%64%59%53%50%47%44%41%37%34%32%29%27%25%23%21%21%21%20%5%10%16%26%32%35%37%40%43%44%45%47%50%51%52%53%54%55%54%54%54%53%54%1%4%6%7%9%10%12%13%15%17%18%19%20%22%23%24%24%24%1%1%1%2%2%TOTALNepextoErelziBenepaliEnbrelUS$MnQ12015Q12016Q12017Q12018Q12019Q12020Q12021126 126 130 135 128 138 139

175、 138 134 146 160 163 162 163 162 164 148 147 145 121 119 110 122 131 124 103 105 108 100%100%100%100%100%96%91%87%78%72%69%65%59%56%53%50%47%43%41%37%35%32%30%29%27%22%21%21%4%9%13%22%28%30%32%36%38%40%41%43%46%48%48%49%50%51%53%53%54%54%54%1%3%5%6%8%9%10%11%11%15%16%18%18%18%19%23%23%23%1%1%1%2%2%E

176、tanercept has seen a volume increase of 50%while costs have been reduced by 16%(at list price level)(Exhibit 17).Quarterly etanercept defined daily doses in Germany by product,20152021iqviainstitute.org|23Source:IQVIA MIDAS,Dec 2021;IQVIA Institute,Nov 2022.Notes:Benefit-sharing program start date v

177、aried across regions.Source:IQVIA MIDAS,Dec 2021;IQVIA Institute,Sep 2022.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

178、 to the benefit sharing program alone and are driven by a number of biosimilar policies and levers.Exhibit 18:Uptake of infliximab biosimilars over time and spending on infliximab biologics and biosimilars over timeTOTALZesslyFlixabiInflectraRemsimaRemicadeDefined daily doses(Millions)Q12015Q12016Q1

179、2017Q12018Q12019Q12020Q120213.3 3.4 3.5 3.6 3.6 3.8 4.0 4.0 4.2 4.2 4.3 4.5 4.5 4.6 4.7 4.7 4.8 4.7 5.0 4.8 4.9 4.9 5.2 5.6 5.8 5.9 6.2 6.3 98%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%6%8%9%10%11%12%15%15%16%17%18%17%17%17%16%16%17%17%17%17%19%23%28%34%37%40%1

180、%4%1%4%6%8%10%12%14%15%20%23%24%24%25%25%24%24%24%24%24%24%25%27%25%23%20%17%16%15%4%7%6%8%8%11%13%15%12%10%11%12%13%13%13%12%12%12%11%10%2%3%4%4%4%5%5%6%6%6%6%6%TOTALZesslyFlixabiInflectraRemsimaRemicadeUS$MnQ12015Q12016Q12017Q12018Q12019Q12020Q1202191 88 91 92 92 98 102 94 95 95 99 98 102 90 88 84

181、 83 79 83 79 79 77 87 95 100 101 105 103 98%92%88%85%82%79%77%73%65%59%55%51%48%42%40%37%38%36%34%32%30%26%25%23%21%20%18%16%4%6%8%9%10%11%13%15%16%17%19%20%22%22%22%22%22%23%23%23%22%25%30%36%42%45%49%1%1%4%6%7%9%11%12%14%18%22%24%25%27%29%29%30%30%31%31%31%33%35%33%29%26%23%22%20%2%4%3%5%5%7%9%10%

182、10%10%10%11%12%14%14%14%13%13%12%12%2%2%1%2%2%3%3%4%3%3%3%3%etanerceptinfliximabTOTALadalimumabUS$MnQ12015Q32015Q12016Q32016Q12017Q32017Q12018Q32018Q12019Q32019Q12020Q32020Q12021Q3202121.3 67.6 130.3 209.6 311.0 435.2 556.8 682.5 823.5 969.2 1,159.1 1,365.4 1,594.5 2.9 13.8 23.4 24.3 26.3 23.8 28.2

183、37.2 50.5 65.2 84.0 109.0 162.4 217.2 268.8 318.2 372.2 424.8 497.1 575.0 660.7 11.9 27.9 46.2 67.5 88.0 108.0 131.4 160.4 195.6 231.9 266.9 306.5 343.8 395.8 452.8 513.2 577.9 643.7 715.9 785.8 858.8 932.8 1,007.3 1,085.3 1,164.8 1,246.5 1,333.6 1,426.6 163 12 28 46 67 87 104 128 209 255 291 333 36

184、8 424 490 585 711 858 1,035 1,259 1,511 1,758 2,008 2,281 2,559 2,903 3,274 3,682 BENEFIT SHARING(SHARED SAVINGS)PROGRAMS:CASE STUDIES FROM EUROPE GERMANYInfliximabs volume of use has doubled while costs have remained relatively stable(at list price level)(Exhibit 18).Quarterly infliximab defined da

185、ily doses in Germany by product,20152021Quarterly infliximab spending in Germany by product,20152021Exhibit 19:Cumulative savings due to entry of biosimilars(anti-TNF)Utilizing IQVIA data to estimate savings since the entry of biosimilars,the total savings due to biosimilar use(at a list price level

186、)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 pol

187、icies suggest that they have played a role in the overall use(Exhibit 19).Cumulative biosimilar savings in Germany,US$Mn,Q1 2015Q4 202124|Shared Savings Programs in Europe:Lessons for the United StatesCase study:Italy BACKGROUNDIn Italy,policies related to biosimilars are often made at a regional le

188、vel.In general,there has been a push to increase biosimilar uptake through the use of various affordability measures such as prescribing targets,purchasing framework agreements,and related.There is a degree of regional variability in the choice of policies that are adopted.Campania is the only regio

189、n in Italy that has adopted a benefit sharing program to encourage use of biosimilars.24STRUCTURE OF BENEFIT SHARING PROGRAMFrom 2016 onward,a benefit sharing program was established by the regional health ministry in Campania that covered all hospital use molecules that have biosimilar competition.

190、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

191、use of biosimilars as well,however,these have not been captured in publicly available literature.IMPACT OF THE PROGRAM AND OF BIOSIMILAR USEPublished literature In general,Italy has witnessed high uptake of biosimilars across most regions.It is challenging to estimate the impact of the benefit shari

192、ng program in Campania given the prevalence of a number of other policies to promote biosimilar uptake in Campania and across regions.On the whole,Campania has witnessed higher biosimilar uptake than the national average in some cases(bevacizumab,rituximab and infliximab)while it has been lower than

193、 the national average in other cases(adalimumab,etanercept and somatropin)(Exhibit 20).25 The reinvestment of savings in innovative therapies would be important to consider as well,but data to assess this is limited.BENEFIT SHARING(SHARED SAVINGS)PROGRAMS:CASE STUDIES FROM EUROPE ITALYSource:AIFA Re

194、gional Biosimilar Data May 2022(accessed Oct 2022).Notse:Benefit sharing program start date varied across regions.Exhibit 20:Level of biosimilar uptake Campania vs average across Italy CampaniaItaly84%93%79%98%94%98%24%99%77%100%84%99%98%100%20%100%adalimumab bevacizumab etanercept filgrastim inflix

195、imab rituximab somatropin trastuzumab iqviainstitute.org|25BENEFIT SHARING(SHARED SAVINGS)PROGRAMS:CASE STUDIES FROM EUROPE ITALYIQVIA 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).Source:IQVIA

196、 MIDAS,Dec 2021;IQVIA Institute,Nov 2022.Note:Benefit-sharing program start date varied across regions.Exhibit 21:Uptake of adalimumab biosimilars over time and spending on adalimumab biologics and biosimilars over timeQuarterly adalimumab spending in Italy by product,20152021TOTALIdacioAmgevitaHyri

197、mozImraldiHumiraDefined daily doses(Millions)Q12015Q12016Q12017Q12018Q12019Q12020Q120211.9 1.9 1.9 1.9 2.0 2.1 2.1 2.1 2.0 2.3 2.3 2.4 2.4 2.5 2.4 2.4 2.4 2.6 2.5 2.6 2.7 2.6 2.6 2.8 2.9 2.9 3.0 3.0 100%100%100%100%100%100%100%100%100%100%100%100%100%100%100%96%77%66%59%52%46%43%39%36%32%28%27%25%2%

198、7%10%12%14%18%20%24%31%33%33%30%26%1%2%5%8%10%13%16%19%24%2%15%25%29%33%33%31%27%21%20%20%20%19%1%2%2%3%4%5%TOTALIdacioHyrimozAmgevitaImraldiHumiraUS$MnQ12015Q12016Q12017Q12018Q12019Q12020Q1202170 70 71 72 70 75 74 72 69 82 89 90 93 94 91 87 83 88 85 84 87 83 88 94 95 96 95 92 100%100%100%100%100%10

199、0%100%100%100%100%100%100%100%100%100%97%80%70%63%56%51%48%44%41%37%33%31%30%1%6%8%10%12%16%17%21%27%30%30%27%24%2%14%23%27%31%32%30%27%21%20%20%20%19%2%5%7%9%12%14%17%22%1%2%2%3%4%5%Quarterly adalimumab defined daily doses in Italy by product,2015202126|Shared Savings Programs in Europe:Lessons for

200、 the United StatesBENEFIT SHARING(SHARED SAVINGS)PROGRAMS:CASE STUDIES FROM EUROPE ITALYSource:IQVIA MIDAS,Dec 2021;IQVIA Institute,Nov 2022.Notes:Benefit-sharing program start date varied across regions.Exhibit 22:Uptake of etanercept biosimilars over time and spending on etanercept biologics and b

201、iosimilars over timeQuarterly etanercept spending in Italy by product,20152021TOTALErelziBenepaliEnbrelDefined daily doses(Millions)Q12015Q12016Q12017Q12018Q12019Q12020Q120211.6 1.6 1.6 1.5 1.6 1.6 1.6 1.5 1.6 1.6 1.6 1.7 1.7 1.7 1.6 1.6 1.5 1.5 1.5 1.4 1.5 1.4 1.5 1.5 1.5 1.5 1.5 1.4 100%100%100%10

202、0%100%100%100%99%96%92%85%80%76%68%60%57%54%48%44%42%39%37%36%34%31%30%29%28%1%4%8%15%20%24%32%40%42%42%43%46%46%49%50%51%53%54%55%53%53%1%4%9%10%12%12%13%13%13%15%15%17%19%TOTALErelziBenepaliEnbrelUS$MnQ12015Q12016Q12017Q12018Q12019Q12020Q1202160 59 58 55 55 57 56 53 52 55 58 58 60 57 53 50 47 45 4

203、3 41 42 41 44 46 45 44 43 40 100%100%100%100%100%100%100%99%97%94%89%85%82%75%68%66%63%58%54%51%48%46%45%43%40%39%38%36%1%3%6%11%15%18%25%32%33%34%36%38%39%42%43%44%46%48%49%48%48%1%3%7%8%10%9%11%11%11%12%13%15%16%Etanercept has seen a marginal volume decrease while costs have been reduced by 29%(at

204、 list price level)(Exhibit 22).Quarterly etanercept defined daily doses in Italy by product,20152021iqviainstitute.org|27Exhibit 23:Uptake of etanercept biosimilars over time and spending on etanercept biologics and biosimilars over timeQuarterly infliximab defined daily doses in Italy by product,20

205、15-2021TOTALInflectraRemsimaZesslyFlixabiRemicadeDefined daily doses(Millions)Q12015Q12016Q12017Q12018Q12019Q12020Q120211.7 1.6 1.7 1.7 1.7 1.7 1.8 1.7 1.8 1.9 1.7 1.8 1.9 1.9 1.9 1.8 1.9 1.9 1.9 1.8 1.9 1.8 1.9 2.0 2.0 1.9 2.1 2.1 100%94%87%79%74%66%61%55%49%46%45%39%35%29%23%22%19%16%14%13%10%9%8%

206、8%7%7%6%6%2%7%10%18%24%30%33%34%37%42%44%44%54%55%57%55%52%1%1%3%7%8%11%13%15%17%4%8%14%18%27%23%30%33%35%36%37%35%34%29%28%26%25%24%23%23%24%19%14%13%9%12%14%2%5%7%9%11%12%15%18%19%18%22%23%27%30%26%26%27%27%27%23%20%21%16%14%14%12%11%Source:IQVIA MIDAS,Dec 2021;IQVIA Institute,Nov 2022.Notes:Benef

207、it-sharing program start date varied across regions.Source:IQVIA MIDAS,Dec 2021;IQVIA Institute,Nov 2022.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

208、 not be directly attributable to the benefit sharing program alone and are driven by a number of biosimilar policies and levers.Quarterly infliximab spending in Italy by product,20152021Cumulative biosimilar savings in Italy,US$Mn,Q1 2015Q4 2021TOTALInflectraRemsimaZesslyFlixabiRemicadeUS$MnQ12015Q1

209、2016Q12017Q12018Q12019Q12020Q1202131 29 30 29 30 31 31 29 30 32 31 32 35 34 33 32 31 31 31 29 30 29 32 34 35 33 35 35 100%95%88%82%76%69%64%58%52%49%49%43%38%32%26%24%21%16%15%13%10%9%9%8%7%8%6%6%2%5%6%8%10%11%14%17%18%17%20%22%26%29%25%26%27%27%27%23%20%21%15%14%14%12%11%3%7%12%16%21%25%28%31%33%34

210、%35%33%32%28%27%25%24%24%23%23%24%18%14%13%9%12%14%2%7%9%17%24%29%33%34%36%42%44%44%54%54%56%55%52%1%1%3%7%8%11%13%15%17%etanerceptinfliximabTOTALadalimumabUS$MnQ12015Q32015Q12016Q32016Q12017Q32017Q12018Q32018Q12019Q32019Q12020Q32020Q12021Q320212.3 7.4 15.4 25.0 36.5 50.7 65.0 75.9 87.1 99.4 111.1 1

211、26.9 145.9 1.8 3.3 2.4 2.3 0.5 2.1 6.5 12.3 18.6 26.3 34.7 43.9 54.1 64.4 72.5 80.5 88.3 95.9 104.9 115.1 3.3 7.3 11.7 16.7 21.8 26.8 32.3 39.0 46.5 53.4 57.8 62.7 66.5 71.6 78.0 84.8 92.0 100.2 108.9 117.4 126.5 135.3 142.5 149.3 156.0 161.6 169.3 178.3 3 7 12 17 22 27 32 39 48 57 60 65 67 74 85 99

212、 118 142 169 198 231 265 291 317 344 369 401 439 BENEFIT SHARING(SHARED SAVINGS)PROGRAMS:CASE STUDIES FROM EUROPE ITALYInfliximabs volume of use has increased marginally while costs have remained relatively stable(at list price level)(Exhibit 23).Utilizing the IQVIA data to estimate savings since th

213、e 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 sav

214、ing to any one specific policy,but discussions around benefit sharing policies suggest that they have played a role in the overall use in Campagnia.Exhibit 24:Cumulative savings due to entry of biosimilars(anti-TNF)28|Shared Savings Programs in Europe:Lessons for the United StatesOncology Care Model

215、 in United StatesExhibit 25:Comparison of oncology biosimilar share trend by provider OCM status%of new-to-brand patients13%11%18%29%31%32%28%30%1%12%16%30%30%30%42%43%44%50%5%8%9%13%14%15%16%19%18%5%11%17%28%31%34%38%43%43%45%Source:IQVIA LAAD Medical Procedure Claims,US Market Access Strategy Cons

216、ulting analysis.%of new-to-brand patientsPre 2019 launches Avg(n=3)Pre 2019 launches Avg(n=3)While a shared savings or benefit sharing program for biosimilars has not been implemented in the U.S.,the Oncology Care Model(OCM)can offer insights into the impact of programs that are based on incentivizi

217、ng affordability.OCM ran from 2016 to 2021 and participants covered one-fourth of Medicare FFS chemotherapy-related cancer care practices.The goal of OCM was to utilize appropriately aligned financial incentives to enable improved care coordination,appropriateness of care,and access to care for bene

218、ficiaries undergoing chemotherapy.OCM encouraged participating practices to improve care and lower costs through an episode-based payment model that financially incentivized high-quality,coordinated care.Performance-based payment are used to incentivize practices to lower the total cost of care and

219、improve care for beneficiaries during treatment episodes.As such,OCM providers may have greater financial incentive to administer biosimilar products compared to providers not taking part in the OCM.26 However,there were no direct incentives for incentivizing the use of biosimilars.Based on a 2021 I

220、QVIA study,27 OCM participants had a slightly higher level of uptake for biosimilars launched in 2019 compared to those that did not take part in OCM(Exhibit 30).This difference may be driven by the pressure to reduce costs,however,given the affordability benefits that the use of biosimilars can pro

221、vide,the difference is not large for biosimilars launched in 2019.This suggests that a greater focus on incentivizing biosimilars may be required to actively enhance biosimilar uptake.Overall across Europe,benefit sharing programs have been used extensively.While data on the impact of these programs

222、 is not always readily available,in countries where such data is provided(e.g.,Ireland,England,France),an increase in biosimilar use leading to savings for the health system can be observed.Cases such as the one in Ireland suggest that a benefit sharing program had a large impact.Prior research on t

223、hese programs has also highlighted the importance of educating physicians and patients on biosimilars,and establishing a regular line of communication across patients,physicians and health bodies leading the program are important for its successful implementation.Communicating the savings achieved a

224、nd the impact of reinvestment have also been identified as useful for generating greater engagement from physicians.These aspects will be important to reflect on in the U.S.context as shared savings programs are considered.OCM participant(2%)Other(98%)iqviainstitute.org|29Lessons for the U.S.+As Eur

225、opean examples show,benefit sharing programs,as part of an overall set of biosimilar policies,can be an approach to increasing biosimilar uptake and subsequently,increasing savings+Shared savings programs can also allow for enhanced patient care through reinvestment of savings by specialties/clinica

226、l teams+Increased biosimilar use can reduce overall costs and may increase overall patient access+Government health ministries and insurers have generally been the central driving forces behind benefit sharing programs+Pilot studies can be useful in understanding the best approaches to benefit shari

227、ng and can ensure that appropriate incentives are provided while physician and patient autonomy in decision-making is maintained+Physician and patient education to increase comfort with biosimilar use and regular communication of the impact of such a policy can be importantHealth policies applied in

228、 Europe have a different context from the U.S.;however,a number of lessons can be taken from the experiences of biosimilars in European countries.With many biosimilars expected to launch in the U.S.in the next five to ten years,it is important that the use of biosimilars is optimized.The case studie

229、s researched for this report offer insights that could potentially be considered as the U.S.evaluates legislation to improve access to biosimilars,which include proposals for shared savings programs for Medicare part B.BENEFIT SHARING PROGRAMS CAN HELP INCREASE BIOSIMILAR UPTAKEBenefit sharing progr

230、ams can be an approach to increasing biosimilar uptake and subsequently,increasing savings.They can also allow for enhanced patient care through reinvestments.Across the case studies,the use of benefit sharing has been associated with an increase in use of biosimilars.While other policies may impact

231、 biosimilar uptake,the Ireland example is of particular interest as the use of biosimilars was substantially low prior to the program and biosimilars saw substantial increase in uptake once the program was implemented.Ireland has also seen the savings that were shared with the specialties be used to

232、 improve patient care.France also witnessed increases in biosimilar use after the implementation of benefit sharing programs.Regional examples in Germany and the UK point to a similar dynamic.INCREASED BIOSIMILAR USE CAN REDUCE OVERALL COSTSIncreasing use of biosimilars which are generally lower in

233、cost has led to savings in each of the case studies discussed earlier.While policies related to incentivizing affordability overall are in place in a number of European countries/regions,a specific policy targeted at biosimilars may provide more impetus to increase use of biosimilars.In the U.S.,the

234、 Oncology Care Model has led to some preference for biosimilars due to their cost advantages,however,a more targeted approach toward incentivizing biosimilars could prove more effective.In a number of countries,the increasing use of biosimilars has not only led to reduced costs but also to an increa

235、se in overall use.This increase in use suggests that lower cost of biosimilars may have allowed for greater use due to overall affordability.However,it is 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

236、molecule remained steady or declined slightly upon biosimilar entry.30|Shared Savings Programs in Europe:Lessons for the United StatesGOVERNMENT HEALTH MINISTRIES HAVE DRIVEN DEVELOPMENT OF BENEFIT SHARING PROGRAMSGovernment health ministries and departments and insurers have generally been central

237、driving forces behind benefit sharing programs.The benefit sharing programs have been led by government bodies in most countries;for example,in Ireland,the Health Services Executive developed the program,while in France,both the general program and the pilot study were led by the health ministry and

238、 the National Health Insurance Fund.Similarly,regional health ministries and departments in Italy and the UK have led benefit sharing programs.In the U.S.,given the large potential for savings for Medicare,CMS Innovation Center may be well suited to test potential innovative approaches to enhancing

239、biosimilar use.PILOT STUDIES CAN HELP IN UNDERSTANDING BEST APPROACHESPilot 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 decision-making is maintained.Several countries(su

240、ch as France,Germany,UK)initially implemented benefit sharing programs at a pilot level before expanding it more broadly.These pilot models allowed the countries to experiment with different models and approaches.A similar approach may be suited for the U.S.,as a pilot study would allow for experime

241、ntation on aspects such as level of incentive,voluntary vs compulsory,targets,etc.,while ensuring physician and patient comfort with such policies.This will also help ensure that the policy is effective before broader use.It is crucial that patients and physicians feel comfortable with such policies

242、 and that these pilot models ensure that prescribing decisions are being made with clinical factors as the driving criteria.PHYSICIAN EDUCATION AND COMMUNICATION MATTERSPhysician education to increase comfort with biosimilar use and regular communication of the impact of such a policy can be importa

243、nt.Optimal biosimilar use will require participation and alignment of multiple stakeholders and factors across the healthcare system.As part of the benefit sharing programs,most countries had programs to increase the understanding of biosimilars among physicians so that they had increased comfort wi

244、th their use.While there is growing acceptance of biosimilars globally(e.g.,the recent statement on interchangeability of reference medicines and biologics by the European Medicines Association),education efforts can help overcome any concerns from patients or physicians.CONCLUSIONAs an increasing n

245、umber of lower-cost biosimilars enter the U.S.market,there is an important opportunity to capitalize on potential savings they could provide,thereby reducing overall healthcare expenditure while maintaining the sustainability of the overall market.Shared savings models hold the potential to align ph

246、ysician incentives with cost saving efforts without having an impact on overall healthcare quality.Examples from Europe suggest that such models,along with other biosimilar policies,can increase savings due to greater biosimilar use.As such models are considered,it will be important to ensure that p

247、hysicians and patients feel comfortable with biosimilars and have autonomy to make decisions.Developing such a model will likely require leadership from CMS and partnership with providers,physicians,and patient advocacy groups.While other policies to encourage biosimilar use will also be needed,deve

248、loping,and assessing pilot shared savings models at this stage can help with ensuring that benefits from biosimilars are optimized moving forward.iqviainstitute.org|31APPENDIX:BENEFIT SHARING(SHARED SAVINGS)PROGRAMS:CASE STUDY SUMMARIES FROM EUROPECase study summary:IrelandSource:Duggan et al,Uptake

249、 of biosimilars for TNF-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 direc

250、tly attributable to the benefit sharing program alone and are driven by a number of biosimilar policies and levers.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 (selec

251、ted based on cost and other factors)in 201819 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 policiesSTRUCTURE OF PROGRAM EUR 500 p

252、rovided 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 USEUptake Adalimumab:patients on biosimilars increased from 166 in May 2019

253、 to over 3400 on BVB in May 2020 Etanercept:patients on biosimilars increased from 104 in May 2019 to over 1800 by May 2020 By 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 2021Change in volume of use and cost

254、 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

255、Jun 2019 to July 2020 is EUR 22.7 million (based on available literature)Estimated 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

256、 provided to specialties as part of the benefit sharing to be invested back between July 2019 and July 2020Reinvestments 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

257、clinics and extra clinic time to allow for more infusions;funding has also been used for hiring local consultants,education programs and infrastructure.32|Shared Savings Programs in Europe:Lessons for the United StatesCase study summary:FranceSource:Incentives promoting use of biosimilar medicines i

258、n 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;I

259、QVIA 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

260、 biosimilar policies and levers.BACKGROUND Biosimilar uptake was low(80%switch to biosimilarsIMPACT OF THE PROGRAM AND OF BIOSIMILAR USEUptake North Bristol Example Infliximab:52 patients were switched to the biosimilar out of 64/65(80%).97%patients satisfied with switching process.National Overall,

261、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 Adalimumab:Volume increased by 55%while costs have increased by 42%(at list price level)Etan

262、ercept: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 North Bristol Example GBP 200,000 in savings from switching to biosimilarsNational Total estimated savings due to the use

263、 of anti-tnf biosimilars at a national level(at a list price level based on IQVIA Institute calculations)=$998 Mn Note:These savings may not be directly attributable to the benefit sharing program alone and are driven by a number of biosimilar policies and leversReinvestment North Bristol Example Th

264、e 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 treatments34|Shared Savings Programs in Europe:Lessons for the United StatesCase study summary:GermanySource:Lacosta,Vulto et

265、al,Qualitative Analysis of the Design and Implementation of Benefit-Sharing Programs for Biologics Across Europe,Mar 2022;available at:https:/ et al.,Learnings from Regional Market Dynamics of Originator and Biosimilar Infliximab and Etanercept in Germany,2020;IQVIA MIDAS and IQVIA Institute Analysi

266、s.APPENDIX:BENEFIT SHARING(SHARED SAVINGS)PROGRAMS:CASE STUDY SUMMARIES FROM EUROPEBACKGROUND Biosimilar policies are developed by Health insurance companies(Krankenkassen;KKs)and regional associations of health insurance accredited companies(Kassenrztliche Vereinigungen;KVs)Different regions and in

267、surance companies can establish varying biosimilar quota levels In 2015,a pilot benefit sharing program was started for the region of Westphalia-Lippe by BARMER,a health insurance company Health Services Executive designed a Best Value Biologic(BVB)program to promote use of BVBs(selected based on co

268、st and other factors)in 201819 Time frame:2015 onwards Stakeholders:BARMER,Westphalia-Lippe providers Molecules:Anti-TNFs(infliximab,etanercept,adalimumab)Note:Benefit Sharing is a component of biosimilar related policiesSTRUCTURE OF PROGRAM Voluntary program that providers can opt-in Prescription o

269、bjectives set in consultation between BARMER and providers Providers meeting objectives given financial remuneration(amount not specified)and were exempted from adhering to budget capsIMPACT OF THE PROGRAM AND OF BIOSIMILAR USEUptake Westphalia-Lippe Infliximab:Westphalia-Lippe witnessed faster upta

270、ke of biosimilar compared to other regions reaching over 80%by 2018 Etanercept:Westphalia-Lippe witnessed faster uptake of biosimilar compared to other regions reaching over 70%by 2018 The benefit sharing program has been extended to other regions since the initial pilot but details of the program v

271、ary and are not publicly availableNational 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 policiesChange in volume of use and costs since biosimilar entry Na

272、tional 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 Whil

273、e 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 Note:These savings may not be directly attributable to the benefit sharing program alo

274、ne and are driven by a number of biosimilar policies and leversReinvestment Details on reinvestment are not available,exemption form budget caps likely to increase access to biologicsiqviainstitute.org|35Case study summary:ItalyAPPENDIX:BENEFIT SHARING(SHARED SAVINGS)PROGRAMS:CASE STUDY SUMMARIES FR

275、OM EUROPEBACKGROUND Biosimilar policies are made at regional level by regional health ministries in consultation with providers Campania 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 pu

276、blicly available literature Time frame:2016 onwards Stakeholders:Campania Ministry of Health,Regional providers(Hospitals/Clinics)Molecules:all hospital use molecules that have biosimilar competition Note:Benefit Sharing is a component of biosimilar related policiesSTRUCTURE OF PROGRAM 50%of the sav

277、ings 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%IMPACT OF THE PROGRAM AND OF BIOSIMILAR USEUptake Campania Campania has witnessed higher biosimilar uptake th

278、an the national average in some cases(bevacizumab,rituximab and infliximab)However,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

279、 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 difficultChange in volume of use and costs since biosimilar entry National Adalimumab:Volume increased by 25%since biosimilar entry whil

280、e 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 t

281、o 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 Note:These savings may not be directly attributable to the benefit sharing program alone and are driven by a

282、number of biosimilar policies and leversReinvestment Details on reinvestment are not availableSource:Lacosta,Vulto et al,Qualitative Analysis of the Design and Implementation of Benefit-Sharing Programs for Biologics Across Europe,Mar 2022;available at:https:/ Regional Biosimilar Data May 2022(acces

283、sed Oct 2022);IQVIA MIDAS and IQVIA Institute Analysis.36|Shared Savings Programs in Europe:Lessons for the United StatesMETHODOLOGY FOR CALCULATING SAVINGSTo estimate the savings associated with the entry of the biosimilar,we compare the actual sales that took place with the hypothetical scenario w

284、here the biosimilar is not available in the market(or the program was not started)and therefore,the molecule price per DDD stays constant at pre-expiry(or pre-start of program)prices across the time period.This approach to calculate the savings has been previously adopted in studies which assessed s

285、avings from biosimilars in individual countries.28 This approach allows U.S.to account for savings due to the lower price of the biosimilar as well as the potentially lower price of the other somatropin products due to the increased price competition from the biosimilar.The following dataset was uti

286、lized to conduct this analysisIQVIA MIDAS is a unique platform for assessing worldwide healthcare markets.It integrates IQVIAs national audits into a globally consistent view of the pharmaceutical market,tracking virtually every product in hundreds of therapeutic classes,and provides estimated produ

287、ct volumes,trends and market share through retail and non-retail channels.MIDAS data are updated quarterly and retain 12 years of data.Historic archives of MIDAS were used to extend analyses to the full time period analyzed,2005 to 2021.Methodologiesiqviainstitute.org|37References 1.Andrews L,Ralsto

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289、/default/files/private/pdf/264416/Part-B-Drugs-Trends-Issue-Brief.pdf.3.The Medicare Payment Advisory Commission(MEDPAC).Prescription drugs.2022 Jul 19 cited Accessed October 30,2022.In:July 2022 Data Book:Health Care Spending and the Medicare Program Internet.cited Accessed October 30,2022.Availabl

290、e from:https:/www.medpac.gov/wp-content/uploads/2022/07/July2022_MedPAC_DataBook_Sec10_v2_SEC.pdf.4.European Medicines Agency(EMA).Biosimilar medicines:Overview.Human regulatory Internet.Accessed October 30,2022.Available from:https:/www.ema.europa.eu/en/human-regulatory/overview/biosimilar-medicine

291、s-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%20Biosimil

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293、ial 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):e0190147.10.NHS England.Commissioning framework for biological medicines(including bi

294、osimilar medicines),.Leeds,UK:NHS England.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 Prog

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296、eric-drugs.13.Brill A.Shared Savings Demonstration for Biosimilars in Medicare:An Opportunity to Promote Biologic Drug Competition:Matrix Global Advisors.Available from:https:/ B,Smith A,Barry M.Uptake of biosimilars for TNF-inhibitors adalimumab and etanercept following the best-value biological me

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304、22 Aug 4.Available from:https:/innovation.cms.gov/innovation-models/oncology-care.27.The IQVIA Institute.Biosimilars in the U.S.:Reimbursement and Impacts to Uptake.Available from:https:/ M,Ro-lvarez I,Carcedo D,Villacampa A.Budget Impact Analysis of Biosimilar Products in Spain in the Period 2009-2

305、019.Pharmaceuticals(Basel).2021;14(4).iqviainstitute.org|39About the authorsMURRAY AITKENExecutive Director,IQVIA Institute for Human Data Science Murray Aitken is Executive Director,IQVIA Institute for Human Data Science,which provides policy setters and decisionmakers in the global health sector w

306、ith objective insights into healthcare dynamics.He led the IMS Institute for Healthcare Informatics,now the IQVIA Institute,since its inception in January 2011.Murray previously was Senior Vice President,Healthcare Insight,leading IMS Healths thought leadership initiatives worldwide.Before that,he s

307、erved as Senior Vice President,Corporate Strategy,from 2004 to 2007.Murray joined IMS Health in 2001 with responsibility for developing the companys 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 an

308、d 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 Phar

309、maceutical 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.VIBHU TEWARY Project Director,IQVIA Institute for Human Data ScienceVibhu Tewary is a Project Director at the IQVIA Insti

310、tute for Human Data Science and is based out of New York,NY.His key areas of interest include healthcare policy,global market access,and economic modeling.Vibhu has authored multiple reports on global healthcare policy and market access.Prior to joining IQVIA,he worked as a researcher in a policy th

311、ink tank in India.Vibhu did his undergraduate studies at the Indian Institute of Technology,Madras,and holds an MBA from Duke University.40|Shared Savings Programs in Europe:Lessons for the United StatesThe IQVIA Institute for Human Data Science contributes to the advancement of human health globall

312、y through timely research,insightful analysis and scientific expertise applied to granular non-identified patient-level data.Fulfilling an essential need within healthcare,the Institute delivers objective,relevant insights and research that accelerate understanding and innovation critical to sound d

313、ecision making and improved human outcomes.With access to IQVIAs institutional knowledge,advanced analytics,technology and unparalleled data the Institute works in tandem with a broad set of healthcare stakeholders to drive a research agenda focused on Human Data Science including government agencie

314、s,academic institutions,the life sciences industry,and payers.Research agendaThe research agenda for the Institute centers on five areas considered vital to contributing to the advancement of human health globally:Improving decision-making across health systems through the effective use of advanced

315、analytics and methodologies applied to timely,relevant data.Addressing opportunities to improve clinical development productivity focused on innovative treatments that advance healthcare globally.Optimizing the performance of health systems by focusing on patient centricity,precision medicine and be

316、tter understanding disease causes,treatment consequences and measures to improve quality and cost of healthcare delivered to patients.Understanding the future role for biopharmaceuticals in human health,market dynamics,and implications for manufacturers,public and private payers,providers,patients,p

317、harmacists and distributors.Researching the role of technology in health system products,processes and delivery systems and the business and policy systems that drive innovation.Guiding principlesThe Institute operates from a set of guiding principles:Healthcare solutions of the future require fact

318、based scientific evidence,expert analysis of information,technology,ingenuity and a focus on individuals.Rigorous analysis must be applied to vast amounts of timely,high quality and relevant data to provide value and move healthcare forward.Collaboration across all stakeholders in the public and pri

319、vate sectors is critical to advancing healthcare solutions.Insights gained from information and analysis should be made widely available to healthcare stakeholders.Protecting individual privacy is essential,so research will be based on the use of non-identified patient information and provider infor

320、mation will be aggregated.Information will be used responsibly to advance research,inform discourse,achieve better healthcare and improve the health of all people.About the Instituteiqviainstitute.org|41CONTACT US100 IMS Drive Parsippany,NJ 07054 United Statesinfoiqviainstitute.org iqviainstitute.or

321、gCopyright 2022 IQVIA.All rights reserved.12.2022.ENTThe 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

322、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.