Title:Breastmagneticresonanceimaging

Title:Breastmagneticresonanceimaging

Agency:MedicalServicesAdvisoryCommittee(MSAC) MailDropPoint106

CommonwealthDepartmentofHealthandAgeing GPOBox9849CanberraACT2601Australia

Reference:MSACApplication1098Assessmentreport

FirstprintedMay2007

ISBN1 741862035

Aim:

Toassessthesafety,effectivenessandcost-effectivenessofmagneticresonanceimaging (MRI)ofthebreastasanadditionorreplacementto mammographywithorwithoutbreast ultrasoundforscreeningasymptomatichigh-riskwomenundertheageof50years;andin those aged50yearsandolder.

Resultsandconclusions

Safety:

BreastMRIisasafeprocedureinpatientswithoutcontraindicationstoexposureto magneticfields.

Effectiveness:

NorandomisedcontrolledtrialshaveassessedMRIinbreastscreeningfor evidenceaboutitsimpactonpatientoutcomes.Accuracystudieshaveprovidedstrong evidencethatMRIisa moresensitiveandlessspecifictestthanmammographyfordetecting breastcancer.TherewasconsistentevidencethataddingMRIto mammographyprovidesa

2.6-foldincreaseintestsensitivity(MRI+mammographysensitivity94%[95%CI86-98%];

mammographysensitivity36%[95%CI25-48%;incrementalsensitivityofMRI58%[95%CI 46-70%]).EstimatesoftestspecificityusingMRIvaried,butonestudyshoweda3-fold increaseintherateofinvestigationsforfalsepositivefindings.Existingevidencethat mammographyhasahighersensitivityinolderwomensuggeststheincrementalaccuracyof MRIislikelytobelowerinthisagegroup.Therewasalackofclinicalevidencetodetermine

thehealthbenefitsgainedby earlierdetectionofbreastcancerinwomenathighrisk.

Cost-effectiveness:

Basedonmodelledestimatesoftheeffectsofearlydetection,MRImay potentiallybecost-effectiveforscreeningveryhigh-riskwomensuchasBRCA1mutation carriersaged35-54years,butisunlikelytobecost-effectiveforscreeningBRCA2carriersor womenwithawiderriskoragedistribution.ThetotaladditionalcostofimplementingMRI for breastcancerscreeningwilldependonthecostanduptakeoftheprocedure,the

sensitivityofstandardmammographyscreeningprotocolsthatincludetheoptionof performinga screeningultrasoundandpatientbaselinerisk.

Recommendation:

BreastMRI,whencombinedwithmammography,issafeandeffectiveinthe diagnosisofbreastcancerinasymptomaticwomenathighrisk,whenusedaspartofanorganised surveillanceprogram.EvidencesuggeststhatbreastMRIincombinationwithmammography

maybecost-effectivewhencomparedwithmammographyaloneinhighriskwomenagedless than50years.

MSACrecommendsinterimpublicfundingforbreastMRIinthediagnosisofbreastcancerin asymptomaticwomenwithahighriskofdevelopingbreastcancerwhenusedaspartofan organisedsurveillanceprogram.Evidenceshouldbereviewedinnotlessthan3years.The MinisterforHealthandAgeingendorsedthisrecommendationon5February2007

Methods:

MSACconductedasystematicreviewofthebiomedicalliteratureuptoMarch

2006toassessthesafetyandeffectivenessofbreastMRI.Apublishedevaluationofthecost- effectivenessofMRIforscreeningwomenathighriskofbreastcancerintheUnitedStates wasusedtodiscusseconomicconsiderations.Asecondaryeconomicanalysiswasperformed basedonthismodel,butexcludingindirectcostsandapplyingAustralianrelativeprices.