艾昆纬-患者服务和市场准入季度顾问

WhitePaper

Q1,March2023

PatientServicesand

MarketAccess

QuarterlyAdvisor

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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.

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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.

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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.

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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