CRAcharSRivr

EuropeanAccessHurdlesPortal&theRootCausesAnalysis

Smallermarkets

RevisedCountryAnalysis

May2025

Associates

Approach:Wehavefollowedamulti-stepapproachtounderstandtherootcausesofunavailabilityanddelayinsmallermarkets

Definingthequestion

Companyinterviews

Solutionsandreporting

Literaturereview

?Establishwhattheexpected

challengeswillbewiththePortal

2025data

?Drafthypothesesonhowthedatacanbebetter

explained,

particularlyforsmallermarkets

?Collaboratewith

nationaltrade

associationstohostfocusgroupsand

understandlocal

accesschallengesandpolicypriorities

?Conduct1:1

interviewsbetweenCRAteamand

company

representatives

?Pressure-testhowtheidentified

challengeshave

impactonfilingandaccess

?Developproposedpolicysolutionsforovercomingthe

identifiedchallenges

?Draftreportonrootcausesinsmallermarkets

?PublishinApril/May

Countryfocusgroups

?Conductreviewofexistingevidenceinthepublicdomain:

oAcademic

publications

oGreyliterature(policypapers,industry

publications,media,etc)

MaltaCyprusLatviaLithuaniaEstoniaSloveniaCroatiaN.MacedoniaMontenegro

2

AssociatS

CRAchariSRivr

Approach:Wehaveappliedthisframeworktounderstandpatternsoffilingandavailabilityineachsmallermarket

1

2

3

4

…becausefeaturesofthe

localsystemmakeit

impracticaltofile

Examples:

?Non-transparentP&R

criteriaandmethodologies

?Lowlikelihoodofsuccess

?Under-resourcedHTAbs

?Waitinglistsforreimbursement

…becauselocal

requirementsmakeit

difficultorimpossiblefor

theMAHtofile

Examples:

?Requirementsforpriceor

assessmentsinothermarkets

?Expectationsofpriceor

assessmentsinothermarkets

?Lackofnecessarylocaldataorexpertise(lowpatient

population)

…becauseitis

unnecessarytofileto

obtainaccess

Examples:

?Directtotendering

?Class-levelservicelists

?Alternativeaccessschemesthatprovidefasterpatient

access

Hypotheses

Whymighttherebedelaysinfilingofanewlycentrallyapprovedmedicine?

…becauseitis

unsustainable(thebusiness

casecannotbemade)for

theMAHtodoso

Examples:

?Unsustainablepricingrules

?Unpredictablebudget

allocationdecisionsanduseofclawbacks

IfMAHslackalocalpresenceinasmallermarket,thiscanmakeitimpossible,impracticalorunsustainableforthem

tofileanewmedicineforP&R,dependingonthelocalcontextandP&Rrequirements

3

Summaryresults:Wefindthatthereasonsfordelaysinfilinginsmallermarketsaremulti-facetedanddrivenbythelocalcontext

Whyaretheredelaysinfilingofnewlycentrallyapprovedmedicines?

Relativeimportanceofeachfactorin:

…becauseitisunnecessarytofiletoobtainaccess

…becauselocal

requirementsmakeitdifficult

orimpossiblefortheMAHto

file

…becausefeaturesofthe

localsystemmakeit

impracticaltofile

…becauseitisunsustainable(thebusinesscasecannotbemade)fortheMAHtodoso

Malta

Cyprus

Latvia

Lithuania

Estonia

Slovenia

Croatia

N.Macedonia

Montenegro

4

Sources:EuropeanAccessHurdlesPortaldatacollectioncycle6(N=94products);CRAliteraturereviewandinterviewswithpharmaceuticalcompaniesandtrade

associations(conductedDec2024-Feb2025)

Abbreviations:MAH=marketingauthorizationholder

Key:

Relativeimportance(inthelocalcontext)ofeachpotentialargumentforexplainingthefilingdata

AssociatS

CRAchariSRivr

Malta

NewperspectiveonRootCauses

1.TherearenodirectbarriersimpactingthetimingoffilinginMalta,butinpractice,payersreferencethecompletedassessmentsanddecisionsmadeinotherEuropeancountries

2.TheMalteseP&Rsystemischronicallyunder-resourced,leadingtodelaysindecision-making,budgetaryconstraintsseespecifictherapyareasprioritizedforprocurement

3.Thereisasignificantlackoftransparencyastoaproduct’sstatusafterfilingandasignificantbacklog,discouragingfilling

4.Thetendersarelargelysingle-winner,price-onlyandlasting3-4years,meaninginnovativemedicinescanbefrozenoutofthepublicreimbursementmarket

InMalta,thereisalowreimbursementrate(2%)ofinnovativemedicinesandalowfilingrate(9%)

P&Roverview

?EitherMAHsorMedicalConsultantscanfileforinclusionontheGovernmentFormularyList(GFL)

?PharmacistswithintheDPAcompileHTAsincludingclinicalandbudgetimpactassessmentsforreviewbytheGFLAC

?TheGFLACandACHCBreviewoutputsfromtheDPAanissuebothtechnicalandfinancialrecommendationstotheMoHonwhetheraninnovativeproductshouldbeincludedontheGFL

?AlongwiththeMinisterforFinance,theChiefMedicalOfficerandSeniorHealthOfficials,theMoHisresponsiblefor

settingoutprioritizationbeforetheCPSUareresponsibleforprocurement,negotiatingwithMAHsandissuingtenders

Alternativeaccess

(15%)

?ItisnotnecessaryformedicinestohavefiledandbelistedontheGFLtobidforatender,creatingthe

possibilityforreimbursedpatientaccesswithoutfilingandgoingthroughthestandardreimbursementsystem

?TheMalteseCommunityChestFundofferspublicaccessforproductswhicharenotsuppliedviastandardreimbursementrouteanddoesnotrequirefiling

?TheExceptionalMedicinesTreatmentCommittee(EMTC)assessandapprovemedicinesonanamedpatientbasisforrarediseasemedicinesnotcurrentlyontheGFL

Sources:EuropeanAccessHurdlesPortaldatacollectioncycle6(N=94products);CRAliteraturereviewandinterviewswithpharmaceuticalcompaniesandtradeassociations(conductedDec2024-Feb2025)

5

Abbreviations:ACHCB=AdvisoryCommitteeforHealthCareBenefits;CPSU=CentralProcurementSupplyUnit;DPA=DirectorateforPharmaceuticalAffairs;GFL=GovernmentFormularyList;GFLAC=GovernmentFormularyListAdvisoryCommittee;HTA=healthtechnologyassessment

Malta

InMalta,itisnotnecessarytofileamedicineforP&Rinordertoachievebroadpatientaccess

3

4

2

WhatdoesthePortaldatatellus?Howcanweinterpretthisconsideringourunderstandingofthemarket?

tofiletoobtainaccess

Statusoffilingandreimbursement1

…becauseitisunnecessary

92%of

products

areunfiled

9%?9%ofproductshavebeenfiledforinclusionontheGovernment

FormularyList(whichdoesn’tnecessarilyguaranteepatientaccess)

?Patientsmayhaveaccesstomanyofthe92%ofunfiledproducts,as

productscanbedirectlytenderedandprocuredfromwholesalers

15%o15%availabilitythroughanalternativepublicchannelislikelyanunderrepresentationofcompanywillingnesstoprovide

access;itpartiallyrepresentsthedifficultyforinnovative

medicinestowintenders(classlevel,winner-takes-all,pricecriterion,canbecompetingagainstgenerics)

oItseemslikelythatsomeoftheremaining77%havebeen

submittedtotendersuponrequestfromtheCPSUandnot

succeeded;thePortalisnotsetuptocapturethisnuance

77%

15%

9%

Malta

ReimbursedorfiledforP&R

NotyetfiledforP&R(available

throughotherpublicchannel)

NotyetfiledforP&R(unavailable)

6

Sources:EuropeanAccessHurdlesPortaldatacollectioncycle6(N=94products);CRAliteraturereviewandinterviewswithpharmaceuticalcompaniesandtrade

associations(conductedDec2024-Feb2025)

Abbreviations:CPSU=CentralProcurementSupplyUnit;P&R=pricingandreimbursement

Key:=underrepresentedinPortaldata<>=fairlyreflectedinPortaldata

AssociatS

CRAchariSRivr

Malta

WeexpectthattheimpactoflocalfilingrequirementsisunderrepresentedinthePortaldataforMalta

WhatdoesthePortaldatatellus?

Reasonsprovidedfornon-filing

4%

13%17%

14%

3%

2%3%

6%

32%

6%

Malta

LackofhealthcareinfrastructureLackofhealthcarefunding

Sizeofthetreatablepopulation

LackofcompanypresenceinthelocalmarketThecostoflaunchingisnotrecoverable

Countryfilingrequirements

Theimpactofexternalreferencepricing

EvidencepackageunlikelytomeetcountryreqsLowvalueattributedtoclasscompetitors

Other

2

3

4

1

Howcanweinterpretthisconsideringourunderstandingofthemarket?

becauselocalrequirementsmakeitdifficultorimpossibletofile

6%

?Countryfilingrequirementsislikelytobeunder-representedinthePortalresults

oWhilstthereisnoformalrequirementthatmakesitimpossibletofile,thereareinformalpreferences.Asacountryofonly

500,000people,payerswouldprefertoleverageassessmentsfromothercountriesforefficiency

?Budgetimpactmodelsmeanthatthesizeofthetreatable

populationimpactsfeasibilityoffilinginMaltaasitcanbedifficultorimpossibletosourcelocaldata;weseethisrepresentedinthePortalresults

17%<>

7

Sources:EuropeanAccessHurdlesPortaldatacollectioncycle6(N=94products);CRAliteraturereviewandinterviewswithpharmaceuticalcompaniesandtrade

associations(conductedDec2024-Feb2025)

Key:=underrepresentedinPortaldata<>=fairlyreflectedinPortaldata

AssociatS

CRAchariSRivr

Malta

AmajorissueimpactingfilingdecisionsinMaltaislikelynotbeingfullycapturedbythecurrentoptionsinthePortal

8

WhatdoesthePortaldatatellus?

Reasonsprovidedfornon-filing

4%

13%17%

14%

3%

2%3%

6%

32%

6%

Malta

LackofhealthcareinfrastructureLackofhealthcarefunding

Sizeofthetreatablepopulation

LackofcompanypresenceinthelocalmarketThecostoflaunchingisnotrecoverable

Countryfilingrequirements

Theimpactofexternalreferencepricing

EvidencepackageunlikelytomeetcountryreqsLowvalueattributedtoclasscompetitors

Other

Sources:EuropeanAccessHurdlesPortaldatacollectioncycle6(N=94products);CRAliteraturereviewandinterviewswithpharmaceuticalcompaniesandtrade

associations(conductedDec2024-Feb2025)

Abbreviations:P&R=pricingandreimbursement

2

3

4

1

Howcanweinterpretthisconsideringourunderstandingofthemarket?

…becausefeaturesofthelocal

systemmakeitimpracticaltofile

Missing?LackoftransparencyoftheP&Rprocessafterfilingisamajor

concerninMalta,anddeterscompaniesfromfilingbecausetheyaren’tthenabletotrackthestatusoftheirproductorenterinto

reasonabledialogueornegotiationwithauthorities

32%oOurhypothesisisthatthisissuecannotbepickedupbythe

Portal’scurrentreasonsfornon-filing,andmayinpartexplainsomeofthehighproportionof‘Other’responsesthatare

consistentlypickedupinthedata

14%<>?Lackofcompanypresencecanexacerbatethedifficultiesthat

companiesexperienceinnavigatingtheunconventionalMalteseP&Rsystem;weseethisreflectedinthePortaldata

Key:=underrepresentedinPortaldata<>=fairlyreflectedinPortaldata

AssociatS

CRAchariSRivr

Malta

ItischallengingforcompaniestomakeareasonablebusinesscasetolaunchinMaltaasaresultofsignificantbudgetconstraints

9

WhatdoesthePortaldatatellus?

Reasonsprovidedfornon-filing

4%

13%17%

14%

3%

2%3%

6%

32%

6%

Malta

LackofhealthcareinfrastructureLackofhealthcarefunding

Sizeofthetreatablepopulation

LackofcompanypresenceinthelocalmarketThecostoflaunchingisnotrecoverable

Countryfilingrequirements

Theimpactofexternalreferencepricing

EvidencepackageunlikelytomeetcountryreqsLowvalueattributedtoclasscompetitors

Other

Sources:EuropeanAccessHurdlesPortaldatacollectioncycle6(N=94products);CRAliteraturereviewandinterviewswithpharmaceuticalcompaniesandtrade

associations(conductedDec2024-Feb2025)

Abbreviations:MAH=marketingauthorizationholder

2

3

4

1

Howcanweinterpretthisconsideringourunderstandingofthemarket?

…becauseitisunsustainable(the

businesscasecannotbemade)for

theMAHtodoso

13%?LackofhealthcarefundingmeansthatevenproductsthathavehadapositiveHTAdecisionmaynothavehadbudgetallocatedtoenable

theirreimbursement

6%?Thisisexacerbatedbytheuseoftendersasabudgetmanagement

tool,oftenataclass-level(singlewinner,pricebased).ThischallengeismostlikelyunderrepresentedinthePortaldataastheroleof

tendersisnotspecificallycaptured.Wehypothesisethatsomecompaniesmayalsohavecategorisedthisissueas‘Lowvalueattributedtoclasscompetitors,

17%?Thesmallsizeofthetreatablepopulationcompoundstheimpact

ofbudgetaryrestrictionsandprice-basedtendersonmakinga

reasonablebusinesscasetolaunchanewmedicine;someofthe17%representedinthePortaldataislikelyduetothischallenge

Key:=underrepresentedinPortaldata<>=fairlyreflectedinPortaldata

AssociatS

CRAchariSRivr

WhatdoesthePortaldatatellus?

StatusofP&R

Reasonsfornon-filing

4%

13%

17%

14%

3%

6%

2%3%

6%

32%

77%

15%

9%

ReimbursedorfiledforP&R

NotyetfiledforP&R(available

throughotherpublicchannel)

NotyetfiledforP&R(unavailable)

Lackofhealthcareinfrastructure

Lackofhealthcarefunding

Sizeofthetreatablepopulation

LackofcompanypresenceinthelocalmarketThecostoflaunchingisnotrecoverable

Countryfilingrequirements

Theimpactofexternalreferencepricing

EvidencepackageunlikelytomeetcountryreqsLowvalueattributedtoclasscompetitors

Other

Malta

TherawPortalresultsforMaltawillthereforeneedtobeframedwithamorenuanceddescriptionofthecomplexbarrierstofiling

RelativeSummary

importanceinMalta:

…becauseitisunnecessarytofiletoobtainaccess

…becauselocalrequirements

makeitdifficultorimpossible

fortheMAHtofile

…becausefeaturesofthelocal

systemmakeitimpracticalto

file

…becauseitisunsustainable(thebusinesscasecannotbemade)fortheMAHtodoso

BudgetaryconstraintsandthesmallpotentialmarketsizeinMaltaaremajorchallengesfor

makingaviablebusinesscase;weseethisreflectedinthePortaldata

15%availabilitythroughanalternativeschemeislikelyanunder-representationofcompanywillingnesstoprovideaccess(throughtenders,CommunityChestFund).

Suggestspotentialneedtoaddnewreason

relatedto‘lackoftransparentP&Rprocess’;difficultiesexacerbatedbylackofcompany

presenceappearfairlyreflected(14%)

17%‘sizeoftreatablepopulation’needstobeputincontextofdifficultiesforBImodelling;6%countryfilingrequirementsdependson

definitionof‘requirements’

4

2

3

1

10

Sources:EuropeanAccessHurdlesPortaldatacollectioncycle6(N=94products);CRAliteraturereviewandinterviewswithpharmaceuticalcompaniesandtrade

associations(conductedDec2024-Feb2025)

Abbreviations:BI=budgetimpact;MAH=marketingauthorizationholder;P&R=pricingandreimbursement

Key:

Relativeimportance(inthelocalcontext)ofeachpotentialargumentforexplainingthefilingdata

AssociatS

CRAchariSRivr

Cyprus

NewperspectiveonRootCauses

1.TherearenodirectbarriersimpactingthetimingoffilinginCyprus,butinpractice,payersreferencethecompletedassessmentsanddecisionsmadeinotherEuropeancountries

2.TheMACareunder-capacityandhavecomplexguidelines,includingtheneedtodevelopCyprus-specifictherapeuticprotocolsforeachproduct,contributingtosignificantdelays,discouragingfilling

3.ThereisalackoftransparencyforMAHsontheprogressoftheirproductsubmissionandindirectreferencetoreimbursementandHTAinotherjurisdictions(theuseofGreeceasakeyreferencemarketresultsindownwardpricepressure)

4.Budgetpressuresareintense,thepharmaceuticalexpenditurebudgethasnotriseninlinewithamemorandumofunderstandingwiththeindustry,norinlinewiththegrowthofGESY’stotalbudget

5.Budgetimpactanalysesaredifficulttoachievewithoutaccesstolocalepidemiologicaldata,discouragingfilingfororphanproducts

InCyprus,thereisalowreimbursementrate(1%)ofinnovativemedicinesandalowfilingrate(20%)

P&Roverview

?ManufacturersmustfileforinclusioninthepositivereimbursementlistoftheNationalHealthSystem(GESY)

?TheMedicinesAdvisoryCommittee(MAC)arethenresponsibleforassessingthesubmissions;althoughclinicalbestpracticesareconsidered,themainfocusisonthebudgetimpactoftheinnovativeproduct

?IftheMACrecommendsinclusion,theMedicinesReimbursementAdvisoryCommittee(MRAC)willnegotiateanacceptablepricewiththemanufacturerforinclusioninthepositivereimbursementlist

Alternative

access(27%)

?UntilJan2025,alargeproportionofinnovativemedicinesweremadeavailableviathenamed-patientbasis

routeattheMoH,whichhadfundingof~€100mn,didnotrequiremanufacturerfiling,allowedhigherpricesandsawashorterdelaytopatientaccess

?However,thisrouteisnowunderthecontrolofGESY,leavingthefutureuncertain

11

Sources:EuropeanAccessHurdlesPortaldatacollectioncycle6(N=94products);CRAliteraturereviewandinterviewswithpharmaceuticalcompaniesandtradeassociations(conductedDec2024-Feb2025)

Abbreviations:GESY=NationalHealthSystem;HTA=healthtechnologyassessment;MAC=MedicinesAdvisoryCommittee;MAH=marketingauthorizationholder;MoH=MinistryofHealth;MRAC=MedicinesReimbursementAdvisoryCommittee;P&R=pricingandreimbursement

Cyprus

PatientshaveaccesstomorePortalproductsthroughalternative

accessschemesthanproductsthathavebeenformallyfiledforP&R

WhatdoesthePortaldatatellus?Howcanweinterpretthisconsideringourunderstandingofthemarket?

2

3

4

Statusoffilingandreimbursement

53%

…becauseitisunnecessarytofile

toobtainaccess

1

80%of

products

areunfiled

27%

20%

Cyprus

ReimbursedorfiledforP&R

NotyetfiledforP&R(available

throughotherpublicchannel)

NotyetfiledforP&R(unavailable)

20%?20%ofproductshavebeenfiledforinclusioninthepositive

reimbursementlistoftheNationalHealthSystem(GESY)

oOnly1%areactuallyreimbursedandhenceavailableinCyprus27%?AgreaterproportionofPortalproducts(27%)havenotbeenfiledfor

reimbursementthroughGESYbutareaccessibletopatientsthroughanalternativeaccessschemefundedbytheMinistryofHealth;thisprocessgenerallyworksfasterthantheprocessforlistingonthepositive

reimbursementlist

oFortheremaining53%ofproducts,itisnotbenecessaryforallofthemtobefiledforreimbursementinthefutureinorderforpatientsinCyprustohaveaccess,assomeproductswillbebettersuitedtothenamedpatientroute*

*AsofJanuary2025,thenamedpatientprogrammeisnowundertheremitofGESY(ratherthantheMinistryofHealth).ItisuncertainwhattypesofmedicineswillbeeligibleifGESYaltertheexistinginclusioncriteriaandprocess

12

Sources:EuropeanAccessHurdlesPortaldatacollectioncycle6(N=94products);CRAliteraturereviewandinterviewswithpharmaceuticalcompaniesandtrade

associations(conductedDec2024-Feb2025)

Abbreviations:GESY=NationalHealthSystem

Key:=underrepresentedinPortaldata<>=fairlyreflectedinPortaldata

AssociatS

CRAchariSRivr

Cyprus

Informalfilingrequirementsandsmallpatientnumberscanimpactthespeedoffilingofnewmedicines

13

WhatdoesthePortaldatatellus?

Reasonsprovidedfornon-filing

120

15%

14%

2%8%

2%1%

8%

36%

Cyprus

LackofhealthcareinfrastructureLackofhealthcarefunding

Sizeofthetreatablepopulation

LackofcompanypresenceinthelocalmarketThecostoflaunchingisnotrecoverable

Countryfilingrequirements

Theimpactofexternalreferencepricing

EvidencepackageunlikelytomeetcountryreqsLowvalueattributedtoclasscompetitors

Other

Sources:EuropeanAccessHurdlesPortaldatacollectioncycle6(N=94products);CRAliteraturereviewandinterviewswithpharmaceuticalcompaniesandtrade

associations(conductedDec2024-Feb2025)

Abbreviations:HIO=HealthInsuranceOrganisation;IRP=internationalreferencepricing;P&R=pricingandreimbursement

2

3

4

1

Howcanweinterpretthisconsideringourunderstandingofthemarket?

becauselocalrequirementsmakeitdifficultorimpossibletofile

8%?Countryfilingrequirementsislikelytobeunder-representedinthe

Portalresultsaswhilstthereisnoformalrestriction,Cypriothealth

authoritiesdoconsiderhowmanycountriesanewmedicinehasbeenevaluatedinandtheoutcomeofthoseevaluations

+2%oListpricesettingisbasedonIRPwithabasketof10reference

countries;inpractice,muchfocusisplacedontheGreekprice.ThismayimpactspeedoffilingandP&Rdecisionmakingin

Cyprus

15%<>?Budgetimpactmodelsmeanthatthesizeofthetreatable

populationimpactsfeasibilityoffilinginCyprus;weseethis

representedinthePortalresults

oInsomecases,thedataexists(heldbytheHIO)butisnotaccessibleforcompaniestouseintheirsubmission

Key:=underrepresentedinPortaldata<>=fairlyreflectedinPortaldata

AssociatS

CRAchariSRivr

Cyprus

IntroductionofthenewP&Rsystemhasbeenahugeachievement,butinitialbacklogsmayhavedisincentivisedfilingofnewmedicines

14

WhatdoesthePortaldatatellus?

Reasonsprovidedfornon-filing

120

15%

14%

2%8%

2%1%

8%

36%

Cyprus

LackofhealthcareinfrastructureLackofhealthcarefunding

Sizeofthetreatablepopulation

LackofcompanypresenceinthelocalmarketThecostoflaunchingisnotrecoverable

Countryfilingrequirements

Theimpactofexternalreferencepricing

EvidencepackageunlikelytomeetcountryreqsLowvalueattributedtoclasscompetitors

Other

Sources:EuropeanAccessHurdlesPortaldatacollectioncycle6(N=94products);CRAliteraturereviewandinterviewswithpharmaceuticalcompaniesandtrade

associations(conductedDec2024-Feb2025)

Abbreviations:P&R=pricingandreimbursement

2

3

4

1

Howcanweinterpretthisconsideringourunderstandingofthemarket?

…becausefeaturesofthelocal

systemmakeitimpracticaltofile

Missing?TheNationalHealthSystemwasonlyintroducedin2019,resultingin

aninitialbacklogofproductsthatneededtobefiledforP&R.Duringthistransitionperiod(2019-2024),companiesmayhavebeen

deterredfromfilingnewmedicinesuntilthebackloghadbeenclearedandtheagencyhadcapacitytoreviewnewsubmissions

36%oThisisanuancedchallengethatisnotpickedupbythenine

generalisedresponseoptionsinthePortal.Itisreasonabletoassumeahighproportionof‘Other’responsesmaybelinkedtothissituation

oCompoundingthis,andlikelyalsocapturedinthe‘Other

category’isthecomplexityandlackoftransparencyoftheP&Rprocess,whichdiscouragescompaniesfromfiling

additionalproductswhentheyremainuncertainaboutthestatusofpreviouslysubmittedmedicines

Key:=underrepresentedinPortaldata<>=fairlyreflectedinPortaldata

AssociatS

CRAchariSRivr

Cyprus

ThepharmaceuticalbudgethasnotgrowninlinewiththegrowthofGESY’stotalhealthcarebudget

15

WhatdoesthePortaldatatellus?

Reasonsprovidedfornon-filing

120

15%

14%

2%8%

2%1%

8%

36%

Cyprus

LackofhealthcareinfrastructureLackofhealthcarefunding

Sizeofthetreatablepopulation

LackofcompanypresenceinthelocalmarketThecostoflaunchingisnotrecoverable

Countryfilingrequirements

Theimpactofexternalreferencepricing

EvidencepackageunlikelytomeetcountryreqsLowvalueattributedtoclasscompetitors

Other

Sources:EuropeanAccessHurdlesPortaldatacollectioncycle6(N=94products);CRAliteraturereviewandinterviewswithpharmaceuticalcompaniesandtrade

associations(conductedDec2024-Feb2025)

Abbreviations:GESY=NationalHealthService;MAH=marketingauthorizationholder

2

3

4

1

Howcanweinterpretthisconsideringourunderstandingofthemarket?

…becauseitisunsustainable(the

businesscasecannotbemade)for

theMAHtodoso

?ThereissomeevidencetosupportthatMAHscanstruggletomake

thenecessarybusinesscasetofileanewmedicineinCyprus:

10%<>o‘Lackofhealthcarefunding’constitutes10%ofreasonsfor

non-filing.SincetheintroductionoftheNHS,whilstthetotal

budgetforfinancingthehealthsystemhasincreased(from

900mEURin2019to1.76bnin2024),theamountofthe

budgetallocatedtowardsmedicinesisexpectedtoremainstagnant

21%<>o‘Lackofcompanypresence’inCyprusmaybeaddingtothis

commercialhurdle,ascompaniesneedtoinvestinlocalconsultants,distributorsand/orwholesalers

Key:=underrepresentedinPortaldata<>=fairlyreflectedinPortaldata

AssociatS

CRAchariSRivr

WhatdoesthePortaldatatellus?

StatusofP&R

Reasonsfornon-filing

2%

10%

15%

14%

2%

8%

53%

27%

20%

2%

1%

8%

36%

ReimbursedorfiledforP&R

NotyetfiledforP&R(available

throughotherpublicchannel)

NotyetfiledforP&R(unavailable)

Lackofhealthcareinfrastructure

Lackofhealthcarefunding

Sizeofthetreatablepopulation

LackofcompanypresenceinthelocalmarketThecostoflaunchingisnotrecoverable

Countryfilingrequirements

Theimpactofexternalreferencepricing

EvidencepackageunlikelytomeetcountryreqsLowvalueattributedtoclasscompetitors

Other

Cyprus

ThePortaldatasupportthatwhilstnavigatingthenewP&Rprocessischallenging,manyproductsareaccessiblethroughothermeans

RelativeSummary

importanceinCyprus:

…becauseitisunnecessarytofiletoobtainaccess

…becauselocalrequirements

makeitdiff