Summaryof Key Matters for Consideration by the Applicant

1171

Final Decision Analytic Protocol to guide the assessment of sexual health medicine professional attendance and case conferencing items

June 2012

Table of Contents

MSAC and PASC

Purposeofthisdocument

Summaryof key matters for consideration by the applicant

Purpose of application

Background

Currentarrangementsforpublicreimbursement

Intervention

Description

Prerequisites

Co-administeredandassociatedinterventions

Listing proposed and optionsfor MSAC consideration

ProposedMBSlisting

Clinicalplaceforproposedintervention

Other relevant considerations

Clinical claim

Economic analysis

MSAC and PASC

TheMedical ServicesAdvisoryCommittee(MSAC)is anindependentexpertcommitteeappointedby theMinisterforHealth and Ageing(the Minister)tostrengthenthe roleof evidenceinhealthfinancing decisionsinAustralia.MSACadvisestheMinisteron theevidencerelatingtothesafety,effectiveness, andcost-effectivenessof newandexistingmedical technologiesandproceduresandunderwhat circumstances public funding should besupported.

TheProtocol AdvisorySub-Committee(PASC)is astandingsub-committee ofMSAC.Itsprimary objectiveisthedeterminationofprotocolstoguideclinicalandeconomicassessmentsof medical interventionsproposed forpublic funding.

Purposeofthisdocument

Thisdocumentisintendedtoprovideadecisionanalyticprotocolthatwill beusedtoguidethe assessment of an intervention for a particular population of patients.

Protocolsguidingtheassessmentof thehealthinterventionaretypicallydevelopedusingthewidely accepted“PICO”approach.ThePICOapproachinvolves acleararticulationofthefollowingaspectsof the question for public funding the assessment is intended to answer:

Patients –specificationofthecharacteristicsofthepatientsinwhomtheinterventionis to be considered for use

Intervention– specificationof the proposed intervention and how it is delivered

Comparator – specification of the therapy most likely to be replaced by the proposed intervention

Outcomes –specificationofthehealthoutcomesandthehealthcareresourceslikelytobe affected by the introductionof the proposed intervention

However,asdiscussedonp.5below,inthecaseofsexualhealthmedicineprofessionalattendance andcase conferencingitems, PASCresolvedthatthe adoptionof thestandard PICOapproachwasnot appropriateasan assessmentfocussed onsuch anapproachmay besonarrowthatit wouldnotbe informativeto MSAC.

Summaryofkeymattersforconsiderationbythe applicant

ThePASCrequeststhattheapplicantnotethefollowingissuesandaddresstheseissuesinits assessment:

Anassessmentreportissoughtthatpresentstheoverallbodyofevidencethatcouldinforma judgement as to the overall comparative effectiveness, safety and cost-effectiveness of a model of careinvolvingsexualhealthmedicinespecialists comparedwithalternativemodelsofcare(e.g., managementofpatientsbyGPsonly).Inaddition toconsideringmodelsofcarethatdifferby provider of medical service, models of care that involve different types of services should also be comparede.g.,inthiscase whereboth professional attendance andcase-conferencingitemsare sought,amodelofcareinvolvingonlyprofessional attendancesshouldbecomparedwithamodel ofcarethatinvolvesbothprofessionalattendancesandmulti-disciplinary case-conferencing activities.

Onthebasisofthelikelyclaimsofpotentialclinicalequivalenceorsuperiorityforthemodelof careinvolvingsexualhealthmedicinespecialistscomparedwith alternatemodelsofcare,PASC consideredthattheassessmentreportwouldpresent either acost-minimisation or cost- effectiveness analysis, respectively.

Broaderconsiderationsbesidestheimpactonapatient’squality-adjustedsurvivalshouldbe presentedinanapplicationrequesting theavailabilityofadditionalsexualhealthmedicineMBS items. For example, workforce issues that maybe addressed (and the downstream impact on patientoutcomes)byavailabilityofsuchitemscould beaddressed.Similarly,impactsonfactors such as transmission ratesof sexually transmitted infections couldbe reported.

Inadditiontoacomparisonofmodelsofcareinvolvingsexualhealthmedicinespecialistswith alternativemodels ofcare,PASCrecommendedthatany assessmentpresentedto MSAC should address a wider setof claims including:

oWhat evidence isavailable to demonstrate thatthere isunmet need forsexual health medicinespecialistsintheprivatesector,inthepublicsectorandoverall(e.g.,howlongdoes apatienthavetowaittoseea sexualhealthmedicinespecialist; whatproportionofpatients withsexualhealthproblemsinwhomtheservicesofasexualhealthspecialistareindicated donotaccesssuchservices;hasa shortageof supplybeenidentifiedbyother partiessuch as state health departments,etc)?

oWhatevidenceisavailableinrelationtotheconsequencesofunmetneed(e.g.,ifapatient hasacommunicablediseaseandhastowaitto receivetreatment,thismighttranslateto increased transmissionof the disease)?

oTowhatextentisthefailuretoaccesssexualhealthmedicineservicesduetoshortageof sexualhealthmedicinespecialists(i.e.,duetoworkforceshortage)?Towhatextentisthe failuretoaccesssexualhealthmedicineservicesduetootherfactors(e.g.,requirementfor a referral, fees)?

oWhat evidence exists to support the claim that increasing reimbursement for services deliveredby sexualhealth medicine specialistsin theprivate sectorresultsin an increase in supply of sexual health medicine specialists?

oWillanincreaseinsupplyofsexualhealthmedicinespecialistsresultinimprovedaccessto sexualhealthmedicineservices(i.e.,expansioninnumberofpatientsaccessing sexualhealth medicine services)?

oWhatevidenceisavailablewithrespecttotheeffectsofdifferentapproachestofundingfor thevariousmodelsofcarethatarepossible? Towhatextentwillincreased fundinginthe privatesectorcauseatransferofservicesfromthepublictotheprivatesector?Towhat extentwillincreasedfundingintheprivatesectorresultinanoverallincreaseinexpenditure on theseservices?

Purpose of application

Anapplicationrequestingthelistingof fourtime-tieredprofessionalattendance(consultation)items andsixtime-tieredcaseconferencingitemsonthe MedicareBenefitsSchedule(MBS),tobeprovided by sexualhealthmedicine specialists,hasbeenprogressedbytheDepartmentofHealth and Ageing (DoHA) inconsultation withthe Australasian ChapterofSexualHealth Medicine(AChSHM). The AChSHMinitiallyrequestedaccesstoagreaternumberof MBSitems than DoHAactually proposedto PASC(e.g.itemsforcomplexplanning andmanagementwerealsorequested).DoHAconsideredthat thetime-tieredandcaseconferencingitems asproposedcouldpotentiallybeusedfor suchpurposes, andAChSHMdidnotobject.PASCdidnotdeterminethattheapplicationbebroadenedtoinclude itemsforcomplextreatmentandmanagementplanning,butdidnotruleouttheissue.Theapplicant is seeking a funding model that reflectscontemporarysexual healthmedicine practice.

PASCnotedthattheapproachofatraditionalMSACHTAassessmentwouldseektoderiveestimates ofthecomparativeeffectiveness,safetyandcost-effectivenessofMBSoftheproposedscenario (where four time-tiered professional attendance and sixtime-tiered case-conferencingitems wouldbe available andclaimed)versusthecurrentscenario (wherecurrentlyavailablespecificMBSprofessional attendance andcase-conferencingitemsare claimed)usingthe standardMSAC PICO(pluseconomic evaluation approach). PASC consideredthat such anapproach was not appropriate in this case for two reasons:(i)theapproach wastoonarrowtopermitassessmentofvariousclaimsmadebythe AChSHM;and(ii)theapproachwaslikelytobeunhelpfulininformingMSACaboutthe valueof servicesprovidedbysexualhealthmedicinespecialistsbecausedata andevidencetoinformsucha specificapproachwereunlikelytobeavailable.For example,therewereunlikelytobedatatoanswer thequestion astowhatthehealth outcomes associatedwithafundingmechanisminvolving4time- tieredserviceswouldbecomparedwith afundingmechanismthathadonlyaninitialassessmentitem and a review item.

AlthoughPASCconsidered that MSACwouldbeunlikelytobe able toansweraquestionastowhether itwouldbepreferabletohavefourtime-tiered professionalattendance(consultation)itemsandsix time-tieredcaseconferencingitemsontheMBSfor sexualhealthmedicinespecialists,comparedwith currentlyavailableanduseditems,PASCconsideredthatevidencemaybeavailabletopermitMSAC toprovideadvicetotheMinisterastothecomparativeeffectiveness,safety andcost-effectivenessof servicesdeliveredbysexualhealthmedicinespecialistsversus alternativemodelsofcare(e.g., managementofpatients byGPsonly)i.e.,evidencewaslikelytobeavailabletopermit MSACto determine a response to thequestion astowhetherdedication ofresourcesto this specialtywas worthwhile in a generalsense. PASC agreed thatthefinal DAP should reflect this approach.

Background

Currentarrangementsforpublicreimbursement

There arecurrentlynospecificsexual healthmedicineprofessionalattendanceorcaseconferencing itemsavailable on theMBS.

Sexualhealthmedicinewasrecognisedasaspecialityin2009bytheAustralianMedicalCouncil.It wasreported toPASCthatthere arecurrentlyapproximately115 sexual health medicinespecialistsin Australia andthata minority of sexual health medicine practice isprovided in the privatesetting.

Inthe2010/11FederalBudget,sexualhealthmedicinespecialistsweregrantedaccesstotheGroup A3specialist itemsontheMBS.Medicaredataasof 26October2011indicatethat23sexualhealth medicine specialists had registered to use A3 specialist attendance items. The large majority of sexual healthmedicinespecialistshavenotregistered with Medicarebecausethey prefertoseek Medicare reimbursementfortheirservicesintheircapacitiesasGPs,other medicalpractitioners,etc,asbelow, ratherthanthroughitemsincludedinA3ofthe MBS.Itis suggestedthatthisdecisionappearstobe influenced by the fact that, given the mode of practiceused to deliver sexual health medicine services, the A1, A2,and A15 item structures provide a higherlevel of remuneration thanthe A3 item structure. Reimbursement for services is currently claimed under the following groups ofMBS services:

GROUP A1– GENERALPRACTITIONERPROFESSIONAL ATTENDANCES

FiguresprovidedbytheAChSHMindicatethat19% ofsexualhealthmedicinespecialistshold Fellowshipof the RoyalAustralianCollegeofGeneral Practitionersand are able accesstothis group of items.

GROUP A2– OTHER MEDICALPRACTITIONERPROFESSIONAL ATTENDANCES

Sexual health medicinespecialists who arenon-vocationallyregisteredGPs,specialisttrainees or other medical practitioners andare able access tothis group ofitems.

GROUP A3– SPECIALIST PROFESSIONALATTENDANCES

March2011dataindicatethatonlytwomedicalpractitionershaveregisteredwithMedicare

Australia as sexual healthmedicine specialists.

GROUP A4– CONSULTANT PHYSICIAN PROFESSIONALATTENDANCES

FiguresprovidedbytheAChSHMindicatesthat10%ofsexualhealthmedicinespecialistshold FellowshipoftheRoyalAustralasianCollegeofPhysicians(RACP)andareabletoaccessto this group ofitems.

GROUP A8– CONSULTANT PSYCHIATRISTPROFESSIONALATTENDANCES

TheChapter hasindicated thatonesexualhealth medicinespecialistholdsaFellowshipofthe RoyalAustralianandNewZealandCollegeofPsychiatrists(RANZCP)andwouldhaveaccess to this groupof items.

GROUP A15– CASE CONFERENCING

There are no existing case conferencingitems for specialists. However, sexual health medicine specialistswhohavenotregisteredwith Medicare Australia as Group A3 ‘specialists’, and for Medicarepurposesare‘GPs’,haveaccesstoexistingGroupA15caseconferencingitems721-

758. Consultantphysicianshave accesstocaseconferencingitems820-858; andconsultant psychiatristshave access to case conferencing items861-880.

Theproposalnotesthatthetraditionalstructureofspecialistprofessionalattendances(e.g.,Groups A3andA4oftheMBS)provideamoregenerously rebateditemforaninitialattendanceandaless generouslyrebateditemforafollow-up attendance. TheAChSHMarguesthat theattendance itemsin thissectionoftheMBShavebeenavailableto,and reflectthenatureofthepracticeof,procedural specialists,i.e.thosewhosepractices alsoinvolve significantproceduralwork.Theproposalsuggests thatthistraditionalstructuredoesnotsuitdiscussion-based,cognitivespecialtiessuchassexual healthmedicine,whichrelyontimespentwithapatienttoassessandresolvemorecomplexissues.

TheAChSHM claimsthattheA3itemsprovideinadequatereimbursementforclinicallyeffectivesexual healthmedicinepracticebecausethey areaconsulting ratherthanprocedural specialty.Hence,itis proposedthatanapplicationbe submittedtoMSAC requesting listingoffourtime-tiered professional attendance(consultation)itemsandsixtime-tieredcaseconferencingitemsontheMBS,tobe provided by sexual healthmedicine specialists.

Intervention

Description

Inrelationtoprofessionalattendanceitems,asexualhealthmedicinespecialistwould,typically, obtainapatient’ssexualclinicalhistory,conductexpertexamination,order relevanttesting,and provide follow-up treatment and management (viaa number of consultations,as required).

Asinitialandfollow-upconsultationscanbeeither shorterorlonger,dependingonapatient’sneeds, time-tiereditemshavebeenproposedtoenable sexualhealthmedicinespecialiststobilltherelevant item based on time spentwith a patient.

Inrelationtocaseconferencingitems,itisproposed thattheseitemswouldonlyapplytoaservicein relationtoa patientwhosuffersfromatleastone medicalcondition,thathasbeen(orislikelytobe) presentfor atleast 6months,or thatisterminal, andhascomplexneedsrequiringcarefrom a multidisciplinaryteam.PASCpresumed that anote wouldbeincludedintheitemdescriptor forcase conferencingitemsdirectingphysicianstoexplanatorynotesassociatedwiththeitemthatspecify thesecriteria.

The case conferencing items would enable a multidisciplinary team to carry out the following:

discuss a patient’s history;

identify a patient’s multidisciplinary careneeds;

identifyoutcomestobeachievedbymembersofthecaseconferenceteamgivingcareand service to thepatient;

identifytasksthatneedtobeundertakentoachievetheseoutcomes,andallocatingthose tasks to members of the case conferenceteam;and

assesswhether previouslyidentified outcomes (if any) have beenachieved.

Prerequisites

REFERRAL

Theproposed itemdescriptors(provided inTable1) indicatethatthepatientmustbereferredforthe interventionbyamedicalpractitionerotherthanthesexualhealthmedicinespecialistwhoisto providetheintervention.Thereferralprocesswill beinaccordancewiththeMBSG6.1Referralof Patients to Specialist or Consultant Physician.

ALTHOUGHTHEPROPOSEDITEMDESCRIPTORSFORPROFESSIONAL ATTENDANCES INCLUDETHEREQUIREMENT FORA REFERRALFROMAMEDICALPRACTITIONER,THEPROPOSALNOTESTHATTHENEEDTOOBTAINAREFERRALFROMAGP MAYCOMPROMISEACCESSTOTIMELYSEXUALHEALTHSPECIALISTADVICEANDTREATMENT.

TRAINING

Itisproposedthatonlyqualifiedsexualhealthmedicinespecialistswillbeabletoclaimforthe delivery of the proposed MBS items.

Inordertobeacceptedintothetrainingprogramtoacquirefellowshipofthe AChSHM,an applicant must firstly satisfyall three of the following conditions:

(i) Be a registered medical practitioner in Australia or New Zealand.

(ii)EITHER holdFellowship ofone of the following Colleges or Faculties:

Physicians (FRACP) Adult InternalMedicine or Paediatrics & Child Health

Dermatology(FACD)

Obstetrics and Gynaecology (FRANZCOG)

General Practice (FRACGPand FRNZCGP)

Pathology (FRCPA)

Psychiatry (FRANZCP)

Public healthMedicine (FAFPHM)

Rural and RemoteMedicine (FACRRM)

Surgery (FRACS – urology)

OR in the case of overseas trained specialists (including general practitioners) hold a qualification consideredequivalent by the relevant Australian or New Zealand medical college OR have completed BasicTraining ofthe RACP (including success in the FRACPExamination)

(iii)have asatisfactory practicehistory (no professional misconduct or disciplinary issues).

Trainees are thenexpectedtocompleteformalinstructionviaunitsinuniversitycoursesinthe following areas:

Fertility regulation

Sexual healthcounselling

HIV medicine

Sexual healthmedicine

Epidemiology

Biostatistics

Sexualassault

Principles ofadult education

Theproposal foranapplicationnotesthat,byrequiringfellowshipwithanotheraccreditedmedical college and then requiring a further three years advanced training in sexual health medicine, specialists in sexual healthmedicine ineffect train for approximately 10 years.

Co-administeredandassociatedinterventions

Asnotedabove,arequirementwillbethatreferral fromamedicalpractitionerberequiredpriortoa professional attendance by a sexual health medicine specialist.

Nootherspecificservices arerequiredtobeadministeredpriorto,withorfollowingtheproposed medicalservices.However,follow-upservicesthatmightneedtoberenderedfollowingasexual health medicine service would be discussed during the consultation. A sexual health medicine

specialist mayordervariouspathologytestsordiagnosticimagingservicesduringaninitialor subsequent consultation for assessmentof a patient’sstatus.

Listing proposed and optionsfor MSAC consideration

ProposedMBSlisting

Theproposed MBSitemdescriptors are providedin Table1(Pleasenote:Itemsforcomplex treatment and management planning are not included in this table,as the issue was not resolved at PASC)

Table 1:Proposed MBSitemdescriptorfor proposed sexual health medicine services

Althoughthe proposeditemdescriptorsdonotspecifythepatient populationtowhomtheitemsmay bedelivered, PASCconsidereditreasonabletoassumethatasexualhealth medicinespecialist would onlybeattendingtopatientswithsexualhealthproblems.However,itnotedthatpatientsrequiring theservicesofa sexualhealthmedicinespecialistareaheterogeneousgroup.PASCagreedthatno specificationofthepatientpopulationtowhomtheitemsmaybedeliveredneedstobeincludedin the MBS itemdescriptors.

Asdiscussed onp.5,PASC resolvedthat thetraditionalMSAC HTA assessmentapproach,whichwould seektoderiveestimatesofthecomparativeeffectiveness,safety andcost-effectivenessofMBSofthe proposedscenario(wherefourtime-tieredprofessional attendanceand sixtime-tieredcase- conferencing itemswould beavailable andclaimed)versusthecurrentscenario(where currently availablespecificMBSprofessional attendance and case-conferencingitems areclaimed),wasnot appropriatefortworeasons:(i)the approachwastoonarrowtopermitassessmentofvariousclaims madebytheAChSHM;and(ii)theapproachwas likelytobeunhelpfulininformingMSACaboutthe value of servicesprovided bysexual healthmedicinespecialistsbecausedata andevidence toinform such a specific approach were unlikely to be available. For example, there were unlikely to be data to answerthequestionastowhatthehealthoutcomes associatedwithafundingmechanisminvolving4 time-tieredserviceswouldbecompared withafundingmechanism thathadonlyaninitialassessment itemandareviewitem.AlthoughPASCconsideredthatMSACwouldbeunlikelytobeabletoanswer aquestionastowhetheritwouldbepreferabletohavefour time-tieredprofessionalattendance (consultation)andsixtime-tieredcaseconferencingitemsontheMedicareBenefitsSchedule(MBS)

forsexualhealthmedicinespecialistscomparedwiththecurrentlyavailableandused items,PASC consideredthatevidencemaybeavailablethatwouldpermitMSACtoprovideadvicetotheMinister as to thecomparative effectiveness, safety andcost-effectivenessof services asdelivered bysexual healthmedicinespecialistsversusalternativemodelsofcareforpatients(e.g.,managementof patientsbyGPs)i.e.,evidencewaslikelytobeavailabletopermitMSACtodeterminearesponseto thequestionastowhetherdedicationofresourcestothisspecialtywasworthwhileinageneral sense.

Thus,PASCresolvedthatthe“intervention”should bemorebroadlydefinedthanasproposedabove. PASCresolvedthatitwouldbeappropriatefor an assessmentreporttopresentthe overall bodyof evidencethatcouldinformajudgementastothe overallcomparativeeffectiveness,safety andcost- effectivenessofamodel ofcareinvolvingsexualhealthmedicinespecialistscomparedwithother potentialmodelsofcare(e.g.,managementofpatientsbyGPsormanagement ofpatientsby consultantphysicians).In addition toconsideringmodels ofcarethatdifferbyproviderof medical service,modelsofcarethatinvolvedifferenttypes ofservicesshouldalsobecomparede.g.,inthis casewherebothprofessionalattendanceandcase-conferencingitemsaresought,amodel ofcare involvingonlyprofessionalattendancesshouldbecomparedwith amodelofcarethatinvolvesboth professional attendancesand multi-disciplinary case-conferencing activities.

Duetothe widerangeofreasonspatientsmayconsulta sexualhealthmedicinespecialist,andin recognition thatthestrengthofevidenceforsomesexualhealth conditions maybebetterthanfor other sexual health conditions,PASC recommended that the overallbody ofevidence shouldbe presentedinasystematisedmannersothatevidence forsimilarconditionsispresentedtogether.For example, at thehighestlevel, servicesdeliveredtopatientscouldbeclassifiedon thebasisas to whetherthepatienthaspresentedwithacommunicableor anon-communicabledisease.Further breakdown of theevidencecouldbepossible.For example, servicesdelivered topatientspresenting withacommunicablediseasecouldbeclassifiedon thebasisastowhetherthepatienthasablood borneornon-bloodbornecommunicabledisease;and servicesdeliveredtopatientspresentingwitha non-communicablediseasecouldbepresentedseparatelydependingonwhetherthepatientseeks treatment of dermatoses, sexualfunction/dysfunction,pain syndromes,reproductivehealth services, etc. It was important, however, that the number of classificationsremained limited so that conclusions couldbedrawnthatcouldbeconsideredapplicabletoothersexualhealth conditionswherethe evidence was more limited.

Clinicalplaceforproposedintervention

Patients ofsexual health medicine include people ofall ages who suffer from any type of sexual health disorder.Sexualhealthmedicineinvolvesthe assessment,diagnosisandtreatmentof avarietyof sexual-relateddiseasesandsymptoms(e.g.HIVand othersexuallytransmitteddiseases;genitalpain; sexualfunction;and skinproblems).Sexualhealthspecialistsmanagearange ofcomplexmedicaland otherissues withpatients.Itisclaimedthataccesstospecialistsensurespatientsareexposedto greaterexpertisethanotherwise wouldbeavailable.Benefitsflow topartners,families andthe community as a whole.

Theproposalforanapplicationindicatesthattheclinicalplaceforaprofessionalattendancebya sexualhealth medicinespecialistoccursat thepointatwhicha generalpractitionermakesaclinical judgement that such an attendance is necessary.

Other relevant considerations

Inconsideringcomments received ontheConsultationDAP,PASCnoted that thefundamentalclaim madebysexualhealthmedicinespecialistsisthat thecurrentMBSrebatestructureareinsufficientto supporta viable private practicespecialising in sexualhealth medicine.

PASCnotedthatthefundamentalobjectiveofthe MBSwasnottoprovidearemunerationsystemfor health practitioners but, instead, the MBS is apublic subsidy system intended to ensure that Australianpublichaveequitableaccesstoeffective,safeandcost-effectivemedicalservices. However, PASCacknowledgedthat,ifamodelofcareinvolvingsexualhealthmedicine specialists,provided incrementalhealthbenefitsatareasonableincrementalcostcomparedtoother models ofcare,andif therewascurrentlyashortageofsexual healthmedicinespecialistssuchthatpatientsrequiringsuch carewereunabletoreceiveit,then expansion ofthenumber ofservicesprovidedbysexualheatlh medicine specialists in theprivate sectorwould be desirable.

Inadditiontoacomparisonofmodelsofcare involvingsexualhealthmedicinespecialistswith alternativemodels ofcare,PASCrecommended thatanyassessmentpresentedto MSACshould address a wider setof claims including:

Whatevidenceisavailabletodemonstratethatthereisunmetneedforsexualhealthmedicine specialistsintheprivatesector,inthepublicsectorandoverall(e.g.,howlongdoesapatient havetowait toseeasexualhealthmedicinespecialist;whatproportionofpatientswithsexual healthproblemsinwhomtheservicesofasexualhealthspecialistareindicateddonotaccess such services;hasa shortage ofsupplybeenidentifiedbyotherparties suchasstatehealth departments, etc)?

Whatevidenceisavailableinrelationtotheconsequencesofunmetneed(e.g.,ifapatienthasa communicabledisease andhastowaittoreceive treatment, thismighttranslatetoincreased transmissionof the disease)

Towhatextentisthefailuretoaccesssexualhealthmedicineservicesduetoshortageofsexual healthmedicinespecialists(i.e.,duetoworkforceshortage)?Towhatextentisthefailureto accesssexualhealthmedicineservicesduetootherfactors(e.g.,requirementforareferral, fees)?

Whatevidenceexiststosupporttheclaimthatincreasingreimbursementforservicesdeliveredby sexualhealth medicinespecialistsintheprivatesectorresultsin anincreaseinsupplyofsexual health medicine specialists?

Willanincreaseinsupplyofsexualhealthmedicinespecialistsresultinimprovedaccesstosexual healthmedicineservices(i.e.,expansioninnumber ofpatients accessingsexualhealthmedicine services)?

Whatevidenceisavailablewithrespecttotheeffectsofdifferentapproachestofundingforthe variousmodelsofcarethatarepossible?Towhatextentwillincreasedfundingintheprivate sectorcauseatransferofservicesfromthepublictotheprivatesector?Towhatextentwill

increasedfundingintheprivatesectorresultinanoverallincreaseinexpenditureonthese services?

Clinical claim

PASCanticipatedthatan application consideringthecomparativeeffectiveness,safetyandcost- effectivenessofamodelof careinvolvingsexualhealthmedicinespecialistswithalternativemodelsof care would claim that:

•Patientswhoaremanagedbyamodelofcareinvolvingdeliveryofservicesbyasexualhealth medicinespecialistexperienceeitherequivalentor superiorquality-adjustedsurvivalcomparedto patients managed by alternative models of care.

•Appropriatefunding(viathelistingoftheproposeditems)forservicesprovidedbysexualhealth medicinespecialistsislikelytocreateafinancialincentiveforsexualhealthmedicinespecialists toprovideadditionalservicestopatientsinthe privatesectorandthiswillhaveapositiveimpact to the community overall.

Inrelationtothe outcomesthat shouldbeused tojudgethe effectiveness ofvariousmodelsof care, PASCnotedthat,ultimately,quality-adjustedsurvivalwouldbetheappropriatemetrictoconsider. PASCthusadvisedthatstudiesreporting outcomesthathadanimpacton apatient’squality-adjusted survivalwouldberelevantforpresentationinanapplication.PASCagreedthattheoutcomessuch as rate of recurrence of infection, prevention of serious sequelae, effect of successful contact tracing, relief of psychological symptoms through treatment of erectile dysfunction were examples of outcomes thatcouldeitherdirectlyor indirectlybe showntohavean impactonquality-adjusted survival.

Economic analysis

Onthebasisofthelikelyclaimsofpotentialclinical equivalenceorsuperiorityforthemodelofcare involvingsexualhealthmedicinespecialistscomparedwithalternativemodelsof,PASCconsidered thattheassessmentreportwouldpresenteitheracost-minimisationorcost-effectivenessanalysis, respectively.

Anappropriateeconomic analysiscould alsoincorporatecostsandbenefitsassociatedwithtransfer of services delivered under the public system to the private system and also costs and benefits associated with expansion of availability of sexual health medicine services through the MBS. Estimates of transfer ratesshould besupported withevidence.

Broaderconsiderationsbesidestheimpactonapatient’squality-adjustedsurvival shouldbepresented inanapplicationrequestingtheavailabilityofsexualhealthmedicineMBSitems. Forexample,as discussedinthepreviousparagraph,workforceissuesthatmay beaddressedbyavailabilityofsuch itemscouldbeaddressed.Similarly,if,forexample,aclaimismadethatprovisionofservicesby sexualhealthmedicinespecialistswillresultinreducedtransmissionofcertain infections,thenthere will need to be a consideration of these impacts.