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FIGHTING FOR YOUR PATIENTS: SUCCESSFUL PRIOR AUTHORIZATION TIPS FROM THE PROS Alyson Harty, RN, BSN, Clinical Nurse Manager Mount Sinai Institute for Liver Medicine Susan Lee PharmD, BCPS, CDE, Specialist Pharmacist, Sandra Atlas Bass center for Liver Diseases, Medicine Service Line-Northwell Health Sarah Penrose FNP-BC, Nurse Practitioner, Mount Sinai Institute for Liver Medicine Empire Liver Foundation June 7, 2016

FIGHTING FOR YOUR PATIENTS SUCCESSFUL PRIOR …...Jun 07, 2016  · CONFIRM HEPATITISC DIAGNOSIS Hepatitis C Antibody (AB) + Hepatitis C Viral Load (Quantitative) + Hepatitis C Genotype

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Page 1: FIGHTING FOR YOUR PATIENTS SUCCESSFUL PRIOR …...Jun 07, 2016  · CONFIRM HEPATITISC DIAGNOSIS Hepatitis C Antibody (AB) + Hepatitis C Viral Load (Quantitative) + Hepatitis C Genotype

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

Page 2: FIGHTING FOR YOUR PATIENTS SUCCESSFUL PRIOR …...Jun 07, 2016  · CONFIRM HEPATITISC DIAGNOSIS Hepatitis C Antibody (AB) + Hepatitis C Viral Load (Quantitative) + Hepatitis C Genotype

SettingTheTone

Page 3: FIGHTING FOR YOUR PATIENTS SUCCESSFUL PRIOR …...Jun 07, 2016  · CONFIRM HEPATITISC DIAGNOSIS Hepatitis C Antibody (AB) + Hepatitis C Viral Load (Quantitative) + Hepatitis C Genotype

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

Page 4: FIGHTING FOR YOUR PATIENTS SUCCESSFUL PRIOR …...Jun 07, 2016  · CONFIRM HEPATITISC DIAGNOSIS Hepatitis C Antibody (AB) + Hepatitis C Viral Load (Quantitative) + Hepatitis C Genotype

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

Page 5: FIGHTING FOR YOUR PATIENTS SUCCESSFUL PRIOR …...Jun 07, 2016  · CONFIRM HEPATITISC DIAGNOSIS Hepatitis C Antibody (AB) + Hepatitis C Viral Load (Quantitative) + Hepatitis C Genotype

• 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

Page 6: FIGHTING FOR YOUR PATIENTS SUCCESSFUL PRIOR …...Jun 07, 2016  · CONFIRM HEPATITISC DIAGNOSIS Hepatitis C Antibody (AB) + Hepatitis C Viral Load (Quantitative) + Hepatitis C Genotype

• 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

Page 7: FIGHTING FOR YOUR PATIENTS SUCCESSFUL PRIOR …...Jun 07, 2016  · CONFIRM HEPATITISC DIAGNOSIS Hepatitis C Antibody (AB) + Hepatitis C Viral Load (Quantitative) + Hepatitis C Genotype

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

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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

Page 9: FIGHTING FOR YOUR PATIENTS SUCCESSFUL PRIOR …...Jun 07, 2016  · CONFIRM HEPATITISC DIAGNOSIS Hepatitis C Antibody (AB) + Hepatitis C Viral Load (Quantitative) + Hepatitis C Genotype

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

Page 10: FIGHTING FOR YOUR PATIENTS SUCCESSFUL PRIOR …...Jun 07, 2016  · CONFIRM HEPATITISC DIAGNOSIS Hepatitis C Antibody (AB) + Hepatitis C Viral Load (Quantitative) + Hepatitis C Genotype

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

Page 11: FIGHTING FOR YOUR PATIENTS SUCCESSFUL PRIOR …...Jun 07, 2016  · CONFIRM HEPATITISC DIAGNOSIS Hepatitis C Antibody (AB) + Hepatitis C Viral Load (Quantitative) + Hepatitis C Genotype

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.

Page 12: FIGHTING FOR YOUR PATIENTS SUCCESSFUL PRIOR …...Jun 07, 2016  · CONFIRM HEPATITISC DIAGNOSIS Hepatitis C Antibody (AB) + Hepatitis C Viral Load (Quantitative) + Hepatitis C Genotype

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.

Page 13: FIGHTING FOR YOUR PATIENTS SUCCESSFUL PRIOR …...Jun 07, 2016  · CONFIRM HEPATITISC DIAGNOSIS Hepatitis C Antibody (AB) + Hepatitis C Viral Load (Quantitative) + Hepatitis C Genotype

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

Page 14: FIGHTING FOR YOUR PATIENTS SUCCESSFUL PRIOR …...Jun 07, 2016  · CONFIRM HEPATITISC DIAGNOSIS Hepatitis C Antibody (AB) + Hepatitis C Viral Load (Quantitative) + Hepatitis C Genotype

NewYorkStateMedicaidDrugUtilizationReviewBoardUpdate4/27/2016

Page 15: FIGHTING FOR YOUR PATIENTS SUCCESSFUL PRIOR …...Jun 07, 2016  · CONFIRM HEPATITISC DIAGNOSIS Hepatitis C Antibody (AB) + Hepatitis C Viral Load (Quantitative) + Hepatitis C Genotype

• 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?

Page 16: FIGHTING FOR YOUR PATIENTS SUCCESSFUL PRIOR …...Jun 07, 2016  · CONFIRM HEPATITISC DIAGNOSIS Hepatitis C Antibody (AB) + Hepatitis C Viral Load (Quantitative) + Hepatitis C Genotype

• 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

Page 17: FIGHTING FOR YOUR PATIENTS SUCCESSFUL PRIOR …...Jun 07, 2016  · CONFIRM HEPATITISC DIAGNOSIS Hepatitis C Antibody (AB) + Hepatitis C Viral Load (Quantitative) + Hepatitis C Genotype

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

Page 18: FIGHTING FOR YOUR PATIENTS SUCCESSFUL PRIOR …...Jun 07, 2016  · CONFIRM HEPATITISC DIAGNOSIS Hepatitis C Antibody (AB) + Hepatitis C Viral Load (Quantitative) + Hepatitis C Genotype

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

Page 19: FIGHTING FOR YOUR PATIENTS SUCCESSFUL PRIOR …...Jun 07, 2016  · CONFIRM HEPATITISC DIAGNOSIS Hepatitis C Antibody (AB) + Hepatitis C Viral Load (Quantitative) + Hepatitis C Genotype

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

Page 20: FIGHTING FOR YOUR PATIENTS SUCCESSFUL PRIOR …...Jun 07, 2016  · CONFIRM HEPATITISC DIAGNOSIS Hepatitis C Antibody (AB) + Hepatitis C Viral Load (Quantitative) + Hepatitis C Genotype

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

Page 21: FIGHTING FOR YOUR PATIENTS SUCCESSFUL PRIOR …...Jun 07, 2016  · CONFIRM HEPATITISC DIAGNOSIS Hepatitis C Antibody (AB) + Hepatitis C Viral Load (Quantitative) + Hepatitis C Genotype

CONFIRM DIAGNOSIS OF CIRRHOSIS

• FibroSure hasexcellentutilityforidentificationofcirrhosis,butlesseraccuracyforearlierstages. ¹

• Cirrhosisprovenbylabtestingoftenleadstoarequestfromtheinsuranceforadditionaldiagnosticinformation

• Biopsy/Fibroscan• Imagingconsistentwithcirrhosis, ie:portalhypertension,nodularcontour

²•

1 ShaheenetalAmJGastroenterol 2007;102:2589–26002 EmblemHealthHepatitisCPriorAuthorizationForm

Page 22: FIGHTING FOR YOUR PATIENTS SUCCESSFUL PRIOR …...Jun 07, 2016  · CONFIRM HEPATITISC DIAGNOSIS Hepatitis C Antibody (AB) + Hepatitis C Viral Load (Quantitative) + Hepatitis C Genotype

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

Page 23: FIGHTING FOR YOUR PATIENTS SUCCESSFUL PRIOR …...Jun 07, 2016  · CONFIRM HEPATITISC DIAGNOSIS Hepatitis C Antibody (AB) + Hepatitis C Viral Load (Quantitative) + Hepatitis C Genotype

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

Page 24: FIGHTING FOR YOUR PATIENTS SUCCESSFUL PRIOR …...Jun 07, 2016  · CONFIRM HEPATITISC DIAGNOSIS Hepatitis C Antibody (AB) + Hepatitis C Viral Load (Quantitative) + Hepatitis C Genotype

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.

Page 25: FIGHTING FOR YOUR PATIENTS SUCCESSFUL PRIOR …...Jun 07, 2016  · CONFIRM HEPATITISC DIAGNOSIS Hepatitis C Antibody (AB) + Hepatitis C Viral Load (Quantitative) + Hepatitis C Genotype

SAMHSAHRSACenterforIntegratedHealthSolutions- DrugandAlcoholScreeningTools

Page 26: FIGHTING FOR YOUR PATIENTS SUCCESSFUL PRIOR …...Jun 07, 2016  · CONFIRM HEPATITISC DIAGNOSIS Hepatitis C Antibody (AB) + Hepatitis C Viral Load (Quantitative) + Hepatitis C Genotype

PREP-C- https://prepc.org/

Page 27: FIGHTING FOR YOUR PATIENTS SUCCESSFUL PRIOR …...Jun 07, 2016  · CONFIRM HEPATITISC DIAGNOSIS Hepatitis C Antibody (AB) + Hepatitis C Viral Load (Quantitative) + Hepatitis C Genotype

PREP-C- https://prepc.org/

• Ifpatientanswersquestionappropriatelymayreducenumberofquestionspersection

• Onaveragecantakeanywherefrom15-30minutesperpatient

Page 28: FIGHTING FOR YOUR PATIENTS SUCCESSFUL PRIOR …...Jun 07, 2016  · CONFIRM HEPATITISC DIAGNOSIS Hepatitis C Antibody (AB) + Hepatitis C Viral Load (Quantitative) + Hepatitis C Genotype

ADDITIONAL DOCUMENTATION

• Negativedrugtoxicologyreport,urine• Notrequiredbyallinsurances,reviewcriteria• Ensurethetestperformedlistsalltoxinswhichweretested

• Inthephase3Ion-1studyofsofosbuvir/ledipasvirwithorwithoutribavirin,ontreatmentillicitdrugusedidnotimpacttreatmentoutcome

• BaselineNs5aresistancetesting• CheckPAcriteria,notneededforallHCVtreatmentregimens

• ConsultwithpackageinsertandAASLDtreatmentguidelines

1

1.Grebely etalEASL2016

Page 29: FIGHTING FOR YOUR PATIENTS SUCCESSFUL PRIOR …...Jun 07, 2016  · CONFIRM HEPATITISC DIAGNOSIS Hepatitis C Antibody (AB) + Hepatitis C Viral Load (Quantitative) + Hepatitis C Genotype

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

Page 30: FIGHTING FOR YOUR PATIENTS SUCCESSFUL PRIOR …...Jun 07, 2016  · CONFIRM HEPATITISC DIAGNOSIS Hepatitis C Antibody (AB) + Hepatitis C Viral Load (Quantitative) + Hepatitis C Genotype

PriorAuthorizationProcess

Page 31: FIGHTING FOR YOUR PATIENTS SUCCESSFUL PRIOR …...Jun 07, 2016  · CONFIRM HEPATITISC DIAGNOSIS Hepatitis C Antibody (AB) + Hepatitis C Viral Load (Quantitative) + Hepatitis C Genotype

PriorAuthorization

Chartnote

CBC/CMP

ViralLoad

Genotype

Fibrosisscore

ResistanceTesting

Page 32: FIGHTING FOR YOUR PATIENTS SUCCESSFUL PRIOR …...Jun 07, 2016  · CONFIRM HEPATITISC DIAGNOSIS Hepatitis C Antibody (AB) + Hepatitis C Viral Load (Quantitative) + Hepatitis C Genotype

PrescriptionsenttoaPharmacy

Approved Denied

Whichpharmacy canprovide themedication?

Copay>$50

FinancialAssistanceprogram

NextPAGE!!!

32

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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

Page 34: FIGHTING FOR YOUR PATIENTS SUCCESSFUL PRIOR …...Jun 07, 2016  · CONFIRM HEPATITISC DIAGNOSIS Hepatitis C Antibody (AB) + Hepatitis C Viral Load (Quantitative) + Hepatitis C Genotype

Controversies

• Prescriptionvs medicalinsurance• Illicitdruguse/Alcoholabuse

Page 35: FIGHTING FOR YOUR PATIENTS SUCCESSFUL PRIOR …...Jun 07, 2016  · CONFIRM HEPATITISC DIAGNOSIS Hepatitis C Antibody (AB) + Hepatitis C Viral Load (Quantitative) + Hepatitis C Genotype

Appealprocess

Page 36: FIGHTING FOR YOUR PATIENTS SUCCESSFUL PRIOR …...Jun 07, 2016  · CONFIRM HEPATITISC DIAGNOSIS Hepatitis C Antibody (AB) + Hepatitis C Viral Load (Quantitative) + Hepatitis C Genotype

Increasedcostleadstopayerslimitingaccesstotherapyby:

• Approvedprovidersonly

• F3-4disease (advancedfibrosis)

• Extra-hepaticmanifestations

• Failuresofprevioustherapies

• Approvalfor14or30daysonly

• Applyforreauthorizationatendof

firstmonth

• Futilityrulesforinitiatingtherapy

• Strictnon-replacementpolicy

• StrictETOHanddrugpolicy

• Strictvacationpolicy

• Adherencemonitoringprograms

• Limitcoveragetoonceinalifetime

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Appeals

• PriorAuthorization• InternalAppeal• InternalExternalAppeal• StateFinanceDepartment• “Selfinsured”or“Selffunded”plans

• employer,ratherthananinsuranceplan,assumestheriskforpayingforcoveredservices

• self-insuredemployerspayforeachoutofpocketclaimastheyareincurredinsteadofpayingafixedpremiumtoaninsurancecarrier

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AppealProcess

PAdenied • 3-7days

Appealdenied

• Internalappeal30-90days• Internalexternalappeal3-5days

NYSFDApproved!

• Expedited3days• Standard30days

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• Selffundedpatients:• NojurisdictionfromNYSFinanceDepartment• HumanResourceDepartment

• Unionplans• Learntheunion’sprocess• Unionofficeistheindependentreviewerofthemedicationapproval

• DenialletterfromunionàManufacturerFinancialAssistanceProgram

• Patientswithnoprescriptioncoverage• Requiredtoutilizemanufacturerassistanceprogram

SpecialCircumstances

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“Selfinsured”or“Selffunded”plans

• employer,ratherthananinsuranceplan,assumestheriskforpayingforcoveredservices

• self-insuredemployerspayforeachoutofpocketclaimastheyareincurredinsteadofpayingafixedpremiumtoaninsurancecarrier

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Appealletterstoinsurancecompanies

• Bespecific• Addresstheinsurancecompany• PatientName,dateofbirth,IDorreference#• Statesobjectiveandsubjectiveinformation• Backitupwithsupportivedata

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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________.

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FinancialAssistance/Resource

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Approvedmaynotmeanapproval…

• Deductible• Insurancepays$5,000forthelifetime• Coveragepays75%• Approvedbutpatienthastoburdenthe100%ofcost

• Preferredmailorderpharmacy

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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

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FinancialAssistanceviaManufacturescoupons

• NotapplicabletopatientswithMedicaidandMedicareprescriptioninsurance

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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

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• PatientAssistanceNetworkwww.panfoundation.org866-316-7263

• PatientAdvocateFoundationwww.copays.org866-512-3861

• Healthwellwww.healthwellfoundation.org800-675-8416

• Gooddayswww.gooddaysfromcdf.org877- 968-7233

FinancialAssistanceFoundations

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FinancialAssistance

• Diagnosis• Product• Productinsurancecoverage• Financialqualifications

• householdsizeandincome,demographics,etc.

• U.S.citizenship(viaSSN)

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Nootheroptions…

• Clinicaltrials• Changeofprescriptioninsuranceplan• Benchtime• NYSAttorneyGeneral’soffice

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Summary• Settingthetone

No,youwon’thavethemedicationtomorrow

• PA ClinicalCriteriaCompletePApacketwillsaveyoutimeinthelongrun

• PAprocessInitialdenialvs “FinalAdverse”Denial

• AppealprocessTheultimatejurisdictionfornon-selffundedinsuranceplansisfromtheNewYorkStateFinanceDepartment.

• FinancialAssistance/ResourceUtilizemultipleresources

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PostQuestions

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Question1

Whatarethepatient'sbarriersofmedicationsapproval?

A.InsurancemedicationformularyB.EarlystagesofliverfibrosisC.HistoryofintravenousdruguseD.NoneoftheaboveE.Alloftheabove

Answer:(E)Rationale: ChoicesA-Cmaybereasonswhypatient's PArequestmaybedenied.

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Question2

Mostappealsmustbesubmittedwithin90daysofthedenial,orelseanewPriorAuthorizationmustbeinitiated

A.TrueB.False

Answer:(A)Rationale: Insurancecompaniesmayhavelimitation onwhenanappealcanbeinitiated

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Question3

Howmanytimescanadenialbeappealed?A.1-2timesB.2-3timesC.3-4timesD.4-5timesE.5-6times

Answer:(B)Rationale: 1stappeal tothe insurancecompanies internalappeal,secondandthirdmayhappensimultaneously onetotheinsurancecompanies external appealandanothertotheNewYorkStatesFinanceDepartment.

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Question4

TheultimatejurisdictionfornonselffundedinsuranceplansinNewYorkStatescomesfromNewYorkStateFinanceDepartment.

A.TrueB.False

Answer:(A)Rationale: Selffundedplansmustappealbacktothecompany'sHumanResourcesdepartment butallotherfundscanappealtotheNYSFinanceDepartment

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ThankYou!