Overcoming Barriers to HCV Care STACEY B . TROOSKIN MD PHD

D IREC TOR OF V IRAL HEPATIT IS PROGRAMS

PH ILADELPHIA F IGHT COMMUNITY HEALTH CENTERS

PHILADELPHIA , PA

Disclosures  GrantSupportfromGileadSciences,FOCUSprogram

 AdvisoryBoard,GileadSciences

Epidemiology of HCV in the US  Mostcommonblood-borneinfec@onintheUS◦  3.2millionto5.2millionpersonschronicallyinfected◦  Birthcohort1945-1965:3.27%an@bodyposi@ve◦  Non-Hispanicblacks:6.31%◦  Non-Hispanicwhites:2.92%◦  MexicanAmerican/other:2.78%

 50%to75%ofindividualschronicallyinfectedwithHCVareunawareoftheirinfec@on

ArmstrongGL.AnnalsofIntMed,2006144;705-714

SmithBD.AASLDposter#394,2011ChakE.LiverInternat.2011,2:1090-1101

Treatment cascade for people with chronic HCV infecNon

YehiaB.PLoSOne.2014;9(7)e101554.

Birth Cohort with high rates of HCV

CDC.MMWR.August17,2012,Vol.61,No.4ArmstrongGLetal.AnnInternalMed,2006;144:705–14.

CDC RecommendaNons for HCV tesNng  BirthCohortbasedscreening◦ Allindividualsbornbetween1945and1965shouldbetestedatleastonceforHCV

◦ AllindividualsoutsideofthiscohortwithaHCVriskfactorshouldbescreened◦ Cost-effec@ve◦ 1-@mecohortscreeningwouldiden@fyabout86%ofundiagnosedcases,comparedwith21%withrisk-basedscreening

 USPreven@veServicesTaskForce:GradeBrecommenda@on

ReinDB.AnnInternMed.2012;156(4):263-70hep://www.uspreven@veservicestaskforce.org/uspsf/uspshepc.htm CDC.MMWR2012;61(No.RR-4).

Vineretal.Hepatology.2015Mar;61(3):783-9.

0

5000

10000

15000

20000

25000

30000

HCVinfected(es@mate)

HCVAb HCVRNA HCVinmedicalcare HCVan@viraltreatment

Num

bero

fInd

ividua

ls

47%

22%

6% 3%6%

Philadelphia Cascade of Care 2010-2013

0

200

400

600

800

1000

1 3 5 7 911131517192123252729313335373941434547495153555759616365676971737577798183858789919395

2003

0

200

400

600

800

1000

1 3 5 7 911131517192123252729313335373941434547495153555759616365676971737577798183858789919395

2005

0

200

400

600

800

1000

1 3 5 7 911131517192123252729313335373941434547495153555759616365676971737577798183858789919395

2007

0

200

400

600

800

1000

1 3 5 7 9111315171921232527293133353739414345474951535557596163656769717375777981838587899193

Coun

t

2009

0

200

400

600

800

1000

1 3 5 7 9111315171921232527293133353739414345474951535557596163656769717375777981838587899193

2011

Age

Num

bero

fInd

ividuals

Anewpopula@onofyoungHCVcasesisemerginginPhiladelphia2007-2103

0

200

400

600

800

1000

1 3 5 7 91113151719212325272931333537394143454749515355575961636567697173757779818385878991

2013

DataprovidedbyDr.KendraVinerPhDfromthePhiladelphiaDepartmentofPublicHealth

hep://www.cdc.gov/vitalsigns/heroin/

Birth Cohort tesNng recommendaNons

CDC.MMWR.August17,2012,Vol.61,No.4ArmstrongGLetal.AnnInternalMed,2006;144:705–14.

Opioidepidemic

Percentage of all admissions to substance abuse treatment centers by persons aged 12-29 yrs (N=217,789) by year - Kentucky, Tennessee, Virginia, and West Virginia, 2006-2012

ZibbellJ.MMWR.May8,2015,Vol.64No.17

Incidence of acute hepaNNs C among persons aged </= 30 years, by urbanicity and year - Kentucky, Tennessee, Virginia and West Virginia 2006-20012

ZibbellJ.MMWR.May8,2015,Vol.64No.17

New cases of HCV and deaths from old infecNons are both on the rise

hep://www.cdc.gov/hepa@@s/hcv/sta@s@cshcv.htm

The Chronic HepaNNs Cohort Study (CHeCS) Doubling of mortality rate, 2007-2013

SlidecourtesyofS.Holmberg,presentedatIDSA2015

Evolving HCV Treatment

0

10

20

30

40

50

60

70

80

90

100

IFN IFNIFN/RBVIFN/RBV PEGPEG/RBVBOC/TVRNewDAAs6m12m 6m 12m12m12m

1986 1998 2001 2002 2011 2013-presentSV

RRA

TE(%

)

AdaptedfromStraderDB.ClinLiverDisease2012,1:1;6-11.

SVR (Cure) Associated with Decreased All-Cause Mortality

0

5

10

15

20

25

30

35

All-CauseMortality

HCC LiverFailure

SVR(n=192)

No-SVR(n=338)

10-yearC

umula@

veIncide

nceRa

te

530pa@entswithadvancedfibrosis,treatedwithinterferon-basedtherapy,andfollowedfor8.4(IQR6.4-1.4)years

VanderMeeretal.JAMA2012;308:2584

8.9

26

5.1

21.8

2.1

29.9

Vineretal.Hepatology.2015Mar;61(3):783-9.

0

5000

10000

15000

20000

25000

30000

HCVinfected(es@mate)

HCVAb HCVRNA HCVinmedicalcare HCVan@viraltreatment

Num

bero

fInd

ividua

ls

47%

22%

6% 3%6%

Philadelphia Cascade of Care 2010-2013

Community based tesNng Ates@ngandlinkagetocarecampaignthats@mulatesdemandforandprovides

HIVandHCVtes@ngacrossanen@rezipcode.

Female 49.1AfricanAmerican 91.0Single 81.1Age

<4747-67

71.029.0

Educa@onLessthanhighschoolHighschooldegree/GEDAtleastsomecollege

17.650.931.5

IncomeLessthan$10,000 $10,000-$14,999$15,000-$29,999>$30,000

46.418.717.817.1

Self-iden@fiedsexualorienta@on Heterosexual 89.0Gay/Lesbian 4.9Bisexual 6.1

Everincarcerated 36.3

DoOneThingbaselinepopula@oncharacteris@csn=1,301 TrooskinSetal.JGIM.2015Jul;30(7):950-7.

TesNng and Linkage to Care Protocol OraQuick® rapid HCV antibody test reactive

HCV RNA Detected

HCV RNA Not Detected

Patient Navigator notifies patient and

provides counseling Patient Navigator notifies patient and

provides counseling + insurance assessment

Insured with a primary care provider

Insured with no known primary care provider

Patient Navigator facilitates PCP acquisition

Uninsured

Patient Navigator facilitates appointment with clinical social

worker

Blood draw for confirmatory HCV PCR

PCP Visit

Obtain Referral to subspecialist

HCV PaNents

 1,301par@cipantsweretestedforHCV◦  3.9%an@-HCVseroprevalence◦  2.8%chronicallyinfected

 8%ofan@-HCVposi@vepar@cipantswerealreadyengagedinHCVcare Ofthosechronicallyinfectedindividuals:◦  58%awareofinfec@onbutnotengagedincare◦  36%uninsured◦  58%hadanAudit-Cscorecommensuratewithalcoholusedisorder◦  80%par@cipantshadseriousco-morbidi@essuchasmentalillnessandaddic@on

DoOneThingCampaignHCVTes@ngandLinkagetoCareCascaden=1,301

58%

TrooskinSetal.JGIM.2015Jul;30(7):950-7.

Lessons Learned from Do One Thing

 TheHCVcarecon@nuumiscomplex

 Mul@plebarriersexist◦  Referrals◦  Obtainingmedica@onforpa@ents/payerrestric@ons

 Pa@entnaviga@oniskeywhenpa@entsaretestedviaoutreach Outreachtes@ngandcommunityengagementisawaytore-engageindividualslivingwithHCVnotcurrentlyincare

 ImmediateblooddrawforPCRconfirmatorytes@ngisnecessary◦  Localhospitallabscanpartnertoprocessandtestspecimensonnightsandweekends

TheseinformedourdesignofCADifference

ClinicalTes@ng CommunityTes@ng

Pa@entNaviga@on

SubspecialtyCareforHCV

Integrated Community Based HCV TesNng: Lessons Learned  Integra@ngHCVtes@ngintoexis@ngHIVandSTItes@ngprogramshasadvantages◦  Sustainabilityfromdiversifiedfundingsources◦ Reachesindividualsatgreatestrisk◦  1183tested,an@-HCVseroprevalence11.5%

 Educa@onisrequiredforstaff◦  Testersshouldbetrainedphlebotomists

 Communica@oniskeywhencommunitytestersdonotalsoactasthepa@entnavigator

 Maintainingalowpa@entnavigatortopa@entra@oiscri@cal

ClinicalTes@ng CommunityTes@ng

Pa@entNaviga@on

SubspecialtycareforHCV

Impact of HCV TesNng Prompts on Type of HCV Screening Test Ordered

2014

0.00%

10.00%

20.00%

30.00%

40.00%

50.00%

60.00%

70.00%

80.00%

90.00%

100.00%

Prac@ce1 Prac@ce2 Prac@ce3 Prac@ce4 Prac@ce5 Prac@ce6 Total

%ageofEligiblePaB

entste

sted

forH

CV

*EMRpromptsaddedJuly2014

Jan'14-Jun'14 Jul'14-Dec'14 Jan'15-Dec'15

Impact of EMR prompts on Percentage of Eligible Baby Boomers Tested for HCV

IntegraNng HCV TesNng into primary care: Lessons Learned

 TheprevalenceofHCVishighinurbanprimarycareprac@ces◦  6029pa@entstested,an@-hcvseroprevalence8.23%

 PCPsarebusy!Tes@nghastobeeasyandmeaningful◦  Eliminateoutdatedorlessusefultestsfromtes@ngmenus

 Educatetheprovidersandtheirstaff&providefeedback GettoknowyourITstaff◦  LearnwhatyourEMRcanandcannotdo◦  Themorethattes@ngcanbeautomated,thebeeer◦  QCmustbeapartoftheprocess

 Theroleofthenavigatorovendiffersinaclinicaltes@ngmodel

Next steps

TheJonathanLaxTreatmentCenterTheYouthHealthEmpowermentProject

TheJohnBellHealthCenter

COMMUNITYBASEDTESTINGSyringeExchangeProgramDrugTreatmentProgramsHomelesssheltersOpioidsubs@tu@onprogramsSeniorCenters

Vineretal.Hepatology.2015Mar;61(3):783-9.

0

5000

10000

15000

20000

25000

30000

HCVinfected(es@mate)

HCVAb HCVRNA HCVinmedicalcare HCVan@viraltreatment

Num

bero

fInd

ividua

ls

47%

22%

6% 3%6%

Philadelphia Cascade of Care 2010-2013

AASLD/IDSA: Who should be treated?

www.hcvguidelines.org

Treatment is recommended for all paNents with chronic HCV infecNon, except those with short life expectancies that cannot be remediated by treaNng HCV, by transplantaNon, or by other directed therapy. PaNents

with short life expectancies owing to liver disease should be managed in consultaNon with an expert.

RaNng: Class I, Level A

Current Challenges in HCV Care: Wholesale AcquisiNon Costs

◦  LED/SOF)x8weeks $63,000◦  LED/SOFx12weeks $94,500◦ VEL/SOFx12weeks $74,760◦  ELB/GRAx12weeks $54,600◦  PrODx12weeks $83,319 ◦  SIM/SOFx12weeks $150,360◦ DAC/SOFx12weeks $148,000

◦ WACdoesnotincludenego@ateddiscountsandrebates

◦  ArlenePrice,Janssen(PersonalCommunica@on) HaganLMetal.Hepatology60,37-45,July2014.hep://www.hepa@@sc.uw.edu/page/treatment/drugs/simeprevir-drug www.fairpricingcoali@on.org

Current Challenges in HCV Care

 Restric@vecriteriafordrugapprovalformanypayers◦  Sobrietyrequirement◦  Prescriberrequirement◦ Diseaseseverityrequirement◦ HIVmaynotbeami@ga@ngfactor

 Arduouspriorauthoriza@onprocessforproviders

BaruaSetal.,AnnInternMed.2015;163(3):215-223CanaryLAetal.,AnnInternMed.2015;163(3):226-228

Current Challenges in HCV Care

 Approximately8hrsofstaff@meperpa@ent

 1to4monthstogothroughtheprocess

SubmitPriorAuthoriza@on Denial Denial Denial

PeertoPeerAppeal Appeal

Grievance

When insurance will not cover drugs what are the opNons?  Waitfornewdrugstobeapproved◦  Noguaranteethatthosewillbecovered/pa@entwillqualify

 Waitun@lpa@entqualifies◦  Sobriety◦  Worseningfibrosis

 Takelegalac@on

 Applytopa@entassistanceprogramstoobtainfreedrug◦  Thereisonlyonecompanythatdoesthiscurrently◦  Financialinforma@ontoqualify◦  Proofthatpa@entdoesnotqualifyforinsurance◦  Challengingtonavigate

Incidence of Absolute Denial of DAA Therapy, By Insurance

LoReetal.ClinGastroandHep.2016;14(7)1035-1043.

N=2321Nov2014throughApril2015

Advocacy in Philadelphia Philadelphia-areacollec@vededicatedtoimprovingthecon@nuumofhepa@@sCpreven@on,care,andsupportservicesinPhiladelphia

www.hepcap.org

HepCAP  Bimonthlypublicmee@ngs◦ Scien@ficupdates◦ LocalEpidemiology◦ Accesstocare:challengesandbestprac@ces◦ Advocacy

 PrimaryCareProviderEduca@on Coali@onandRela@onshipbuilding◦ May12015StateWideHCVSummit◦ StateMedicaid,P&T

Changes to State Medicaid Rx RestricNons

2014 F3/F4 Noexcep@onforHIVpa@ents Nodrugsoralcoholfor6months SpecialistPhysician

2015/2016 F2forHCVMonoinfectedpa@ents F0forHIV/HCVCoinfec@onoranyonewithextrahepa@cmanifesta@on Nosobrietyrequirement Experiencedprovider

You can help improve the cascade!  Locally: CometothenextHepCAPmee@ng◦ WednesdayDecember7th2016@5:30pm,DepartmentofPublicHealth500SBroadStreet

 Na@onally: www.NVHR.org 

www.NVHR.org

Thank you!  DoOneThingTeam◦  AmyNunnScD,BrownUniversity

 CaDifferenceTeam◦  LoraMagaldi,MACaDifferenceProjectCoordinator◦  CarlaColeman,MBALinkageCoordinator◦  Ta-WandaPreston,Outreachspecialist◦  Students,volunteers,pa@ents

 AlexShirreffsMPH,GovernmentCo-ChairofHepCAP◦  HepCAPmembers

 NVHR◦  RyanClary◦  TinaBroder◦  EmilyStets

 GileadFOCUSandPreventCancerFounda@on