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Markus Siebert, Chair of the MedTech Europe Evidence & Payers WG;
Senior Director Health Economics & Reimbursement, OUS - Abbott
Some Thoughts about Funding MedTech
Innovation in Europe
2018
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Innovation Funding Schemes in Europe
2018
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Snapshot of schemes
FRANCE:INNOVATIONFUNDING• Earlysupportforbreakthrough
innovation• Manufacturercanapply• Fastreviewprocess(105days)• Co-funding• 3technologiessince2015
GERMANY:INNOVATIONFUNDINGFORNEWDIAGNOSTICORTHERAPEUTICMETHODS(NUB)• Innovativetechnologies,whosecostsarenotcovered(fully)by
DRGs• Onlyhospitalsapply• Two-tierprocess:INEKclearance,thenpricenegotiations
betweenhosp andpayer• About9%ofallapplicationsare“cleared“forfunding
negotiationssince2012(337outof3866)• Outofthese,34NUBfundingagreementsweremade
ENGLAND:COMMISSIONINGTHROUGHEVALUATION(CTE)• Good,butinsufficientevidencetojustifyroutine
commissioning• Noapplicationprocess,butactivatedbyNHSEngland• FullyfundedbyNHSEngland• 7technologiessince2014.
THENETHERLANDS:CONDITIONALFUNDINGOFMEDICALPROCEDURES• Innovationneedstomeetcriteriaof
conformitywith“scienceandpractice”
• InitiatedbyDutchHealthcareInstitute• Co-fundingbetweenmanufacturer
andgvt• 19medtech innovationsselectedsince
2014
AUSTRIA:PROVISIONALCODESFORNEWDIAGNOSTICORTHERAPEUTICMETHODS• Provisionalcodeforrare,innovativeprocedureswithinsufficientclinicaldata• Insufficientreimbursementinthemeantime• Noclinicalstudyactivated• Hospitalapply• 50provisionalcodessince2012
2018
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Assessment from industry perspective
Poor Predictability: Out of 14 schemes 10 were evaluated as having ‘limited value in the planning of market access for innovation’ (no manufacturer application; no involvement in study design; no possibility to initiate any other market access activities in the meantime, lack of transparency)
Innovation and Technology Tariff (England) was evaluated as highly relevant (e.g. simple application process) but clinical areas are clearly defined and only technology with proven value are allowed
Innovation Funding (France) was evaluated as highly relevant (quick process, solid option from companies good but not enough evidence to establish the procedure) but only very limited amount of technologies was selected (2016=1, 2017=2)
RIHN (France) only innovation funding option for IVD tests in Europe.
Government co-funded clinical studies in Germany real opportunity for outpatient sector as it is the only way for manufacturer to introduce new procedure code into the outpatient benefit catalog
Limitedpotential Valuableforcertaincategory
2018
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Conclusions so farBackground
1. Healthcaresystemsneedtoencouragetheintroductionanddevelopmentofinnovativetechnologies:
2. TheEuropeanCommissionconsidersinnovationasoneofthemajorinstrumentsforimprovingpatientoutcomesandguaranteeingvalueformoneyinhealthcare.
3. Thereisempiricalevidencethatpoliticalsupportandavailabilityofdedicatedfundingandresourcesmayincreasethelikelihoodofimplementinginnovationsinhealthcare.*
*Mylotte etal;JournaloftheAmericanCollegeofCardiology,2013
CurrentLimitations• Dedicatedfundingschemestorewardinnovationhaveonly
beenimplementedinafewcountries,oftenintheformofcoveragewithevidencedevelopmentprograms.
• Theseschemesaretypicallyinconsistent,non-transparent,unpredictable andlimitedinscopeandtime.
• ThereisalsooftennolinktopermanentF&Rdecisionscausinguncertainty forpayers,healthcareprovidersandindustryalike.
WhatWeRecommend• Specificbudgetsneedtobeallocatedtosupportandreward
value-basedinnovationasabridgetoapermanentF&Rdecision.
• Processes needtobetransparentandpredictable,withmanufacturersbeingarespected,trustedpartner
2018
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My personal proposal20
18 ©
The M
edTe
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orum
. All r
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Rep
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in w
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part
is pr
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PotentialBenefit
MarketaccessproposalforInnovativemedicaldevicesinEurope
Earlydialoguewith• HTA• Payers• Industryabouteligibility
European-coordinatedAdviseonthepotentialbenefit
ActualBenefit
1 2 3b
EuropeanReimbursement“Clearance”
European(co-)fundedconditionalcoverage
Programme
NationalReimbursementA
NationalReimbursementB
NationalReimbursementC
4b
4a
Positiveevidence
Negativeevidence
5
3a
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• ProvideopportunityforEarlyDialogueandGuidanceformanufacturers
• Establishacoherentandpredictableprocessoninnovationfunding
• UsethepowerofaEuropean-levelassessmentofthe(potential)benefitandavoidnationalduplication
• Speedupnationaldecision-makingprocessesthroughaEuropean“reimbursementclearance”
• Improvecapacityandspeedthrough(co-)fundingfromEUresearchfunds
• ShowclearcommitmentfromEuropetoMedTech Innovation
Advantages
2018
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ibited
.
2018
© The
Med
Tech
For
um. A
ll righ
ts re
serve
d - R
epro
ducti
on in
who
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in pa
rt is
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2018
© The
Med
Tech
For
um. A
ll righ
ts re
serve
d - R
epro
ducti
on in
who
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in pa
rt is
proh
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2018
© The
Med
Tech
For
um. A
ll righ
ts re
serve
d - R
epro
ducti
on in
who
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in pa
rt is
proh
ibited
.
2018
© The
Med
Tech
For
um. A
ll righ
ts re
serve
d - R
epro
ducti
on in
who
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in pa
rt is
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ibited
.
2018
© The
Med
Tech
For
um. A
ll righ
ts re
serve
d - R
epro
ducti
on in
who
le or
in pa
rt is
proh
ibited
.
2018
© The
Med
Tech
For
um. A
ll righ
ts re
serve
d - R
epro
ducti
on in
who
le or
in pa
rt is
proh
ibited
.
2018
© The
Med
Tech
For
um. A
ll righ
ts re
serve
d - R
epro
ducti
on in
who
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rt is
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ibited
.
2018
© The
Med
Tech
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um. A
ll righ
ts re
serve
d - R
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on in
who
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rt is
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.
Key Principles of Payer Engagement
Thinking and communicating across silos and beyond hierarchies of healthcare systems
Articulating key messages to payers that align all stakeholders around outcomes, costs, and the differing perspectives of ‘value’.
Ensure there is an aligned message from industry towards payers
Ensure that medical devices are kept as one of the most innovative sectors in Europe.
Foster a community of trust between payers and the MedTech industry20
18 ©
The M
edTe
ch F
orum
. All r
ights
rese
rved -
Rep
rodu
ction
in w
hole
or in
part
is pr
ohibi
ted.
2018
© The
Med
Tech
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um. A
ll righ
ts re
serve
d - R
epro
ducti
on in
who
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in pa
rt is
proh
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.
2018
© The
Med
Tech
For
um. A
ll righ
ts re
serve
d - R
epro
ducti
on in
who
le or
in pa
rt is
proh
ibited
.
2018
© The
Med
Tech
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um. A
ll righ
ts re
serve
d - R
epro
ducti
on in
who
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in pa
rt is
proh
ibited
.
2018
© The
Med
Tech
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um. A
ll righ
ts re
serve
d - R
epro
ducti
on in
who
le or
in pa
rt is
proh
ibited
.
2018
© The
Med
Tech
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um. A
ll righ
ts re
serve
d - R
epro
ducti
on in
who
le or
in pa
rt is
proh
ibited
.
2018
© The
Med
Tech
For
um. A
ll righ
ts re
serve
d - R
epro
ducti
on in
who
le or
in pa
rt is
proh
ibited
.
2018
© The
Med
Tech
For
um. A
ll righ
ts re
serve
d - R
epro
ducti
on in
who
le or
in pa
rt is
proh
ibited
.
2018
© The
Med
Tech
For
um. A
ll righ
ts re
serve
d - R
epro
ducti
on in
who
le or
in pa
rt is
proh
ibited
.