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1、Incentives For Using Biosimilars In France And EuropeAnalysis,assessment,and perspectivesAPRIL 2023A SANDOZ REPORT CARRIED OUT BY IQVIA IN COLLABORATION WITH:ISABELLE DURAND-ZALESKI Professor of Public Health Medicine and Doctor of Economics.Director of URCEco.THIERRY THOMAS University Professor-Hos
2、pital Practitioner,rheumatology specialist.Head of department,CHU de Saint-Etienne Saint-Etienne University HospitalWith an annual growth twice as fast as that of the total market for medicinal products,biologics represent 35%of pharmaceutical spending in Europe.The use of biosimilars,manufactured u
3、sing a biotechnological process similar to that of existing biologics and for which the patent is in the public domain,is an important source of savings for health systems,and is growing rapidly.In France,a study conducted by IQVIA showed that biosimilar medicinal products provided a 2.4 billion sav
4、ing between 2012 and 2022.According to the income and expenses report by French national health insurance,100 million,including 40 million in 2022 and 2023,could be saved each year if biosimilars could achieve an 80%rate of market penetration.This was the case in the hospital context in 2021,unlike
5、in the outpatient setting,where these medicinal products constitute only 31%of sales volumes for biologics.In France,it is the use of biosimilar medicinal products that generates the most savings(67%,according to the IQVIA study),and as a result,in order to accelerate their use,various incentives we
6、re introduced.The Article 51 test progamme in the hospital setting,in particular,has been recognized as a“success”by the strategic council for health innovation.Addendum 9 to the national contract between private physicians and health insurance also produced visible and encouraging results in the co
7、mmunity setting.Ireland,England,Germany and Spain have also deployed incentives to encourage the adoption of biosimilars and expand access to biologics.The calculation mechanisms and implementation of these measures vary,making it difficult to replicate them in other countries.However,the adoption o
8、f biosimilars in these different countries,like the measures deployed in France,depends on incentives that are often based on the sharing of value between prescribers and health authorities,and makes it possible to generate savings for health systems.Simplicity,legibility,and taking into account spe
9、cific benefits for the hospital setting and community prescribers,as well as support from the authorities may be considered to be components favoring the success of the next incentives in achieving the 80%market penetration rate set by the national health strategy.The mechanisms of these measures wi
10、ll need to consider and adapt to the patients situation(are they treatment-nave,or being treated?),the goal of the treatment(is it a one-time prescription,or is it the patients long-term treatment?),and the biosimilars previous results.The levers that may expedite the market penetration of biosimila
11、rs are clearly identified by experts:first of all,the influence of the hospital context on the outpatient setting,as well as enhanced communication regarding the bioequivalence of biosimilars,and publication of scientific studies based on real-life health data.In the medium term,a growing proportion
12、 of medications will lose their exclusivity by 2027,and we do not plan to compete by developing biosimilars for each of these biologics.In the long term,the question of patient access to all biologics recently authorized in Europe arises if they are not included on national reimbursement lists.In co
13、nclusion,both in France and in other European countries,the use of biosimilars naturally causes a prescription cost effectiveness challenge,and on one hand,access needs to be guaranteed;on the other hand,incentives must continue to be offered in order to motivate their prescription,in order to promo
14、te growth of their market penetration rate and prepare for the arrival of future biosimilars.SynopsisTable of contentsIntroduction 3Place and benefits of biosimilars 4 Incentives to promote biosimilars 7The case of France 7Other incentives in the European Union 10Critical analysis of the measures to
15、 incentivize the use of biosimilars in France 12Hospitals,the primary vector for the diffusion of biosimilars 12The influence of hospitals on the community setting,and the specific French situation of hospital prescriptions fulfilled in community pharmacies(PHMEV)13General incentives not targeting s
16、pecific issues 13Clear,but often forgotten,incentive rules 15.And to be adapted to new forms of reference drugs 16Conclusions and perspectives 17In the short term 17In the medium term 18In the long term 19Appendix 1 20Appendix 2 21Appendix 3 22Appendix 4 23Appendix 5 24References 25 |3Biosimilars ar
17、e drugs obtained by a biotechnological process similar to that of existing biologics,referred to as reference products,and for which the patent is in the public domain.Biologics are made from living cells,making them more complex and more expensive to produce than conventional drugs.Biosimilars,desp
18、ite their complex(5-6 years)and expensive(100-300 million)development process,1 offer a less expensive alternative to reference biologics,while ensuring the same efficacy and safety for the patient.In France and Europe,biosimilars play an important role in reducing health costs while maintaining qua
19、lity of care.This economic concern is even more important given the current context(economic crisis,budgetary pressure,aging population,therapeutic innovation,etc.),that biologics and their biosimilars mainly target chronic conditions such as cancer,chronic inflammatory diseases,or autoimmune diseas
20、es.Therefore,in order to support the adoption of biosimilars,France and other European countries may,among other things,introduce prescription incentives.“What are the different measures and how do they work?What impact did they have?What can they teach us about the future?“This report was created i
21、n collaboration with:Prof.Isabelle Durand-Zaleski,Professor of Public Health Medicine and Doctor of Economics,and Prof.Thierry Thomas,University Professor-Hospital Practitioner,specialty rheumatology.This is based on a literature analysis completed by data generation from IQVIA databases.Prof.Pascal
22、 Paubel,Pharmacist,University Professor-Hospital Practitioner,Member of the Institut Droit et Sant Institute of Law and Health(Universit de Paris University of Paris)was consulted for this work.Introduction4|Incentives for using biosimilars in France and Europe:analysis,assessment,and perspectivesPl
23、ace and benefits of biosimilars in Europe BIOLOGICS:A CONSIDERABLE AND GROWING PART OF PHARMACEUTICAL EXPENSES Biologics represent 35%of all pharmaceutical expenditure in Europe(catalogue price),with a compound annual growth rate(CAGR)of 11.3%over the past five years(2016 2022).This rate is nearly t
24、wo times higher than the total medicinal product market in Europe,the CAGR of which reached 6.3%2 over the same period.Given the importance of biologics,the adoption of biosimilars and increased competition are increasingly critical success factors in the current economic context for European care s
25、ystems.In 2006,the European Union(EU)approved the first biosimilar(somatropin growth hormone).Since then,the EU has approved the largest number of biosimilars worldwide.3 By the end of 2022,19 reference biologics(see Figure 2)share the market with,on average,3.8 biosimilars per proprietary medicinal
26、 product(adalimumab alone has 10 biosimilars approved in Europe).4 In 2019,the European Medicines Agency(EMA)took a stance on the interchangeability of biosimilars by stating that it was under the jurisdiction of the member states of the EU,although any decision concerning the switch must involve an
27、 agreement between the prescriber and the patient.Figure 1:Annual market growth rate of the drugs and biologics market in the European Union between 2016 and 2022EU growth(YoY,%)Year-over year(YoY)spending growth(%)14 1210 864202016 2017 2018 2019 2020 2021 2022*Biologics CAGR(2016-2022):11.3%Total
28、EU market CAGR(2016-2022):6.3%Small molecules CAGR(2016-2022):3.4%|5BIOSIMILARS IN FRANCE,AN SAVINGS AND EFFICACY CHALLENGEThe prices of biosimilars are defined by the framework agreement established between the Leem Les entreprises du mdicament(Medication companies)and the Centre for European Polic
29、y Studies(CEPS)5 and are impacted by four price reduction mechanisms:The decrease in price of the reference drug on the arrival of biosimilars The difference in price between the reference drugs and biosimilars The subsequent price decreases over time The convergence of pricesMoreover,market competi
30、tion tends to broadly favor the reduction in established prices(including reference biologics).In the income and expenses report(July 2022),the French national health insurance presents an accounting projection of the savings associated with achieving the target of 80%market penetration of biosimila
31、rs on the reference market by 2022,set by the National Health Strategy(SNS Stratgie Nationale de Sant).Considering the price of biosimilars,which are on average 15 to 30%lower than those of the reference drugs,the savings generated by the market penetration of biosimilars are therefore estimated to
32、reach“100 million,including 40 million seen in 2022 and 2023”.6This French national health insurance analysis can be supplemented with an estimation produced by IQVIA teams between 2012 and 2022,which shows that cumulative biosimilar savings are estimated at 2.4 billion(see IQVIA method of calculati
33、on in the Appendix).A sharp acceleration in these savings has been seen over the last five years due to the doubling of the number of reference biologics concerned by the launch of biosimilars(Figure 3).Figure 2:Number of biosimilars approved in Europe by molecule and by yearSource:IQVIA analysis of
34、 EMA list(last accessed November 2022)The Impact of Biosimilar Competition in Europe 2022;Prepared for European Commission(DG SANTE)December 20223253522111421131113111111111111443414121119111211119431161111181614 1210 86420#of central approvalsCentrally approved biosimilars by molecule type(2006-202
35、2)2006 2007 2008 2009 2010 2011 2012*2013 2014 2015 2016 2017 2018 2019 2020 2021 2022insulin human(rDNA)ranibizumab insulin aspart bevacizumab pegfilgrastim adalimumab trastuzumab teriparatide rituximab insulin lispro etanercept enoxaparin sodium insulin glargine infliximab follitropin alfa filgras
36、tim epoetin zeta epoetin alfa somatropinOrder:newest to oldestBackground:Cumulative#of new molecules with biosimilars6|Incentives for using biosimilars in France and Europe:analysis,assessment,and perspectivesIn France,savings are mostly generated via two mechanisms,the respective importance of whic
37、h varies depending on the products:the use of biosimilars,resulting in 67%savings,and the price effect,producing 33%savings.Figure 3:Cumulative savings generated by biosimilars over 10 years in FranceIn 2012,on a European scale,estimates suggest that savings could be approximately 12 billion to 34 b
38、illion by 2020.In 2022,cumulative cost savings on the catalog price resulting from the impact of the competition of biosimilars in Europe reached more than 30 billion.7 Beyond this savings issue,it is important to note that the diversification of production sources and the stimulation of competition
39、 contribute to securing supply chains by reducing the risk of supply disruptions and stock shortages.Changes in the cumulative savings generated by biosimilars over 10 years-()267,737,788 16,002,08519,496,42923,168,57626,922,251 30,274,71234,166,04638,109,01742,188,23245,329,05949,419,31553,351,3875
40、7,520,97063,364,68469,378,81675,605,40388,213,008101,078,004114,898,528132,769,162161,223,470191,117,312219,018,541247,043,438317,873,019381,116,771446,577,826530,512,726617,669,188712,324,903811,750,711922,024,4391,061,848,6351,202,920,7521,350,900,3801,498,411,6421,644,813,8321,816,581,9822,000,06
41、7,4182,184,037,3052,370,115,108SOMATROPINFILGRASTIMEPOETINPresent before recordsFOLLITROPININFLIXIMABINSULIN GLARGINEETANERCEPTRITUXIMABPEGFILGRASTIMADALIMUMABENOXAPARINTRASTUZUMABTERIPARATIDEBEVACIZUMABQ12012Q32012Q12013Q32013Q12014Q32014Q12015Q32015Q12016Q32016Q12017Q32017Q12018Q32018Q12019Q32019Q
42、12020Q32020Q12021Q32021Q12022INSULIN ASPARTFigure 4:Split of the origin of the savings made between price effect and competition effect2 37067%33%81466%34%29279%21%2779%21%1234%66%0,0287%13%21070%30%18026%74%17079%21%15048%52%13475%25%11492%8%8497%3%7622%78%5989%11%4796%4%274630621343578349259626877
43、15412290,021474613572101105821753462141 599Savings Cumulative total(M)MeanSavings Price effect(M)Savings Biosimilar effect(M)TOTALINFLIXIMABADALIMUMABRITUXIMABINSULIN GLARGINEPEGFILGRASTIMETANERCEPTEPOETINBEVACIZUMABFILGRASTIMENOXAPARINTRASTUZUMABSOMATROPINFOLLITROPINTERIPARATIDEINSULIN ASPART |7Inc
44、entives to promote biosimilars THE CASE OF FRANCE The Ecart Mdicament Indemnisable reimbursable drug differential(EMI)is a device,not specific to biosimilars,the purpose of which is to encourage Hospitals Buyers to negotiate the lowest possible prices for medicinal products on the list of drugs and
45、services reimbursed on top of inpatient care,while limiting over-reimbursement by health insurance.In this way,if an hospital is able to negotiate a price below the standard rate,50%of the savings generated will be allocated back to it(sharing the savings between the French health insurance and the
46、hospital).However,the EMI is not a permanent solution,as the standard rates are routinely reduced by health authorities,particularly due to competition from biosimilars.Furthermore,the EMI only applies to medicinal products on the list of drugs and services reimbursed on top of inpatient care,which
47、are expensive and innovative drugs mainly used in hospitals.In addition,they are paid for directly by the social security budget.9 It should be noted that biosimilar molecules will have to be removed from the list of drugs and services reimbursed on top of inpatient care due to a regular decrease in
48、 the standard rate(price 30%lower than the GHS rate),ultimately limiting the EMIs efficacy.The Contrat dAmlioration de la Qualit de lEfficience des Soins improvement in the quality and efficiency of care contract(CAQES),created by the Social Security Funding Law of 2016,is a tripartite agreement bet
49、ween the Regional Health Agencies Agences Rgionales de Sant(ARS),the French national health insurance system,and Hospitals.The purpose of the CAQES“is to improve the practices,the provision of care regulations,and the efficiency of French national health insurance spending”.10 As such,CAQES 2018-202
50、2 proposed specific national indicators for biosimilars that experts interviewed deemed to be of benefit for their development with regards to purchasing,hospital prescriptions for drugs dispensed in a community pharmacy(PHMEV),or even information for patients.However,the COVID-19 health crisis has