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Market Access - Getting ready for Personalized Medicine!


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A presentation outlining the potential gains, pitfalls and strategies needed to realize the value in Personalized Medicine (Companion Diagnostics, Therapies).

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Market Access - Getting ready for Personalized Medicine!

  1. 1. Personalized MedicineHow ready is the market for youand how ready are you for the market?Executive Insight AG. Company Snapshot Presentation.Our offering
  2. 2. Estimated Development of Personal Medicine Core AreasThe future clearly liesin Personalized Medicine$ bnTotal: $ 24bnTotal: $ 42bn The Personalized MedicineMarket Size is said toexperience substantialgrowth in the next years -up to $ 42bn by 2015 (MDxtests and targeted2*Esoteric Lab Services or Tests involve testing for substances (e.g. biomarkers) which is usually not performed in a “routine clinical lab”. These Tests usually requirespecialized personnel and hardware therefore they are often outsourced from hospitals to research labs (e.g. part of big university clinics, specialized private labs etc.)Source: PwC 2012+61%tests and targetedtherapies) compared to $24 bn. in 2009
  3. 3. In principle,everyone stands to winClearer basisfor developingtreatment guidelinesDiagnostics:A more attractive business modelbuilt on value based pricingHigher efficacy &less side effectsPharma /DiagnosticsIndustryPharma /DiagnosticsIndustryPolicyMakersPolicyMakersPatientPatientPharma:From the outdated blockbustermodel to niche-busters3Lower costRight drugs for theright patients, especiallyfor cancerBetter balance betweenefficacy vs costBetter prediction oftreatment outcomePayers/AssessorsPayers/AssessorsProvidersProvidersPrescribers/PathologistPrescribers/Pathologist
  4. 4. Fearful that biopharmas use personalizedmedicine to disguise higher pricingPoor understanding of the differencebetween the prognostic vs predictive testsHowever, many Policy Makers and Payers/assessorsare unwilling, unsure or unprepared to adapt4between the prognostic vs predictive testsSceptical of unfamiliar clinical dataevidence used to justify economic value,yet unable to propose alternatives
  5. 5. No holistic view of Rx and CDx(undermines the whole concept ofpersonalized medicine)Rx assessment mechanismsblindly applied to CDx (eg.: sameThe current Market Access system is thereforeunable to unleash the full value of CDx5blindly applied to CDx (eg.: samedata requirements)Technology-based reimbursementcriteria may not recognize thevalue of CDx
  6. 6. In turn, Biopharmas treadin uncharted waters in Market AccessWith different funding dynamics for CDx and Rx, howwill unfunded CDx jeopardize MA of the Rx?Will the CDx linked to a Rx go through thereimbursement process together or separately? Howwill it affect the timeline?What new add-on funding opportunities exist for6What new add-on funding opportunities exist forcombined Rx/CDx approaches?How should the CDx feed into the health economicdata model?How can we enhance Market Access by combining theearly access programs of both the Rx and CDx?
  7. 7. Biopharmas also face new challenging questionsin developing a successful business modelWhat is the best “distribution model” for promoting theCDx component and overcoming any local lab capacityhurdles?How can payer partnership program enhance MarketAccess of your Rx/CDx combination, if at all?7Access of your Rx/CDx combination, if at all?Which pricing option (combined or separate) for Rx/CDxin which markets give you a competitive edge?
  8. 8. Personalized MedicineThis is whereExecutiveInsight comes in…Executive Insight AG. Company Snapshot Presentation.Our offering
  9. 9. Executive Insight can undertake a rigorous reviewof your Pricing and Reimbursement StrategyP&R pathway &evidencerequirementsBest Market AccessoptionDiagnostic TestG-BA• Test for early detection§§§ 92; 25;26 SGB-VKap. 2 § 10 VO-GBA• Real innovation:Kap 2 § 2 (1) VO-GBA- Either: not included in the EBM in any way- Or: significant change orunderlying technologyBenefitattributed(+ / -)Potential forbenefitrecognizedCoverage with evidencedevelopment§ 137ePerforms benefit assessment§§ 135;137cDecision§§§ 92;25; 26 SGB-VKap. 2 § 10 VO-GBAG-BA consults BA on significanceof innovationKap. 2 § 2 (2) VO-GBA• Technology already(‘somewhat’) included in EBMthrough (generic coding, or codefor highly similar procedure)Performs HTA assessment(if required by the BA)Anlage 22 Kap. 32 EBMDecides on entry of new code andEBM point value§ 87, SGB-VLEGEND:ActionsRequirementsRequirements testearly detectionLegal basisInstitution orDecisionBewertungs-ausschussAG LaborAlign expectationswith external andinternalstakeholdersNeeds of9Enable optimal useof resourcesDevelop win-winvalue propositionsfor key stakeholdersNeeds ofthe network ofstakeholdersLink Strength 1 2 3 4MarketAccessMedical ExpertsInterviewscoveringallrelevantclinicianandpayersforthe in-andoutpatientsettingLeverageExecutiveInsightexpertnetworkStakeholderPayers KOLsNational Regional Hospital Clinicians PathologistNumber ofinterviews7x 2x 5x 7 2x
  10. 10. ...set up a winningsustainable Business ModelPayer partnershipDistribution mix Pricing modelsPerformancebasedagreements (PBS)10Assess feasbility oftesting clusters forfaster patientaccess and uptakeExplore schemes whichcan increase chance oftargeted prescription(eg: introduction of eligibilityquality assurance)Propose models thatreflect new customerneeds and valueperception(combined or separateofferings)Value addedagreements(VAA)Financialbasedagreements(FBA)
  11. 11. ... and help you prepareefficiently for successful launchEarly accessprogramsPre-launch activityroadmap11Develop CUP, NPPand ROK for fasterpatient access anduptakeHighlight criticalsuccess factors thatensure optimal andtimely preparation forlaunch
  12. 12. Do not use personalized medicine as a disguisefor pure market expansionReach out to a truly eligible patients throughquality management programsWe pursue the true spirit of releasingthe full value of Personalized MedicineA true personalizedmedicine approach12Do not circumvent standard Market Accessoptions to accelerate reimbursementHelp to shape the system so that fast accessbecomes possible through standard processesAcceleration insteadof circumvention
  13. 13. We bring to your projects our unique setof expertise in Personalized MedicineMedical experts with the in-depthunderstanding of patient pathways toevaluate and propose MA optionsAG LaborKBV / GKV-SVÄrztliche Berufsverb.Med. Fachgesellsch.HerstellerverbändeDürfen einen Antrag auf Aufnahme in den EBM stellenDatenanforderungen (außer Antrag kommt von KBV / GKV-SV) sind wie folgt:- Beleg des medizinischen Nutzens durch klinische Studiendaten (ggf.vergleichende Studien zuetablierten Parametern;insbesondere wenn diese ein Substitutions- /Verbesserungspotentialaufzeigen- Angaben zu Kosten und Patientenvolumenentwicklung ‚BudgetImpact‘Rein administratives Institut(Kopf dahinter ist das COC-L)Bestehend aus 7 KBV und 7AntragCOC-LBeratung / HTADas Kompetenzzentrum Labor (COCwird fastausnahmslos bei jedem Antraginvolviertund ist im Endeffekt fast gänzlichfür die Empfehlung des AG LaborverantwortlichP&R country experts withexperienced in P&R pathwaysand evidence requirementsorMDx labOP-PräparatorMDx-lab*OP-Präparator>90% <10%Ambulant Stationär Histologie-labBiopsie(Durch dieadjuvanteIndikation wird die Genmutationsanalyseandem OP-Präparat vorgenommen werden)DRG>95%EBMEBM~70% DRG / Drittmittel(Nur in „late stage“Fällen initiiert dasKH die Therapie)(ZE könnendenAnteilder stationärenBehandlungen erhöhen)~30%orMDx labOP-PräparatorMDx-lab*OP-Präparator>90% <10%Ambulant Stationär Histologie-labBiopsie(Durch dieadjuvanteIndikation wird die Genmutationsanalyseandem OP-Präparat vorgenommen werden)DRG>95%EBMEBM~70% DRG / Drittmittel(Nur in „late stage“Fällen initiiert dasKH die Therapie)(ZE könnendenAnteilder stationärenBehandlungen erhöhen)~30%13Bestehend aus 7 KBV und 7GKV-SV VertreternMDS / MDKDer MDK / MDS hätte die MöglichkeitdieseHTA Kompetenz aufzubauen,hat sich bisheraber noch nicht in diese Richtung positioniertBewertungs-ausschussVorbereitung /EmpfehlungEntscheidung über AufnahmeEntscheidung über Punktewert(Bazar artige Verhandlung)Nein JaorZeit / KrankheitsentwicklungI II III IVStage:(Platin Chemotherapie)(MAGE-A3)(Xalkori)(Iressa)EBM DRG (+ZE)(Platin Chemotherapie +Avastin)(Tarceva)orZeit / KrankheitsentwicklungI II III IVStage:(Platin Chemotherapie)(MAGE-A3)(Xalkori)(Iressa)EBM DRG (+ZE)(Platin Chemotherapie +Avastin)(Tarceva)“You get access to a senior consulting teamwho have deep competency and experiencein their respective areas.”Global Top 3 Pharma,Specialty Care Excellence“…theyre working with you and notjust putting a lot of junior people in theprojects to learn and be trained”“they came across as more knowledgeableand more experienced”
  14. 14. We take a front seat in shapingPersonalized Medicine policiesMember of standing panel of 10 payers and5 policy makers from major EuropeanPublish articles on earlyaccess programs and payerpartnerships programs(‘innovative contracting’)145 policy makers from major Europeanmarkets, competent in all questions related toPersonalized MedicineTrack RecordDeveloped pricing models for 5 major Rx/CDx solutionsAccompanied PPP’s from initial discussions between Payers andPharma to successful PPP implementationEstablished test cluster pilots successfully in major EU markets
  15. 15. Finally, our client-partners seemto like the way we work with themOpenCollaborationCreativePragmatism• We challenge constructively• Before going into new solutions, we leverageand maximize our customer internalknowledge, expertise and competences• We develop an approach based on ourexperience with what works and whatdoesn’t• We provide actionable recommendationsUncovering your true needsby embedding ourselves in your teamknowledge, expertise and competences“they made my priorities their priorities,they really did”“the collaboration and flexibilityis a real strengths of theirs”“they are very good at beinga critical friend““they have a pragmatic view ofhow things actually getimplemented and executed onceyou develop the strategy ““merging within the team culture andacting as a part of the team”• We provide actionable recommendationsthat remain valid after we leave“they have just delivered verystrong results consistently”“fantastic brains and innovationthat they have “they do generate a chemistry matchbetween themselves and the customer
  16. 16. Your contact persons:If you want support in defining your plans andcan identify with our thinking, contact usAndrea SobrioMobile: +41 79 456 87 16a.sobrio@executiveinsight.chKlarissa HodayMobile: +41 79 446 93 7916Company address:Mobile: +41 79 446 93 79k.hodayl@executiveinsight.ch16Executive Insight AGMetallstrasse 9CH-6304 ZugTel. +41 (0)41 710 71
  17. 17. Appendices – About Executive Insight17
  18. 18. Our place in the industry –consistent thought leadership2000 2004 2007 2011Move from block bustersto niche productsIncreasingly complex andintertwined environmentEmerging power ofpayersValue expectations alongthe whole patientpathwayOur flagship methodologies provided timely answers to the most challenging issuesRegionally basedBusiness Model forNarrow indicationproductsNetwork BasedCommercializationPayer Engagement andContractingBeyond the PillNetworkedHealthcare SeriesJournal of MedicalMarketingOrganisationalPolygamyPharmaceuticalExecutiveCheck out our website for all related publication and TL on the topics The Pill:More than Just aSloganFarmafocusInnovativeContractingPharmaceuticalExecutive
  19. 19. Our team - a unique mix of industry,consulting and medical backgroundsInterdisciplinary team of 20professionalsMeet some of our experts here: (see the entire team online)CONSULTING EXPERTS INDUSTRY EXPERTS MEDICAL EXPERTSSuzan Esslinger• Theoretical medicine,PhD in Molecular BiologyAndrea Sobrio• > 10 years healthcareconsulting experienceEric Janvier• > 17 years pharmaindustry experienceCover the EU big 5 languages (English,German, French, Italian, Spanish) andbeyond (e.g. Chinese)PhD in Molecular Biology• Expert for Medical Info.,Education & RegulatorySandra Schoenes• Medical doctor• General andorthopaedic surgeonconsulting experience• Focus: Market Access,Commercial ModelsMeike Wenzel• > 10 years healthcareconsulting experience• Focus: Sales, Customer& Market InsightsMarc Pesse• > 10 years healthcareconsulting experience• Focus: NetworkMapping & Mgt.industry experience• Finance & BusinessDevelopmentWendy van der Lubbe• > 7 years pharmaindustry experience• Product Mgt. &Medical AffairsFrancesca Boggio• > 3 years medicaldevice industry• > 8 years consulting• Strategic marketingDr. Morteza Yazdani• PhD in Neuroscience• Diploma inBiotechnology
  20. 20. Our servicesMARKET ACCESSWe support our clientsin in-depthunderstanding of theHC environment andthe design of solutionsthat meet payersREGULATORYWe support you withbuilding a regulatorystrategy to successfullyaccompany yourproduct through itsMARKETINGWe support our clients indeveloping a compellingvalue proposition thatgoes beyond the productto ensure “value beyondSALESWe help you find theright balance betweenadding true value tocustomer interactionsand realisingthat meet payersobjectives and needsproduct through itsentire life cycleto ensure “value beyondthe pill”and realisingefficienciesCUSTOMER & MARKET INSIGHTSWe offer innovative methods for generating fresh customer insights
  21. 21. Our clients