Educating the Marketplace to Support Successful Diabetes Product Launches Report Summary

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Pharmaceutical and biotech companies realize the importance of educating the payer sector to improve the likelihood of a successful launch of their new products. As payers’ influence in the marketplace has grown, so has the importance of effective payer education tactics- no more so than in the diabetes therapeutic area where competition is fierce for prime formulary positioning. This Best Practices®, LLC benchmarking study provides benchmarks around timing of payer-oriented market education and effective education tactics for payers.

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  • Key on the slide is “insight gathering”
  • Key on the slide is “insight gathering”
  • Key on the slide is “insight gathering”
  • Educating the Marketplace to Support Successful Diabetes Product Launches Report Summary

    1. 1. BEST PRACTICES,®LL1Copyright © Best Practices®, LLCEducating the Marketplace toSupport Successful DiabetesProduct Launches
    2. 2. BEST PRACTICES,®LL2Copyright © Best Practices®, LLCKey Study ObjectivesResearch Objective and MethodologyStudy Objective & MethodologyThis field research and benchmarkingstudy probed the broad array of medicaleducation and marketing practicesconducted two to three years prior tolaunch that best inform and shape themarketplace.A quantitative survey harvested currentbest practices and emerging trends ineducating the marketplace to supportsuccessful product launches. In addition,deep-dive executive interviews wereconducted with selected participants toprovide qualitative insights and emergingtrends.•Identify key education tactics forthought leaders, physicians, patients,and payers•Assess key market-educationpractices, including thought leaderservices, MedEd, scientificpublications, patient advocacy &education, clinical trials & payereducation•Identify key timing factors &education mix•Describe critical market entry pitfallsand future trendsThis study explores best practices in educating, informing and preparing themarketplace for new products – through Physician, Patient, and Payer education,publications, advocacy and communication strategies.
    3. 3. BEST PRACTICES,®LL3Copyright © Best Practices®, LLC10 Steps To Excellence: Key Themes from Market Education ResearchBrand, medical and market education leaders describe various best practices foreducating and shaping the market for new bio-pharma products. These practices can bedistilled into 10 key areas that articulate a blueprint for market education excellence.MARKETMARKETEDUCATIONEDUCATIONEXCELLENCEEXCELLENCE1. DevelopIntegratedContinuousThought LeaderStrategies2. ManageClinical Trials ToWin HighlyRegardedInvestigators &TLs3. Data DisclosuresInform MedicalCommunity of YourProgress &Commitment7. Start PayerEducation Early;Focus On Cost& HealthOutcomes4. CommunicateClinical ScienceThru Journals &Congresses5. Use Multi-Channel Med.Ed. To InformHealth CareProviders8. Use PR & NewTechnologies ForLeveraged Reach toPatients, Physicians,& Payers10. AllocateMarket Ed Mix ToReflect T.A. &CompetitiveLandscape6. InformPatients ThruEducation &Advocacy GroupCollaborations9. OrchestrateMed Ed TimingTo Reach RightConstituenciesAt Right Times“I think its going toboil down to beingable to actually identifyby individual customerwhat channel theywant information fromand how youre goingto reach them mostefficiently, and almostgoing through adecision tree thatlooks at effectivenessand cost . . ..”-Senior Vice President, Marketing“I think its going toboil down to beingable to actually identifyby individual customerwhat channel theywant information fromand how youre goingto reach them mostefficiently, and almostgoing through adecision tree thatlooks at effectivenessand cost . . ..”-Senior Vice President, Marketing
    4. 4. BEST PRACTICES,®LL4Copyright © Best Practices®, LLCUniverse of Learning: 26 Companies EngagedResearch participants included 34 executives and managers from 26 leadingpharmaceutical, biotech and medical device companies.Participating Companies
    5. 5. BEST PRACTICES,®LL5Copyright © Best Practices®, LLCUniverse of Learning: Job Titles and Executive InterviewsInterview Class• Executive Director,Global Marketing• Associate BrandDirector• Senior Manager,New ProductCommercialization• National SalesManager• Manager, ClinicalResearch• Senior ProductManager/PayerMarketing• Senior Manager,Health CareSolutions• Medical Adviser• Senior VP, CommercialOperations• Senior VP, Marketing• Executive Director,Commercial Operations• Head Clinical & MedicalServices• Vice President, Marketing• Senior Director,• Director, CommercialAnalysis• Senior Manager, Marketing• Manager, Market Research• Senior Director, Diabetes• Group Sales & BrandManager• Senior Manager,Commercial DevelopmentJob TitlesResearch participants’ roles ranged from senior leaders of commercial operations tomanagers of Diabetes brand teams and therapeutic franchise groups. “Lessons learned”executive interviews were conducted with select companies.
    6. 6. BEST PRACTICES,®LL6Copyright © Best Practices®, LLCDiabetes/Cardiovascular Segment: 11 Participants EngagedDiabetes/Cardiovascular research participants included 11 executives/managers at 8companies. Three cardiovascular respondents were integrated with 8 Diabetesrespondents because of similar structural therapeutic area requirements for marketentry and common safety factors now under review by the FDA.Benchmark Partners –Diabetes/CardiovascularParticipant Titles –Diabetes/Cardiovascular• Senior VP, Commercial Operations• VP, Marketing• Executive Director, Global Marketing• Associate Brand Director• Senior Manager, New ProductCommercialization• National Sales Manager• Manager, Clinical Research• Senior Product Manager/Payer Marketing• Senior Manager, Health Care Solutions• Medical Adviser• Group Sales & Brand Manager
    7. 7. BEST PRACTICES,®LL7Copyright © Best Practices®, LLCDiabetes Thought Leader Education Mirrors Benchmark(n=11)Developing Diabetes Thought Leaders: Please check when you should start each activity foreducating thought leaders.DiabetesDevelopingIntegratedThought LeaderStrategiesConductingAdvisory BoardsProvidingMedicalScienceLiaisonServicesEngagingThoughtLeaders &KeyInvestigatorsin ClinicalTrial ProtocolDevelopmentCommunicatingCriticalInformation andSharing ResearchInsightsPre-Clinical 9% 0% 0% 18% 9%Phase I 9% 18% 18% 18% 0%Phase II 55% 36% 9% 36% 36%Phase III-3 Years 18% 18% 18% 9% 18%Phase III-2 Years 9% 0% 9% 9% 18%Phase III-1 Year 0% 18% 36% 0% 9%NDA thru Launch Year 0% 9% 9% 9% 9%The Diabetes marketplace is well developed and populated with many well-established products. Thisperhaps explains why the Diabetes product teams seem to closely reflect the multi-therapeutic areasbenchmarks. Most thought leader services commence in Phase II. Medical Science Liaison servicesusually commence in Phase III about one year prior to launch.
    8. 8. BEST PRACTICES,®LL8Copyright © Best Practices®, LLCGet KOLs In at Phase II to Create Ownership“You have to let them think theyre designingthe development program. So you involvethem from Phase II onward and they help youwrite the protocols, and by the time theyvegone through that, its their baby just as much asit is yours” – Global Head of Clinical and MedicalServices“You have to let them think theyre designingthe development program. So you involvethem from Phase II onward and they help youwrite the protocols, and by the time theyvegone through that, its their baby just as much asit is yours” – Global Head of Clinical and MedicalServicesIf your compound doesn’t have a novel Method of Action or it’s not a first-in-class, it can be difficult to bringKOLs into your development program. One approach is to get the KOL involved in the planning of thedevelopment program so that they develop a feeling of ownership.“We’d let doctors have raw substance samples so that they could get their Ph.D. studentsplaying with it and some of the pre-clinical publications would come out from their own labs.We control that quite tightly, but other companies I worked with used to use that as a way ofengaging key opinion leaders and generating extra useful data. It really got the guysinvolved. They could play with it in their own hands and do what they want with it and designsome of their own studies. That really gave them a feeling of ownership. ”– Global Head of Clinical and Medical Services“We’d let doctors have raw substance samples so that they could get their Ph.D. studentsplaying with it and some of the pre-clinical publications would come out from their own labs.We control that quite tightly, but other companies I worked with used to use that as a way ofengaging key opinion leaders and generating extra useful data. It really got the guysinvolved. They could play with it in their own hands and do what they want with it and designsome of their own studies. That really gave them a feeling of ownership. ”– Global Head of Clinical and Medical Services
    9. 9. BEST PRACTICES,®LL9Copyright © Best Practices®, LLCInvestigator Segmentation Systems Help Tailor OutreachSegment investigators to understand their motivations and objectives and to fine-tuneyour recruitment and relationship plan to reflect investigator motivation profile.DrugDevelop-ersBusinessMindedCareerClimbersPublishersThoughtLeadersScienceMotivatedHealers““It’s not clear that each investigatorIt’s not clear that each investigatoris just one segment. There is ais just one segment. There is apredominant motivation and apredominant motivation and asecond and third motivation.second and third motivation.Money is not usually the primaryMoney is not usually the primarydriver. They don’t want to godriver. They don’t want to gobankrupt. When you ask them, theybankrupt. When you ask them, theytell you money is third or fourthtell you money is third or fourthlevel of importance.”level of importance.”-- Senior Director, Clinical Operations,-- Senior Director, Clinical Operations,Pharmaceutical CompanyPharmaceutical CompanyPhysician Motivation SegmentsPhysician Motivation Segments
    10. 10. BEST PRACTICES,®LL10Copyright © Best Practices®, LLCDiabetes IISs Occur – But Later in Phase III or Post-LaunchClinical Trial Tactics: Please check all stages during which you conduct investigator-initiatedstudies (non-registration studies)Total Benchmark Class83%53%57%43%17%17%0% 20% 40% 60% 80% 100%Post LaunchLaunch1 year pre-launch (Ph III)2 years pre-launch (Ph III)3 years pre-launch (Ph III)Phase IIDiabetes Segment88%38%63%25%13%0%0% 20% 40% 60% 80% 100%Post LaunchLaunch1 year pre-launch (Ph III)2 years pre-launch (Ph III)3 years pre-launch (Ph III)Phase II(n=30) (n=8)The Diabetes segment uses Investigator-Initiated Clinical Studies (IISs) more cautiously than the largerbenchmark class. Early-stage IISs are less frequent than in the overall benchmark class. New safetyconcerns regarding cardiovascular risk and anti-diabetes medicines may prompt companies to be morecautious before granting requests to stage small clinical trials exploring an investigator treatment idea.
    11. 11. BEST PRACTICES,®LL11Copyright © Best Practices®, LLCEarly Access Programs Common in Diabetes“I think in all specialty areas thelevel of experimentation is high. …They will put every patient into somekind of study, because drugs tend tocome to market very quickly with thenew drugs, which means that all thedetails are not worked out. It willhave been tested in one population,but maybe the doctor thinks it couldbe of benefit in another populationor a slightly different way of use orwhatever.” – Global Head of Clinicaland Medical ServicesEarly Access Programs can benefit patients who are looking for solutions for life-threatening and non-life-threatening conditions. EAPs can provide insights early on forpotential new therapies.Benefits of EAPs Provide potentially life-saving therapiesto patients not participating in pivotaltrials Provide physicians with direct positiveexperience of their patients who benefitfrom therapy Provide physicians with additionalexperience with different patients whodiffer from overall trial group Provide insights that may revealadditional marketplace potential fortherapyBenefits of EAPs Provide potentially life-saving therapiesto patients not participating in pivotaltrials Provide physicians with direct positiveexperience of their patients who benefitfrom therapy Provide physicians with additionalexperience with different patients whodiffer from overall trial group Provide insights that may revealadditional marketplace potential fortherapy
    12. 12. BEST PRACTICES,®LL12Copyright © Best Practices®, LLCDiabetes TA Employs Primary & Secondary Journals and Congresses(n=31)Please rate the importance of publishing your clinical results in various channels:Total Benchmark Class4%10%17%83%83%25%72%47%17%13%4%3%79%17%Internet Self-publicationMinor Congresses or Events (Regional/Local)Alternative MediaSecondary JournalsOnline Scientific PublicationsPrimary JournalMajor Congresses or Events (Intl/Natl)Highly Important ImportantDiabetes Segement13%22%33%89%89%50%56%56%25%25%Internet Self-publicationAlternative MediaMinor Congresses or Events (Regional/Local)Online Scientific PublicationsSecondary JournalsPrimary JournalMajor Congresses or Events (Intl/Natl)Highly Important Important(n=8)The Diabetes therapeutic segment places highest importance on publishing clinicalresearch in primary journals and secondary journals, along with presenting clinicalresearch at national and regional congresses. Similar to the multi-therapeutic areabenchmark class, online publications can also be important.
    13. 13. BEST PRACTICES,®LL13Copyright © Best Practices®, LLCDiabetes Publication Productivity Lags The Benchmark Class(n=6)Publication Productivity: Please estimate the number of publications (by type) you would expect to issueduring the Phase III to Launch period to adequately prepare the market for your products entry:Total Benchmark Class25thPercentileMean Median75thPercentileAbstracts 7 15 10 19Peer-reviewed Manuscripts/Papers 4 7 5 8Non-peer Reviewed Papers 2 7 7 10Presentations by Investigators 5 12 10 14Poster Sessions 6 15 10 19(n=26)Diabetes25thPercentileMean Median75thPercentileAbstracts 5 13 8 10Peer-reviewed Manuscripts/Papers 4 9 5 9Non-peer Reviewed Papers 1 4 3 8Presentations by Investigators 5 11 8 10Poster Sessions 6 14 9 18The Diabetes segment trails the total benchmark class’ productivity levels – measuredin terms of abstracts, non-peer-reviewed manuscripts, and presentations. Yet, it leadsin terms of peer-reviewed papers – suggesting this is essential in the competitiveDiabetes landscape. Top quartile productivity leaders in the benchmark class out-produce diabetes abstracts & presentations by 30-50 percent.Green = productivity leader Red = productivity laggardNote: Therapeutic segment is compared to benchmark. Significant variation between TA and benchmark is noted with green spotlighting high productivity and red spotlighting lowproductivity.
    14. 14. BEST PRACTICES,®LL14Copyright © Best Practices®, LLCIn Diabetes Arena, Don’t Ignore Blogs“In diabetes they are very active inchat rooms and blogs and online.For example, each region tends tohave a diabetes expert thateveryone looks to for his or herblog, and they often critique on thelatest and greatest. They critiquewhat each company is doing. Wehave found them to be quitepowerful in their opinion. So in myprevious company people in thosepositions, they would call in to get aresponse, and we would answerthem. We would talk with them.”– National Sales Manager,Managed CareDiabetes is one of the therapeutic areas where blogs are an important informationsource for patients and savvy pharmaceutical organizations are plugged into thatdomain. While interactions need to be tempered with caution, they can be useful for boththe company and patients.http://www.battlediabetes.com/fake-lifescan-test-strips/
    15. 15. BEST PRACTICES,®LL15Copyright © Best Practices®, LLCIntegrate PR and Advocacy with Right Message“Typically its integrated from a PRperspective and an advocacyperspective, so youre going to workwith the right type of patientadvocacy groups and your publicrelations campaign to build the righttype of messages and disseminatethem.” – Senior Vice President,Commercial“Typically its integrated from a PRperspective and an advocacyperspective, so youre going to workwith the right type of patientadvocacy groups and your publicrelations campaign to build the righttype of messages and disseminatethem.” – Senior Vice President,CommercialWhile it makes strategic sense to marry a public relations campaign with collaborativework you’re doing with an advocacy group, it needs to be done carefully. Steer clear ofbranded messages and focus on a therapeutic area and disease state information.“You have to focus on the level ofunmet need, and then building off ofthe unmet need then you talk aboutemerging areas or targets or programsthat are addressing that and its donein a balanced but strategic manner.” –Senior Vice President,Commercial“You have to focus on the level ofunmet need, and then building off ofthe unmet need then you talk aboutemerging areas or targets or programsthat are addressing that and its donein a balanced but strategic manner.” –Senior Vice President,CommercialTactics Strategy
    16. 16. BEST PRACTICES,®LL16Copyright © Best Practices®, LLCBuild Payer Perspectives into NegotiationsWhen negotiating with payers, use clinical data that shows what’s in it for them – howyour product’s value can help them gain market share on their competition. If it’s a bloodpressure product, show 90 percent of their patients will be controlled and thus there arefewer strokes/heart attacks.“The other thing was to thinkabout whats in it for them. So ifyoure selling to an HMO, howcan your product help that HMOmeet its targets? Not just whatdoes your product do for thepatients, but what does yourproduct do for the HMO, howcan it help them reduce costs,how can it help it attract patientsbetter than other HMOs?”– Global Head of Clinical andMedical Services“The other thing was to thinkabout whats in it for them. So ifyoure selling to an HMO, howcan your product help that HMOmeet its targets? Not just whatdoes your product do for thepatients, but what does yourproduct do for the HMO, howcan it help them reduce costs,how can it help it attract patientsbetter than other HMOs?”– Global Head of Clinical andMedical ServicesApril 23, 2009 Link to story
    17. 17. BEST PRACTICES,®LL17Copyright © Best Practices®, LLCDiabetes Targets PCPs & Nurses EarlierTargeting the Right Groups for Education at the Right Time: Please note when you begin toeducate different target audiences in your overall efforts to educate the market.(n=24) (n=8)The Diabetes segment follows the Specialist → Primary Care Physician → Nurse Practitioner cascade.However, it introduces targeting to Primary Care Physicians and Nurse Practitioners somewhat earlier – attwo year pre-launch – than the overall benchmark. It also more actively ramps up specialist targeting inearly Phase III. This likely reflects the importance of PCPs and Nurses in diabetes treatment.Specialist Physicians Primary Care Physicians Nurse Practitioners0%10%20%30%40%50%60%70%80%90%100%3 Years 2 Years 1 Year Launch PostBefore Before Before Year LaunchLaunch Launch Launch YearTotal Benchmark Class Diabetes Segment0%10%20%30%40%50%60%70%80%90%100%3 YearsBeforeLaunch2 YearsBeforeLaunch1 YearBeforeLaunchLaunchYear
    18. 18. BEST PRACTICES,®LL18Copyright © Best Practices®, LLCBest Practices & Lessons Learned: KOLs & TimingBenchmark partners shared their best practices and key lessons learned regardingmarket education for successful new product launches. Beginning education early andinvolving Key Opinion Leaders (KOLs) are top practice areas.Use KOLS Wisely & Often “KOL development, support and integration are key.” “Have the KOLs own the content.” “Use KOLs where possible.” “KOL management and thought leader engagement needs to beearly – to partner through the highs and lows of development.”Begin Early . . . “Obtain early input from all parties, including payers and patients,not just investigators and prescribers.” “You can NEVER start too early.” “Engage payers early.” “Educate early; at least one year prior to launch.” . . . However “Have a detailed plan and be cautious spending too much money too soon.”

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