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WhitePaper
Q1,March2023
PatientServicesand
MarketAccess
QuarterlyAdvisor
|3
Quarterlyoverview
Changeisaconstantwhenitcomestomarketaccess.Overtheyears,thebiopharmaceuticalindustryhasexperienceditsshareofdisruptions,frominnovativepayercontrolstoaglobalpandemic.2022concludedwithalarge-scalebill,theInflationReductionAct(IRA),butitsmajorhealthcareprovisionshaveyettobeenacted.Theindustryalsocontendedwithcontinuedmarginpressures,increasingpatientaccessbarriers,andcontroversialapprovalsandlaunches--theeffectsofwhichwillinfluencemarginsandstrategiesintheyearsahead.
Asweheadinto2023,theIQVIAMarketAccessCenterofExcellenceispayingattentionto10eventsandtrendsthatcouldshapethefuturemarketaccesslandscape.
Youcanreadourrecentlypublishedblogdetailingthoseeventsandtrendsonthefollowingpage.
Additionally,thisyear,alongwithourquarterlyadvisornewsletter,whitepapers,andblogs,wearelaunchingayear-longwebinarseriescalledIQVIA’sMarketAccessMasterClass.Theintentistodivedeeplyintomodernissuesfacingtheindustry,liketheIRA,inanefforttobringmorenuancedcontenttoourthoughtleadership.TheMasterClassisfree,withallepisodesbeingrecordedandavailableon-demand.Makesuretoregistersoyoucanstayontopofthelatesttrends.
LukeGreenwalt
VP,MarketAccess
CenterofExcellence
Newyearandfamiliarchallenges:Whattowatchinmarketaccessfor2023
IN2023,THEIQVIAMARKETACCESSCENTEROFEXCELLENCEISPAYINGATTENTIONTO10EVENTSANDTRENDSTHATCOULDSHAPETHEFUTUREMARKETACCESSLANDSCAPE.
ByLukeGreenwalt,VicePresident,MarketAccessCenterofExcellence,IQVIA
HEALTHPOLICYANDTHEINFLATIONREDUCTIONACT
TheInflationReductionAct(IRA)isthemostrecentlegislationfromagovernmentthatisincreasinglyfocusedonpharmaceuticalspendingandattunedtomarketaccessdynamics.AsofJanuary2023,theIRArequiresfreerecommendedvaccines,$35monthlycapsonpatients’insulinspending,priceinflationpenalties,andadjustedbiosimilarreimbursementinMedicare.Overthenextseveralmonths,U.S.policymakersandgovernmentorganizationssuchastheCentersforMedicare&MedicaidServices(CMS)andtheDepartmentofHealth&HumanServices(HHS)areexpectedtoprovideevenmoreclarityonmanyoftheIRA’skeyprovisionsthroughrulemaking.
Focusremainsonthedetails:
•ItiscurrentlyunclearhowpriceswillbenegotiatedinMedicare.Whileguidelineshavebeenreleasedthatindicatethefloorofthenegotiateddiscount(maximumfairpricerangingfrom25-60%offoftheprice),manufacturersarelookingtounderstandwhattheceilingmightbeandhoweithersideofthenegotiationwilljustifyitsrecommendations.Fornow,CMSplanstopublishthefirst10drugscoveredunderMedicarePartDthathavebeenselectedfortheMedicareDrugPriceNegotiationProgrambySeptember2023.
•MaximumFairPriceimplementationisanotherareaofinterestbecausenegotiationswillnotinfluenceproducts’wholesaleacquisitioncosts(WACs).Afairexpectationisthatmanufacturerswillberesponsibleforprovidingadditionalrebatestopayerswhowillfloattheunnegotiatedcostatthepointofsale.Still,uncertaintyinthedrugacquisitionchaincanchallengeforecastsandplanning.
•CongressionalBudgetOffice(CBO)estimatesindicatethatpremiumswilloffsetthegreaterpayerliabilitiesfromPartDredesign,butthatcouldrequiresizableincreasesthatmaynotbefeasibleforCMStooffset.Theindustrymustbepreparedforthepossibilitythatmanufacturerswillbeaskedtoabsorbsomeofthosecostseitherbyhigherrebatesortighterutilizationmanagement.
•CMSiscurrentlyrequestingandreviewingcommentsfromtheindustry.Stakeholdersarelikelytousethistimebeforerulemakingisfinalizedtopetitionfortheirinterests,aswellaslegallychallengesomeoftheprocessandprovisionsoftheIRA.
Meanwhile,pharmaceuticalmanufacturersandotherstakeholdersmust
anticipateandplanforIRAimpact
.Scenario-basedmodelingwillplayacrucialroleinearlystrategydecisionmaking.Stakeholdersmustalsolooktootherpoliticalactivitiessuchasexecutiveorders,rules,andbillsthatarelikelytotacklehealthcaretransparency,pricing,andinequality.
DEMONSTRATIONOFVALUE
TheIRAopensthedoorformoregovernmentoversight,buttheindustryhasgrappledwiththequestionofvalueforyears-eitherthroughalternativecontracting,indication-basedaccess,orpreviousattemptsondrugpricecontrol.NowCMSwillstandupitsDrugPriceNegotiationProgramwhichwillconductpharmacoeconomicanalysesandnegotiateMedicarepriceswithdrugmanufacturersaspartofitscharter.WhilelimitedtoMedicarefornow,marketsareprimedmorethaneverforclinicalandeconomicevaluationofcostsandmanufacturerswillneedtobeprepared.
4|PatientServicesandMarketAccessQuarterlyAdvisor,Q1,March2023
|5
Atminimum,someevolutionbeyondthetraditionalpriceandpayeraccessapproachistobeexpectedandmayevenopenthedoorforthirdpartiestoweighinorforHealthTechnologyAssessmentdebatestobegin.
Leqembisetsthetonein2023asabranddefendingitspricingdecisionatapproval.Timewilltellwhetherpublicpricejustificationbecomespartofgenerallaunchstrategyandwhetherotherstakeholderswillagreewiththeevaluation.Despiteabrand’sreasoning,payercoveragemaynotfollow,orotherorganizations,suchastheInstituteforClinicalandEconomicReview(ICER,)mayhaveadifferentassessment.Evenmorechallenging,theindustrydoesnothaveauniformunderstandingofvalue.
Itmaynotbepossibletosimplydefinevalue.Rather,asmarketaccessprofessionals,wemustask,valuetowhom?Pharmaceuticalinnovationisontheprecipiceofnovel,sometimescurative,developmentswherepatientsareeagerforachanceatdiseasemanagementifthecoverageandcostscanonlysupportit.
INNOVATIONPIPELINE
ItisanexcitingtimeinbiopharmawithbreakthroughsinAlzheimer’s,genetherapy,metabolicdiseases,andvaccines.Thelistgoeson.Itisexciting,butalsochallenginggiventhemarket’sconflictbetweentheneedforinnovationandthefinitecapacityforcost.Thiscapacityisstrainedbyanagingpopulation,risingcosts,andepidemics.Historyhasdemonstratedthatacure(aswithHepatitisC)isnotenoughtoearnwidespreadaccess.Aduhelm’smorerecent,troubledlaunchhasfurtherandundeniablychangedthewaymanufacturersareevaluatingtheirportfolios.
Thestakestoinvestandlauncharehigherthan
ever,necessitatingcarefulpipelinemanagement.
Manufacturerswillhavetoconsidertheclinicalpositioningoftheirproductsandmarketaccessstrategymuchearlierinthepre-launchprocessastheboundariesbetweenbothaspectsareblurring.Theclinicalprofileofadrugwillhavebearingonitsprospectsinthemarketandultimatelyaffectthelong-termviabilityofadrug’sdevelopment.
EXPANDINGPAYERCONTROL
Payercontrolhasbeenontheriseforyearsasrestrictionratesaregrowingandfewer,selectproductsachievepreferentialstatus.Already,thenumberofuniqueformularyexclusionsaveragedover600across2023’snationalpreferredformularies.Butthatisonlyonepieceofthefullcontrolpicture.
Formularyrestrictions
andexclusions
areexpandingintonewmarketsthathavepreviouslybeenconsidereduntouchable,suchasoncologyandevensomeprotectedclasses.Thiscouldbeanunexpectedshiftwithsizeableaccessandmarginimplicationsformanypharmaceuticalbrands,particularlyaspayersmustcompensatefornewcostliabilitiesundertheIRA.Monitoringandforecastingwillprovevitaltolong-termsuccess.
Whileformularyleversarealreadyanestablishedformofcontrol,itisIQVIA’sexpectationthattheindustrywillalsoseepayersaddtotheirtoolkits.Onewaytheindustrymightexpecttoseepayersmanageaccessisthroughtriagingpatientsorlimitingtreatmentpopulations.Nationalcoveragedeterminations(NCDs),coveragewithevidencedeterminations(CEDs),andself-administereddrugexclusionlists(SADlists)areexistingmechanismswithinCMS.Thoughnotcommonlyusedtoday,theyprovideanoption,orinspiration,forfutureaccessmanagement.
NEWSITESOFCAREANDACQUISITION
Withpayerrejectionsandcost-sharingontherise,patientsarelookingbeyondtheirbenefitsinordertofillprescriptions.Asoneexample,
pharmacydiscount
cards
mayaccountforlessthan6%ofallprescriptions,butmorethan10%ofinsuredpatientsuseatleastone.Theyhavenearlydoubledinprevalencesince2017andareontracktogrowaspatientsencountermorebarrierstoaccessandarecompelledbythepotentialsavingsout-of-network.CostPlusDrugs,identifiedasapublic-benefitcorporation,isanemergingvariationonthediscountcard,offeringastreamlinedsupplychainandtransparentpricingonmanygenerics.Weexpecttoseemoresuchentriesintothisspaceinthefuture.
Demandforthesesolutionsreflectagrowingtrendamongpatientstakingadvantageoftheiroptions.Manufacturersmightfindopportunitiesforfuturepartnershipwithsuchemergingorganizationsastheylooktosupportpatientsmoredirectlyandimproveaccesstotheirtreatments.Perhapsoneexampleexistswithtelemedicine,whichsawaboostafterCOVID-19.Somecompaniesnowuseonlineplatformstodiagnose,prescribe,andevendistributemedicines–mostlygenericsfornow–tospecificpopulations.Nowmorethanever,patientsareoneonlineadvertisementawayfrombeingdiagnosedforamentalhealthdisorderandprescribedanSSRI.
Newaccesspointsarenotwithouttheirchallenges.Costcontainmentcompaniesarealsomakingheadwayinthemarket,movingprescriptionsthroughpharmacydiscountcardsandotherchannelstokeepspending.Itwillbechallengingbutnecessarytomeasurethesealternativesitesinordertoensurethattreatmentsareasaccessibleasforecastsmightexpect.
MODERNPRACTICESFORLAUNCH
Givenrisingpayercontrol,manufacturersarehavingtoadjusttheirexpectationsforlaunch.Success,inwhateverwayitisdefined,maynotbeachievableforseveralyearsorevenlongerafterlaunchdependingonpayeraccess.Manyoftoday’sforecastsdonotproperlyaccountforthedelayinformularyuptakethathastakenplaceovertheyears,puttinglaunchbrandsinapositiontooffervouchersandbridgeprogramstobypassdelayedcoverage.
However,theseprogramscanhavelong-term
effectsontheperformanceofabrandaswellasthesustainabilityofitssupportprogramwhentheystruggletotransitionpatientstoinsurance.Ofthetop10mostsuccessfullaunchesbetween2020-2022,nearlyallhadaggressivepatientsupportprograms,withsometimesasmuchas80%ofvolumebeingfullyoffsetbymanufacturersupport.
6|PatientServicesandMarketAccessQuarterlyAdvisor,Q1,March2023
|7
PricingpressuresfromtheIRAmakethestakeseven
higherin2023.Manufacturerswillhavetopayrebates
toMedicareforanypriceincreasesthatexceedthe
consumerpriceindex(CPI),makinglaunchprice
particularlyimportant.Manufacturerswillalsohaveto
considerhowthetimingofpricenegotiationwillaffectthelongevityofabrand.Notably,smallmoleculesstandtofacenegotiationsoonerthanlargemolecules,at9yearsafterlaunchinsteadof13.
Combinedwithmarginpressuresthatcontinuetoimpact
theindustry,launchpricepressureswillbeahottopic
inthecomingyears.Withone-thirdofrecentlaunches
pricedabove$200,000peryear,agrowingnumberofproductslaunchedatpricesabove$1million,andtherobustpipelineofinnovationsettolaunchinthenextfewyears,weexpectthelaunchpricedebatetointensify.Manufacturersmustbeginpreparingtheirevidencestrategynow.
PHARMACYBIOSIMILARS
Oneofthelargestbrandsinthehistoryofbiopharma,
Humira,willfacedirectcompetitionin2023as
biosimilarsofadalimumabenterthemarket.Amgen’s
AmjevitawillleadwithexclusivityinJanuaryandseveral
otherswillfollowinJuly.Adalimumabisunlikeinsulin
glargine,thefirstpharmacybiosimilar,inmanywaysandisthereforeaneventtowatchin2023.Stakeholdersacrosstheindustrywillbewatchingtoseewhatstrategiesbothinnovatorandbiosimilarmanufacturersemployforpricing,contracting,marketing,andpatientsupport.Currentexpectationsmayhavesettledonmodestdiscountsandbrand-likestrategies,butitremainstobeseenwhateachcompanywilldo.Biosimilarsuccessliesintheeyeofthebeholderastherearemanywaysthatonecanviewthemarket.
Fromtheinside,wewillalsobewatchingthemarket’sresponse.Theextenttowhichpayerscoverbiosimilaradalimumab,aswellasthefrequencyofpharmacysubstitution,remainsuncertainandunstable.DespitecurrentdynamicsthatfavorLantusoveritsbiosimilars,dynamicscouldchangedependingonthecompetitive
marketforadalimumabandshiftingpayerliabilitieswith
theIRA.Regardless,thisfirstyearwillhaveimplications
forfuture
biosimilarlaunches
aswellasthefavorability
ofbiosimilardevelopmentaltogether.
DEDUCTIBLEACCUMULATORSANDCOPAY
MAXIMIZERS
Thenumberof
deductibleaccumulatorsandcopay
maximizers
aregrowingeveryyear.Theycostsupportprogrambudgetsbillionsofdollarsintotalandaccountforamajorityofspecialtydrugs’copaycardspending.
Theyalsocontinuetoplay
agrowingroleinpayer
budgets
,bothbecomingastrategicleverandpresenting
acontractingpitfallforbrandssubjecttothecontrol.
Tocountermanufacturerandpatientmitigation,theseprogramshaveevolvedovertime.Someusevariablecopayswhileothersmightresembleatraditionalcoinsurancebenefit,makingitdifficultformanufacturerstobudgetappropriately.Theuseofvariablecopaysalsocreatesachallengetoidentifypatientsthatarebetter
suitedforrebateprogramsordebitcardsinsteadof
traditionalcopaycards.In2023,manufacturersmust
analyzetheiraccumulatorandmaximizerexposure,even
goingsofarastoincorporatethesedynamicsintotheir
pre-launchforecasts.Theymustalsostrategizetoensure
thelong-termsustainabilityoftheirsupportprograms.
Giventherecentgrowthoftheseprograms,theindustryresponse,theregulatoryresponseofmoreandmorestatebans,patientadvocacy,andmorepublicawareness,thesecontrolswillremaincontroversial.Treatingproductslikeoncologics,HIVanti-virals,HepatitisC,andmultiplesclerosisdrugsasnon-essentialmedicationisbadforpatientsandpublichealth.Legislatorsarewellwithintheirrightstoseekbansforprogramsthathurtpatientoutcomes.
PATIENTACCESSDISPARITIES
Healthequityisapriorityfortheindustry,includingIQVIA.Fornow,industryisonlybeginningtoaddressdisparities,butalreadypoliciesareinfluencingclinicaltrialdesignandinvestigatinghealthdeserts.Marketaccessalsohasaroletoplay,by
identifyingand
addressingstructuralaccessbarriersacrosspopulations
.
Severaldrugmanufacturerspledgedfundstoaddressdisparitiesanddisadvantagesinhealthcare.Asmarketaccesspractitioners,weseethisasanopportunitytolookatequityasawhole-fromsymptomtotreatment.Assolutionsaredevelopedthatwillhopefullybridgegapsinrepresentationanddiagnosis,theindustryalreadyhasmanytoolsatitsdisposaltominimizebarrierstoaccess.Thesetoolscouldseemajorinnovationsinthecomingyearsasinvestmentsinequitycontinue.
PERSISTING340BCHALLENGES
340Bremainsoneofthelargest
margin-mitigating
concerns
fordrugmanufacturerstoday.
Explosive
growthinthechannel
hasdoubledutilizationoverthelast5yearswithlittlesignofabatement.Thefinancialincentiveforcoveredentitiestoexpandtheuse340Bishighandthereislittleappetitefromlegislatorsorregulatorstomakechangestothesystem.
Inrecentyears,publiclegaldisputeshavechallengedpracticeswithinthe340BprogramandtheHealthResourcesandServicesAdministration’s(HRSA)authoritytopenalizemanufacturersforlimiting340Bdistribution.Intheabsenceofclarityaround340Bscope,manufacturersareattemptingtolimit340Btothe1996patientdefinition,whileprovidersarepushingtoexpandtheprogram.Pressureisonlawmakerstobetterclarifythescopeandrules,asthescaleofthisprogramcouldnothavebeenanticipatedwhenitwasfirstdesigned.
AddingtotheintensityoftheissueareprovisionsintheIRAthatallowfor340B-reimbursedprescriptionstobeexcludedfrominflationarydiscounts.Giventhegenerallackofvisibilityinto340Btransactions,thelargepreponderanceofMedicareclaimsthatarealsotransactedthroughthe340Bchannel,andthecomplexdebatesurroundingtheissue,theprogramwillcontinuetobecontroversial.
Fiveyearsandcounting:Deductibleaccumulatorsandcopaymaximizersin2022
ByJamesBrown,VicePresident,U.S.MarketAccessStrategyConsulting,IQVIA
RahelEhrenberg,Principal,U.S.MarketAccessStrategyConsulting,IQVIA
RuthyGlass,PhD,Consultant,U.S.MarketAccessStrategyConsulting,IQVIA
BenjaminPlotnik,Associate,U.S.MarketAccessStrategyConsulting,IQVIA
Introduction
IQVIAhasreportedondeductibleaccumulator
andcopaymaximizerprogramssince2017.The
lastpublicationin2020,
ThreeYearsIn:Deductible
AccumulatorsandCopayMaximizersin2020
,examined
theirprevalenceandcostimpactsinceimplementation.
Accumulatorsandmaximizersexisttoextractthemost
valuefrommanufacturer-supportprograms,offsetting
patientdeductiblesandcopays,aswellasthepayer
expenditures.Wecontinuetomonitortheseplansand
evaluatewhattheymeanforpatientsandthecopaycard
budgetsthatsupportthem.
8|PatientServicesandMarketAccessQuarterlyAdvisor,Q1,March2023
|9
Overtheyears,accumulatorsandmaximizershavemanagedtogrowdespitemanystakeholders’opposition.In2021,43%ofcoveredlivesincommercialplanswereinplansthathaveimplementedaccumulators,while45%wereinplansthathaveimplementedmaximizers.Thegrowthofaccumulatorandmaximizerplanshasledtotheirincreasedproportionintotalassistancespend,costingmanufacturersmorethananestimated$5billiondollarsincopaybudgets.Pharmaceuticalmanufacturersandpatientadvocacygroupshave
filedlawsuitsagainstthepharmacybenefitmanagers(PBMs)andpolicymakersthatarebehindaccumulatorandmaximizerproliferation.Stategovernmentspassedandimplementedbansthatprohibiteddeductibleaccumulatorsinanystate-sponsoredplans.Nevertheless,accumulatorsandmaximizers,combined,affectasmanyasathirdoftheprivatelyinsuredpatientsusingspecialtymedicinesforconditionsthatincludeautoimmunedisordersandcancer.
Asaccumulatorandmaximizerplanscontinuetotakerootinprescriptioncost-sharingeconomics,data-driveninsightsareneededtoestablishtheirtrueimpact.
Inatimewhenpharmaceuticalmarginsarebeingcompressed,patientcost-sharingisrising,andsupportbudgetsarestrained,itismoreimportantthaneverfortheindustrytounderstandandquantifythisimpact.Thisreportprovidesthedataandanalyticsrequiredtodoso.
EXECUTIVESUMMARY
•Prevalence:
»Acrossselectspecialtymarkets,exposuretoorprevalenceofaccumulatorandmaximizerplansgrewfrom14%ofcommercially-insuredpatientsin2019to33%in2022.
»Accumulatorandmaximizerprevalence/growth
trendsvaryacrossandwithintherapeuticareas,mostlyreflectingdifferencesinpatientsupportprogramdesigns.
»Growthinaccumulatorandmaximizerprevalenceislargelydrivenbytheincreasedsaturationwithinlargespecialtypharmaciesthatareverticallyintegratedwithpharmacybenefitmanagers.
•Costs:
»Patientcostexposures,andthus,thebuy-downofacopaycardredemptionwithinanaccumulatorormaximizerplan,is3-5timesmorethanthatofredemptionswithintraditionalplans.
»Theaveragebuy-downpercopaycardredemptionisincreasingatagreaterratewithinmaximizerscomparedtoaccumulators,drivenlargelybyevolvingmaximizerdesigns.
»Asaresult,patientswillexhausttheirassistancefundssoonerandmorefrequentlyin2022comparedtoprioryears.
•Policy:
»By2022,14statespassedlawsprohibitingtheuseofdeductibleaccumulators,thoughtheycanonlyapplytostate-sponsoredplanssuchasthoseinthehealthcareexchanges.
»Statelawsthatprohibitdeductibleaccumulatorshavebeenlargelyineffectiveatstuntingaccumulatorgrowthamongcommercially-insuredpatientsinstatesthathaveimplementedthem.
Clickheretoreadthefullwhitepaper:
FiveYearsandCounting:DeductibleAccumulatorsandCopayMaximizersin2022
Disruptioninthemarket:CostPlusDrugs
ByJayKrippes,FieldDirector,NationalAccounts,IntegratedPatientServices,PatientSupportServicesCenterofExcellence
HannahDeibert,NationalAccountManager,IntegratedPatientServices,PatientSupportServicesCenterofExcellence
MarkCubanisawell-knownentrepreneurandinvestor,bestknownforhisroleasowneroftheDallasMavericksbasketballteamandasapanelistonthetelevisionshow"SharkTank."Inrecentyears,CubanhasalsobeenvocalaboutthehighcostsofprescriptiondrugsintheUnitedStates.Cubanstates,“TheonlytrueunderstandingofdrugpricingthatconsumersorpatientshaveisviathepharmabroMartinShkreliiwiththeideathatyoucanraiseadrugpriceby5000%...ifyoucanraiseitby5000%,there'sareallygoodchanceyoucanreduceitby5000%.”ThatconceptwasthegenesisofCuban’sproposedsolutioncalled“CostPlus”pricing.
OnJanuary19,2022,CubanlaunchedMarkCubanCostPlusDrugCompany(MCCPDC)stating,“Westartedthiscompanyasanefforttodisruptthedrugindustryanddoourbesttoendridiculousdrugprices.”Theconceptbehindcostpluspricingissimple:apharmaceuticalmanufacturerproducesagenericdrugandsellsitforapricethatisequaltothecostofproductionplusasmallprofitmargin.Thispricingmodelisintendedtomakegenericdrugsmoreaffordableforconsumerswhilestillallowingthemanufacturertoturnaprofit.
ThelargestchallengeMCCPDChadtoovercome,accordingtoCuban,washowcanwegetpharmaceuticalmanufacturers,distributors,orwholesalerstoselltoMCCPDCdirectly?Cubansharesittookusmorethanthreeyearstogetthroughthatprocess,tobeabletoselltheirfirstdrugalbendazole.Trustwasakeycomponentforthatprocess.Cubansays,“InitiallyIwasnot[goingto]putmynameonit…butIputmyname…becauseitshowedthosemanufacturersanddistributorsthatIwascommittedfinancially,andthattherewasalevelof
trustbecauseIwasputtingmynameonit.It'stheonlybusinessI'veeverputmynameon.”
MCCPDCintendsnottochargemuchmorethanthedrugmanufacturingcosts."Every
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