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.