M2M - Att a - PSD 1137 - MEI 6.9.10 Members Endorsed Minutes

MedicalServicesAdvisoryCommittee

PublicSummaryDocument

ApplicationNo.1137–MiddleEarImplantforSensorineural, ConductiveandMixedHearingLosses

Sponsor/Applicant/s:LifeSystemsMedicalPtyLtd

DateofMSACconsideration:49thMSACmeeting,29-30July2010

1.PurposeofApplication

On24November2008,LifeSystemsMedicalPtyLtdappliedforconsiderationofpublic fundingforMiddleEarImplant(MEI)foruseinpatientswithSensorineuralHearingLoss (SNHL),ConductiveHearingLoss(CHL)andMixedHearingLoss(MHL).Publicfundingfor MEIwassoughtforuseinadultpatientswhohavemildtoseverehearingimpairmentand cannotachievesuccessoradequatebenefitfromestablishedtherapy.

TheapplicantappliedforanassessmentofitsVibrantSoundbridgesystem,butasMSACpolicy istodogenericassessmentsallMEIswereassessed.

2.Currentarrangementsforpublicreimbursement

MEIproceduresarenotlistedontheMBS.

3.Background

Hearinglossisverycommonwithapproximately13%ofAustraliansaffectedbytotalorpartial hearinglossin2004-05(ABS2007). Hearinglosscanhinderinterpersonalcommunication, whichmayleadtosocialisolation,areductioninqualityoflife,andstressforfamilyand friends. Affectedadultsmaynotbeabletoworkproductively,whileaffectedchildrenmayhave languageanddevelopmentaldifficulties.Hearinglosshasalifelongimpactoneducationaland employmentopportunities.

Specificallytrainedear,noseandthroat(ENT)surgeons,performMEI.

MSACnotedMEIwillaugmentexistingoptionsofboneanchoredhearingaid(BAHA)and cochlearimplant(CI)whenconventionalhearingaidsdonotworkorcannotbetolerated.

MSACagreedthereissufficientevidenceforMEItobeanoptionforexperiencedpractitioners tochooseforpatientswhowerenotsuitableforcurrentlyavailablealternativesbecauseof problemssuchasotitismediaandotitisexterna,butthattherewasahighthresholdforclinical expertise/positioningofthedevice.

4.Clinicalneed

During2006-07theOfficeofHearingServicessubsidisedthefittingof124,657hearingaids. However,therearecommonproblemswiththedeviceswhichmayleadtopatientsdiscontinuing theiruse,suchasacousticfeedback,discomfort,earocclusion,inadequateamplification,regular maintenance,hygieneoftheearcanalandperceivedsocialstigma.

MEIwasproposedforpatientswithmildtosevereSNHL,CHLorMHL,whohadfailedatrial ofanexternalhearingaidforatleastthreemonthsbeforebeingconsideredforMEI.MEIisnot proposedforpeoplewithprofoundhearingloss–CIiscurrentlyconsideredtheonlyeffective optionforthosewithprofoundhearingloss.

MSACnotedthatthemostcommontypeofhearingloss(SNHL)isage-related.Therefore,as theAustralianpopulationages,itislikelythatthenumberofpeoplesufferingfromhearingloss andfailinganexternalhearingaidwillincrease. Otitismediaisaverycommonchildhood infection,withahigherprevalenceamongstIndigenouschildren(4%)comparedtonon- Indigenouschildren(2%).

MEIwasproposedforadultswithmildtosevereSNHL,CNHorMHL,whohadfailedatrialof anexternalhearingaidforatleastthreemonthsbeforebeingconsideredforMEI.

MSACnotedthepaucityofusagedatabutnoted2006-07MBSdataindicatesthat approximately327individualswithsevereHLmaybesuitableforMEIs. MSACalsonotedthe possibilitythatsomeindividualpatientswithexternalhearingaidswhowouldnotreceive BAHAorCImayfindMEItobeamoreacceptableoption,andsopublicfundingofMEImay increasethenumbersofpatientsoptingtoreceiveanimplantratherthanpersistingwithexternal hearingaids.

5.Comparator

Table1:ClinicalcomparatorforMEIrelativetotypeandseverityofhearingloss

INDICATIONS / Mild / Moderate / SevereHL
Sensorineural / MEIvs.BAHA / MEIvs.BAHA / MEIvs.CI
Mixed / MEIvs.BAHA / MEIvs.BAHA / MEIvs.CI
ConductiveHL / MEIvs.BAHA / MEIvs.BAHA / MEIvs.BAHA

MEIisanalternativetoBAHAwhichiswellestablishedandeffectivebuthasanumberof detractions,mostlyrelatedtotheneedforabonepegandmaintenanceofthis. CIinvolvesan additionalmagnitudeofinterventionandrisk.TheprincipalquestionforMSACwashowmuch betterisMEIthanBAHAinthemajorityofcasesandseverities?MSACnotedexpertopinion suggestsupportforoccasionswhereanindividualmightconsiderMEIoverotheroptions,but MSACcouldnotdefineanyparticularsubgroupsforthisinaconsistentway.

InpatientswithmildormoderateSNHL,CHLorMHL,MSACconsideredtheappropriate comparatortobeaBAHA. InpatientswithsevereSNHLorMHL,MSACconsideredthe appropriatecomparatortobeacochlearimplant. InpatientswithsevereCHL,MSAC consideredtheappropriatecomparatortobeaBAHA.

6.Scientificbasisofcomparison

Thesourcesofevidenceincludedpublishedliterature,productandmanufacturerinformationand patientinteraction. TherewasnoheadtoheadscientificcomparisonofMEIversusBAHAorCI. Safetydataareavailableonlyfromcaseseriesandexperiencewiththetechniquehasbeentooshorttoassesseffectivenessadequately.MSACnotedthetechnologyhasbeeninuseforapproximately10years,includingintheUnitedStatesandEurope,buttheredoesnotappeartohavebeenalargeuptakeandthetechnologyhasnotbeensubjecttorigorousassessment.

7.Safety

MSACnotedthatduetotheabsenceofcomparativeevidenceitisnotpossibletoaccurately comparetheratesofadverseeventsbetweenpatientsreceivingMEI,CIorBAHA. Caseseries datawasusedtoassesstheabsolutesafetyofeachdevice. Atotalof1,222patientswereusedto informthesafetyofMEI.

MSACwasconcernedaboutthelackofdataonthelongtermsafetyandclinicaloutcomesfor theuseofMEI,includinglossofresidualhearing,orincircumstanceswheretheMEI subsequentlyneedstoberemovedandanotherimplantused.

MSACagreedtherearenolongtermsafetydataavailableforMEIbutonthelimitedavailable evidence,MEIislikelytobeatleastassafeasBAHAandCI.SurgicalcomplexityofMEIis similartoCIandgreaterthanBAHA.CIisamoreriskyprocedurethanBAHA,andBAHAsite problemsarenotexperiencedwithMEI.

8.Clinicaleffectiveness

MSACnotedtherewasapaucityofhighlevelevidencewithwhichtoassesstheeffectiveness oftheMEI. EighteencomparativestudieswereavailabletoassesstheeffectivenessofMEI versustheexternalHA. However,theseconclusionsarelimitedbythepaucityofhighlevel evidence. ThelackofhighqualitystudiesmayberelatedtotherelativeyouthoftheMEI procedure.

Intheabsenceofanycomparativestudies,MSACcouldnotbeconfidentofthecomparative effectivenessofMEIversusBAHA,andthuscouldnotconcludethatMEIismoreeffectivethan BAHAinanypatientgroup.

MSACfurthernotedthattherewasonlyonecomparativestudyavailabletoassessthe effectivenessofMEI(10patients)versusCI(123patients). Thisstudy(Verhaegenetal.,2008) concludedthatpatientsfittedwithaVibrantSoundbridge(VSB)oranOtologicsMET(which arebothMEIs)donotdemonstratebetterspeechrecognitionscoresthanpatientsfittedwith conventionalhearingaids. However,theVSBandOtologicsMETareagoodoptioninpatients withmoderatetosevereSNHLandexternalotitismedia. Fromthisnonrandomised, retrospectivestudy,MSACconsideredthatMEImaybelesseffectivethanCI.

ThemajorityoftheavailablestudiesassessedMEIinpatientswithSNHL. Thisisreflectiveof theanticipatedAustralianpracticesuggestedbytheclinicalexperts.

MSACcautionedagainsttheverysmallnumberofstudiesofhighlyvariablequality,andagreed thatsuperioreffectivenessofMEIoverCIorBAHAcouldnotbedemonstrated.

9.Economicevaluation

Duetoinsufficientdataoncomparativeeffectivenesstosupportafullcost-effectiveness analysis,acostcomparisonwasconductedforthedifferentcostsassociatedwitheachofthe threeprocedures.

MSACnotedtherewasnomeasureofthemagnitudeofclinicalbenefitincludedinthe economicanalysis.

MSACnotedtheassessmentsoughtparitywiththeexistingMBSitemforCI.

MSACnotedthatsubstantialco-payment/outofpocketexpenseswouldbelikelyforsomeMBS

items.

MSACnotedtherewouldbemajorout-of-pocketexpensesforin-hospitalservicesbutthatthese donotcontributetotheSafetyNetaccumulations.

MSACdidnotagreewithexpertopinionandthenumberssuggestedintheapplication,thatMEI wouldreplacecurrentCIandBAHAuse,orthattherewouldbealargepoolofunmetneedof thosewithhearinglossduetothecosmeticattractionofMEIversusBAHA,butrathernoted,

theselectionofMEIoverBAHAorCIisdeterminedonacase-by-casebasisanddependsonthe patient’sindividualcircumstancesandoptions. MSACnotedthatindividualswhocurrently persistwithhearinglossoralessthanoptimalhearingaid,mayconsiderMEIimplantationbut wouldnotconsiderBAHAorCI. Sensitivityanalysissuggeststhatifonepercentofthe estimatedpoolofindividualswithmoderateorseverehearinglosselectedtohaveMEI,the additionalcostwouldbe$2,291,787. Theseestimatesarebasedonprevalencedataofhearing lossinAustraliaandincludealargeproportionofolderAustraliansforwhomanMEIwouldnot besuitable.

MSACagreedthatthemainreasonforimplantationofaMEIisnotcosmetic,butrathermedical reasonsinsubjectswithchronicexternalotitiswhocannottolerateocclusionoftheexternalear canal.MSACalsoacceptedthatsomepatientswould‘choose’MEIduetogreaterconvenience thanBAHAandCI.

MSACnotedthebasecaseassumedfullsubstitutiongivingacostsavingperpatientof$5,878inthecurrentpoolofpatients,andthatsubstitutionofMEIforCIwouldbecostsaving(76%of currentpoolhaveCI),whilstsubstitutionforBAHAwouldbecost-increasing(24%ofcurrent poolhaveBAHA). Therefore,theneteffectiscostsavingwithfullsubstitutionifMEIresultsin patientsbeingatleastaswelloffas,orbetteroffthan,afterBAHAorCI.MSACnotedthe outcomesdependonthetypeandseverityofHL,andpresenceoftherapy-resistantexternal

otitis(oranyothermedicalconditionsthatmayariseoutofusingBAHAorCI),andwould thereforeinfluencethelevelofsubstitutionacrosscategories. However,theevidencesuggests thatfullsubstitutionisunlikely(lowusagetodate)andMEIdoesnotappeartobesuperiorto CI.

Forthepoolofpotentialnewpatients,MSACconsideredthecost-effectivenessofMEIforthose patientswhowouldnothavehadBAHAorCIbutwhomightnowhaveMEI(currentpool: 433 total;newpool:481).ComparingMEIwithanotherstudyofCI:CIgave2.4timesgreater increaseinSF-36mentalscores,for3.3timesthecost.

MSACconcludedthatMEIismoreexpensivethanBAHA,butlessexpensivethanCI.

MSACwasunabletoidentifyanyparticularsubgroupofpatientswhowouldbesuitablefor MEI duetofailureofhearingaidsandotherconservativetreatment. Inpatientsforwhom BAHAissuitable,MEIwouldbeamoreexpensiveoption,butwithnoevidenceofimproved hearingtojustifytheextraexpense. InpatientsforwhomCIissuitable,MEIwouldbecheaper, butonthelimitedcurrentlyavailableevidence,maybelesseffective.

10.Financial/budgetaryimpacts

MSACestimatedthefirstyearcostofanMEI,BAHAandCIis$23,873,$15,207and$34,466 respectively. FeerangeforMEIisassumedtobethesameasforCIintheeconomicanalysis. TheincrementalcostofusingMEIasopposedtoaBAHAis$8,666(24%ofcurrentpoolhave BAHA). TheincrementalcostsavingofusinganMEIasopposedtoaCIis$10,593(76%of thecurrentpoolhasCI).Inthebasecase,ifpatientpoolreceivingBAHAorCIisfully substitutedwithMEIthenthecostsavingperpatientis$5,878.

However,MSACfounduncertaintyaroundtheutilisationestimates,butacknowledgedthe applicant’sresponsetothefinalAssessmentReportstressedtheimportanceofenforcing appropriatemedicalindicationsforuseofMEI.

Basedon2006-07MBSdata,thetotalcostofBAHAwouldbe$1,611,957(106patients)and thetotalcostofCIwouldbe$11,270,250(327patients). Thisgivesatotalcostof$12,882,207. IfMEIwereusedinsteadofBAHAandCI,thetotalcostwouldbe$10,336,916. Hence,the costsavingsofperformingMEIasadirectreplacementforBAHAandCIwouldbeover$2.5 million.

11.Othersignificantfactors

IfMEIwereMBSlistedthenpatientswhowouldcurrentlynothaveBAHAorCImayhave MEI(newpoolofpatients). Thereisalsoapotentialunmetneedfrompatientswhorequirea hearingaidbutchoosenottouseone,andmayoptforMEI.

MSACnotedthattheapplicanthadnotsoughtapprovalforuseofMEIinchildren,butnoted thatBAHAmaypresentsafetyissuesduetodevicelooseningandthepropensityforpoorersite maintenanceandhygienewhenusedinchildren. MSACconsideredthatchildrenwithhearing lossmayrepresentacurrentunmetclinicalneedforanimplantbecauseotitisexterna(which complicatesorprecludestheuseofexternalhearingaids)andotitismediaareverycommon childhoodinfections,andaremoreprevalentamongstIndigenouschildrencomparedwithnon- Indigenouschildren.

ThepotentialvolumeofunmetneedwhichmaybesatisfiedifMEIweretobelistedontheMBSisunknown,andmayleadtoMBS“leakage”,althoughthecomplexityoftheprocedureislikelytoactasabarrier. Thecurrentpoolofpatientswithfullsubstitutionis433intotal. Thenewpoolwouldbearound96-481patients(1-5%ofthosewithmoderate-severeHLandnootitis). Thebasecasecostoffsetis$10.3millionforthecurrentpatientpool,butthenewpatientpoolcouldaddupto$11.5milliontotheMBS.

12.SummaryofconsiderationandrationaleforMSAC’sadvice

MSACdiscussedtheassessmentofmiddleearimplant(MEI)foruseinpatientswith sensorineuralhearingloss(SNHL),conductivehearingloss(CHL)andmixedhearingloss (MHL). InpatientswithmildormoderateSNHL,CHLorMHL,MSACconsideredthe appropriatecomparatortobeaboneanchoredhearingaid(BAHA). Inpatientswithsevere SNHLorMHL,MSACconsideredtheappropriatecomparatortobeacochlearimplant(CI). In patientswithsevereCHL,MSACconsideredtheappropriatecomparatortobeaBAHA.

MSACnotedthepaucityofutilisationdatabytypeandseverityofhearingloss,butconcluded thatlownumbersofindividualswithhearinglosswhowouldreceiveBAHAorCIwouldopt insteadtoreceiveMEI,basedoncurrentMBSservicesforBAHAandCI,andonassumptions abouttheproportionofCIusedforsevere(ratherthanprofound)hearingloss.

MSACalsonotedthepossibilitythatsomeindividualpatientswithexternalhearingaidswho wouldnotreceiveBAHAorCImayfindMEItobeamoreacceptableoption,andsopublic fundingofMEImayincreasethenumbersofpatientsoptingtoreceiveanimplantratherthan persistingwithexternalhearingaids.

MSACwasconcernedaboutthelackofdataonthelongtermsafetyandclinicaloutcomesfor theuseofMEI,includinglossofresidualhearing,orincircumstanceswheretheMEI subsequentlyneedstoberemovedandanotherimplantused.

Intheabsenceofanycomparativestudies,MSACcouldnotbeconfidentofthecomparative effectivenessofMEIversusBAHA,andthuscouldnotconcludethatMEIismoreeffectivethanBAHAinanypatientgroup.

MSACfurthernotedthattherewasonlyonecomparativestudyavailabletoassessthe effectivenessofMEI(10patients)versusCI(123patients). Fromthisnonrandomised, retrospectivestudy(NHMRCLevelIII),MSACconsideredthatMEImaybelesseffectivethan CI.

Duetoinsufficientdataoncomparativeeffectivenesstosupportafullcost-effectiveness analysis,acostcomparisonwasconductedforthedifferentcostsassociatedwitheachofthe threeprocedures. MSACnotedthatMEIismoreexpensivethanBAHA,butMEIisless expensivethanCI.

Overall,MSACfoundthattherewereinsufficientclinicalgroundstorecommendMEIfor

publicfundingbecausetheweakclinicalevidenceavailabledidnotdemonstratesuperiorityover otheroptions,andthereareinadequatedataonlongertermsafety.

MSACthereforerejectedtheapplicationonthebasisofitsinabilitytoidentifyparticularsub groupsofpatientsforwhomlistingcouldbejustifiedintermsofcomparativecost-effectiveness; uncertaintyaroundlongtermsafety,andtheavailabilityofBAHAandCIascurrentalternatives forallMEIindications.

13.MSAC’sadvicetotheMinister

Afterconsideringthestrengthoftheavailableevidenceinrelationtothesafety,effectiveness andcost-effectivenessofthemiddleearimplantasatreatmentforhearingloss,MSACdoesnot supportpublicfundingformiddleearimplants.

14.ContextforDecision

ThisadvicewasmadeundertheMSACTermsofReference:

AdvisetheMinisterforHealthandAgeingonthestrengthofevidencepertainingtonew andemergingmedicaltechnologiesandproceduresinrelationtotheirsafety, effectiveness andcost-effectivenessandunderwhatcircumstancespublicfundingshould besupported.

AdvisetheMinisterforHealthandAgeingonwhichnewmedicaltechnologiesand proceduresshouldbefundedonaninterimbasistoallowdatatobeassembledto determinetheirsafety,effectivenessandcost-effectiveness.

AdvisetheMinisterforHealthandAgeingonreferencesrelatedeithertonewand/or existingmedicaltechnologiesandprocedures.

UndertakehealthtechnologyassessmentworkreferredbytheAustralianHealth

Ministers’AdvisoryCouncil(AHMAC)andreportitsfindingstotheAHMAC.

15.LinkagestoOtherDocuments

MSAC’sprocessesaredetailedontheMSACWebsiteat: