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SpecialtyPharmacyOverviewBrianBurke VPNationalAccounts
9/14/2012
SpecialtyPharmacyisthepracticeofdispensingcomplextherapiesdeliveredbyexperthealthcarepractitionerstopatientswithchronicandacuteillnesses.Thismodelcoordinatesconditionspecificcoreservicesdesignedtoimprovepatientaccessandachieveoptimalclinicaloutcomes*
*AsdefinedbyCharterMembersofNationalCoalitionofSpecialtyPharmacies,October2008
Specialty Pharmacy Defined
WhatMakesaDrugaSpecialty? MorethanjustsayingItsabiologic Targetsadiseasewithasmalltomediumpopulation Seriousunmetmedicalneeds Includesoneormoreofthefollowingfeatures:
Usuallyalargemoleculeinjectible Increasingly,smallmoleculeoraldrug Coverageunderthemedicalbenefitbutincreasinglyunderthepharmacybenefit
Primarilyprescribedandadministeredbyaspecialist Oftenrequiresspecialhandling(expressorovernightshipping),refrigerationandstorage
Requiresdiseasemanagementservices(e.g.,patienteducation,monitoring,copayassistance,etc.)
HighCost(over$1,200permonth)
Specialty Pharmaceutical Defined
Factors Determining Classification as Specialty Pharmacy by Plans
4
On a scale of 1-5, where 1 = no impact at all and 5 = extreme impact, please rate the impact each factor has in determining whether a drug category is classified as specialty pharmacy.
*Averageminimummonthlycosttomeetthehighcostcriteriawas$1,200in2010and$1,154in2011**Newselectionin2011
EMD Serono Specialty Digest, 8th edition
Specialty Product Disease States Defined
ALS Alzheimer's Arthritis Asthma BloodModifiers CMV COPD CrohnsDisease CysticFibrosis Dialysis EnzymeReplacement GrowthHormone Hemophilia
HIV/AIDS Infertility IVIG MentalHealth MultipleSclerosis Oncology Psoriasis RheumatoidArthritis RSV Osteoporosis Transplantation ViralHepatitis
Specialty Pharmacy Services Defined
PatientServices 24/7PatientSupport RegistryCapabilities EducationalServices ReimbursementSupport/Benefitinvestigation/Prior
Authorizations/FoundationSupport ComplianceInitiatives Outcomemonitoring
CoordinationofCarewithProviders ClearlyDefinedBusinessModel
PhysicianRelationships/Referrals DifferentiatedbyMarketingServices
Specialty Pharmacy Services..Value Proposition
PreLaunchPreLaunch
LaunchLaunch
ContinuumofCareContinuumofCare
Drug Development $1.3 Billion
Market Access: Rebate Accrual $$$Product Marketing: Agency $$$
Sales Force: Salary, Training. Travel $$$
An ounce of prevention is worth a pound of cureBenjamin Franklin
Specialty Pharmacy Services..Value Proposition
Service Expectations
ComprehensivePatientCare24/7NurseorpharmacistoncallBenefitsInvestigation/PAOvernightdeliverytohomeorofficeTemperaturecontrolledpackagingOnlinesupportgroups
Service Expectations
Clinical extensionofofficeCompliancemanagementCustomizeddosedeliveryReimbursementcoordinationCodingandbillingassistance
Service Expectations
CompetitivepricingCustomizedprograms(atgrouplevel)Seamless,dedicatedaccountmanagementandtransitionMarketingandsalessupport
ServiceExpectations
BroaddistributionSpecialhandling/temperaturecontrolOvernightdeliveryPatientandofficeassistanceDirectpatientinteractionReimbursementcoordinationPAP/REMSexecution
Patient Physician Payor Pharma/Manufacturer
PhysicianRegistryPatientRegistryPharmacyRegistry
REMSManagement
BenefitsVerificationPriorAuthorization&AppealPAP
ReimbursementSupport
WelcomeCallsProductEducationLatetoFillCalls
PatientEducationandSupport
ControlledNoLeakage867/852Data
Distribution
DispensingDataInterventionDataOutcomesData
Data
DrugAccessChallenges:ManufacturersandtheirIntendedVision
For Every 100 Prescriptions Initially Written, Only 15 to 20 Prescriptions are Continued After
the Initial Supply
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TheFoundationforManagedCarePharmacy.MedicationAdherence:ManagingforTotalValue.2010.Availableat:http://208.40.175.32/cecity/components/util/pdf/docs/pdf/15208_print.pdf
Factors Impacting Adherence and Persistency to Therapy Regimen
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WorldHealthOrganization(WHO).AdherencetoLongTermTherapies EvidenceforAction.2003.Availableat:http://www.who.int/chp/knowledge/publications/adherence_full_report.pdf.
AgingWorldPopulation: Over500millionorabout8%ofpeople(worldwide)areoverage65 Theelderlypopulationisexpectedtogrowtomorethan1billionby2030;
thiswillaccountfor13%oftheworldpopulation* Themostrapidincreaseintheelderlypopulationisindeveloping
countries
Source:UnitedNationsDepartmentofEconomicandSocialAffairs*U.S.StateDepartment
Specialty Pharma Growth Drivers
Specialty Pharmacy Overview
SpecialtyProductsareavailableformorethan30diseasestates
In2008,197BiotechnologydrugsonthemarketintheUS* 19%ofwhichwereInfusedProducts* Through2012,thetopthreespecialtydiseasestates,
inflammatoryconditions,MSandcancer,willaccountfortwothirdsofspecialtydrugspendunderpharmacybenefits^
*Source: Dean Erhardt. D2 Pharma Consulting LLC. Presented at ECRM, Scottsdale, AZ. November 17, 2008.
^Curascript 2009 specialty drug trend report.
Specialty Pharmacy Overview: Yesterday
$100billionspentin2010 Lessthan2%ofthepopulationrepresented20%ofthetotal
drugspend In2010,sixofthetop20therapeuticclasseswerespecialty In2010,sevenofthetop20drugswerespecialtyproducts 150+FDAmandatedRiskEvaluationMitigationStrategies
(REMS)everincreasing
20112012USPharmaceuticalMarket Specialtyisthefastedgrowingsegmentandisexpectedtogrowata
rateof20%to23.5%annually* Itisestimatedthatspecialtyspendwillclimbtomorethan40%of
totaldrugspendby2030** Thespecialtycategoryisreceivinghighattentionduetothehighcost
ofdrugs Ninemedicinesnowcostmorethan$200,000peryear^ Averageannualpercentchangeinmanufacturerpricesforwidelyusedspecialtyprescriptiondrugsremainshighin2010=9.2%^^
*Curascript 2009specialtydrugtrendreport.**Source:IMS2008HealthYearinReview^Herper M.Theworldsmostexpensivedrugs.Forbes.February22,2010.^^AARPPublicPolicyInstitute.RXWatchdogReport:BrandNameandSpecialtyDrugsPricesContinuetoClimb.Washington,DC:AmericanAssociationsofRetiredPersons.May2010.
Specialty Pharmacy Overview: Today
Limited Distribution Specialty Products
Manufacturer Drug Manufacturer Drug Manufacturer Drug Manufacturer Drug
Actelion Tracleer,Ventavis,Zavesca BayerMirena,Nexavar Novartis
Exjade,Visudyne
Organon Implanon
AstraZeneca Iressa,Synagis Biomarin Kuvan OrphanMedical XyremRareDiseaseTherapeutics Orfadin
Biogenidec Tysabri,Rituxan Celgene Revlimid Questcor ActharGel Shire Elaprase
BMS Erbitux GileadSciences Letairis Serono Zorbtive UnitedTherapeutics Remodulin
Endo SupprelinLA GenzymeCerezyme,Fabrazyme,Myozyme
Tercica Increlex,Somatuline ZLBBehring Vivaglobin
GenentechAvastin,Herceptin,Xoliar,Lucentis,
Nutropin,Raptiva,GSK Tykerb Pfizer Inlyta Alexion Soliris
Source: Armada Health Care internal data base.
Specialty Pharmacy Pipeline: Oncology
Oncologymakesup40%ofthespecialtypipeline Ashifttooralchemotherapyagentsisoneofthemajortrends
inspecialty Oraldrugsmakeup35%oftheoncologypipeline By2013,thepercentageoforaloncologydrugswillreach25%,up
from10%in2009
*WalgreensSpecialtyPharmacyStateoftheIndustryReport2009.
Specialty Product Pipeline
Specialty Manufacturer Pipelines
Specialty Pharmacy Pipeline: Deep Dive
Orphandrug:Rarediseasesaffectinglessthan200,000U.S.people Potential25to30millionpatientsacrosstheU.S. Research&DevelopmentisactivelyencouragedthroughtheNational
InstituteofHealthsrareandneglecteddiseaseinitiativeandtheU.S.FDA
ORPHAN DRUGS IN DEVELOPMENT
Category #
Other 37
Transplantation 20
Respiratory 14
Infectious Disorders 31
GrowthDisorders 5
Genetic 67
Gastrointestinal 10
Category #
EyeDisorders 11
Cardiovascular 6
Blooddisorders 12
Autoimmune 18
Cancerrelated 10
Skincancer 31
Bloodcancer 79
Cancer 107
SpecialtyPharmaceuticals:EvolvingCustomer
Armada Membership Profile
Consistsofthenationsleadinglocal,regionalandnationalSpecialtyPharmacyProvidersprovidingcomprehensiveprescriptionservicesanddiseasestatemanagementprogramsforspecificchronicconditions
HomeInfusion/Home
Health
Clinics/IDNs/OutpatientPharmacies
RetailChains/Independents
National
SpecialtyPharmacies
Regional
Independent
Specialty Pharmacy Players
TraditionalCustomer1. ClosedShopspecialtypharmacy
Largepubliccompanies PBMowned Independent Chainownedseparatelocation
2. Fullcontractloads3. Generallyhaveaccesstolimiteddistributionproducts4. Havephysician/payersalesforce5. Developedinternaldispensingsystem6. Armadaprovidescomplimentaryservices7. ArmadaprovidestypicalGPOservices8. Armadacollectsdailydispensingdataspecialtyproducts9. Armadaprovidescontractingopportunities
Specialty Pharmacy Players
NewSpecialtyCustomer1. SPpatientsareambulatory2. MoreproductsareaccessibletoOpenAccesspharmacies
35%ofoncologypipelineareoraldrugs
3. Stillafair#oflimiteddistributionproducts4. Trendtowardsgreaterpharmacyaccessfrompayers
i.e.UnionPlans
RetailCustomer1. Increasedaccesstopatients2. Basicpatientservices
Facetofacepharmacisttime Pointofsalemessaging
3. Limited,butgrowingaccesstomanufacturerdiscounts4. Lackofaccesstolimiteddistributionproducts5. Lackofpatientoutreachcapabilities6. LimitedresourcesforcomplicatedP