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. Executive Insight AG. Company Snapshot Presentation.Our offeringPersonalized MedicineHow ready is the market for youand how ready are you for the market?
  2. 2. 2Estimated Development of Personal Medicine Core AreasThe future clearly liesin Personalized Medicine*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$ bnTotal: $ 24bnTotal: $ 42bn+61%The Personalized MedicineMarket Size is said toexperience substantialgrowth in the next years -up to $ 42bn by 2015 (MDxtests and targetedtherapies) compared to $24 bn. in 2009
  3. 3. 3In principle,everyone stands to winLower costRight drugs for theright patients, especiallyfor cancerClearer basisfor developingtreatment guidelinesBetter balance betweenefficacy vs costDiagnostics:A more attractive business modelbuilt on value based pricingBetter prediction oftreatment outcomeHigher efficacy &less side effectsPharma /DiagnosticsIndustryPolicyMakersPayers/AssessorsProvidersPrescribers/PathologistPatientPharma:From the outdated blockbustermodel to niche-busters
  4. 4. 4 Fearful that biopharmas use personalizedmedicine to disguise higher pricing Poor understanding of the differencebetween the prognostic vs predictive tests Sceptical of unfamiliar clinical dataevidence used to justify economic value,yet unable to propose alternativesHowever, many Policy Makers and Payers/assessorsare unwilling, unsure or unprepared to adapt
  5. 5. 5 No holistic view of Rx and CDx(undermines the whole concept ofpersonalized medicine) Rx assessment mechanismsblindly applied to CDx (eg.: samedata requirements) Technology-based reimbursementcriteria may not recognize thevalue of CDxThe current Market Access system is thereforeunable to unleash the full value of CDx
  6. 6. 6In turn, Biopharmas treadin uncharted waters in Market Access With 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 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. 7Biopharmas also face new challenging questionsin developing a successful business model What 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? Which pricing option (combined or separate) for Rx/CDxin which markets give you a competitive edge?
  8. 8. Executive Insight AG. Company Snapshot Presentation.Our offeringPersonalized MedicineThis is whereExecutiveInsight comes in…
  9. 9. 9Executive Insight can undertake a rigorous reviewof your Pricing and Reimbursement StrategyP&R pathway &evidencerequirementsBest Market AccessoptionDiagnosticTestG-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 or underlying 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)Anlage22 Kap. 32 EBMDecides on entry of new code andEBM point value§ 87, SGB-VLEGEND:ActionsRequirementsRequirements testearly detectionLegal basisInstitution orDecisionBewertungs-ausschussAG LaborAlign expectationswith external andinternalstakeholdersEnable optimal useof resourcesDevelop win-winvalue propositionsfor key stakeholdersNeeds ofthe network ofstakeholdersLink Strength 1 2 3 4MarketAccessMedicalExpertsInterviewscoveringallrelevantclinicianandpayersforthe in-andoutpatientsettingLeverageExecutiveInsight expert networkStakeholderPayers KOLsNational Regional Hospital Clinicians PathologistNumber ofinterviews7x 2x 5x 7 2x
  10. 10. 10...set up a winningsustainable Business ModelPayer partnershipDistribution mix Pricing modelsAssess 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)Performancebasedagreements (PBS)Value addedagreements(VAA)Financialbasedagreements(FBA)
  11. 11. 11Develop CUP, NPPand ROK for fasterpatient access anduptake... and help you prepareefficiently for successful launchEarly accessprogramsPre-launch activityroadmapHighlight criticalsuccess factors thatensure optimal andtimely preparation forlaunch
  12. 12. 12Do not use personalized medicine as a disguisefor pure market expansionReach out to a truly eligible patients throughquality management programsDo not circumvent standard Market Accessoptions to accelerate reimbursementHelp to shape the system so that fast accessbecomes possible through standard processesWe pursue the true spirit of releasingthe full value of Personalized MedicineAcceleration insteadof circumventionA true personalizedmedicine approach
  13. 13. 13We 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.Herstellerverbände Dürfen einen Antrag auf Aufnahme in den EBM stellen Datenanforderungen (außer Antrag kommtvon 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 istdas COC-L) Bestehend aus 7 KBV und 7GKV-SV VertreternAntragCOC-LBeratung / HTAMDS / MDK Der MDK / MDS hätte die MöglichkeitdieseHTA Kompetenz aufzubauen,hatsich bisheraber noch nichtin diese Richtung positioniert Das Kompetenzzentrum Labor (COC-L)wird fastausnahmslos bei jedem Antraginvolviertund istim Endeffektfastgänzlichfür die Empfehlung des AGLaborverantwortlichBewertungs-ausschussVorbereitung /Empfehlung Entscheidung über Aufnahme Entscheidung über Punktewert(Bazar artige Verhandlung)Nein Ja3MonatefallsalsVoraussetzunginderFachinformationerwähnt,ansonstenkanndieAufnahmeindenEBMlängeralseinJahrdauernAufnahmeverfahren EBM(= ‚black box: Informationen zu Bewertungsstatus und Entscheidungsbegründungen müssen nicht offen gelegt werden)P&R country experts withexperienced in P&R pathwaysand evidence requirementsorMDx labOP-PräparatorMDx-lab*OP-PräparatorZeit / KrankheitsentwicklungI II III IVStage:(Platin Chemotherapie)(MAGE-A3)(Xalkori)(Iressa)>90% <10%Ambulant Stationär Histologie-labBiopsie(Durch die adjuvante Indikation wird die Genmutationsanalysean dem OP-Präparat vorgenommen werden)DRGEBM>95%DRG (+ZE)EBMEBM~70% DRG / Drittmittel(Nur in „late stage“Fällen initiiert dasKH die Therapie)(ZEkönnen den Anteilder stationärenBehandlungen erhöhen)(Platin Chemotherapie +Avastin)(Tarceva)~30%“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. 14We take a front seat in shapingPersonalized Medicine policiesMember of standing panel of 10 payers and5 policy makers from major Europeanmarkets, competent in all questions related toPersonalized MedicinePublish articles on earlyaccess programs and payerpartnerships programs(‘innovative contracting’)Track Record Developed pricing models for 5 major Rx/CDx solutions Accompanied PPP’s from initial discussions between Payers andPharma to successful PPP implementation Established 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“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 develop an approach based on ourexperience with what works and whatdoesn’t• 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 customerUncovering your true needsby embedding ourselves in your team
  16. 16. 16Company address: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 79k.hodayl@executiveinsight.ch16Executive Insight AGMetallstrasse 9CH-6304 ZugTel. +41 (0)41 710 71
  17. 17. 17Appendices – About Executive Insight
  18. 18. Our place in the industry –consistent thought leadershipRegionally basedBusiness Model forNarrow indicationproductsNetwork BasedCommercializationPayer Engagement andContractingBeyond the Pill2000 2004 2007 2011NetworkedHealthcare SeriesJournal of MedicalMarketingOrganisationalPolygamyPharmaceuticalExecutiveMove from block bustersto niche productsIncreasingly complex andintertwined environmentEmerging power ofpayersValue expectations alongthe whole patientpathwayOur flagship methodologies provided timely answers to the most challenging issuesCheck 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 Biology• Expert for Medical Info.,Education & RegulatorySandra Schoenes• Medical doctor• General andorthopaedic surgeonAndrea Sobrio• > 10 years healthcareconsulting experience• Focus: Market Access,Commercial ModelsMeike Wenzel• > 10 years healthcareconsulting experience• Focus: Sales, Customer& Market InsightsMarc Pesse• > 10 years healthcareconsulting experience• Focus: NetworkMapping & Mgt.Eric Janvier• > 17 years pharmaindustry experience• Finance & BusinessDevelopmentWendy van der Lubbe• > 7 years pharmaindustry experience• Product Mgt. &Medical AffairsFrancesca Boggio• > 3 years medicaldevice industry• > 8 years consulting• Strategic marketingCover the EU big 5 languages (English,German, French, Italian, Spanish) andbeyond (e.g. Chinese)Dr. 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 payersobjectives and needsREGULATORYWe support you withbuilding a regulatorystrategy to successfullyaccompany yourproduct through itsentire life cycleMARKETINGWe support our clients indeveloping a compellingvalue proposition thatgoes beyond the productto ensure “value beyondthe pill”SALESWe help you find theright balance betweenadding true value tocustomer interactionsand realisingefficienciesCUSTOMER & MARKET INSIGHTSWe offer innovative methods for generating fresh customer insights
  21. 21. Our clients