MedicalServicesAdvisoryCommittee
PublicSummaryDocument
ApplicationNo.1143–RadiofrequencyAblationforthetreatmentof
Barrett’sOesophagus
Applicant:DeviceTechnologiesAustraliaPtyLtd
DateofMSACconsideration:51stMSACmeeting,2December2010
1.PurposeofApplication
On13October2009,DeviceTechnologiesAustraliaPtyLtdrequestedthatMSACundertake anassessmentofRadiofrequencyAblation(RFA)forthetreatmentofdysplasticBarrett’s Oesophagus(BO).
MSACnotedthatBOwithlow-gradedysplasia(LGD)istreateddifferentlytoBOwith
high-gradedysplasia(HGD),duetothedifferentratesofprogressiontooesophagealcancer. MSACconsideredthestrengthoftheevidenceinrelationtoRFAinthetreatmentofBO separatelyforLGDandHGD.
2.Currentarrangementsforpublicreimbursement
RFAisgenerallyprovidedasadayprocedureperformedunderconscioussedationinan outpatientsettingbyagastroenterologistorsurgeontrainedintheprocedure. RFAforthe treatmentofBOisnotcurrentlylistedontheMBS.
ThefeeforMBSitem30479wasconsideredbyMSACtoaccuratelyreflectthetimeand expertiserequiredtoperformRFAandwasthereforeusedintheeconomicevaluationofthe procedure. Atthetimeofthisappraisal,thisitemattractedafeeof$458.05. Theexisting descriptorforMBSitem30479is:ENDOSCOPYwithLASERTHERAPYorARGON PLASMACOAGULATION,forthetreatmentofneoplasia,benignvascularlesions,strictures ofthegastrointestinaltract,tumorousovergrowththroughoroveroesophagealstents,peptic ulcers,angiodysplasia,gastricantralvascularectasia(GAVE)orpost-polypectomybleeding,
1ormoreof.
Theapplicantproposedafeeof$1,330forthisprocedurebasedonthefeefortheMBSitem fordouble-balloonenteroscopy. NoMBSdescriptorwasproposedforthisprocedure.
Thecomparatorsfor RFAfor BOwithLGDareconservativetherapy(acidsuppressionand surveillance)andargonplasmacoagulation(APC). Thecomparatorsfor RFAfor BOwith HGDareAPC,endoscopicmucosalresection(EMR)andoesophagectomy.
TheprimaryMBSitemforconservativetherapyis30473,whichhasafeeof$170.40. The itemdescriptoris:
OESOPHAGOSCOPY(notbeingaservicetowhichitem41816or41822applies), GASTROSCOPY,DUODENOSCOPYorPANENDOSCOPY(1ormoresuch procedures),withorwithoutbiopsy,notbeingaserviceassociatedwithaserviceto whichitem30476or30478applies
TheprimaryMBSitemforoesophagectomyis30535,whichhasafeeof$1,632.35. The itemdescriptoris:
OESOPHAGECTOMYwithgastricreconstructionbyabdominalmobilisationand thoracotomy
MSACnotedthatneitherAPCnorEMRarecurrentlyfundedontheMBSforthetreatment ofBO.
3.Background
Barrett’sOesophaguswithDysplasiaisaconditionresultinginametaplasticchangetothe liningoftheoesophagus,suchthatthenormalsquamousepitheliumisreplacedbycolumnar epithelium. Thedisorderseemstobeacomplicationofchronicgastro-oesophagealreflux disease(GORD),althoughasymptomaticindividualsmightalsobeaffected,anditisarisk factorforthedevelopmentofoesophagealadenocarcinoma,acancerwithrapidlyincreasing incidenceindevelopedsocieties.
Althoughthenaturalhistoryofthediseaseisnotfullyunderstood,thebiggestriskfactorsfor progressiontocancerarethelengthoftimewithabnormalmucosaandthedegreeof dysplasia. Expertpathologistscandifferentiatebetweenlowgradedysplasia(LGD)andhigh gradedysplasia(HGD). HGDisgenerallyacceptedasaprecursortooesophagealcancer whichcarriesapoorprognosis,butnotallpatientswithLGDprogresstoHGD.
ThepurposeofRadiofrequencyAblation(RFA)istothermallydestroydysplasticmucosa, allowingforre-epithelialisationwithhealthysquamousepithelium.Initially,asizingballoon is usedtomeasurethediameteroftheoesophaguswhilstthepatientisunderconscious sedation. Anappropriatelysizedradiofrequencyballooncatheteristhenintroducedovera guidewireinaside-by-sidemannerwithanendoscope.Thecatheter’sballoonistheninflated andradiofrequencyenergyapplied,circumferentiallyablatingtheepitheliumofthe oesophagustolessthanonemillimetre.Theablatedepitheliumisthenremovedbythe clinicianusingirrigation,suctionandlightpressure. Oncedysplasiahasprogressedto adenocarcinoma,invadingtodeeplayers(laminapropriaorbeyond),oesophagectomyisthe treatmentofchoicetoensurenopotentiallymalignantcellsremaininanycelllayer.
MSACconsideredthatinatypicalyearofRFAtreatment,thefollowingMBSitemswould beclaimed(ifRFAwaspubliclyfunded):
•30479/newitem–RFA(x3)
•30473–Oesophagoscopy
•20740–Anaesthesia(x4)
MSACagreedthattheaccuratediagnosisofdysplasticBarrett’sOesophagusisanimportant anddifficultstepinthetreatmentalgorithm,andnotedexpertadvicethattwoexperienced pathologistsshouldconferonthefinalgrading. MSACconsideredthatthechoiceof treatment shouldbeoverseenbyamulti-disciplinaryteamand,ifconsideredappropriatefor thepatient,RFAshouldbeperformedbyanappropriatelytrainedspecialistgastroenterologist orsurgeon.
RFArequiressimilartimeandexpertisetoendoscopiclasertherapyorAPC,whicharelisted ontheMBSunderitem30479. TheinclusionofRFAforBOwitheitherLGDorHGDon theMBSwouldrequireamendmentofMBSitem30479orthecreationofanewitem.
Inaclinicalsetting,RFAforLGDandHGDisundertakenoncedysplasticBOhasbeen confirmedbypathologytesting.
MSACnotedexpertadvicethattwoexperiencedpathologistsshouldconferonthefinal gradingofBO. MSACagreedthatprofessionalbodiesshouldbeinvolvedindeveloping standardsforboththediagnosticprocessaswellasfortheconductoftheprocedure.
4.Clinicalneed
MSACnotedthatbothLGDandHGDBOcanbetreatedwithcurrentlyfundedservices. It notedthatoesophagectomyistheonlytreatmentcurrentlyfundedforHGD,whichisan invasiveprocedurewith30-50%morbidityandaround2%mortalityintheAustraliansetting.
MSACnotedthatoncedysplasiahasprogressedtoadenocarcinoma,invadingtodeeplayers (laminapropriaorbeyond),thenRFAisnotindicated.Rather,anoesophagectomyisthe treatmentofchoicetoensurenopotentiallymalignantcellsremaininanycelllayer.
MSACnotedthatanestimated100patientsper yeararediagnosedwithHGDinAustralia, withanaverageageatdiagnosisof60. Approximately300patientsperyeararediagnosed withLGD.
MSACalsonotedthattherearelimiteddataavailableregardingtheprevalenceofBarrett’s OesophagusinAustralia. However,therehasbeenanincreaseinthefrequencyofdiagnosis ofBarrett’sOesophagusfrom2.9to18.9per1000endoscopiesbetween1992and2002, althoughthesedatadonotspecifytheseverityofdiseaseorlevelofdysplasia.
5.Comparator
MSACnotedthatBOwouldbediagnosedduringanendoscopy. FollowingdiagnosisofBO, thepatientwouldreceivemultipleendoscopicbiopsieswhichwouldthenbegradedby experiencedpathologists. Aconfirmeddiagnosisofdysplasiawouldresultintreatmentbeing undertakendependingonthegradingofthedysplasia;RFAwouldbeoneoptionfor treatment.
ListingofRFAontheMBSwouldresultinsomeinstancesofRFAbeingusedinsteadof conservativetherapyorAPCinthecaseofdiagnosedLGD;oroesophagectomy,APCor EMRinthecaseofdiagnosedHGD. MSACthereforeagreedthatconservativetherapyand APCweretheappropriatecomparatorsforLGDBO;andthatoesophagectomy,APCand EMRweretheappropriatecomparatorsforHGD.
Photodynamictherapyisanotherablativetechniqueusedinternationallytotreatdysplastic BO. Thetechniqueemploysphotosensitisingagentswhichareingestedbythepatient. MSACdidnotconsiderphotodynamictherapyasacomparatorbecauseitisnotusedin Australia,asexposuretolight(particularlysunlight)cancauseseriousadversereactionsfor manydaysfollowingtreatment.
6.Scientificbasisofcomparison
TheprimarysourceofevidenceforMSAC’sadvicewasanassessmentreportproducedby contractedevaluators. Theassessmentreportcomprisedofascientificliteraturereviewthat wasinformedbyanadvisorypanelofclinicalexpertsandaconsumerrepresentativewho ensuredthattheassessmentconsideredrelevantconsumerissuesandappropriatelyreflected theAustraliansetting.
Thefindingsofonerandomisedcontroltrial(RCT),fivecaseseries,twohealthtechnology assessments,threesetsofguidelinesandfourreviews(includingtwoCochranereviews)were includedintheassessmentreport.
Fiveofthesixavailablestudies,includingoneRCT,mettheinclusioncriteriaforassessment ofsafety. MSACnotedthattheselimiteddatawerenotcomparative,whichpreventeda directcomparisonofthesafetyofRFAwithotheravailabletreatments.
Sixstudies,includingoneRCT,mettheinclusioncriteriafortheassessmentofeffectiveness. MSACnotedthatthelimitedstudiesshowedonlyshort-termdata,withamaximumof24 monthsfollow-up. MSACfurthernotedthatalackofcomparativedatapreventedtheclinical effectivenessofRFAbeingdirectlycomparedtootheravailabletreatments.
7.Safety
MSACnotedthattheliteraturereportedfewmajorcomplicationsfollowingmultiple treatmentsessions. Mostadverseeventsreportedwereminorandresolvedwithout intervention.
MSACagreedthatthelimitedevidencesuggeststhatRFAissafeforthetreatmentof Barrett’sOesophaguswithdysplasiaand/orearlyintra-mucosalcancer(IMC). However, lack ofcomparativedatapreventedthesafetyofRFAbeingdirectlycomparedtoother treatmentsavailableforpatientswithLGD,HGDandintra-mucosalcarcinoma(IMC). Asa result,conclusionscannotbedrawnastowhetherRFAissaferthansurveillanceorAPCin patientswithLGD. Inaddition,limitationsintheliteraturealsopreventedthecomparisonof thesafetyofRFAtoAPC,EMRoroesophagectomyforpatientswithHGDandIMC. However,MSACacceptedthatRFAhadlowermorbidityandmortalitythan oesophagectomy.
8.Clinicaleffectiveness
MSACnotedthattheRCTreportedthefollowingeradicationofintestinalmetaplasiaand dysplasiafollowingRFAforLGD:
RFA / Control / pvalueCR-IM% / 81 / 4 / 0.001
CR-D% / 90 / 23 / 0.001
* CR-IM:completeeradicationofintestinalmetaplasia
*CR-D:completeeradicationofdysplasia
MSACnotedthattheRCTreportedthefollowingeradicationofintestinalmetaplasia followingRFAforHGD:
RFA / Control / pvalueCR-IM% / 74 / 0 / <0.001
* CR-IM:completeeradicationofintestinalmetaplasia
MSACalsonotedthattheincidenceofsubsquamousintestinalmetaplasiawaslowerinthe
RFAgroupthanthecontrolgroupforLGDandHGD.
Inthenon-RCTstudies,completeeradicationofintestinalmetaplasiawasreportedin54-79%
ofcases,andcompleteeradicationofdysplasiawasreportedin80-100%ofcases.
ThelimitedliteraturesuggestsRFAiseffectiveforachievinghistologicaleradicationof intestinalmetaplasiaanddysplasiaatamucosallevel. Lackofcomparativedataprevented theclinicaleffectivenessofRFAbeingdirectlycomparedtootheravailabletreatments. Asa result,MSACcouldnotconcludewhetherRFAisaseffectiveormoreeffectivethan surveillanceorAPCinpatientswithLGD. Similarly,MSACwasunabletoconclude
whetherRFAislessormoreeffectivethanAPC,EMRoroesophagectomyinpatientswith
HGD.
MSACfoundthelengthoffollow-upstudies,rangingfrom11-24monthsintheincluded studies,wasinsufficienttodeterminelong-termsuccessincancerprevention.
MSACnotedtheexactincidenceofBOwithdysplasiainAustraliaisuncertain. Italsonoted alackofevidenceontherateofprogressionofLGDtoHGD.
9.Economicevaluation
Therewassufficientevidencetoconductafullcost-effectivenessanalysisofRFAforthe treatmentofLGD.Adecisionanalyticmodelwasdeveloped,whichprovidesaframework fordecisionmakingunderconditionsofuncertainty.Theeconomicevaluationestimatedthe incrementalcost-effectivenessofRFAcomparedtosurveillance.
MSACnotedtherewasinsufficientcomparativedataavailabletoconductacost- effectivenessanalysisonRFAforHGD,thereforeacostanalysiswasconductedtocompare thedifferentcostsassociatedwiththeprocedureanditscomparators.
MSACfoundthatreplacingsurveillancewithRFAforLGDwouldyieldanadditional benefitof0.129QALYsatanadditionalcostof$10,175. Thisresultedinanincremental cost-effectivenessratio(ICER)forRFAcomparedwithsurveillanceof$78,975perQALY.
Themaindriversofthecost-effectivenessresultaretheprobabilityoferadicationoflow gradedysplasiaaftertreatmentwithRFA,theprobabilityofprogressingtocancerfromlow gradedysplasia,andthecostofRFA.
Inthesensitivityanalysis,ifthefrequencyofsurveillanceisreducedaftereradicationoflow gradeorhighgradedysplasia,theresultingICERis$71,075.
MSACfoundthatforHGD,basedonanestimatedprevalenceof100cases,ifdirect replacementofRFAoccurredforoesophagectomy,theoverallcostsavingswouldbe
$1,259,446. IfRFAwasusedtotreat100patientsinsteadofEMRorAPC,therewouldbea totaladditionalcostof$778,146or$606,155respectively. Thiscostanalysisassumedthat RFA,EMR,APCandoesophagectomyhaveequivalenteffectiveness,withnoaccountfor reductioninqualityoflifewithoesophagectomy.
MSACnotedthattheaverageco-paymentsforoneyearofRFAtreatmentwouldbe$487for bothLGDandHGD. Theyalsonotedthatthepatientwouldbeliableforthedisposable cathetersusedineachRFAprocedurewhichwouldcostthepatient$6,339inthefirstyear.
MSACnotedthatallMBSitemsforRFA,EMRandAPCareperformedintheoutpatient setting. Thereforeanyoutofpocketcostassociatedwiththeseitemswillcontributetowards theExtendedMedicareSafetyNet(EMSN).Thetotaloutofpocketcostsfortheseitemsis belowthe$1,126threshold($562.90forconcessioncardholders). Consequently,outof pocketcontributionproceduresrelatingtoBOareunlikelytoimpactupontheEMSN.
MSACnotedthattheICERofRFAforLGDwassensitivetotheprobabilityoferadicationof LGDaftertreatmentwithRFA,therateofprogressionfromLGDtoHGDand/orcancer,and thecostofRFA. MSACnotedthattheICERwaslikelytoremainveryhighbutuncertainin anysensitivityanalysesinvolvingtheseparameters.
WhenreviewingtheeconomicimplicationsofRFAforHGD,MSACnotedthatiftherateof RFAtreatmentfailureleadingtooesophagectomyweretobeconsidered,theremaybea reductionintherelativecost-effectivenessofRFAforHGD. Conversely,MSACalsonoted theassessmentreportdidnotattempttoquantifythecostofmortalityassociatedwith oesophagectomy,whichislikelytopositivelyaffecttherelativecost-effectivenessofRFA.
10.Financial/budgetaryimpacts
MSACnotedestimatesthatapproximately100patientsperyeararediagnosedwithhigh gradedysplasia(HGD)inAustralia,withanaverageageatdiagnosisof60.Approximately
300patientsperyeararediagnosedwithLGD.
MSACnotedthatbasedonanestimatedincidenceof299casesofBOwithLGDperyear, RFAforLGDwouldincuracostof$489,433perannumtotheMBS. Basedonanestimated incidenceof100casesofBOwithHGDperyear,RFAforHGDwouldcosttheMBS
$163,690perannum.
11.Othersignificantfactors
ForBOwithHGD,MSACnotedthatoesophagectomyisahighlymorbidprocedure comparedwithRFAandthatRFAiscostsavingcomparedwithoesophagectomy. However, MSACwasnotabletodeterminethenumberofpatientswhowouldfailRFAandultimately berecommendedtohaveoesophagectomy.
MSACnotedthatRFAismorecostlythanAPCandEMRbutthattherewasnocomparative clinicaleffectivenessdatafortheseprocedures. ItnotedthataCochranereviewconcluded thatRFAappearedtobethemostsuccessfultherapytodateforpatientswithHGDinBO aftercomparingthedifferentinterventions(exceptoesophagectomy). MSACalsonotedthat theRFAcathetersarenotabletobeincludedontheProsthesisList,andthusmaybeacost thatwouldbebornebythepatient.
MSACsuggestedthatrelevantprofessionalgroupsshoulddevelopsomeformof accreditationforthisprocedure.
12.SummaryofconsiderationandrationaleforMSAC’sadvice
MSACreconsideredthestrengthoftheevidencerelatingtothesafety,effectivenessandcost- effectivenessofradiofrequencyablation(RFA)forthetreatmentofBarrett’sOesophagus
witheitherlowgradedysplasia(LGD)orhighgradedysplasia(HGD).MSACnotedthat therearelimiteddataavailableregardingtheprevalenceofBarrett’sOesophagusin Australia. However,therehasbeenanincreaseinthefrequencyofdiagnosisofBarrett’s Oesophagusfrom2.9to18.9per1000endoscopiesbetween1992and2002,althoughthese datadonotspecifytheseverityofdiseaseorlevelofdysplasia. MSACnotedestimatesthat approximately100patientsperyeararediagnosedwithhighgradedysplasia(HGD)in Australia,withanaverageageatdiagnosisof60.Approximately300patientsperyearare diagnosedwithLGD.ThenaturalhistoryofBOispoorlyunderstoodhoweverHGDis generallyacceptedasaprecursortooesophagealcancer.Theskillsofexpertpathologistsare
neededtodifferentiatebetweenlowgradedysplasia(LGD)andhighgradedysplasia(HGD).
MSACseparatelyconsideredthestrengthoftheevidenceinrelationtoradiofrequency ablation(RFA)inthetreatmentofBarrett’sOesophaguswitheitherLGDorHGD. RFAis generallyprovidedasadayprocedureperformedunderconscioussedationinanoutpatient settingbyagastroenterologistorsurgeontrainedintheprocedure.
ForLGD,RFAwascomparedwithcurrentconservativetherapy(acidsuppressionand surveillance)andAPC.ForHGD,RFAwascomparedwithoesophagectomyoralternative endoscopictherapies(includingEndoscopicMucosalResection(EMR)andArgonPlasma Coagulation(APC)). MSACfoundthattheevidencebaseforthisassessmentwasverypoor, withonerandomisedcontrolledtrial(RCT)applicabletotheAustraliansetting,andthe
lengthoffollowupintheincludedstudiesinsufficienttodeterminethelongtermsuccessrate
ofRFA.
MSACagreedthatthelimitedevidencesuggeststhatRFAissafeforthetreatmentof Barrett’sOesophaguswithdysplasiaand/orearlyintra-mucosalcancer(IMC). However, lack ofcomparativedatapreventedthesafetyofRFAbeingdirectlycomparedtoother treatmentsavailableforpatientswithLGD,HGDandIMC. Asaresult,conclusionscannot bedrawnastowhetherRFAissaferthansurveillanceorAPCinpatientswithLGD. In addition,limitationsintheliteraturealsopreventedthecomparisonofthesafetyofRFAto APC,EMRoroesophagectomyforpatientswithHGDandIMC. HoweverMSACaccepted thatRFAhadalowermorbidityandmortalitythanoesophagectomyandthuswouldbemore desirablethananoesophagectomy
ThelimitedliteraturesuggestsRFAiseffectiveforachievinghistologicaleradicationof intestinalmetaplasia(IM)anddysplasiaatamucosallevel. Lackofcomparativedata preventedtheclinicaleffectivenessofRFAbeingdirectlycomparedtootheravailable treatments.
WhenreviewingtheeconomicimplicationsofRFAforLGD,MSACtooknoteofthelow progressionratefromLGDtoHGDand/orcancer.ForLGD,replacingsurveillancewith RFAwouldyieldanadditionalcostof$10,175perpatient,givinganincrementalcost- effectivenessratio(ICER)forRFAcomparedtosurveillanceof$78,975perqualityadjusted
lifeyear(QALY)gained. MSACconcludedthatthisICERwassensitivetotheprobabilityof eradicationofLGDaftertreatmentwithRFA,therateofprogressionfromLGDtoHGD and/orcancer,andthecostofRFA.MSACnotedthattheICERwaslikelytoremainvery
highbutuncertaininanysensitivityanalysesinvolvingtheseparameters.
WhenreviewingtheeconomicimplicationsofRFAforHGDMSACnotedthatiftherateof RFAtreatmentfailureleadingtooesophagectomyweretobeconsidered,theremaybea reductionintherelativecost-effectivenessofRFAforHGD. Conversely,MSACalsonoted theassessmentreportdidnotattempttoquantifythecostofmortalityassociatedwith oesophagectomy,whichislikelytopositivelyaffecttherelativecost-effectivenessofRFA. Takingtheseuncertaintiesintoaccount,MSACconcludedthatRFAforHGDwaslikelyto haveacostadvantageoveroesophagectomy.
MSACwasunabletodeterminethecost-effectivenessofRFAforHGDduetolimitationsof thedata. CostingshowedthatRFAislikelytobelessexpensivethanoesophagectomy,but moreexpensivethanAPCandEMR. Furthermore,duetothecostofthedisposable catheters,theremaybeaccessandequityissuesforuninsuredpatientswithlow socioeconomicstatus,whothereforemaybemorelikelytochooseotherformsoftreatment
ofHGDduetothelowercosttothepatient. However,theassessmentreportdidnotethatthe methodoftreatmentforHGDcanvarydependingonclinicalpresentationandtreatment methodsarenotalwaysinterchangeable.
MSACnotedthatoesophagectomyisaninvasiveprocedurewithmorbidityofapproximately
30-50%andmortalityof2%inAustraliancentres. MSACalsonotedthatoesophagectomyis currentlyfundedthroughtheMBS,butEMRandAPCforBarrett’sOesophagusarenot reimbursed.
MSACalsoagreedthattheaccuratediagnosisofdysplasticBarrett’sOesophagusisan importantandcomplexstepinthetreatmentalgorithm,andnotedexpertadvicethattwo experiencedpathologistsshouldconferonthefinalgrading. Thechoiceoftreatmentshould beoverseenbyamulti-disciplinaryteamand,ifconsideredappropriateforthepatient,RFA shouldbeperformedbyanappropriatelytrainedspecialistgastroenterologistorsurgeon. MSACagreedthatboththeclinicaleffectivenessandeconomicbenefitofRFAdependupon theaccuracyofthediagnosisofHGD,andnotedthatprofessionalbodiesshouldbeinvolved indevelopingstandardsforboththediagnosticprocessaswellasfortheconductofthe procedure.
MSACagreedthat,atleastintheshortterm, RFAissafeandeffectiveforLGD,butitisnot cost-effective. MSACfurthernotedthatLGDmayregressfollowingconservativetreatment forgastro-oesophagealrefluxdisease(GORD),anddoesnotnecessarilyprogresstoHGDor cancer. MSACthereforedidnotsupportpublicfundingforRFAforBarrett’sOesophaguswithLGD.
ForHGD,MSACtookintoaccountthattheonlyothercomparativeprocedurereimbursedon theMBS,oesophagectomy,isaninvasiveprocedurewithsignificantmorbidityandmortality ratescomparedtoRFA. AsRFAforHGDappearstobesafeandclinicallyeffective,and costsavingcomparedwithoesophagectomy,MSACsupportspublicfundingforRFAfor Barrett’sOesophaguswithHGD.
13.MSAC’sadvicetotheMinister
Onthebasisofitshighcostanduncertaintyofclinicalbenefitduetouncertaintyof progressionratefromBarrett’sOesophaguswithlowgradedysplasia(LGD)tooesophagealcancer,MSACdoesnotsupportpublicfundingforradiofrequencyablation(RFA)inthe treatmentofBarrett’sOesophaguswithLGD.
Basedonabettersafetyprofileandlowercostthanoesophagectomy,butnotinglackof evidenceofcomparativeclinicaleffectiveness,MSACsupportspublicfundingforRFAfor Barrett’sOesophaguswithhighgradedysplasia(HGD). MSACadvisesthatthediagnosisof HGDshouldbeconfirmedbytwoexpertpathologistswithexperienceinupper gastrointestinal pathology,thattreatmentoptionsforpatientswithHGDshouldbereviewed byanappropriatemulti-disciplinaryteam,andthatRFAshouldbeperformed(where indicated)byanappropriatelyqualifiedspecialistgastroenterologistorsurgeonwhohas receivedspecifictrainingintheprocedure.
14.ContextforDecision
ThisadvicewasmadeundertheMSACTermsofReference. “MSACisto:
AdvisetheMinisterforHealthandAgeingonmedicalservicesincludingthosethatinvolve neworemergingtechnologiesandproceduresand,whererelevant,amendmenttoexisting MBSitems,inrelationto:
•thestrengthofevidenceinrelationtothecomparativesafety,effectiveness, cost-effectivenessandtotalcostofthemedicalservice;
•whetherpublicfundingshouldbesupportedforthemedicalserviceand,ifso,the circumstancesunderwhichpublicfundingshouldbesupported;
•theproposedMedicareBenefitsSchedule(MBS)itemdescriptorandfeefortheservice wherefundingthroughtheMBSissupported;
•thecircumstances,wherethereisuncertaintyinrelationtotheclinicalor
cost-effectivenessofaservice,underwhichinterimpublicfundingofaserviceshouldbe supportedforaspecifiedperiod,duringwhichdefineddatacollectionsunderagreed clinicalprotocolswouldbecollectedtoinformare-assessmentoftheservicebyMSAC attheconclusionofthatperiod;
•othermattersrelatedtothepublicfundingofhealthservicesreferredbytheMinister. AdvisetheAustralianHealthMinister’sAdvisoryCouncil(AHMAC)onhealthtechnology
assessmentsreferredunderAHMACarrangements.
MSACmayalsoestablishsub-committeestoassistMSACtoeffectivelyundertakeitsrole. MSACmaydelegatesomeofitsfunctionstosuchsub-committees.”
15.LinkagestoOtherDocuments
MSAC’sprocessesaredetailedontheMSACWebsiteat: