Title:LeukoScan®foruseindiagnosticimagingofthelongbonesandfeetinpatients withsuspectedosteomyelitis,includingthosewithdiabeticfootulcers

Agency:MedicalServicesAdvisoryCommittee(MSAC) CommonwealthDepartmentofHealthandAgeing GPOBox9848,CanberraACT2601,Australia

Reference:MSACApplication1056AssessmentReport

Firstprinted:September2003

ISBN0642823758

Aim

Toassessthesafety,effectivenessandcost-effectivenessofLeukoScan® foruseindiagnosticimagingof thelongbonesandfeetinpatientswithsuspectedosteomyelitis,includingthosewithdiabeticfootulcers,

relativetocomparatordiagnosticradiopharmaceuticalsie,technetium-99mstannouscolloidlabelledwhite bloodcell(WBC)scanningorgallium-67scanning.

Conclusionsandresults

Safety

Theavailablepublishedandunpublisheddatasuggestthatthelevelofadverseeventsandtheprobabilityof inducingahumananti-mouseantibody(HAMA)responsefollowingLeukoScan® administrationareboth low.LeukoScan®offersasafetyadvantageovertechnetium-99mstannouscolloidlabelledWBCscanning withreducedpreparationrequirementsandnoneedforbloodhandling.Italsooffersasafetyadvantage

overgallium-67scanningthroughreducedexposuretoionisingradiation.Inbothcases,thesafety advantageappearstobemarginal.

Effectiveness

Therearenohead-to-headstudiesofLeukoScan®andthemaintechnologiesthatitmightreplacein

Australia(ie,technetium-99mstannouscolloidlabelledWBCscanningorgallium-67scanning).Therefore, ananalysiswasundertakenoftrialsreportingadirectcomparisonofthediagnosticaccuracyof

LeukoScan®withindium-111andtechnetium-99mlabelledhexamethylpropyleneamineoxime(HMPAO) WBCscanning(diagnosticmodalitiesincommonusageinternationally).Thediagnosticaccuracyof

LeukoScan®wasnotsignificantlydifferentfromindium-111ortechnetium-99mlabelledHMPAOWBC

scanninginpatientswithdiabeticfootulcersnorinthosewithsuspectedosteomyelitisofthelongbones.

Cost-effectiveness

Aneconomicanalysiswasconductedtoexplorethecost-effectivenessofLeukoScan®basedonthe marginallybetteraccuracyofLeukoScan® whencomparedwithindium-111andtechnetium-99mlabelled

HMPAOWBCscanning.TheseanalysesindicatethattheincrementalcostofLeukoScan®peradditional patientfreeofosteomyelitisinlongbonesandforpatientsfreeofosteomyelitissecondarytodiabeticfoot

ulceris$24,056and$26,348,respectively.InbothcasestheincrementalcostofLeukoScan® peradditional

patientfreeofosteomyelitisisgreaterthanthecostoftreatingapatientwithosteomyelitis.

Recommendation

LeukoScan® issafeandaseffectiveascurrentmethodsofWBCscanning,butismorecostly.MSAC

recommendsthatadditionalfundingisjustifiedforpatientswhodonothaveaccesstoex-vivoWBC

scanning.

Methods

MSACconductedasystematicreviewofthemedicalliteraturepertainingtoLeukoScan® andcomparator diagnosticradiopharmaceuticalsincludingtechnetium-99mstannouscolloidlabelledWBCscanningand

gallium-67scanning.Inaddition,asearchofstudiesofLeukoScan® withindium-111andtechnetium-99m labelledHMPAOWBCscanningwasconductedinordertoassessdiagnosticaccuracy.Athoroughsearch

ofthemedicalliteraturewascarriedoutviaelectronicdatabasesandhealthtechnologywebsites.Those citationsthatmetpredefinedinclusioncriteriawereincludedinthereviewofevidence.