getting to access : context for innovative approaches for access to innovative therapies

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Page 1: GETTING TO ACCESS : Context for Innovative Approaches for Access to Innovative Therapies

D U R H A N E W O N G - R I E G E R

ContextforInnova-veApproachesforAccesstoInnova-veTherapies

Page 2: GETTING TO ACCESS : Context for Innovative Approaches for Access to Innovative Therapies

Innova&veMedicinesOfferOpportuni&esandChallenges

� Whythisforumma9ers:Innova-vedrugtherapiesaremedicinesthatcan:¡  Offerasubstan-alimprovementoverexis-ngtherapies;forexample,biologicscanmodifytheunderlyingcauseofacondi-onratherthanjusttreatthesymptoms;

¡  Addressanunmetneed;manydrugsforrarediseasearethefirsttobedevelopedforthatcondi-on

¡  Targetthe(unique)characteris-csofasubgroupofpa-entsbasedongene-cmakeupand/orotherindividualcharacteris-cs

¡  Curethedisease;forexample,byelimina-ngthecause(hepa--sCvirus),replacingabnormalcells(stemcellreplacement),ormodifyingthefaultygene

Page 3: GETTING TO ACCESS : Context for Innovative Approaches for Access to Innovative Therapies

Innova&veMedicinesOfferOpportuni&esandChallenges

�  Butinnova-vetherapiescomeatapricethatisoKenconsidered“unaffordable”undercurrentassessmentprocesses¡  Individually,therapiestendtobemuchhigherthanthe“old”therapies

theyarereplacing¡  Thenumberofinnova-vetherapiesisincreasing,asistheimpactondrug

budgets¡  Ourassessmentprocessesdonotaddressinnova-on;theyweredeveloped

todeterminehowmuchincrementalcostshouldbepaidforincrementalbenefitstoexis-ngtherapiesandhowtoallocatedrugbudgetstoachievemostoverallhealthofapopula-on,regardlessofthecondi-onsandneed

¡  Individualhigh-costtherapiescanhaveaniden-fiableimpactonoveralldrugplanbudgets,whetherprivateorpublic

Page 4: GETTING TO ACCESS : Context for Innovative Approaches for Access to Innovative Therapies

AccesstoMedicines:Vic-mofAging

�  Agingeconomieswithlimited,zero,ornega-vegrowthpuSngpressureongovernmentstomeetincreasedneedswithfewerresources

�  Aginghealthinfrastructuresorganizedaroundout-datedmodelsofcareandinefficienttechnology¡  Resourcesallocatedaroundhospital-basedcri-calcare¡  Lackofinvestmentinchronicdiseasesandpreven-on

�  Agingpopula-onsrequiringmorehealthcare¡  Be9erhealthcare,nutri-on,safetyresultinmorepeoplelivinglongerandgeSngdiseasesofoldage

�  Agingdrugbudgets¡  Stableordecreasingbudgetsbuiltoninfluxofgenericsubs-tutes¡  Innova-vetherapiesofferingunprecedentedbenefitstobroaderaswellasnichepopula-onsbutat

unprecedentedprices�  AgingR&Dapproaches

¡  Research“quagmire”indiscretephasesandRCTgoldstandard¡  Earlyregulatoryapprovals(forunmetcri-calneeds)leadingtorejec-onbypayersforlackof

evidence¡  Lackofacceptedscien/ficmethodologytoevaluate“real-world”data(andlackoftechnologyto

collect)

Page 5: GETTING TO ACCESS : Context for Innovative Approaches for Access to Innovative Therapies

Innova/onsElsewhere

�  ADAPTSMART(EMA/EUNEHTA/IMI)�  NEWDIGS-MIT�  UKHST�  Germany,FranceManagedAccess/CED

Page 6: GETTING TO ACCESS : Context for Innovative Approaches for Access to Innovative Therapies

EURORDIS

�  NewBlueprinttoCutcostsandfasttrackR&D�  EarlydialogueandEuropeancollabora/onondetermina/onofvalue

�  Europeancoopera/onframeworkforfairpricesandsustainablehealthcarebudgets

�  Con/nuumofevidencegenera/on

Page 7: GETTING TO ACCESS : Context for Innovative Approaches for Access to Innovative Therapies
Page 8: GETTING TO ACCESS : Context for Innovative Approaches for Access to Innovative Therapies

Innova/veMedicinesOfferOpportuni/esandChallenges

�  Identify options for access that work for all ¡  Supportmanagedaccess(criteria-based,monitored)¡  Addresseskeyconcernsofallstakeholder(/meliness,placeintherapy,value,

budgetimpact)¡  Forwardlookingtobestintegratefuturemedicines(rare,personalized/

targeted,stemcellandgenemodifica/on,repurposed,biosimilars)�  Iden/fywaysforallstakeholderstoworkcollabora/velytowardconsensusapproach¡  Iden/fywhatisworkingincurrent(Canadian)approachesandshouldbe

enhanced¡  Iden/fywhatisgeXnginthewayandstrategiesforaddressing¡  Iden/fyareasofagreement(keep),disagreement(resolve),andambiguity

(clarify)¡  Iden/fypathwaystoopencommunica/on,transparency,andengagement

(ofallstakeholders)