Reviewof funding arrangements forchemotherapy services:Response.

JoondalupHospitalPharmacyoperatesanonsitechemotherapydruginfusionservice supplyingJoondalupHealthCampusinnorthmetropolitanPerth.SouthwestHospital PharmacyprovidesasimilaronsiteservicetoStJohnofGodHospitalBunbury,acountry location180kmsouthofPerth.Theservicesoperateinasimilarwayandarethusauseful comparisonbetweenmetropolitanandregionalareas.

Costsandcomplexitiesinvolvedin theprovisionofchemotherapydrugs

Questions:

1.Aretheresignificant differences in theprocessesor costsof compounding certain infusible chemotherapymedicines? If so, pleaseidentifythose medicines;describe the different practices or processes and evidenceto support your position.

Somemedicinesinvolvesignificantlydifferent methodsandtakemuchmoretimeto dispensethanothers.Someexamplesthatwedispense arelistedbelow.

Drug/Device / Issue / Process / Time
Paclitaxel(NAB) / Slowpreptime / Slowlyaddsalineand
letsit / 20-30mins
Cyclophosphamide / Slowtodissolve / Requiresalotof
shaking / 15-20mins
Trastuzumab / Avoidbubbles / NOshaking / 10mins
Elastomerics/CADD
casette / Extrastepsto
compoundinthese specialist devices / Extralabourrequired
oversyringesPVC
infusionbags / 10-15mins

2.If you described a different practicefor certain infusible chemotherapymedicines(in response to Q1)should thesebemanaged or funded differentlyto other chemotherapy medicines? If so, pleasedescribe a possible alternativefunding model for these medicines.

There ispotentialforadifferential offundingthattakesintoaccountthetimefor preparationandperhapsspecialistconsumables.OnemethodwouldbetohavethePBAC andorthePBPAattachanextrapaymentfordegreeofdifficulty incompounding.

ThisextraamountwouldseemtobenotinlinewithotherPBSmedicinesthattake considerablymoretimetodispense.Examplessuchasclozapine,whichrequiresblood monitoring andrecordkeepingorthalidomidewhichhasaspecialdispenseprocess includingpatientinterviewsandspecialistconfirmations.Theseexamplesdonotattract extrafundingfordispensingpharmacistsbuttake much greatertimethanthestandard dispensingfeewouldseemtopayfor.

Ruralandregionalchemotherapyprovision

Questions:

1.Aretheresignificant differences in thecostsor processes for providing chemotherapy services in rural and regional areas? How doarrangements varybetweenpublicand private sectors, and what is the effect on accessibilityof services? Pleaseprovideany data or evidenceyou haveto support your position.

OurtwopharmaciesarelocatedinaPerthmetropolitanhospitalandacountryhospitalin BunburysouthofPerth.Thetwopharmacieshavesimilarequipment,procedures,staffing requirementsandhoursofoperation.

OurexperienceshowsthatmajorcostsaremoreexpensiveinBunburythanin Perthdue toscarcity ofskilledlabour,deliverycosts,maintenancecostsandhigherinventorylevels.

Seetable1 inCostings template

Thusthemarginalcosttocompoundperitemishigherinthecountryprobablybyas muchas$10 perinfusion.

ThebenefitforthePBSisthesignificantreductioninwastagethatoccurswiththeuseof

3rdpartycompounders.Ourmodelisonewhereinfusionsare compoundedonadaily basisafterbloodresultsandpatientstatusisreviewed.Theexternalsupplymodel requiresthatdosesareordered48hoursinadvancemeaningupto5%areunused. Itis truethatunuseddosesmaybekeptforalaterdatebutthisoftenhasrequirednurses adjustingdosesanddiscardingunusedportionswhichiswastefulandpotentially unsafe.

Inventorylevelsarekepthighatsignificantcosttothebusiness.ThePBSfundingmodel assumes“justintime”supplywhichisineffectiveinWAcountryareaswheremanydrugs aredelivered3-5daysafterorder.

Theincreaseincapitalcostsisduetoequipmentsupplierscharginghigherfreightand installationcostsincountryareas.

2.Do consumers or providershave extra additionalcostsor other factors thatlimit access to services in theseareas? Pleaseprovide anydata or evidenceto indicatethe differencein costs or other factors for consumers.

Countryconsumersaregenerallyshieldedfromextracostsbyacombinationofthe pharmacyabsorbingsomecostsandthehospitalprovideragreeingtosome charges.An exampleisAbraxane(NAB Paclitaxel)wheretheproductsponsorcharges$30 pervial greaterthanthePBSagreedprice.Thisextracostispassedontothehospitalorpatient dependent onproviderbillingagreements.

3.Does the quality of services varyin rural and regional and remoteareas compared to moreurban areas? What,ifanything, should be changed about current funding arrangements to address?

Thequalityoftheserviceprovidedbyourpharmaciesisidenticalinbothcountryand metropolitansites. Thecosts ofmaintainingthesimilarqualityareoutlinedabove.The greatestcostisthatofholdinghigherinventorylevels toenableonthedayoftreatment delivery.Thecostofholdinghigherinventoriesinisgenerallyoffsetbyhighermarginsin otherindustries.

ThePBSzeromarginremunerationformulamakesthisdifficult foracountrypharmacy to holdextremelyhighcostitemstothesamelevelasmorecommonitems.Workpractices arecreatedwherecertain itemswillrequirealongerleadtimeof3-5daysdependingon manufacturerdeliverytimes.

Qualityofinfusionpreparations

Questions:

What aretherangeof relevant guidelines and standards thatapply to chemotherapy services across States and Territories? How arethesestandards enforced– i.e. regulations, on-site audits? Which if any of thesestandards should applywheredrugs arebeing compounded on-site, or purchased froma third party, or prepared days before the infusion is delivered? How are adverseeventsmonitored and reported?

Ourfacilitiesutilisepharmaceuticalisolatorstocreateasafeworkplaceforthe compoundingofcytotoxics.Theequipment,environment,workpracticesandsafety proceduresaresubjecttooversightbytheWAprivatehospitallicensingunit,Licensing andRegulatoryUnit(LARU).LARUhasjurisdictiononpharmacieswithinprivatehospitals suchasours.

OurfacilitiesandequipmentcomplywithAustralianstandards: AS1386Cleanroomsandcleanworkstations.

AS4273Design,installationanduseofpharmaceuticalisolators.

AS1807,Cleanrooms,workstations,safetycabinetsandpharmaceuticalisolators–

methodsoftest.

StaffaretrainedexternallyatTheBoxHillInstituteinMelbourneandvalidated microbiologically byPathwesttestinglaboratoryinPerth.

OurworkpracticesarebasedonSociety ofHospitalPharmacistsAustralia(SHPA) guidelines,WorksafepublishedguidelinesandthecodeofGoodManufacturingPractice (cGMP).

Adverseeventrecordingmechanismsincludeinorderofseverity. Pharmacyinternaladverse eventrecording.

Hospitaladverseeventrecordingandreporting.

WAHealthDepartmentSACcodereporting system.

Is further development of current standards required? If so, in which area is work needed? Is thereother work, such as thedevelopment ofquality programs, required? How can consumersbeinvolved in thedevelopment ofstandards and programs to ensure quality services?

Furtherdevelopmentofstandardsislessimportant thanfurtherdevelopmentofauditand reviewofthestandards.ThePharmacyGuildQualityCareProgram(QCPP)isthewell establishednationalauditforpharmacies.Itwouldmakesense toexpandtheQCPP programtoinvolveauditofthesterileandcytotoxiccompounding.External3rdparty compoundersarealreadyregulatedbytheTGAwhichisappropriate. Thelinkbetween

thecompounderandpharmacyviaservicelevelagreementsandcontractscouldbe reviewedbytheQCPPprogram.

Should meeting anyof thesestandards be a mandatory requirement for Commonwealth funding? If so, which? How would this be managed or enforced? Aretheredifferent standards that should bemet depending on thecircumstances under whichthe infusion is prepared? What would the effect ofany changesbefor consumers, in terms of access to and quality of chemotherapyservices?

Somestandardsareapplicableforsomesituationsandnotforothers.Forinstanceour facilitiesutilisepharmaceuticalisolatortechnologywhichdiffersfromtheindustry standardlaminarflowsafetycabinets#.Standardsthereforedifferdependingonthe methodofmanufacture.ThirdpartyTGAcompoundersare unlikelytousetheisolator method.

ShouldTGAapprovalberequiredforallcompoundingthiswouldeliminatesmall compoundersthatarenotabletocreatesufficientvolumeinregionalcommunitiessuchas Bunbury.Consumerswhocurrentlyreceiveabespokeonthedayoftreatmentinfusion wouldbedelayedbyuptothree daystoreceiveaninfusion.Thedistancestravelledby

ourcountrypatientscanbeasmuchas400km.Onsitecompoundingisimperativefor thesepatients.

There islittleornoevidenceofnoncompliancewithstandardsbypharmaciesand 3rd partycompounders.Theintroductionofgreaterauditpowershouldbearthisinmind.

#Thelaminarflowcabinetsuseairflowasabarrierand areveryeffectivebutmustbewithinahigh classcleanroomwithinterlockingdoors.Theisolatorisanallinonecleanroomand anteroomin onewithabarrierbetweenthe operatorand thecytotoxics.Theisolatorisinherentlysaferforthe operatorduetothebarrierbutlessefficientthanthelaminarflowcabinet.

Othermatterspertinenttofundingforchemotherapyinfusionpreparation

Questions:

1.Arethereanyconcerns in relation to current administrativeprocesses surrounding the provision and claiming ofPBS chemotherapymedicines and infusions?

TheadministrationofthePBSinthehospitalenvironmentisdifficultandthisisespecially sointheareaofchemotherapy. Thedisconnectbetweenthedrugchart,asamethodof orderingandadministration,andthePBSprescriptionasamethodofremunerationis timeconsumingtoadminister.Wehaveinvestedconsiderableeffortandtimetodevelop

ITsystemstolinkthedrugcharttothecompoundingandthePBSprescription. Muchhas beenwrittenabouttheuseofthe medicationcharttobillPBSinsteadofanextra prescription.Thiswouldbeanexcellenthelp.

TheclaimingofPBSchemotherapyinfusionsrequirescodingoftheexactdiseasestateby thepharmacist.ThisisnotarequirementinanyotherareaofPBSclaiming.Thiscodingis oftenquiteintricateandtakestimeforourpharmaciststoensurecongruencewiththe treatmentgiven.

ThedataavailablefromthePBSonthecalculationofwhatispaidforeachinfusionis limited.Soauditandreviewofpaymentstoensurecorrectremunerationisdifficult. There isnomethodtodocumentthepaymentofanindividualclaimedinfusiondirectfromaPBS websiteforinstance.ThedatacollectedbythePBSclaimingsoftwareislittlehelpinthis regard.

Thesupplyoftrastuzumab(Herceptin®)formetastaticbreastcancerisdeliveredtothe pharmacyfreeafterapplicationfromtheoncologist.ThePBSpaysthedrugcompanyfor thedrug.Noclaimingismadebythepharmacist. Thepharmacyisexpectedto compoundanddeliverthe drugforthepatientbutnoreimbursementispaidforthis dispensingandcompoundingwhatsoever. Theadministrativeburdenofmanagingthis systemisonerousbutagain noremunerationisofferedforthiseffort.

2.What if anything shouldbeaddressed in relation to thesematters?

TheadministrativeburdenofPBSrules continuestoincreasewithlittleconsiderationof thepotentialforefficienciesonthepharmacyside.Particularlytheuseofinteractive websitetoolsthatallowcheckingofreimbursement,deliveryoftrastuzumaband calculations offundingexpectedforaparticulardrugdosecombination.Utilising medicationchartsasprescriptionswouldrelieveamajorburden.

3.Arethereother matters not mentioned in other areas of the paper thatshould be considered in developing a sustainable, transparent funding model for chemotherapy infusion services? Arethere consumer issues that maynot havebeen considered that should betaken into account in developing a sustainable funding model for chemotherapyinfusion services?

Oursubmissiontothe priorsenateenquirydescribedconcernsofapplicationofthe acceleratedpricedisclosurearrangements.Oneofthereasonsforconcernin chemotherapyfundingisthatreimbursementreductionsfromPBSforchemotherapy medicineshavebeenlargerandfasterthanwouldhavehappenedifdatahadbeen collectedatthepricepharmacypays.SeeSenateCommiteeReportCRShenton

Wehaveconcernsthatthere isanincompletemechanismforcontrolling thepriceto pharmacyofPBSdrugs.ThebasisofPBSreimbursementcalculationofchemotherapy drugsistheAgreedManufacturerPrice.OurconcernisthatifaPBSdrugsponsor choosestochargeabovethispricethat thereisnoclearmethodforthatmanufacturerto

beheldtoaccount.Thecostthenmaybepassedontotheconsumerormaymean lackof

accesstothedrug.OurexperienceiswithAbraxane(NABPaclitaxel)wheretheproduct sponsorcharges$431.67 a100mgvialinexcessoftheagreedmanufacturerpriceof

$401.48.Webelievethereareotherexamplesofthispracticewithdrugsthatwedonot currentlydispense.

Conclusion

ThisreponsetotheReviewoffundingarrangementsforchemotherapyservicesis intentionallyaconciseansweringofquestionsraisedinthediscussionpaper.Theprimary valueofthissubmissionisthecomparisonbetweensimilarservicesinmetropolitanand countryWesternAustralia.Wewelcomeanyfurtherenquiriesorrequestsforclarification fromthereviewcommittee.

ChristopherShentonMPSMACPPBpharm,GradDipHealthEc

JoondalupHospitalPharmacy

JoondalupHealthCampusWA

SouthwestHospitalPharmacy

StJohnOfGodHospitalBunburyWA

29 July 2013