ENDORSED PSD 1113 - ELT 22.12.09 with Web Address

MedicalServicesAdvisoryCommittee

PublicSummaryDocument

ApplicationNo.1113–EndovenousLaserTherapyforVaricoseVeins

Sponsor:SoleHealthCareProductsPtyLtd

DateofMSACconsideration: 47thMSACmeeting,4December2009

1.PurposeofApplication

EndovenousLaserTherapy(ELT)isaminimallyinvasivetreatmentforvaricoseveins,typically administeredintheoutpatientsetting. Application1113requestingsubsidyofELTunderthe MedicareBenefitsSchedule(MBS)wassubmittedtoMSACinOctober2006andconsideredatits

7March2008meeting.

AnMSACassessmentreportwaspreparedcomparingELTtosurgicalstrippingoftheveins(the comparator),aprocedureconductedinhospital. Onthebasisofthecostanalysispresentedinthe MSACAssessmentReport,itwasconcludedthatELTwasassociatedwithcost-savingscompared withsurgicalveinstripping. CostoffsetsaccruedbecauseELTwasconsiderednottorequire hospitalisation,generalanaesthesia,orasurgicalassistant. Onthisbasis,MSACsupportedpublic fundingoftheprocedureundertheMBSinitsadvicetotheMinister. TheMinisternotedMSAC’s adviceon21May2008.

2.Background

AfternotingMSAC’sadviceinMay2008,theMinisterrequestedfurtherinformationfromthe DepartmentofHealthandAgeing(DoHA)onfinancialimplicationsassociatedwithlistingELTon theMBS. Analysisundertakenbythedepartment’sCostingInformationAnalysis(CIA)Section notedthatthereweresubstantialdiscrepanciesbetweentheestimatesofthefinancialimpacton expendituresundertheMBSpresentedintheMSACAssessmentReportandthosepreparedbythe CIASection.

Ultimately,thediscrepanciesresultedindifferentconclusionsbeingdrawnastowhetherELTiscost-savingcomparedwiththesurgicalprocedure. Incontrasttotheanalysispresentedinthe MSACEvaluator’sassessmentreport,theanalysisconductedbytheCIASectionofDoHAfound thatELTislikelytobemoreexpensivethanthesurgicalprocedure.Themajordifferencebetween theseanalysesrelatedtotheestimationoftheactualcostofELTasaconsequenceoftheExtended MedicareSafetyNet.SincethereisnoconstraintonthefeechargedbyaproviderforanMBS servicethereisnoconstraintontheamountthegovernmentmaybeliable.InthecaseofELTthe patientmayreachtheExtendedMedicareSafetyNetthresholdwiththesupplyofthisservice alone.

3.Comparator

MembersacknowledgedthatinmanycasesMSACdoesnotknowthemarketpricethatmaybe chargedforanewservice,butforcomparatoritemsalreadyontheMBS,cost-effectivenessshould generallybeassumedtohavealreadybeenconsideredandacceptedforthepurposesofthe evaluation.

4.Safety

MSACnotedbutdidnotreviewthepreviousadvicetotheMinisterin2008thatELTisatleastas safeassaphenousjunctionligationandveinstrippingforthetreatmentofvaricoseveins.

5.Clinicaleffectiveness

MSACnotedbutdidnotreviewthepreviousadvicetotheMinisterin2008thatELTisaseffective assaphenousjunctionligationandveinstrippingforthetreatmentofvaricoseveins.

6.Cost-effectiveness

Recognisingthedifficultyindetermininganaccuratemarketpriceforanewservice,members agreedthatMSACcouldprovideadviceontheeffectofarangeofpossiblefeesonthe

cost-effectivenessoftheservice.

7.Financial/budgetaryimpacts

MSACnotedtheimportanceofconsideringtheimpactoffundingrecommendationsonthe MedicareSafetyNet,andthatthiswouldrequireco-operationbetweentheEvaluatorsandtheCIA SectionoftheDepartmentwhenframingtheeconomicevaluationofareport.MSACalso cautionedaboutspecifyinganupperfeethresholdforcost-effectiveness,duetopotentialmoral hazardinrelationtosubsequentfee-setting.

8.SummaryofconsiderationandrationaleforMSAC’sadvice

MSACnotedtheoverviewfromtheEconomicsSub-Committee(ESC)andtheissuesraisedinthe reportcommissionedfromDeakinUniversityconcerningtheimplicationsofdifferentscenarios presentedinthedifferentcostingmethodologies.

MSACdiscussedwhetheritshouldconfirm,modifyorwithdrawitspreviousadviceonpublic fundingofELT.

MSACagreedthatfuturehealthtechnologyassessmentsshouldconsidertheperspectiveofthe wholeofhealthsystembutshouldalsodocumentthefinancialimplicationsfortheMBS. MSAC requestedthatreportsshoulddisaggregatethecoststoshowwhoisbearingthecosts(MBS

out-of-pocketcosttopatients,thestateorcommonwealth).Thereportsshouldalsocapturethe

implicationsoftheMedicareSafetyNet(gapandextended)topotentialpayers.

MSACnotedtheremaybepolicyimplicationsandsensitivitiesassociatedwithpresentingdataon thecosttopayers–particularlyinrelationtotheMedicareSafetyNet.Itwasagreedthatfurther workneededtobecompletedtodevelopaformatforpresentingadviceonthisissuetotheMinister forHealthandAgeing.MSACagreedthisexercisewillalsoprovideconsiderableinsightfora plannedreviewofMSAC’scurrentEconomicGuidelines.Thereviewshoulddefinethe additional informationneededintheapplicationform,thebenefitsthatcanbederivedfromgreaterandearlier inclusionofDoHAexpertise(especiallyintheareasofMBSitemutilisationpatterns, implementationnegotiation,MBSmodellingandimpactoftheMedicareSafetyNetandthe ExtendedMedicareSafetyNet).

MSACvotedtoadvisetheMinisterthat:

MSAC’spreviousadvicebeconfirmedontheprovisothattheMBSfeeforELTbeheldatthe samelevelasthecurrentMBSfeeforthecomparatorandbeexemptfromtheExtended MedicareSafetyNet.TherationaleforthisadviceisthatalthoughELTisaseffectiveasthe comparator,ELTwouldbemorecostlythanthecomparatorifahigherpricewerechargedand governmentborethisadditionalcostasaconsequenceoftheMedicareSafetyNet; and

ifELTwerereimbursedthroughtheMBS,datashouldbecollectedontheactualfeescharged forELT,andreportedtoMSACafter18months,toassesstheimpactofthisprocedureon

out-of-pocketcostsbornebytheconsumer:

9.MSAC’sadvicetotheMinister

MSACacceptedpreviousadviceonEndovenousLaserTherapy(ELT)thatELTisatleastassafe andeffectiveassurgicalveinstrippingforthetreatmentofvaricoseveins. ELTiscost-effectiveat thefeeproposedintheMSACApplication1113Report($606).

MSACsupportspublicfundingforELT,providedthattheMBSfeeisheldatthecurrentMBSfee ofthecomparatorandisexemptfromtheMedicareSafetyNetforthisitem.

ShouldtheMinisterultimatelyagreetolistELTontheMBS,MSACrequeststheDepartmentof HealthandAgeingtoreporttoMSACafter18monthsontheactualfeeschargedforthisprocedure inordertoconsidertheextenttowhichconsumersarebearingout-of-pocketcosts.

10.ContextforDecision

ThisadvicewasmadeundertheMSACTermsofReference:

AdvisetheMinisterforHealthandAgeingonthestrengthofevidencepertainingtonewand emergingmedicaltechnologiesandproceduresinrelationtotheirsafety,effectivenessand cost-effectivenessandunderwhatcircumstancespublicfundingshouldbesupported.

AdvisetheMinisterforHealthandAgeingonwhichnewmedicaltechnologiesandprocedures shouldbefundedonaninterimbasistoallowdatatobeassembledtodeterminetheirsafety, effectivenessandcost-effectiveness.

AdvisetheMinisterforHealthandAgeingonreferencesrelatedeithertonewand/orexisting medicaltechnologiesandprocedures.

UndertakehealthtechnologyassessmentworkreferredbytheAustralianHealthMinisters’ AdvisoryCouncil(AHMAC)andreportitsfindingstotheAHMAC.

11.LinkagestoOtherDocuments

MSAC’sprocessesaredetailedontheMSACWebsiteat:

TheMSACAssessmentReportisavailable at:

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