fighting for your patients successful prior …...jun 07, 2016 · confirm hepatitisc diagnosis...
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FIGHTING FOR YOUR PATIENTS:SUCCESSFULPRIOR AUTHORIZATION TIPS FROM THE PROS
AlysonHarty,RN,BSN,ClinicalNurseManager
MountSinaiInstituteforLiverMedicine
SusanLeePharmD,BCPS,CDE,SpecialistPharmacist,
SandraAtlasBasscenterforLiverDiseases,MedicineServiceLine-Northwell Health
SarahPenroseFNP-BC,NursePractitioner,MountSinaiInstituteforLiverMedicine
EmpireLiverFoundation
June7,2016
SettingTheTone
SETTING THE TONE• MostpatientsareunawareofthedetailsofthePriorAuthorization(PA)process
• Educatethepatient:• Time,effortandpaperworkinvolvedintheprocess• Barrierstoaccessinsurancehasinplace,makingapprovalprocessmoredifficult
• InsuranceFormularyExclusion• HistoryofIVDrugUse• SubstanceUse• Limited PrescribingPrivileges
• Hepatologist, Gastroenterologist, InfectiousDisease• Initialvisit forthese providerscanbeupto3months• Incomplete datatodetermine clinical need ¹
• **Number onereasonfordenial• Poorcommunication between insurerandprovidersoffice
• Insuranceoftenwillstatetheydidnotreceiveforms,orappealswhichweresubmitted
• Adherenceassessment requiredinmostpatients forPAcriteria• Evenwhenproviderfeels it isnotnecessary
SETTING THE TONE• Deflatepatientexpectations:
• Willnotwalkoutofthedoorwithaprescriptiontobringtolocalpharmacy
• Detailed process inordertoobtainprescription• Canbeasshortofawaitas2weeksuntilmedication isapproved,butpresentrealistic timeframesforpatient suchas4-6weeks,orlonger ifinsurancehasextensive criteria
• Patientinvolvement• Encourageyourpatient tofollowupregularlywithyourspecialtypharmacy(weekly/everyotherweek)
• Makethespecialty pharmacytheprimarycontactforpatients toobtainupdatesontheHCVprescription
• Encourageyourpatient tofollowupwiththe insurancecompanyonceanappeal issubmitted forstatusupdates.
• Provideyourpatientwiththecorrectphonenumbertoobtainupdates,notthecustomerservice line
• Decreasedmorbidityandall-causemortality,regardlessofbaselinefibrosis.1
• Decreaseinall-causemortalityinnon-cirrhotics in21,000USVeterans.2– Survivaladvantagesuggestsaneffect onnon-liver–related
comorbidities (cardiovascular disease,diabetes, andnon-liver relatedcancers).
– Similarresults seen inameta-analysis of>34,000patients.3
• Delayingtreatmentuntiladvancedfibrosis/cirrhosishasadetrimentalimpactontreatmenteffectiveness.4
1.AASLD/IDSAHCVGuidance.2015.2.Backus.Clin Gastroenterol Hepatol.2011.3.Hill.AASLD2014.4.McCombs.EASL.2015.
DELAYING TREATMENT CAN HARM PATIENTS:MEDICALREASONS TO TREAT ALL PATIENTS WITH HCV
• Treatmentmayimproveorpreventextra-hepaticcomplicationsnotrelatedtofibrosisstage.1,2,3
• HCVaffectswell-beinginallpatients,regardlessoffibrosisstage.4
• AchievementofSVRhasbeenshowntosubstantiallyimprovepatientfatigue,improvehealth-relatedqualityoflifeandworkproductivity.5
1.Conjeevaram.Gastroenterology.2011.2.Hsu.Gut.2015.3.Torres.LiverIntl.2015.4.Younossi.AlimentPharmacol Ther.2013.5.Younossi.Hepatology.2014
DELAYING TREATMENT CAN HARM PATIENTS:MEDICALREASONS TO TREAT ALL PATIENTS WITH HCV
PATIENTS WITH ADVANCED FIBROSIS WHO ACHIEVE SVRHAVE AMARKED REDUCTION IN LIVER- RELATEDMORBIDITY/MORTALITY
Morgan.Hepatology.2011.
0.3
0.2
0.1
0
Cum
ulat
ive
Pro
port
ion
0 2.5 5.0 7.5
Death Any Cause or Liver Transplantation
p value for 3-way comparison: 0.0002
p value for 2-way comparisonBT/R vs NR: p=0.02SVR vs BT/R: p=0.44SVR vs NR: p=0.0005
0.3
0.2
0.1
0
Cum
ulat
ive
Pro
port
ion
0 2.5 5.0 7.5
Hepatocellular Carcinoma
p value for 3-way comparison: 0.08
p value for 2-way comparisonBT/R vs NR: p=0.93SVR vs BT/R: p=0.05SVR vs NR: p=0.02
Years
Years
0.3
0.2
0.1
0
Cum
ulat
ive
Pro
port
ion
0 2.5 5.0 7.5
Any Liver-Related Outcomep value for 3-way comparison: <0.0001p value for 2-way comparisonBT/R vs NR: p=0.04SVR vs BT/R: p=0.05SVR vs NR: p<0.0001
Years
0.3
0.2
0.1
0
Cum
ulat
ive
Pro
port
ion
0 2.5 5.0 7.5
Decompensated Liver Disease
p value for 3-way comparison: 0.01
p value for 2-way comparisonBT/R vs NR: p=0.24SVR vs BT/R: p=0.07SVR vs NR: p=0.005
Years
0.3
0.2
0.1
0
Cum
ulat
ive
Pro
port
ion
0 2.5 5.0 7.5
Liver-Related Death or Liver Transplantation
p value for 3-way comparison: 0.005
p value for 2-way comparisonBT/R vs NR: p=0.11SVR vs BT/R: p=0.13SVR vs NR: p=0.003
Years
NR BT/R SVR
SVR,sustainedvirologicresponse;NR,virologicnon-responders;BT/R,initialviralclearancebutsubsequentbreakthroughorrelapse
HEPATITIS C- RELATED CIRRHOSIS IS PROJECTED TO PEAKOVER THE NEXT 10YEARS
Num
ber
of p
atie
nts
1,200,000
1,000,000
800,000
600,000
400,000
0
200,000
1990 2000 2010 2020 2030Year
25%of patients with HCV
currently have cirrhosis
37%of patients with HCV are
projected to develop cirrhosis by 2020, peaking at 1 million
DavisGL,etal.Gastroenterology.2010Feb;138(2):513-21,521. 8
TREATMENT HEALTH CARE COSTS IN CHRONIC HCVINCREASE AFTER DEVELOPMENT OF CIRRHOSIS
0
50000
100000
150000
$17,277$22,752
$59,995
$112,547
$145,056
Gordon.Hepatology.2012.
Non-cirrhoticCompensatedDecompensatedHepatocellularLiverliverdiseasecirrhosiscirrhosisCarcinomaTransplant
HCV-relatedcostspery
ear
INCIDENCE OF ABSOLUTE DENIAL OF DAATHERAPY,BYINSURANCE (N=2,321*)
0
10
20
30
40
50
60
Overall Medicaid Medicare CommercialInsurance
LoRe. AASLD,2015.#LB-5
Abs
olut
e D
enia
ls (%
)
377/2321 233/503 40/795 104/1023
*Excludes21patientswithincompletepriorauthorizationafter60days
16%
46%
5%10%
ExtenttoWhichPayersRestrictedAccesstoHCVTreatmentEvaluatedin4StatesUtilizingDataFromaSpecialtyPharmacyfrom11/1/14- 4/30/15.
P<0.001
P<0.001
MEDICAID RESTRICTIONS:BY FIBROSIS STAGE
1.Barua,etal.AnnInternMed. 2015. 2.AASLD/IDSAHCVGuidance.20153.CMSLettertoStateMedicaidAgencies.2015.
74%ofstateslimittreatmenttoadvancedfibrosisorcirrhosis*.1
§ AASLD/IDSATreatmentguidelinesrecommendtreatmentforallHCVpatients.• Restrictingtreatmenttoadvanceddiseaseis“inadequateandshortsighted.2”
• TheCentersforMedicareandMedicaid(CMS)lettertoStateMedicaidAgencies:• Limitingtreatmenttoadvanceddisease“unreasonablyrestrictsaccess”.3
*Datacollectedupto12/14forstatesinwhichinformationwasavailable.Somestateshavesincechangedrestrictions.
MEDICAID RESTRICTIONS:BASED ON DRUG AND/ORALCOHOL USE
88%ofstates include drugoralcoholuseineligibility criteria. 50%requireaperiodofabstinence of3-12monthsand64%requiringnegativeurinedrugscreening*. 1
1.Barua,etal.AnnInternMed. 2015. 2.AASLD/IDSAHCVGuidance.20153.CMSLettertoStateMedicaidAgencies.2015.
§ AASLD/IDSAstatethatthereisnoevidencethesetypeofrestrictionsidentifiesapopulationmorelikelytoadheretoHCVtreatment.2
• CMShasexpressedconcernthatstatesarerequiringaperiodofabstinence.3
*Datacollectedupto12/14forstatesinwhichinformationwasavailable.Somestateshavesincechangedrestrictions.
SVRRESPONSE PREDICTS REGRESSIONMEASUREDBY FIBROTESTIN HCVINFECTED PATIENTS- ‘EARLIEST TREATMENTPROVIDES
MOST REGRESSION’• PatientstreatedwithOBV/PTV/r+DSV ±RBVfor12or24weeks• FibroTestperformedatbaseline(BL)andSVR12visit(SVR12)
• Improvementwasdefined asFibroTest scorechangeofatleast -0.10fromBLtoSVR12
Amongpatients achieving SVR:• 246/255(96%)withBLF0-1hadunchangedfibrosisstage• 59/85(69%)withBLF2hadfibrosisregression• 72/112(64%)withBLF3hadfibrosisregression• 192/377(51%)withBLF4hadfibrosisregression• 27/452(6%)patientswithBLF0-3hadfibrosis
progression
AmongpatientsnotachievingSVR:• 6/22(27%)patientswithBLF2-F4hadfibrosis
regression• 3/8(38%)patientswithBLF0-F3hadfibrosis
progression
Forns,X.etalEASL2016April14-17Barcelona
NewYorkStateMedicaidDrugUtilizationReviewBoardUpdate4/27/2016
• Complex/life-threatening healthconditions
• Complextomanufacture orrequire specialhandlingandadministration
• Injectableororal,self-administered oradministered byahealthcareprovider
• Difficultforpatients totakewithoutongoingclinicalsupport; alsochallengingforproviders tomanage
• Costlytreatment takenbyarelatively smallshareofthepopulationwhohavecomplexmedicalconditions
Thegrowthofspecialtypharmacy.UnitedHealthCenterforHealthReform&Modernization.April2014.
WHAT IS A SPECIALTY MEDICATION?
• Drugspendingisonly10percentofallhealthcarespending,butthat10percentequalsaround$300billionperyear.1
• Spendingonspecialtydrugsin2012intheUnitedStateswasabout$87billion,comprisingroughly25percentoftotaldrugspending2
• The3.6%ofmemberswhousespecialtymedicationsaccountfor25%ofhealthcarecosts. 3
• 40percent ofdrugsunderdevelopment (about650drugs)areconsidered specialtydrugs4
1. CDC/NationalCenterforHealthStatistics2.Thegrowthofspecialtypharmacy.UnitedHealthCenterforHealthReform&Modernization.April2014. 3Specialtytrendmanagementwheretogonext.CVSCaremark.2013.4.Milliman,“Milliman SpecialtyMedicalDrug2010CommercialBenchmarkStudy,”November26,2012:1-27.
STATISTICS OF SPECIALTY MEDICATION
ROLE OF SPECIALTY PHARMACY
• ItisnotrecommendedtoutilizeyourlocalpharmacywhenprescribingHepatitis Ctreatment. SpecialtyPharmacy’sarerecommended inthesesituations becausethisprocess isstandardformostmedications dispensed fromtheirpharmacy.
• Fromthemomenttheprescription iswritten,until thecompletion ofthetherapyprescribedthespecialty pharmacyshouldbeinvolvedtheentireprocess.
• DrugInteractionChecks• HUGEfactorinHCVtreatment intheworldofDAA’s
• Specificallypatientsco-infectedwithHIV
• AssistwithPriorAuthorizationprocessinitsentirety• Calling InsurancetohavePAformsfaxedtooffice• OncePAcompletedbyProvidersofficeSpecialtypharmacyshouldassistinfollowup
• Denial• SpecialtypharmacyshouldbeabletoguideProvidersofficethroughAppealprocess,and
assistinthefollowuponcesubmitted.• Oftentimeshavetemplatestoassistproviderswithappealletters.
• Buildrelationshipswiththepatients• Educateyourpatientstorelyonyourspecialtypharmacytobetheprimarycontactfor
prescriptionupdate
CLINICAL CRITERIA:APPLYING FOR PRIOR AUTHORIZATION
• ConfirmationofHepatitisCDiagnosis(ICD-10B18.2)• EvaluationofLiverFibrosis,and/orCirrhosis• TreatmentHistory• TreatmentReadiness(adherenceassessment)• NegativeDrugToxicologyreport,urine*• BaselineNs5aResistanceTesting*• Evidenceofextra-hepaticmanifestations• Evidenceofconcomitantconditions/comorbidities
*SeePACriteria,notneeded forallinsurances
CONFIRM HEPATITIS CDIAGNOSISHepatitisCAntibody(AB)+
HepatitisCViralLoad(Quantitative)+
HepatitisCGenotype+
HepatitisCDiagnosisConfirmed
1.AdaptedfromLinas BPetal.PLoSONE.2014;9:e97317.
¹
• Diagnosis isonlythebeginning ofthehepatitis Ctreatment cascade
• TherearemanypointswithinthePAprocesswherepatients canbelosttofollowup
• Itisimportanttoensurethatyourpatient,staffandspecialty pharmacyisengagedthroughouttheprocess
EVALUATION OF LIVER FIBROSIS• LiverFibrosiscanbeevaluatedinmanyways:
• LiverBiopsy• Fibroscan
• APRI(ASTtoPlateletRatioIndex)
• Fibrosure (FibroTest- ActiTest)¹
PatientAST(IU/L) x100APRI= AST(upperlimitofNormal) x100
PatientPlateletCount(10⁹/L)
FibrosisStage Range
F0- NoFibrosis 0.00-0.21
F0- F1 0.21-0.27
F1- PortalFibrosis 0.27-0.31
F1-F2 0.31-0.48
Fibrosis Stage Range
F2- Bridgingfibrosisw/fewsepta 0.48-0.58
F3-Bridgingfibrosisw/manysepta 0.58-0.72
F3-F4 0.72-0.74
F4Cirrhosis 0.74-1.00
¹LabcorpTestMenu
Metavir Range
F0-F1 0-7.0kpa
F2 7.1-9.4kpa
F3 9.5– 12.5kpa
F4 >12.5kpa
CONFIRM DIAGNOSIS OF CIRRHOSIS
• FibroSure hasexcellentutilityforidentificationofcirrhosis,butlesseraccuracyforearlierstages. ¹
• Cirrhosisprovenbylabtestingoftenleadstoarequestfromtheinsuranceforadditionaldiagnosticinformation
• Biopsy/Fibroscan• Imagingconsistentwithcirrhosis, ie:portalhypertension,nodularcontour
²•
1 ShaheenetalAmJGastroenterol 2007;102:2589–26002 EmblemHealthHepatitisCPriorAuthorizationForm
CIRRHOTIC PATIENTS• Child’sPughScore:Calculator
toevaluateseverityofCirrhosisinapatient(A,BorC)– Patientsidentifiedashaving
cirrhosis requireadditionalinformationwhenprescribingHCVtherapy, forsafetyreasons
– Protease Inhibitorsandregimenswhichcontainprotease inhibitorsarecontraindicated inpatientswhohavedecompensatedcirrhosis,andChild’sPughScoresofBandC.
1.HepatitisCOnline:Child’sPughCalculator
1
A B C
5-6 7-9 10-15
TREATMENT HISTORY
• TreatmenthistoryinfluenceshowpatientsaretreatedintheworldofDirectActingAntivirals(DAA’s)– TreatmentNaïve
• Neverbeentreated forHepatitisC• May havetheoptionforshorter treatmentdurations
– PreviouslyTreated• Historically:Non-responder/Relapser/Partial• 2016:TreatedwithorwithoutaDAA?
– IftreatedwithaDAA,theoptionsforre-treatment maybelimited.
• Ifthepatienthascirrhosis,andtheywerepreviouslytreatedreviewthePackageinsertandAASLDtreatmentguidelines asdurationoftherapymaybeextended, and/orribavirinmayberecommended toincrease success
TREATMENT READINESS
• Many,ifnotall,insuranceplanswillrequirepatientstotakepartintreatmentreadiness(adherence)assessment.
• TheseassessmentsareimportantastheymaybringtolightbarrierstoinitiatingorcompletinghepatitisCtherapy.
• NYSMedicaidFFSrequiresthecompletionofoneofthefollowingassessments(mostmanagedcareplanswillfollowthiscriteria)
• DAST-10(10Items);AUDIT(10Items),AUDIT- C(3Items),CAGE-AID(4Items)Abovequestionnairescanbefound:• SAMHSAHRSACenterforIntegratedHealthSolutions- DrugandAlcoholScreeningTools:http://www.integration.samhsa.gov/clinical-practice/screening-tools#drugs
OR• PREP-CPsychosocialReadinessEvaluationandPreparationforHepatitisCTreatmenthttps://prepc.org/
• Prep-Chasanabbreviatedevaluationandanextendedevaluationdependentonyouandyourpatient’sneeds.
SAMHSAHRSACenterforIntegratedHealthSolutions- DrugandAlcoholScreeningTools
PREP-C- https://prepc.org/
PREP-C- https://prepc.org/
• Ifpatientanswersquestionappropriatelymayreducenumberofquestionspersection
• Onaveragecantakeanywherefrom15-30minutesperpatient
ADDITIONAL DOCUMENTATION
• Negativedrugtoxicologyreport,urine• Notrequiredbyallinsurances,reviewcriteria• Ensurethetestperformedlistsalltoxinswhichweretested
• Inthephase3Ion-1studyofsofosbuvir/ledipasvirwithorwithoutribavirin,ontreatmentillicitdrugusedidnotimpacttreatmentoutcome
• BaselineNs5aresistancetesting• CheckPAcriteria,notneededforallHCVtreatmentregimens
• ConsultwithpackageinsertandAASLDtreatmentguidelines
1
1.Grebely etalEASL2016
ADDITIONAL DOCUMENTATION:EXTRAHEPATIC MANIFESTATIONS/CONCOMITANT COMORBIDITIES
• CuringHepatitis Creducessymptomsandmortalityfromsevereextrahepaticmanifestations
• cryoglobulinemic vasculitis (affecting10%to15%ofHCV-infectedpatients)
• non-Hodgkinlymphomaandother lymphoproliferativedisorders• HCVinfectedpatientsachievecompleteorpartialremissioninupto75%ofcases
followingsuccessfulHCVtherapy• Qualityoflife(QOL)
• PatientswithSVRhavesubstantially improvedQOL(physical,emotional,andsocialhealth)
• Type2Diabetes• RelationshipbetweenHCVandDMIIincompletely
understood• Prevalenceandincidenceofdiabetesisincreased
inthecontextofhepatitisC• Patientsover40havemorethanathreefoldgreaterrisk• Insulinresistanceandtype2diabetesareindependent
predictorsofamorerapidprogressionofliverfibrosis
AASLD/IDSAHCVGuidance2016
OnlyUsethisinformationininitialPAifasked,orifyoufeelthatthereviewercanactuallyoverturnadecisionifthepatientdoesnotmeetthecriteriasetforthbythe
insuranceplan
PriorAuthorizationProcess
PriorAuthorization
Chartnote
CBC/CMP
ViralLoad
Genotype
Fibrosisscore
ResistanceTesting
PrescriptionsenttoaPharmacy
Approved Denied
Whichpharmacy canprovide themedication?
Copay>$50
FinancialAssistanceprogram
NextPAGE!!!
32
PrescriptionDenied
CallRxinsuranceto
inquirefurther
Non-formulary
Drug
NotPreferredLocation
(Pharmacy)
Exceedsmax
amount
Moreclinicalinfo
required
FaxRxtoPreferredPharmacy(Mailorder)
Planmaycoveracertain$amount
CallRxinsuranceto
inquirefurther
Pt notsickenough
Bothdrugsnot
coveredatall
PriorAuthReq
HighCo-Pay
FinancialAssistanceprogram 33
AppealX2
AppealX2
StepTherapy
Trythe“cheaper”regimen
Tryotherdrug
AppealX2
Controversies
• Prescriptionvs medicalinsurance• Illicitdruguse/Alcoholabuse
Appealprocess
Increasedcostleadstopayerslimitingaccesstotherapyby:
• Approvedprovidersonly
• F3-4disease (advancedfibrosis)
• Extra-hepaticmanifestations
• Failuresofprevioustherapies
• Approvalfor14or30daysonly
• Applyforreauthorizationatendof
firstmonth
• Futilityrulesforinitiatingtherapy
• Strictnon-replacementpolicy
• StrictETOHanddrugpolicy
• Strictvacationpolicy
• Adherencemonitoringprograms
• Limitcoveragetoonceinalifetime
Appeals
• PriorAuthorization• InternalAppeal• InternalExternalAppeal• StateFinanceDepartment• “Selfinsured”or“Selffunded”plans
• employer,ratherthananinsuranceplan,assumestheriskforpayingforcoveredservices
• self-insuredemployerspayforeachoutofpocketclaimastheyareincurredinsteadofpayingafixedpremiumtoaninsurancecarrier
AppealProcess
PAdenied • 3-7days
Appealdenied
• Internalappeal30-90days• Internalexternalappeal3-5days
NYSFDApproved!
• Expedited3days• Standard30days
• Selffundedpatients:• NojurisdictionfromNYSFinanceDepartment• HumanResourceDepartment
• Unionplans• Learntheunion’sprocess• Unionofficeistheindependentreviewerofthemedicationapproval
• DenialletterfromunionàManufacturerFinancialAssistanceProgram
• Patientswithnoprescriptioncoverage• Requiredtoutilizemanufacturerassistanceprogram
SpecialCircumstances
“Selfinsured”or“Selffunded”plans
• employer,ratherthananinsuranceplan,assumestheriskforpayingforcoveredservices
• self-insuredemployerspayforeachoutofpocketclaimastheyareincurredinsteadofpayingafixedpremiumtoaninsurancecarrier
Appealletterstoinsurancecompanies
• Bespecific• Addresstheinsurancecompany• PatientName,dateofbirth,IDorreference#• Statesobjectiveandsubjectiveinformation• Backitupwithsupportivedata
LetterofMedicalNecessityToWhomItMayConcern:
Iamwritingthisappealletterinresponsetoalettertomefrom______servicesdated____denying__________ therapyfortheabovementionedpatient.ThisletterisbeingwrittenafteraSECONDAPPEALletterthatIwroteinsupportofthispatientwasnoteffectiveinoverturningthedecisionof____todeny__________ treatmentduetoitbeing“notmedicallynecessary”.
____isfollowedbymein____.ThispatienthashepatitisC,genotype1Aandrelapsedfollowingtreatmentwithpegylatedinterferonandribavirin.Thepatient’slastFibrosure testisconsistentwithmild-moderatefibrosis
Ibelievethatitismedicallynecessarythatthispatientbetreatedwith_________forherchronichepatitisC.TheFDAapproved_________ forthetreatmentofpatientwithchronichepatitisCandthelatestAASLD/IASGuidanceDocumentdatedDecember2014recommendstreatmentofallpatientsinfectedwithchronichepatitisC.
Theletterfrom___statesthat_____wasdeniedtherapybecausethispatientdoesnothaveadvancedfibrosis.Thesearenotthecriteriaforwhichthesemedicationswereapproved.Therearenopublishedpaperswhichrecommendthedenialofcarethatthisorganizationhasadopted.IwasunawarethatinNewYorkStateaninsurancecompanytoabletopracticemedicineandmakecomplexmedicaldecisionswhichdisagreewithboththetreatingphysicianandtherecommendationsoftheFDA.
TherecentstudybyHilletal.(abstract44)presentedattheannualmeetingoftheAmericanAssociationfortheStudyofLiverDiseasesheldinBostoninNovember2014clearlyshowedthedramaticsurvivalbenefitoftreatingallpatientswithchronichepatitisC,especiallythosewithoutcirrhosis.
KaiserPermanentepresenteddataattheEuropeanAssociationfortheStudyofLiverDiseasesinVienna,AustriainApril2015whichshowedcancerratesinhepatitisCpatientsaresignificantlyhigherthannon-hepatitisCinfectedpatientsforthefollowingcancers:liver,esophagus,stomach,colon,pancreas,myeloma,non-Hodgkin’slymphoma,lung,renal,andprostate.(Nybergetal.EASL2015)
AshepatitisCisassociatedwiththedevelopmentoftheabovementionedcancersandastreatmenthasbeenshowntobebothmedicallyandcost-effective,nottreating_________isakintocommittingmalpractice.
Iwouldhopeandexpectthatyouwouldoverturntheegregiousdenialof________by_____servicesandnotdenyherthetreatmentwhichthispatientneedsandwants.
Pleasedonothesitatetocontactmewithanyfurtherquestions.Mycellphonenumberis________.
FinancialAssistance/Resource
Approvedmaynotmeanapproval…
• Deductible• Insurancepays$5,000forthelifetime• Coveragepays75%• Approvedbutpatienthastoburdenthe100%ofcost
• Preferredmailorderpharmacy
CostofMedicationRegimenGenericName BrandName Costof12weekTreatment
(Wholesale AcquisitionCostWAC)
Simeprevir Olysio® 12week($66,360)
Sofosbuvir Sovaldi® 12week($84,000)
Ledipasvir/sofosbuvir Harvoni® 12week ($94,500)
Daclatasvir Daklinza® 12week($63,000)
Paritaprevir/ritonavir/ombitasvir/dasubuvir
Viekira Pak® 12week ($83,319)
Paritaprevir/ ombitasvir/ritonavir Technivie ® 12week($76,653)
ElbasvirandGrazoprevir Zepatier® 12week($54,600)
48
FinancialAssistanceviaManufacturescoupons
• NotapplicabletopatientswithMedicaidandMedicareprescriptioninsurance
FinancialAssistanceviaPatientAssistance
Medication FinancialAssistance ResourcesHarvoni®&Sovaldi®
SupportPathwww.mysupportpath.com(P)855-769-7284
Daklinza® BMSPatientAssistanceFoundationwww.bmspaf.org(P)800-736-0003
Olysio® JanssenPatientAssistancehttp://www.olysio.com/support/financial-assistance(P)800-652-6227
RibasphereRibaPak®
PatientAssistanceProgramwww.ribapak.com/hcp/resources.html(P)888-668-3393
Viekira®,Technivie® Proceedhttps://www.viekira.com/proceed-program(P)855-765-0504
Zepatier® http://www.merckhelps.com/ZEPATIER(P)866-251-6013 50
• PatientAssistanceNetworkwww.panfoundation.org866-316-7263
• PatientAdvocateFoundationwww.copays.org866-512-3861
• Healthwellwww.healthwellfoundation.org800-675-8416
• Gooddayswww.gooddaysfromcdf.org877- 968-7233
FinancialAssistanceFoundations
FinancialAssistance
• Diagnosis• Product• Productinsurancecoverage• Financialqualifications
• householdsizeandincome,demographics,etc.
• U.S.citizenship(viaSSN)
Nootheroptions…
• Clinicaltrials• Changeofprescriptioninsuranceplan• Benchtime• NYSAttorneyGeneral’soffice
Summary• Settingthetone
No,youwon’thavethemedicationtomorrow
• PA ClinicalCriteriaCompletePApacketwillsaveyoutimeinthelongrun
• PAprocessInitialdenialvs “FinalAdverse”Denial
• AppealprocessTheultimatejurisdictionfornon-selffundedinsuranceplansisfromtheNewYorkStateFinanceDepartment.
• FinancialAssistance/ResourceUtilizemultipleresources
PostQuestions
Question1
Whatarethepatient'sbarriersofmedicationsapproval?
A.InsurancemedicationformularyB.EarlystagesofliverfibrosisC.HistoryofintravenousdruguseD.NoneoftheaboveE.Alloftheabove
Answer:(E)Rationale: ChoicesA-Cmaybereasonswhypatient's PArequestmaybedenied.
Question2
Mostappealsmustbesubmittedwithin90daysofthedenial,orelseanewPriorAuthorizationmustbeinitiated
A.TrueB.False
Answer:(A)Rationale: Insurancecompaniesmayhavelimitation onwhenanappealcanbeinitiated
Question3
Howmanytimescanadenialbeappealed?A.1-2timesB.2-3timesC.3-4timesD.4-5timesE.5-6times
Answer:(B)Rationale: 1stappeal tothe insurancecompanies internalappeal,secondandthirdmayhappensimultaneously onetotheinsurancecompanies external appealandanothertotheNewYorkStatesFinanceDepartment.
Question4
TheultimatejurisdictionfornonselffundedinsuranceplansinNewYorkStatescomesfromNewYorkStateFinanceDepartment.
A.TrueB.False
Answer:(A)Rationale: Selffundedplansmustappealbacktothecompany'sHumanResourcesdepartment butallotherfundscanappealtotheNYSFinanceDepartment
ThankYou!
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