One Page Summary

Title:UrovysionFluorescenceIn SituHybridisation(FISH)Assay

Agency:MedicalServicesAdvisoryCommittee(MSAC) MailDropPoint106

CommonwealthDepartmentofHealthandAgeing GPOBox9849CanberraACT2601Australia

Reference:MSACApplication1084Assessmentreport

FirstprintedMay2006

ISBN0 642829241

Aim

Toassessthesafety,effectivenessandcost-effectivenessofadoptingtheUrovysionFISH Assayinconjunctionwithcystoscopycomparedtocystoscopyalonetodiagnoserecurrence

oftransitionalcellcarcinoma(TCC).

Conclusionsandresults

Safety:UroVysionFISHAssayisasafe,non-invasivetestperformedonvoidedurine.

Effectiveness:ThesensitivityoftheUroVysiontestrangedfrom48%to86%,andthe specificityrangedfrom34%to100%.Basedontheseresultsandconsiderationofvarious pretestprobabilitiesofrecurrence,theclinicalimpactofadoptingUrovysionislikelytobe greatestinpatientswithahighriskofTCCrecurrencewhohaveundergoneatleast1yearof follow-up.Inthesepatients,usingtheUroVysiontesttoselectwhetherafollow-up cystoscopyunderlocalanaesthetic(followinganegativeUrovysiontest)orgeneral anaesthetic(followingapositiveUrovysiontest)isrequiredmeansthatonlyasmallnumber ofpatientswouldunnecessarilyundergocystoscopyundergeneralanaesthetic,andmost patientswouldundergoonlyonecystoscopy,ratherthantwo.Theprobabilityofmissinga recurrencefollowinganegativeUrovysionincreasesinpatientswithhigherrisksorin patientsatlaterstagesintheirfollow-up.

Cost-effectiveness:AneconomicmodelshowedthatthecostsofadoptingUroVysionexceed thecostsofcurrentpractice.Atfiveyears,thecostofadoptingUroVysionwas$7835, comparedto$5959forcurrentpractice.One-waysensitivityanalysesshowedthatunderany plausiblevariationofevidenceofaccuracy,costsorratesofrecurrence,theuseofthe UroVysiontestremainedmorecostlythancurrentpracticewiththeequivalentexpected clinicaloutcomes.

Recommendation:MSACrecommendedthatonthestrengthofevidencepertainingto UroysionFISHassaypublicfundingshouldnotbesupportedforthisprocedure.Theclinical usefulnessofthetestislimitedby thesensitivityandexpenseofthetestandthecost effectivenesswasnotdemonstrated.TheMinisterforHealthandAgeingacceptedthis recommendationon28March2006.

Method

MSACconductedasystematicreviewofthebiomedicalliterature(Medline;EMBASE;Pre- Medline;CurrentContents,TheCochraneLibrary)from1966toMarch2005.Referencelists

andhealthtechnologyassessmentwebsiteswerealsosearched.Aneconomicmodelwasused tocomparethecost-effectivenessofadoptingtheUrovysiontesttoselectwhetherapatient beingmonitoredforTCCrecurrenceundergoescystoscopyunderlocalorgeneralanaesthetic versusstandardpracticewherepatientsinitiallyundergocystoscopyunderlocalanaesthetic

followedby asecondcystoscopyundergeneralanaestheticiftheinitialcystoscopyis

positive.