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1、White PaperAchieving Excellence in Commercialising Cardiometabolic Innovation How commercially successful innovators navigate a uniquely complex opportunityMARKUS GORES,Vice President,EMEA Thought Leadership,IQVIA KIRSTIE SCOTT,Senior Consultant,EMEA Thought Leadership,IQVIA MARINA KONE,Principal,St

2、rategy Consulting,IQVIATable of contentsIntroduction 1The cardiometabolic opportunity:Uniquely complex 2Lessons from cardiometabolic commercial success stories 6I.Deep market insight foundation 8II.Aligned value propositions and customer engagement strategy 12III.High-quality execution and performan

3、ce management 15Organisational implications for cardiometabolic innovators 16References 18About the authors 20Acknowledgements 21 |1We are finding ourselves in the midst of a cardiometabolic renaissance,as the attention of the biopharmaceutical industry returns to an area it largely neglected for mo

4、st of the past two decades.1 Obesity undoubtedly dominates the headlines and creates unprecedented excitement within the industry,and among the public at large.However,the industrys renewed interest in cardiometabolic innovation is much broader than obesity and spans a wide range of indications,for

5、example,heart failure,hypertension,coronary artery disease,atherosclerotic cardiovascular disease,chronic kidney disease,dyslipidaemia,(pre)-diabetes or MASH.Cardiometabolic innovators face unique challenges,such as navigating interdependencies between different indications exhibited as co-morbiditi

6、es in overlapping patient populations,who are treated by multiple HCP specialties.Furthermore,multi-indication therapies are redefining how cardiometabolic risk is managed,for example incretin mimetics such as GLP-1 and GIP receptor agonists which have shown broader benefits across multiple morbidit

7、ies.This adds further complexity to commercialising new products.In this white paper,we will explore what commercial excellence looks like in the context of cardiometabolic innovation,drawing on lessons from commercially successful brands,and identify what it takes to achieve it.Introduction2|Achiev

8、ing Excellence in Commercialising Cardiometabolic Innovation The cardiometabolic opportunity:Uniquely complex Cardiometabolic diseases remain among the leading causes of mortality and morbidity globally,collectively accounting for over one third of all global deaths and impacting health-related qual

9、ity of life by an estimated 500 million Disability-Adjusted Life Years(DALYs).2-4One of the defining features of cardiometabolic diseases is the substantial overlap between different patient populations,because many indications manifest themselves as co-morbidities in the same patient(see Figure 1):

10、Such interdependencies between different indications make it more difficult to answer key strategic questions,for example,who is the ideal patient benefiting the most from a new therapy?Innovators therefore must have a holistic and granular understanding of patient profiles,including their unmet nee

11、ds along multiple risk factors,to inform strategic segmentation into target patient groups to guide the target product profile,brand strategy and positioning of new cardiometabolic therapies.In 2024,cardiometabolic diseases were the focus of 17%of all new clinical trial starts,including phases 1-3,m

12、aking it the second most investigated therapy area after oncology.5Figure 1:Substantial overlap between different cardiometabolic populations*Represents number of patients in each Venn Diagram overlap;*Represents number of patients in a single TA,i.e.have no comorbidity overlapPatient population siz

13、es include 2022+data-active patients,or those with Rx or Dx claims in 2022 or 2023;Not shown due to diagram spacing:Obesity and Renal ONLY overlap;Obesity,Diabetes,and Renal ONLY overlapSource:IQVIA LAAD,January 2018 to June 2023Overlap of selected CV-met U.S.patient populationsNumber ofco-morbiditi

14、esnone12344Presence of co-morbidities in obese patients(by BMI cohort;U.S.patient population)0%27-29.930-34.9Body Mass Index(BMI)35-39.94020%40%60%80%100%Share of patient cohort Cardiovascular disease Overall patient population:133.3M Diabetes Overall patient population:37.4M Renal Overall patient p

15、opulation:29.8MObesity Overall patient population:71.3MNot drawn to scaleCVD61.5M*24.1M*9.9M*Obesity23.5M*915k*Diabetes2.1M*11.6M*6.9M*5.2M*Renal2.7M*8.3M*5.7M*151k*|3Source:IQVIA EMEA Thought Leadership;IQVIA Pipeline Link,September 2024;Unsurprisingly,as interest in cardiometabolic innovation rebo

16、unds,the competitive landscape is becoming increasingly crowded.Many big pharma companies are making significant investments in building cardiometabolic pipelines to establish,re-establish or expand their presence in this therapeutic space(see Figure 2),while numerous Emerging Biopharma Companies(EB

17、Ps)are also pursuing cardiometabolic innovation opportunities.Among big pharma companies,we find portfolio play a common strategy pursued by many.It is characterised by companies assembling multi-asset/multi-indication portfolios to establish a broad presence in the cardiometabolic space.This strate

18、gy requires innovators to carefully co-position their different assets to articulate a clear,joined-up,cross-portfolio value narrative.As portfolios offer multiple value propositions,derived from assets individually and collectively,the ongoing challenge is to address a range of well-defined unmet n

19、eeds across overlapping,comorbid patient populations.Rare CV-metDiabetesObesityLipidaem.RenalMASHStrokeEmbo/ThromHFHTNPresent but with older marketed brand(s)Present with marketed brand(s)Pipeline focusGSKMerck&CoLillyNovo NordiskJ&JPfizerBMSAstraZenecaBIAmgenBayerNovartisRocheSanofiAbbVieBig pharma

20、 footprint across selected CV-met indications Clinical-stage through on-market Figure 2:We are witnessing a cardiometabolic renaissance4|Achieving Excellence in Commercialising Cardiometabolic Innovation RE-DEFINING CARDIOMETABOLIC RISK MANAGEMENTOne of the most consequential events for the manageme

21、nt of cardiometabolic risk was the arrival of multi-indication therapies,specifically GLP-1 receptor agonists and SGLT2 inhibitors,which have shown favourable effects on multiple risk factors,e.g.,blood glucose levels,BMI,blood pressure and kidney function.As demonstrated in a number of cardiovascul

22、ar-renal trials,e.g.,SELECT,6 STEP-HF,7 FLOW,8 SUMMIT,9 DELIVER,10 EMPEROR-Preserved11 and EMPEROR-Reduced,12 GLP-1s and SGLT2s improved functional endpoints and/or reduced the risk of disease progression or cardiovascular adverse events.As such,these agents have the potential to transform cardiomet

23、abolic risk management.Deployed as backbone therapies,they can re-set a patients cardiometabolic risk baseline across co-morbidities,while residual risk is managed by additional therapies layered on top that target a specific indication and/or risk factor,e.g.,treatment-resistant hypertension,inflam

24、mation linked to heart failure or fibrosis in MASH(see Figure 3).ObesityDiabetesHeartfailureKidney diseaseStrokeLipidaemiaMASHHTNRe-set CV-risk baseline by improving multiple risk factorsRe-set CV-risk baseline by improving multiple risk factorsGLP1+SGLT2Addressingresidual riskIL-6nsMRAFactor XIaAld

25、osteronesynthase inh.siRNA/Lp(a)FGF21Inter-dependencies Backbone therapies re-define,possibly shrink downstream opportunities in residual risk A winning cardiometabolic strategy:from single asset to combination/portfolio playIndividual assetsBackbone therapySingle indication focussed therapy“Multi-i

26、ndication therapies have the potential to transform cardiometabolic risk management by re-setting a patients risk baseline.”Figure 3:Emerging backbone therapies are transforming cardiometabolic risk managementNote:Example MoAs shown for illustration,drawn from a range of CV-met assets in development

27、 across the industry;Source:IQVIA EMEA Thought Leadership;HTN:hypertension;IL-6:interleukin-6 inhibitor;nsMRA:non-steroidal mineralocorticoid receptor antagonist;siRNA:small interfering RNA;Lp(A):lipoprotein(a);FGF21:fibroblast growth factor 21ILLUSTRATIVE |5This has profound implications for innova

28、tors who need to understand the impact of backbone therapies on opportunities for managing residual risk.For example,an intervention with a GLP-1 receptor agonist aimed at weight loss,or for controlling diabetes,may shrink the therapeutic opportunity for other treatments by avoiding downstream compl

29、ications from related comorbidities.Innovators therefore must carefully navigate the interdependencies between different treatment options in this emerging new reality.It also raises the importance of combination approaches,within and between companies cardiometabolic portfolios.GO-TO-MARKET COMPLEX

30、ITY:THE NEED TO ENGAGE A DIVERSE CUSTOMER BASEThe manifestation of cardiometabolic indications as co-morbidities is a key driver of Go-To-Market(GTM)complexity,because the same patient is seen by multiple HCP specialties,for example,GPs,diabetologists,endocrinologists,cardiologists,nephrologists,gas

31、troenterologists or hepatologists.In addition,referrals between specialties and fluidity in who ultimately makes particular treatment decisions exacerbate GTM challenges.These prescriber specialties have very different needs and value different benefits delivered by a therapy and/or portfolio,which

32、requires a customer-centric engagement approach with carefully tailored positioning(see Figure 4).Patient with multiple CV-met co-morbidities,seen by multiple HCP specialtiesExample:Farxiga,multi-indication CV-met playSource of business,by HCP specialty;and by indication(MAT 5/2023)Promotional inves

33、tment,by HCP specialty*(FY2023,$)Nephro.HFCKDCVDT2DGPInternalmedicineBy HCPspecialtyBy indicationBy HCPspecialtyEndo.Cardio.CardiologistHFObesityASCVDHTNCKDMASHT2DNephrologistGastro-/Hepatol.EndocrinologistGPNephro.OtherCardio.Endo.GP/internist53%28%76%4%14%6%42%14%16%19%10%9%8%3%Co-morbidCV-met pat

34、ient“The manifestation of cardiometabolic indications as co-morbidities is a key driver of go-to-market complexity.”Notes:*USD spend on interactive engagements only(details and meetings;including F2F,digital and telephone);Only includes selected specialties Source:IQVIA LAAD,MAT May 2023;IQVIA Chann

35、elDynamics FY2023(extracted Feb 2025);IQVIA EMEA Thought Leadership analysisFigure 4:Go-to-market complexity:Diverse prescriber base treating overlapping,co-morbid patient segments6|Achieving Excellence in Commercialising Cardiometabolic Innovation The need to operate co-existing GTM model archetype

36、s with specific CSFs and capabilities,for different brands and/or indications,depending on innovation novelty,market maturity and competitive intensity,adds further complexity,for example:precision play,targeting unmet need/residual risk in specific patient sub-segments;market transformation,to repl

37、ace an existing treatment paradigm and set a new standard of care;or market building,which typically requires establishing new care pathways or embedding new diagnostic approaches.Customer overlap between different parts of a cardiometabolic portfolio necessitates an aligned engagement strategy to a

38、void internal competition for customers and conflicting messaging,or company fatigue by overwhelmed customers.This requires integrated approaches to customer segmentation,clear brand/indication prioritisation and guidance on messaging,including a coherent portfolio narrative,and the efficient organi

39、sation of in-field teams.To make this happen,affiliates will need more guidance from regional and global HQs on how to manage potentially conflicting priorities.Furthermore,portfolio-level investment and resource planning is needed to maximise the commercial opportunity while capturing synergies.Giv

40、en the unique complexity of how the cardiometabolic opportunity presents itself,excellence in commercial execution in this market is elevated beyond being an operational objective to becoming a critical,strategic differentiator for successful innovators.Lessons from cardiometabolic commercial succes

41、s storiesOur comprehensive analysis of the performance of cardiometabolic brands over the past 10 years identified three foundational pillars that underpin commercial excellence(see Figure 5):Deep market insight foundation Comprehensive understanding of market fundamentals and key stakeholders,e.g.,

42、Cardiometabolic patient profiles and their unmet needs Patient journeys,treatment pathways Key HCP specialties,their needs,preferences and prescribing behaviours Competitive dynamics,treatment landscape,differential brand positioningAligned value propositions and customer engagement Coherent value n

43、arrative with aligned co-positioning across brands/indications Clarity on how new therapies fit within cardiometabolic treatment algorithm Translated into clear engagement plans,spanning different prescriber specialties Guidance on segment-specific,yet aligned messaging across value propositionsHigh

44、 quality execution and performance management Precision engagement of target customers with tailored,high-impact campaigns Orchestrated omnichannel approach aligned with HCP channel preferences Accurate,granular market measurement for performance transparency to instill a competitive mindset,guide e

45、xecutionFigure 5:Three pillars of cardiometabolic commercial excellenceSource:IQVIA EMEA Thought Leadership |71.Deep market insight foundation:Successfully navigating the complexity of the cardiometabolic opportunity requires a comprehensive understanding of its market fundamentals and key stakehold

46、ers,for example:cardiometabolic patient profiles and their unmet needs involving multiple co-morbidities;patient journeys and treatment pathways,including intervention points and the relevant HCP specialties involved,their needs,preferences and prescribing behaviours to inform granular customer segm

47、entation;competitive dynamics,including the evolving treatment landscape,differential brand positioning,sales dynamics and promotional investments.2.Aligned value propositions and customer engagement:Overlap of cardiometabolic patient populations and customer segments drives the need for aligned(co-

48、)positioning across brands/indications,with a coherent value narrative that matches multiple value propositions with distinct needs of patient and HCP segments.Innovators must also articulate where their new therapies,individually and collectively,fit in the cardiometabolic treatment algorithm refle

49、cting the increasing interdependencies in managing risk factors.In turn,this positioning strategy must be translated into a clear engagement plan,typically spanning different prescriber specialties.It needs to provide operational guidance on prioritising target customer segments to drive prescriptio

50、ns,with segment-specific,yet aligned messaging across value propositions,and backed by adequate resourcing levels to ensure a competitive presence in the market.3.High-quality execution and effective performance management:Ultimately,competitive advantage and success are determined by the quality of

51、 executing the commercial strategy across brands and indications;for example,precision engagement of target customers with high-impact campaigns through the right channel mix that reflects their preferences.Performance transparency is key for instilling a competitive mindset,making faster,better dec

52、isions,optimally directing resources,and to be able to course correct with agility.Accurate market measurement is a pre-requisite,including understanding the sources of business,brand adoption and market share,at patient level,across indications,different segments and channels.We will now systematic

53、ally explore best practice for each foundational pillar of excellence in commercialising cardiometabolic innovation,illustrated through relevant case examples.8|Achieving Excellence in Commercialising Cardiometabolic Innovation I.Deep market insight foundationThe foundation for achieving commercial

54、excellence is an in-depth understanding of the uniquely complex dynamics underlying a specific cardiometabolic opportunity to inform strategic and operational decisions.Successful cardiometabolic brands therefore dedicate significant,early effort to developing critical insight,for example,how an opp

55、ortunity manifests itself in particular patient profiles with overlapping co-morbidities and in which competitive context;how co-morbid target patients flow through the healthcare system and which prescriber specialties they interact with at different stages along the treatment pathway;or which ther

56、apy attributes different prescribers specialties,and sub-segments,value and their channel preference for receiving information.Such comprehensive,integrated insight must draw on combining multiple data sources,e.g.,real-word data such as anonymised,longitudinal patient-level Rx data,claims data or E

57、MR;commercial data,e.g.,sales,promotional investment and activity;primary research into patient and HCP behaviours,attitudes and preferences;and intelligence gathered by field teams,including both the sales force and medical affairs.“Successful cardiometabolic brands dedicate significant,early effor

58、t to developing critical market insight.”|9PATIENT JOURNEY AND TREATMENT PATHWAY MAPFor example,a leading multi-indication,cardiometabolic brand used granular patient journey and care pathway mapping to understand how patients navigate the healthcare system as they begin to experience the onset of m

59、ultiple co-morbidities,including diabetes,chronic kidney disease and heart failure(see Figure 6).Cardiometabolic patient journeys are particularly complex due to interdependencies between co-morbidities,which manifest themselves at different time points in the natural history of disease,and inevitab

60、ly lead to an expansion of HCP specialties involved at different stages in a patients care.Once the flow of patients through the healthcare system and their touch points were understood,the patient journey was enriched by overlaying the patient experience along the way,e.g.,in their interactions wit

61、h healthcare professionals,facing obstacles along the care pathway,or the burden of living with,and managing,multiple,typically life-long conditions.Such rich,detailed insight helped sharpen the brands positioning across its different indications and the communication of patient-relevant benefits,wh

62、ile ensuring the customer engagement strategy was aligned with key intervention points along this complex patient journey.PINPOINTING OPPORTUNITIES IN CO-MORBID SUB-POPULATIONSFor example,developers of novel therapies for managing blood pressure will need to identify and target specific patient segm

63、ents with unmet need,such as a high-risk sub-population with CV-risk factors and resistant hypertension.The latter is defined as uncontrolled blood pressure despite the use of three or more antihypertensive drugs of different classes,including diuretics,long-acting calcium channel blockers,ACE inhib

64、itors or angiotensin II type receptor antagonists,at maximally tolerated doses.Using IQVIA Disease Analyzer(Germany),a representative database of general and specialist practices in Germany,which captures anonymised,patient-level data on diagnoses and treatments based on ICD-10 and ATC codes,IQVIA q

65、uantified overlap between patients with resistant hypertension and high-risk hypertension patients with multiple CV co-morbidities.These patient segments were subsequently mapped against GP and cardiology practices,respectively(see Figure 7).PresentationDiagnosisTx:Initiation and maintenanceDxDiabet

66、esHeartfailure Early CKDsymptomsCKDeGFR/ACR testDxTherapy adjustmentfor co-morbiditiesDxStage 1AsymptomaticBlood/ECGHF symptomsDxClass 2 Early T2DsymptomsBloodglucose testT2DconfirmedStage 2CKDworsensTxTxInitiate treatment for T2D/renal impairmentTxTxTxSpecialist referral:ophthalmologistDiabetic mac

67、ularoedema symptomsDxStage 3TxOngoingmonitoringDxClass 3 TxIntensified therapyCKD/HFworsenCV-metpatientTxGPEndo.Nephro.Cardio.ILLUSTRATIVEFigure 6:Interconnected cardiometabolic patient journeySource:IQVIA EMEA Thought Leadership10|Achieving Excellence in Commercialising Cardiometabolic Innovation T

68、his analysis highlighted,for example,that 50%of all GP practices and 39%of cardiology practices in Germany see high-risk,co-morbid patients with resistant hypertension,while in terms of absolute numbers the majority of those patients are found in the care of GPs.Typically,GPs manage treatment escala

69、tion,including initiation of the fourth therapy in resistant hypertension patients.GPs may consider specialist referral when a patients blood pressure remains uncontrolled.Such insight forms the basis for granular opportunity pinpointing and integrated HCP/patient segmentation to guide future custom

70、er engagement plans.It also informs effectively directing in-field activities at the most important prescribers treating large volumes of high-risk patients with resistant hypertension.UNDERSTANDING HCP NEEDS AND PREFERENCESAs the cardiometabolic landscape is becoming more crowded and competitive in

71、tensity increases in many markets,successful customer engagement must cut through this noise and deliver relevant,personalised content,and services,via an orchestrated omnichannel approach that reflects prescribers needs and preferences.13Our analysis of IQVIA ChannelDynamics data found a significan

72、t gap exists between HCPs channel preference and the promotional reality across EU4+UK markets,which varies by HCP specialty.For example,among relevant HCP specialties for cardiometabolic therapies,nephrologists report the highest level of misalignment,at 43%,followed by endocrinologists and cardiol

73、ogists at 41%and 40%,respectively,while GPs report the lowest level of mismatch at 33%among this group.GP practices with hypertension patients*(901 practices=100%)Resistant HTN patients High-riskpatients 886 practices(98.3%)454 practices(50.4%)463 practices(51.4%)Practices treating hypertensionHyper

74、tension patients seen by GPs(897k patients=100%)Resistant HTN patients High-riskpatients 168k patients(18.7%)28.4k patients(3.2%)79.8k patients(8.9%)Patient population with hypertensionCardiology practices with hypertension patients*(51 practices=100%)Resistant HTN patients High-riskpatients 51 prac

75、tices(100%)20 practices(39.2%)26 practices(51%)2.8k patients(1.4%)937 patients(0.5%)34.7k patients(17.1%)Resistant HTN patients High-riskpatients Hypertension patients seen by cardiologists(202.3k patients=100%)General practitionersCardiologistsFigure 7:Integrated segmentation:Hypertension patient p

76、rofiles vs.HCP speciality*Percentages show the proportion of practices that see patients in each segment;Source:IQVA Disease Analyzer(unprojected)|MAT 12/2019 MAT 11/2023;Notes:HTN Hypertension,ICD-10 code:I10;high risk HTN patients with CV-comorbidities:heart failure(ICD-10:I50,I11.0,I13.0,I13.2),s

77、troke(I63,I64,G45),CKD(N18)|11Attributes driving Rx decisionRecognition as a chronic diseaseMode of administrationReimbursementCostsSafety/side effect concernsTreatment needHealthcare budgetPatient compliance issues/risk of discontinuationAddressing the treatment gapAvailability of new efficacious a

78、nti-obesity drugsPatient/lifestyle demandUpdated clinical guidelinesRelated co-morbidities/double coveragePatients body compositionLack of progress with lifestyle changesPatients psychological health29%41%38%60%54%34%35%21%38%46%34%74%46%22%46%26%GPsEndocrinologists42%62%46%73%77%42%69%38%38%54%58%6

79、9%54%46%50%50%Cardiologists36%36%56%48%56%56%60%12%40%32%36%68%60%12%68%28%Figure 8:Prescribing decision drivers vary between HCP specialties Example:ObesityQuestions:Which of the following factors are important to you when making the decision to prescribe a treatment for patients living with obesit

80、y?PMR sample:GPs(n=68),Endocrinologists(n=26),Cardiologists(n=25);Source:IQVIA Integrated Insights Tracker:people living with obesity,UK report,November 2024A robust understanding of HCP needs and their communication preferences,at a granular level,is key for closing this gap and to stand out in a c

81、rowded field,be heard and build deeper,lasting customer relationships.Equally important is insight into the drivers of HCP decisions to tailor the portfolio-and indication-narratives,and campaigns,for maximum impact.For example,recent IQVIA primary research14 found great variation among UK GPs,endoc

82、rinologists and cardiologists in the attributes that are most important for them when deciding which treatment to prescribe for patients living with obesity(see Figure 8).A customer profile-guided,orchestrated omnichannel approach must extend beyond commercial teams.15 Medical affairs unique depth i

83、n understanding diseases and clinical practice,combined with the ability to have peer-to-peer discussions with HCPs,is critical to identify gaps in the standard of care and build advocacy for new therapies.Furthermore,medical affairs is well placed to help prescribers navigate an increasingly comple

84、x cardiometabolic landscape,which is at the cusp of seeing cardiometabolic risk management being fundamentally transformed,as we elaborated earlier.12|Achieving Excellence in Commercialising Cardiometabolic Innovation Jardiance promotional effort,peri-label HF expansionJardiance:Breadth and depth of

85、 prescribingBreadth:Coverage of HCP universeDepth(TRx/HCP)Increase in total detail volume,+/-6 months label expansionGP details:Cardio details:4x5.4xJan 2021Dec 2021HFGPsNephro.Endo.Cardio.T2DN/AJan 2021Dec 2021188 21120 3118 2335 41Details by indicationJardiance approved for HFrEF(Aug21)Details by

86、HCP specialtyJardiance approved for HFrEF(Aug21)Endo.Cardio.Nephro.GP82%42%31%54%83%67%46%63%02004006008001,0001,20002004006008001,0001,2003.8xIncrease20212022Figure 9:Engagement expansion beyond core HCP specialty is criticalSource:IQVIA BrandImpact analysis;IQVIA ChannelDynamics;IQVIA OneKey;IQVIA

87、 EMEA Thought Leadership analysisII.Aligned value propositions and customer engagement strategyWhen cardiometabolic assets with multi-indication potential secure approval of additional indications,innovators must articulate a broader,coherent value narrative and expand customer engagement to cover a

88、ll relevant prescriber specialties.This imperative also applies when innovators assemble multi-asset portfolios that target different cardiometabolic indications.Leading companies treat each new indication as a distinct launch,supported by dedicated teams where critical mass allows,to ensure organis

89、ational focus,which is a key prerequisite for achieving outperformance as we demonstrated in IQVIAs extensive Launch Excellence research.16For example,SGLT2 inhibitor Jardiance,originally approved for T2D,subsequently expanded its label to cover Heart Failure,including both patients with reduced eje

90、ction fraction(HFrEF)and preserved ejection fraction(HFpEF),and chronic kidney disease.In preparation for seizing the new commercial opportunities,Boehringer Ingelheim and Lilly significantly stepped up promotional investment around each label expansion,targeting indication-specific messages,tailore

91、d for relevant prescriber specialties,including primary care physicians(PCPs/GPs),endocrinologists,cardiologists and nephrologists.This approach resulted in building important breadth of coverage and depth of prescribing.During the window of 6 months before and after label expansion in heart failure

92、 with reduced ejection fraction(HFrEF),for example,Jardiance increased total detail volume in the U.S.threefold across HCP specialties.Engagement beyond endocrinologists,its original core prescribers,was critical:contacts with GPs and cardiologists increased by a factor of 4 and 5.4,respectively,dur

93、ing this peri-launch period.High levels of prescribing breadth and depth in the primary care setting,achieved via significant in-person engagement with GPs,was particularly important to drive patient volumes(see Figure 9)|13A verbatims analysis using IQVIA ChannelDynamics with IQVIA AI Assistant ill

94、ustrates how promotional messages for Jardiance were tailored to audience-specific needs,while joining up cross-indication benefits(see Table 1):Table 1:Jardiance promotional messages tailored for different HCP specialtiesIn addition to promotional activities,both Boehringer Ingelheim/Lilly and in-c

95、lass competitor AstraZeneca,invested in extensive,early RWE generation to support their respective SGLT2 brands,Jardiance and Farxiga,for example:AstraZenecas CVD REAL landmark observational study,involving 300,000 T2D patients with atherosclerotic CV disease across 6 countries,assessed Farxiga for

96、risk reduction in CV death and hospitalisation for heart failure.17 A second analysis(CVD REAL 2)assessed data from 400,000 T2D patients across 6 countries with or without established CV disease and receiving treatment with SGLT-2 inhibitors,including Farxiga,for risk of all-cause death,hospitalisat

97、ion for heart failure,myocardial infarction and stroke.18 Boehringer Ingelheims/Lillys EMPRISE real-world evidence study involving 200,000 U.S.patients compared Jardiance vs.DPP-IVs for risk reduction in hospitalisation for heart failure in T2D patients.19 Some of these major programmes were initiat

98、ed over 3 years before label expansion and ran alongside key CV-outcomes trials,such as Jardiances EMPA-REG OUTCOME or Farxigas DECLARE.Collectively,these evidence generation efforts focused on demonstrating real-world CV outcomes,characterising the target patient populations that benefit the most,a

99、nd quantifying impact on healthcare resource utilisation and potential cost off-sets,with the findings being disseminated via early medical affairs engagement to build awareness and advocacy for the new indications.Incretin mimetics,such as semaglutide,tirzepatide or survodutide,will face similar ch

100、allenges of managing increasing complexity while entering highly competitive markets as they pursue multi-indication opportunities,e.g.,with semaglutide already being approved for T2D,obesity,chronic kidney disease and CV risk reduction,with additional indications in heart failure and MASH likely to

101、 follow in the near future.HCP SPECIALTYMAIN FOCUS OF PROMOTIONKEY MESSAGESEndocrinologistsManagement of T2D and CV/renal protection“Jardiance lowers HbA1c levels and improves glycaemic control in T2D patients”“Jardiance provides dual benefits in managing T2D and offering CV and renal protection”“Ja

102、rdiance reduces risk of CV death in T2D patients with established CV disease”CardiologistsManagement of heart failure and CV benefits“Jardiance significantly reduces CV mortality and hospitalisations for HFpatients”“Jardiance has proven efficacy in both HFrEF and HFpEF as demonstrated in the EMPEROR

103、 trials”“Jardiance provides CV protection in patients with or without diabetes”NephrologistsManagement of CKD and renal protection“Jardiance slows progression of CKD and reduces risk of end-stage renal disease”“EMPA-KIDNEY trial shows Jardiance reduces risk of CKD progression and CV death by 28%”“Ja

104、rdiance is effective in patients with varying degrees of renal impairment,including those with low eGFR”GPsComprehensive patient management across multiple indications“Jardiance is indicated for T2D,HF and CKD”“Jardiance offers a safe,once-daily dosing regimen”“Early intervention and routine screeni

105、ng are crucial for at-risk patients”14|Achieving Excellence in Commercialising Cardiometabolic Innovation EXTENSIVE MARKET SHAPINGRecent breakthroughs in cardiometabolic innovation have led to pharmacotherapies becoming available in indications that previously had no treatment options,for example me

106、tabolic dysfunction-associated steatohepatitis(MASH).Ensuring health system and care pathway readiness is a key prerequisite for the broad and effective adoption of such novel therapies within the eligible patient population.In March 2024,Madrigals Rezdiffra became the first-ever therapy specificall

107、y approved for the treatment of MASH in patients with moderate or severe liver fibrosis,consistent with fibrosis stages F2 and F3 disease.In preparation for a successful launch,it was critical for Madrigal to dedicate significant,early effort to market shaping to address challenges such as limited d

108、isease awareness,low diagnosis rates and the absence of established care pathways for MASH.20 Specifically,Madrigals extensive market shaping activities21 for its U.S.launch included:Identifying 14,000 target physicians in total,with a primary focus on engaging 6,000 hepatologists and gastroenterolo

109、gists,who treat the majority of the 315,000 diagnosed F2-F3 stage MASH patients.Initial focus on liver-specialists was aimed at capturing patients already diagnosed and under care,while gastroenterologists,who far outnumber hepatologists,are typically less familiar with MASH but will be critical pre

110、scribers for driving future growth.Educating physicians and payers about MASH,the benefits of Madrigals new therapy and the use of non-invasive diagnostics to identify eligible patients.Creating treatment pathways,broadening access and supporting practices with administrative requirements for securi

111、ng reimbursement or acquiring imaging diagnostics.Supporting patients along their MASH treatment journey.Madrigals efforts are paying off,as Rezdiffra is going from strength to strength,delivering impressive revenue growth and beating consensus expectations in each of its first three quarters on the

112、 market.As more late-stage assets in development for MASH progress towards regulatory approval,including several incretin mimetics,e.g.,semaglutide,tirzepatide and survodutide,and other candidates with different MoAs,market development continues to be critical to unlock the sizeable,untapped potenti

113、al of an immature,underserved MASH |15III.High-quality execution and performance managementPerformance transparency is critical to succeed in highly competitive,fast-moving and complex cardiometabolic markets,where overlapping,co-morbid patient populations are served by competing,increasingly multi-

114、indicational products.It drives accountability,focus on competitiveness and high-quality execution,and enables agility by guiding timely business decisions,e.g.,directing the deployment of resources,or informing in-field tactics including when and how to course correct.Given the sheer scale of poten

115、tial cardiometabolic patient populations and target prescriber universes to engage,which can be orders of magnitude higher than for typical specialty care indications,fit-for-purpose market measurement becomes elevated to a high priority;for example,to understand the sources of business,and market s

116、hare,at patient level,across indications,for different patient and prescriber sub-segments and channels.Additionally,in obesity,it will also be important to accurately measure performance across both the private,consumer-led market and in the reimbursed setting.Granular,timely market measurement for

117、ms the basis for defining effective incentives that drive focus on priorities and instil critical behaviours and ways of working.For example,a leading cardiometabolic innovator,with a multi-indication brand competing in several crowded market segments,partnered with IQVIA to implement best-in-class

118、performance management to sustain its competitive advantage.To accurately track brand performance and patient dynamics at indication level in ex-US markets,IQVIA developed an AI-algorithm,trained on medical history and treatment patterns in the target population using representative longitudinal,ano

119、nymised patient-level EMR data.The algorithm was applied to longitudinal prescription data collected at pharmacy level to measure performance by indication.Feeding the latest EMR data into the learning model ensured continuous improvement of the algorithm.This approach delivered accurate performance

120、 transparency on several key metrics at indication level(see Figure 10),e.g.,TRx,NBRx,acquisition of treatment nave patients or patient switches between brands.In addition to monitoring commercial outcomes metrics such as brand sales,prescriptions,market share or number of patients acquired,it is im

121、portant to track execution metrics that are more directly linked to underlying activities that drive performance.For example,as we discussed in another IQVIA publication,the quality of HCP engagement is a strong predictor of launch success.22 Therefore,visibility of execution metrics enables swift,p

122、urposeful changes in tactics,e.g.,HCP targeting,omnichannel call plans,or message prioritisation and delivery.As competition is heating up,innovators must relentlessly focus on consistent,high-quality commercial execution which makes or breaks a successful cardiometabolic franchise.“Performance tran

123、sparency is critical to succeed in highly competitive,fast-moving and complex cardiometabolic markets.”“Innovators must relentlessly focus on consistent,high-quality commercial execution which makes or breaks a successful cardiometabolic franchise.”16|Achieving Excellence in Commercialising Cardiome

124、tabolic Innovation Organisational implications for cardiometabolic innovatorsHow do organisations achieve excellence in cardiometabolic innovation,what mindset,operating model,and capabilities are required to succeed?Faced with the formidable challenges discussed earlier,cardiometabolic innovators m

125、ust address three organisational priorities:1.Portfolio mindset:Maximising the overall cardiometabolic commercial opportunity requires a vision and mindset that rise above individual assets and indications.This allows a holistic view across interdependent opportunities,and how they fit together,to a

126、rticulate a coherent,cross-portfolio value narrative vs.a collection of disparate value propositions.A portfolio mindset is also essential for joined-up strategic planning,including opportunity prioritisation,optimal investment and resource allocation,and the capture of synergies,e.g.,due to custome

127、r overlap.Note,we consider a multi-indication asset a portfolio in a product in this context.2.Structure and governance provide the mechanisms for translating a portfolio mindset into operational reality.Pan-cardiometabolic governance,supported by consistent frameworks and effective,cross-functional

128、 processes with clearly defined decision rights,is crucial to drive organisational alignment around the cardiometabolic strategy,portfolio priorities and critical success factors.It facilitates joined-up decisions above individual assets and indications as a prerequisite for resolving conflicting pr

129、iorities and internal competition for resources or customers,avoiding duplication of efforts and orchestrating seamless execution by in-field teams.Moreover,efficient decision making and planning processes enable organisational agility,which is critical for playing in complex,fast-moving markets.Ove

130、rall performance(product X)Granular indication trackingQ3-24 summaryQ3-24 summaryShare of new patients(%)By indication(all prescribers)Aug-24Sep-24Oct-24Aug-24Sep-24Oct-24Aug-24Sep-24Oct-2420,0002,000T2DMGPCardioOtherNephroGPCardioOtherNephroHFCKDCKD+T2D+HF025,00000By prescriber type(all indications

131、)By prescriber type(patients with CKD only)Delta in new patient acquisitions-6.7%60%T2DM only5.9%20%HF only23.1%10%CKD only2.8%10%CKD+T2D+HFShare of new patients(%)Delta in new patient acquisitions-3.1%80%GP4.9%10%Cardio25.0%5%Nephro12.4%5%OtherShare of new patients(%)Delta in new patient acquisitio

132、ns3.1%35%GP-0.1%10%Cardio25.2%50%Nephro2.4%5%OtherNew to brand patientsNew to brand patients0%10%Figure 10:Effective market measurement and performance tracking Example:Monthly acquisition of new-to-brand patients,by indication,HCP specialty(product X)Source:IQVIA EMEA Thought Leadership analysis su

133、pported by Real-World Analytics and Insights;Illustrative based on IQVIA LRx data in a European countryILLUSTRATIVE |17Heart failurePotentially large customer base(GPs,cardiologists)Relatively narrow customer base(hepatologists,gastroenterologists)Investment allocation across brands,indications,HCP

134、specialtiesMASHPortfolio optimisation020406080100-2LY246810Benchmark spend to target 80%hepato+gastroTime from launch yearWhen to unlock investments?How fast to ramp up resource deployment?What%coverage of HCP universe?How to trade off allocations to maximise portfolio ROI?Key strategicdecisions%PYS

135、 spent on OPEX020406080100-2LY246810Benchmark spend to target 30%GPsADepending on HCP coverage%PYS spent on OPEXTime from launch yearContribution margin($M)Investment allocation:share of brand ABBCCABCD00%100%50%25%75%Efficient frontier10015020025050D3.Enablers:Advanced analytics capabilities are fu

136、ndamental for successfully navigating the complex and highly competitive cardiometabolic landscape.These include sophisticated,data-driven planning tools for portfolio-level prioritisation,such as OPEX modelling and quantifying the P&L impact of trade-offs(see Figure 11),e.g.,contribution margins by

137、 brand,and indication,under different investment allocation scenarios;and data-driven tools that enable rapid decision making and personalised,high-value customer engagement,e.g.,AI digital twins for tactical resource optimisation,dynamic customer targeting or agile,customer-centric omnichannel call

138、 planning across assets,indications and HCP specialties,to enable precision engagement at scale.Innovators at the heart of the cardiometabolic renaissance must overcome uniquely complex challenges to seize a tremendous commercial opportunity.This requires evolving their operating models to compete s

139、uccessfully by delivering commercial excellence at the next level.Figure 11:Data-driven,portfolio-level investment planning Example:OPEX modelling and portfolio ROI optimisation*LY:launch year;PYS:peak year sales;Source:IQVIA proprietary OPEX benchmark and portfolio optimisation models;IQVIA EMEA st

140、rategy consulting.ILLUSTRATIVE“Commercial excellence in this uniquely challenging market is elevated beyond an operational objective to becoming a critical,strategic differentiator for successful innovators.”18|Achieving Excellence in Commercialising Cardiometabolic Innovation References 1.A renaiss

141、ance for cardiometabolic innovation;IQVIA white paper,June 2023:A renaissance for cardiometabolic innovation-IQVIA 2.Global health estimates:Cause-specific mortality,20002019;leading causes of death;The Global Health Observatory,WHO:https:/www.who.int/data/gho/data/themes/mortality-and-global-health

142、-estimates/ghe-leading-causes-of-death 3.Global health estimates:Disease burden,20002019;leading causes of DALYs;The Global Health Observatory,WHO:https:/www.who.int/data/gho/data/themes/mortality-and-global-health-estimates/global-health-estimates-leading-causes-of-dalys 4.Vaduganathan M,Mensah G,T

143、urco J,et al.The Global Burden of Cardiovascular Diseases and Risk.J Am Coll Cardiol.2022 Dec,80(25)23612371;https:/doi.org/10.1016/j.jacc.2022.11.005 5.Global trends in R&D 2024;IQVIA Institute report,February 2024:https:/ 6.Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes;N Engl

144、 J Med 2023;389:2221-2232;https:/www.nejm.org/doi/full/10.1056/NEJMoa2307563 7.Semaglutide in Patients with Heart Failure with Preserved Ejection Fraction and Obesity;N Engl J Med 2023;389:1069-1084;https:/www.nejm.org/doi/full/10.1056/NEJMoa2306963 8.Effects of Semaglutide on Chronic Kidney Disease

145、 in Patients with Type 2 Diabetes;N Engl J Med 2024;391:109-121;https:/www.nejm.org/doi/10.1056/NEJMoa2403347 9.Tirzepatide for Heart Failure with Preserved Ejection Fraction and Obesity;N Engl J Med 2024;https:/www.nejm.org/doi/full/10.1056/NEJMoa2410027 10.Dapagliflozin in Heart Failure with Mildl

146、y Reduced or Preserved Ejection Fraction;N Engl J Med 2022;387:1089-1098;https:/www.nejm.org/doi/full/10.1056/NEJMoa2206286 11.Empagliflozin in Heart Failure with a Preserved Ejection Fraction;N Engl J Med 2021;385:1451-1461;https:/www.nejm.org/doi/full/10.1056/NEJMoa2107038 12.Cardiovascular and Re

147、nal Outcomes with Empagliflozin in Heart Failure;N Engl J Med 2020;383:1413-1424;https:/www.nejm.org/doi/full/10.1056/NEJMoa2022190 13.Time to Take Omnichannel Action,IQVIA white paper,June 2024:https:/ 14.IQVIA obesity tracker,data collection via online HCP survey,October 2024 15.Medical Affairs Ne

148、xt Frontier:Unlocking Omnichannel Engagement,IQVIA white paper,December 2022:https:/ Excellence in Commercialising Cardiometabolic Innovation 16.IQVIA Launch Excellence I-VIII series of bi-annual publications,2007-2023 17.Kosiborod M,et al.Lower risk of heart failure and death in patients initiated

149、on SGLT-2 inhibitors versus other glucose-lowering drugs:The CVD-REAL Study,2017;https:/doi.org/10.1161/circulationaha.117.029190 18.CVD REAL 2 analysis,AstraZeneca press release,12 March 2018:https:/ real-world evidence study,Boehringer Ingelheim press release,5 November 2018:https:/www.boehringer-

150、 20.IQVIA white paper,January 2024:Emerging from the Shadows:A New Era for NASH-IQVIA 21.Madrigal quarterly earnings reports,Q2-Q4/2024 22.No More Surprises:Understanding Predictors of Launch Success,IQVIA white paper,June 2021:https:/ |1920|Achieving Excellence in Commercialising Cardiometabolic In

151、novation About the authorsMARKUS GORESVice President,EMEA Thought Leadership,IQVIAMarkus has over 20 years of experience in life sciences,advising clients in all major geographies on a broad range of topics,including real world evidence strategy,launch readiness,go-to-market models,brand and commerc

152、ial strategies,and building enabling organisational capabilities.Markus is a frequent speaker on the latest industry trends and regularly engages with senior leadership teams of pharmaceutical companies.Prior to his current role in Thought Leadership,he has held leadership positions within IQVIA Rea

153、l World Solutions and QuintilesIMS Consulting Services(formerly the IMS Consulting Group).Markus holds a PhD in Pharmaceutical Chemistry from the University of Hanover and has completed post-doctoral research at the University of California.KIRSTIE SCOTTSenior Consultant,EMEA Thought Leadership,IQVI

154、AKirstie is a Senior Consultant in IQVIAs EMEA Thought Leadership team,based in London.She has experience preparing white papers and delivering presentations across a range of priority healthcare topics such as Launch Excellence,the availability of medicines,and the impact of biosimilars in Europe.A

155、 particular recent focus is how companies with new launches can overcome the challenging post-pandemic environment to achieve launch success.Kirstie has 8 years experience in healthcare and life sciences,previously providing clinical and commercial competitive insights for pharmaceutical companies,a

156、nd working to support industry associations to influence health policy.She holds a degree in Neuroscience from the University of Nottingham.MARINA KONEPrincipal,Strategy Consulting,IQVIAMarina is a Principal with IQVIAs Strategy Consulting team based in London.She has over 12 years of consulting exp

157、erience and advises both big pharma and emerging biopharma clients on a wide range of business issues,including commercial strategy(asset or portfolio),innovative go-to-market models,launch excellence,and organisational design and capability building to support operational excellence.She has deep ex

158、pertise within the cardiometabolic space,with a particular focus on obesity and T2D.Prior to joining IQVIA,Marina gained experience in medical sales with Novartis Pharma Services Inc.,Cyprus,focussing on their cardiometabolic portfolio.She also spent time in academia,researching new potential target

159、s for maintaining pancreatic-cell function in some forms of diabetes.Marina holds a MRes in Structural Molecular Biology and a BSc in Biochemistry,both from Imperial College,L|21Acknowledgements This white paper was supported with expertise from IQVIA Real World Analytics and Insights,IQVIA Integrat

160、ed Research,and IQVIA Brand and Commercial Strategy.In particular,the authors would like to thank Andrea Seltmann,Anna Ostermeier,Cristina Alzaga-Chaudhry and Annabel Taylor for their valuable contributions to the development of this publication.2025.All rights reserved.IQVIA is a registered trademark of IQVIA Inc.in the United States,the European Union,and various other countries.03.2025.EMEA.BCS2025-0518-02FEBCONTACT US