from prescription to patient · 2018. 5. 30. · treatment selection • treatment consists of only...
TRANSCRIPT
From Prescription to Patient:Navigating Barriers to HCV Treatment Initiation
Autumn Zuckerman, PharmD, BCPS, AAHIVP, CSPVanderbilt Specialty Pharmacy
Vanderbilt University Medical Center
Disclosures
• Dr. Zuckerman has no financial or ethical disclosures• No manufacturer or medication preference
Objectives• Describe the financial impact of hepatitis C virus (HCV) treatment
on the healthcare system• Identify current restrictions to HCV treatment common among
third party payers• Recognize access issues related to special populations• Illustrate successful navigation through the process of accessing
direct acting antiviral therapy• Review criteria and options for patient assistance programs • Discuss assistance available for clinicians and staff
Outline
• Brief HCV refresher• HCV treatment financial landscape• Navigating the system
– Patients with prescription insurance– Patients without prescription insurance
• Tools – Manufacturer patient support– HCV treatment access resources
• Access on the horizon
Outline
• Brief HCV refresher• HCV treatment financial landscape• Navigating the system
– Patients with prescription insurance– Patients without prescription insurance
• Tools – Manufacturer patient support– HCV treatment access resources
• Access on the horizon
HCV Epidemiology• 170 million infections worldwide• 3.2 to 5.2 million infections in the US
Webster D et al. The Lancet. 2015// Davis GL et al. Gastroenterology 2010. CDC Viral Hepatitis Surveillance, 2015
HCV and Mortality in the USA
Ly KN et al. Ann Int Med 2012. // Ly KN et al. Clin Infect Dis 2016.
https://hepvu.org/map/.
Incidence of Positive HCV Antibody
Estimating HCV in Hispanics
• National Health and Nutrition Examination Surveys (NHANES) 2007-2010 – 52% male– 63% of Mexican background
Kuniholm , JID, 2014
• Hispanic Community Health Study/Study of Latinos (HCHS/SOL) 2008-2011– 40% Male– 39% Mexican – 16% Cuban– 15% Puerto Rican– 11% Central American– 9% Dominican– 7% South American– 3% Mixed/other Hispanic/Latino
Estimating HCV in Hispanics
• Overall prevalence:– NHANES: 1.5% – HCHS/SOL: 2.0%
• Men vs. women (2.1% vs. 0.9%; p<0.01)• Highest in 40-69 years
Kuniholm , JID, 2014
Kuniholm , JID, 2014
Estimating HCV in Hispanics
Odds Ratio by geographic region• Puerto Rican
– Men: 4.92– Women: 2.90
• South American– Men: 0.04– Women: 0.07
Estimating HCV in Hispanics
Puerto Rican• 11.6%
Mexican • 1.9%
Dominican • 1.5%
Central American• 1%
South American• 0.4%
Cuban• 0.8%
El-Serag, Liver, 2014
• Active HCV 2000-2009 with at least 1 year of follow-up• Ethnicities:
– 56.3% non-Hispanic White– 36.1% African American – 6.0% Hispanic
28% increased risk of cirrhosis and 61% increased risk of hepatocellular carcinoma (HCC) compared to non-Hispanic Whites
HCV Treatment Efficacy in Hispanics• Peginterferon + Ribavirin
– Sustained virologic response (SVR) rates:• Non-Latinos: 49%• Latinos: 34%
• Telaprevir + Peginterferon + Ribavirin– SVR rates:
• Hispanic/Latino: 72%• Non-Hispanic/Latino: 76%
• No difference in SVR rates with interferon-free direct acting antivirals (DAAs) Balart, Liver, 2010
Flamm, J Clin Gastroenterol, 2015
Hepatitis C Virus• Single-strand, positive sense
RNA flavivirus• Spread through blood and
body fluids• Predominantly infects and
replicates in liver cells • No latent reservoir
www.cdc.gov
Slide courtesy of Dr. Cody Chastain
HCV Risk Factors
Daw M et al. Hepatitis C Virus: Molecular Pathways and Treatments, 2014.
Notable Risk Factors for Hispanics:
• Tattooing• Transfusions• Iatrogenic
Blessman, Gastroenterology Nursing, 2007
Natural History of HCV Infection
Thornton K UW/IDSA Hepatitis C Online Course, 2013.
HCV Pathophysiology
Thornton K UW/IDSA Hepatitis C Online Course, 2013.
Factors Impacting Rate of Progression of Fibrosis:
Older age
Male sex
HIV or HBV co-infection
Metabolic factors
Use of alcohol
Genotype 3 infection
HCV Screening• One-time HCV testing recommended for persons
born 1945-1965
AASLD/IDSA HCV Treatment Guidelines 2018.
Risk behaviors• Injection-drug use (current
or ever)• Intranasal illicit drug use
Risk exposure• Long-term hemodialysis
(ever)• Getting a tattoo in an
unregulated setting• Healthcare workers• Children born to HCV-
infected women• Prior recipients of
transfusions or organ transplants
• Ever incarcerated
Other• HIV infection• Sexually active person
about to start HIV PrEP• Unexplained chronic liver
disease• Solid organ donors
HCV Diagnosis
HCV Antibody
Tests for exposure
Near 100% sensitivity once >6 months after
infection
HCV RNA
Tests for active infection
Helps determine treatment duration
HCV Genotype
Defines treatment options
Adds prognostic info
HCV Screening Process
Centers for Disease Control and Prevention (CDC). Testing for HCV infection: an update of guidance for clinicians and laboratorians. MMWR Morb Mortal Wkly Rep. 2013;62:362-5
HCV Genotype in Latinos
• Genotypes 1-6– Genotype 3 leads to
faster fibrosis progression
• Genotype 1a most common in the United States
1a40%
1b27%
1a/1b9%
2b10%
Other14%
GENOTYPE % IN PUERTO RICANS
Rodriguez-Perez, P R Health Sci J, 2004
Approach to Treatment Selection
123456
No Cirrhosis
Cirrhosis:CTP A
CTP B/C
Naïve
Experienced:IFN/RBV
NS5BNS5A
NS 3/4A
Drug Interactions
CKDHIV
Liver TransplantBaseline
Resistance
NS5BNS5A
NS3/4A+/- RBV
8 weeks12 weeks16 weeks24 weeks
GENOTYPE CIRRHOSIS STATUS
TREATMENTHISTORY
OTHERFACTORS
REGIMEN DURATION
Slide courtesy of Alicia Carver, PharmD
Treatment Selection
• Treatment consists of only DAAs– 1 DAA from at least 2 different DAA classes– Interferon is no longer recommended
• Most common length of treatment is 8-12 weeks– Decompensated cirrhosis, previous treatment failures, and genotype
3 generally harder to treat• Addition of ribavirin• Extend treatment to 16-24 weeks
Slide courtesy of Alicia Carver, PharmD
Treatment Response in DAA Era
0
20
40
60
80
100
IFN +Ribavirin
(RBV)
PegIFN IFN + RBV PegIFN+RBV
TPV/BOC+ P/R
DAA +P/R
DAA +/-RBV
Sust
aine
d Vi
rolo
gic
Resp
onse
(%)
Slide courtesy of Susanna Naggie
IFN: InterferonRBV/R: RibavirinPegIFN/P: Pegylatedinterferon alpha
TPV: TelaprevirBOC: BoceprevirDAA: Direct Acting Antiviral
Abbreviations
Non-specific antivirals
Pegylatedinterferon-alfa
Ribavirin
NS3/4A Protease Inhibitors (-previr)Telaprevir
Boceprevir
Simeprevir
Paritaprevir
Grazoprevir
Glecaprevir
NS5A Inhibitors(-asvir)
Ledipasvir
Ombitasvir
Daclatasvir
Elbasvir
Pibrentasvir
Velpatasvir
NS5B Inhibitors(-buvir)
Sofosbuvir
Dasabuvir
Treatment Options
Direct Acting AntiviralsBRAND NAME GENERIC NAME ManufacturerHarvoni™ ledipasvir/sofosbuvir (LDV/SOF) GileadEpclusa™ sofosbuvir/velpatasvir (SOF/VEL) GileadVosevi™ sofosbuvir, velpatasvir, & voxaliprevir (SOF/VEL/VOX) GileadSovaldi™ sofosbuvir (SOF) GileadViekira Pak™ and Viekira XR™
dasabuvir, ombitasvir, paritaprevir, & ritonavir (PrOD) Abbvie
Technivie™ ombitasvir, paritaprevir, & ritonavir (PrO) AbbvieMavyret™ glecaprevir/pibrentasvir (G/P) AbbvieDaklinza™ daclatasvir (DCV) Bristol-Myers Squibb (BMS)Zepatier™ elbasvir/grazoprevir (EBR/GZR) MerckOlysio™ simeprevir (SIM) JanssenCopegus™, Ribapak™ ribavirin (RBV) many
Outline
• Brief HCV refresher• HCV treatment financial landscape• Navigating the system
– Patients with prescription insurance– Patients without prescription insurance
• Tools – Manufacturer patient support– HCV treatment access resources
• Access on the horizon
Cost of HCV Treatment
$37,550
$84,550
$150,360
$94,500 $83,319
$76,653
$147,000
$54,600
$74,760 $74,760
$36,400
Average Wholesale Price (AWP) of 12 week treatment*Cost for 48 weeks ∆Cost for 8 weeks
Cost related to chronic HCV Infection
$17,277 $22,752
$59,995
$112,537
$145,000
Non-cirrhotic liverdisease
Compensatedcirrhosis
End stage liverdisease
Hepatocellularcarcinoma
Liver transplant
Cost per patient per year
Younossi Z, Dig Liver Dis. 2014
• Compared treatment of all fibrosis stages vs. stages ≥F3 and by specific fibrosis stage
• Cost-effective when treatment is initiated at any stage of fibrosis ($50,000 per Quality-adjusted life-years (QALYs) gained)
• Treating earlier results in a substantial decrease in net cost
Chahal JAMA internal medicine, 2016
• Genotype 1: ICERs from $0 to $31,452 per QALY gained• Limitations
– Newer agents– Analyzed using WAC pricing
• “..actual current cost of HCV DAAs, competition and negotiated pricing…continue to limit the public health impact of these new therapies”
• “To be clear, this section is informational. As explained below, actual costs are rarely known. Accordingly, the HCV Guidance does not utilize cost-effectiveness analysis to guide recommendations at this time.”
AASLD/IDSA Guidelines 2017
Absolute Denial of DAA Therapy
16%
46%
5%10%
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
Overall Medicaid Medicare Commercial
Lo Re, AASLD, 2015 #LB-5
Payer restrictions to HCV treatment in 4 states from November 1st, 2014 to April 30th, 2015*Denotes statistical significance
*
Access Restrictions
• Medicaid requirements vary by state• All Payers:
Common• Fibrosis stage• Prescriber type• Substance Use
Less Common
• HIV co-infection• “Once per lifetime”• Genotype• Previous adherence requirement• Specialty pharmacy restriction• Exclusivity agreements
Medicaid Liver Disease Restrictions
10% with known criteria limited access to F474% with known criteria limited access to F3 Barua, Ann Int Med, 2015
Substance Abuse Restrictions
50% required periods of abstention ranging from 1 to 12 monthsBarua, Ann Int Med, 2015
Hepatitis C State of Medicaid Access
https://stateofhepc.org/
Outline
• Brief HCV refresher• HCV treatment financial landscape• Navigating the system
– Patients with prescription insurance– Patients without prescription insurance
• Tools – Manufacturer patient support– HCV treatment access resources
• Access on the horizon
Patient Case 1: Gabriel
• Baby boomer male• Genotype 1a• Stage F0 per ultrasound with elastography• HCV treatment naïve • HIV coinfection• Private insurance contracted with Express Scripts
Patient Case 2: Lucas
• Baby boomer male• Genotype 1a• Treatment naïve• F4 per fibrosure; F2-F3 per US with elastography• Binge drinker with multiple rehab visits• Household income: $21,000 for family of 3• Medicaid insurance
The Insured
• Insurance• Preferred
pharmacy
Benefits Investigation
• PA completion• Supporting
documents
Prior Authorization • Letter requesting
approval• Supporting
documents
Appeal
• Copay card• Foundation
assistance
Financial Assistance • Avoiding lapse in
treatment• Insurance
changes
On-Treatment Considerations
Benefits Investigation
• Goals:1. Determine insurance eligibility
• Do they have active prescription insurance?• Who is the pharmacy benefits manager (PBM)?
2. Identify preferred pharmacies• Do they have to fill with a certain pharmacy?• Is there a penalty to fill with patient’s preferred pharmacy?
3. Obtain prior authorization (PA) form• Phone PAs are usually not effective and lead to immediate denial (in general,
for now)
Benefits Investigation
• Steps for providers:– If you have a preferred pharmacy send them the prescription
• Pharmacies can run benefits claims
– Enroll patients in manufacturer access pathways• These access programs can perform a benefits investigation (BI)
– Discuss patient with designated support staff
Benefits Investigation
• Steps for designated staff:1. Obtain prescription processing information:
• Check patient’s chart or ask patient about their local pharmacy• Call patient for prescription processing information
2. Obtain eligibility and requirements for HCV therapy:• Call pharmacy line from prescription insurance plan
– Preferred pharmacy and any penalties or fill limits for using patient-preferred pharmacy– Deductible– Out of pocket expense– PA requirements transferred to PA department– Request PA form faxed to office
Insured Medication Access Process
Prior AuthorizationPa
per/
Fax • Obtain PA
application• Complete PA
paperwork • Gather
supporting materials
• Fax to insurance
Elec
tron
ic • Covermymeds.com
• All paperwork completed online
Phon
e • Primarily used for PA extension
Cover My Meds
Prior Authorization
• What to include: PA application provided Genotype and viral load Staging: FIB-4 score, ultrasound, CT, etc. Clinical notes Ancillary items requested by certain PBMs
• Resistance testing (elbasvir/grazoprevir)• Urine drug screen• Rehab documentation
• Follow-up if no response in 5 days
Patient Case 1: Gabriel
Patient Case 2: Lucas
Patient Case 1: Gabriel APPROVED!
Document and monitor
dates of approval.
APPROVED!- Now what?
• Pharmacy should run a test claim– Ensure approval– Determine copay
• Determine if patient qualifies copay assistance– Medicaid: does not qualify for assistance copay $0-$3– Medicare: obtain foundation assistance contact patient
• Pharmacy should do this– Commercial: obtain copay card if patient copay is >$10
• Pharmacy should do this
Copay Cards: Gilead SupportPathDrug Patient
CostCopay Card Information Card Details Eligibility
Harvoni® $5 https://www.harvoni.com/support-and-savings/co-pay-coupon-registration
-Max of 25% of the catalog price of a 12-week regimen
-Valid for 6 months from 1st redemption
-Resident of US, PR, or US territories
-No state or federally funded programs
-≥18 years old
Sovaldi® $5 https://www.sovaldi.com/coupons/
Epclusa® $5 http://www.epclusainfo.com/support-and-savings/co-pay-coupon-registration
Vosevi® $5 https://www.vosevi.com/co-pay-coupon-registration
Contact: 1-855-769-7284
Copay Cards: Abbvie ProCeed
Drug Patient Cost
Copay Card Information Card Details Eligibility
Viekira XR® $5 https://www.viekira.com/patient-support/financial-resources
-Max of 25% of the catalog price
-Valid for 12 uses
-Expires 12 months from 1st redemption
-Resident of US
-No state or federally funded programs
-Not valid in Massachusetts
Viekira Pak® $5 https://www.viekira.com/content/pdf/viekira-treatment.pdf
Technivie® $5 https://www.viekira.com/content/pdf/viekira-treatment.pdf
Mavyret® $5 https://www.mavyret.com/
Contact: 1-877-628-9738
Copay Cards: Bristol-Myers Squibb Patient Support CONNECT
Drug Patient Cost
Copay Card Information Card Details Eligibility
Daklinza® $0 https://bmsdm.secure.force.com/patientsupportconnect/patient
Contact: 1-844-442-6663
-Max of $5,000 per 28-day supply of 30mg or 60mg tablets OR up to max of $10,000 per 28-day supply of 90mg
-Resident of US or Puerto Rico
-No state or federally funded programs
-≥18 years old
Copay Cards: MerckDrug Patient
CostCopay Card Information Card Details Eligibility
Zepatier® $5 https://www.merckaccessprogram-zepatier.com/hcp/copay-assistance/
Contact: 1-866-251-6013
-Max of 25% of the catalog price per prescription
-Resident of US or Puerto Rico
-No state or federally funded programs
-≥18 years old
Grant Funding
• Complete grant funding application• Yearly household income• Household size• Retired• File taxes• Submit application online
Grant Funding Grant Patient Cost Information Eligibility
Patient Access Network Foundation (PANF)
$0 https://pharmacyportal.panfoundation.org/Home.aspx
Contact: 1-866-316-7263
-Max of $30,000/year-Reside in US-Income below 400% or 500% FPL-Any insurance
Patient Advocate Foundation (PAF)
$0 https://www.copays.org/diseases/hepatitis-c
Contact: 1-866-512-3861
-Max of $25,000/year-Reside in US-Income below 400% FPL-Any insurance
Chronic Disease Fund (CDF) Based on poverty percentage- up to $50
http://www.mygooddays.org/for-patients/patient-assistance/
Contact:1-972-608-7141
-Max of $30,000/year-Reside in US-Any insurance, must pay at least 50% of copay-Income below 500% FPL
Healthwell Foundation $5/fill https://www.healthwellfoundation.org/fund/hepatitis-c/
Contact: 1-800-675-8416
-Max of $30,000/year-Reside in US-Any insurance-Income below 500% FPL
Back to cases
Patient Case 2: Lucas
Denied- Now What?
1. Call the PBM and ask about rejection.– Why was it rejected?– Is there a preferred agent?– What are the next steps (appeal, peer-to-peer review, external review, etc.)
2. Write appeal letter3. Fax back appeal, original PA paperwork, and any supporting
documentation (AASLD/IDSA Guidelines, clinical trial data, drug interaction analysis, etc.)
Appeal Elements
https://www.mavyret.com/hcp/appealing-prescription-coverage
Appeal Supporting Documents
• Any required appeal form from the insurer (if applicable)• Copy of the denial letter from the insurance company• Patient’s complete medication profile • Patient’s medical profile as warranted• Relevant lab results, diagnostics, pathology reports, including illicit
drug screening results• Relevant treatment guidelines underline applicable sections• Relevant peer-reviewed journal articles• Relevant clinical trial information
https://www.mavyret.com/hcp/appealing-prescription-coverage
Appeal Support
HIVMA/IDSA: http://hcvtreatmentaccess.org/drug-appeals/#section2
Appeal Support
• Mavyret® Medical Exception Request
Patient Case 2: Lucas Appeal
• Reason for request• State denial reason• Relevant medical history
Lucas Appeal
Lucas Appeal• Address denial
Lucas Appeal
• Describe outcome with treatment
• Summary statement
• List inclusions • References
Lucas Appeal
Case 2: Lucas approved!
Special Denials
Early fibrosis• Try to find an additional reason to treat:
– Cryoglobulinemia– Proteinuria, nephrotic syndrome, membranoproliferative
glomerulonephritis– HIV or HBV coinfection– Coexistent liver disease (i.e. NASH)– Debilitating fatigue– Type 2 Diabetes mellitus– Porphyria cutanea tarda– Child-bearing age
Child Bearing
AASLD/IDSA Guidelines Guidance on Ongoing Alcohol/Illicit Substance Use
Centers for Medicare/Medicaid Services (CMS) Guidance
Adherence Readiness
• Denial: “Physician/provider asserts that the patient demonstrates treatment readiness, including the ability to adhere to the treatment regimen. The information sent in does not show your patient meets these criteria.”
https://prepc.org/
Psychosocial Readiness Evaluation to Prepare for hepatitis C treatment (PREP-C)
Outline
• Brief HCV refresher• HCV treatment financial landscape• Navigating the system
– Patients with prescription insurance– Patients without prescription insurance
• Tools – Manufacturer patient support– HCV treatment access resources
• Access on the horizon
The Un-Insured and Under-Insured
Medication Delivery
Setting up the first fill Patient Support on therapy
Patient Assistance Programs (PAP)
Criteria for approval Process of Application
Underinsured
• Apply for Patient Assistance Programs (PAP)– Coverage in the insured varies by manufacturer– Denied Exception Committee
• Discuss this option with a supervisor at the PAP
PAPSecond appeal denied
Appeal denied
PA denied
Uninsured
• Often easiest group to get approved!• Manufacture PAP process relatively simple• All require the following:
Proof of Income
• Tax return• Copy of a disability or
Medicare letter• Social security income
statement• Retirement and/or
pension statement• Pay stub
Proof of residency
• State-issued ID OR• Letter of residency
• Rehab • Housing establishment• Caregiver
Household size
• All income from anyone in the house
Proof of Income
• Letter stating income if no other option is available
• Proof of residency is similar
PAP: Gilead
• http://www.mysupportpath.com• Eligibility:
– Applied and denied for Medicaid and state insurance marketplace
– Ineligible for VA benefits– Provide household income and size
Patient signature required
PAP: Abbvie
• Patient Support• Complete enrollment form• https://www.mavyret.com/cont
ent/dam/abbvie-mavyret-brand/enrollment-form.pdf
https://www.mavyret.com/content/dam/abbvie-mavyret-brand/enrollment-form.pdf
PAP: Merck
• http://www.merckhelps.com/ZEPATIER
• Eligibility:– US resident– No insurance or an
exception based on case– Household income
• $59,400 for one • $80,100 for a couple• $121,500 for family of 4
Back to patient case 2: LucasWhat if he had been denied?
Emilia• Gilead Exception
Committee– Reviews appeals on case-
by-case basis– Include:
• Original PA/appeal/denial information
• Additional letter of medical necessity
• List of medications and how they are obtained
EmiliaAPPROVED!
PAP Medication Delivery
• Prescription faxed to clinic for provider signature– Select delivery to provider or patient
• Pharmacy calls patient for delivery information• Pharmacy calls monthly for prescription refill• Discuss any language barriers with the pharmacy
On-Treatment Considerations
On-Treatment Considerations• PA continuation requirements
– 4 week viral load• PA extension
– Starting later than expected– On treatment viral load detectable
• Insurance changes• Refills
– Encourage the patient to call 7-10 days before running out• Emergency shipments
– Insurance– Manufacturer
Ongoing Alcohol/Illicit Substance Use Considerations
• Counseling:– Payer restrictions if reinfected– ADHERENCE!!
• Tools: apps, phone alarm, pill box, alarmed pill box, accountability (friends/family), checklist
• Plan, plan, plan- be specific
• Close monitoring while on treatment
MyMedSchedule.Com
Outline
• Brief HCV refresher• HCV treatment financial landscape• Navigating the system
– Patients with prescription insurance– Patients without prescription insurance
• Tools – Manufacturer patient support– HCV treatment access resources
• Access on the horizon
Priorities at the First Visit• Educate patients
– Time requirements for the process– Current restrictions and possible barriers to treatment– Need for ongoing communication– Specialty pharmacy requirment
• Obtain necessary work-up– Urine drug screen (based on insurance requirements)– Signature for release of information– Signature on PAP forms
• Confirm contact information• Encourage engagement• Evaluate possible drug interactions
Provider Support: Gilead Support Path
https://supportpathconsent.iassist.com
Provider Support: Gilead Support Path
https://supportpathconsent.iassist.com
PAP: Abbvie
• Patient Support• Complete enrollment form• https://www.mavyret.com/cont
ent/dam/abbvie-mavyret-brand/enrollment-form.pdf
https://www.mavyret.com/content/dam/abbvie-mavyret-brand/enrollment-form.pdf
Provider Support: Abbvie
• Abbvie Nurse Ambassador– Assist with navigating
financial information– Assigned nurse throughout
treatment– Call for adherence
monitoring– Appointment reminder
https://www.mavyret.com/complete-patient-support
Provider Support: Merck Access Program
• Benefits investigation• PA/Appeal
– Obtain the appropriate form and send to office
• Financial assistance after approval
https://www.merckaccessprogram-zepatier.com/static/pdf/merck-access-program-zepatier-enrollment-form.pdf
Provider Support: Merck Access Program
• Benefits investigation• PA/Appeal
– Obtain the appropriate form and send to office
• Financial assistance after approval
https://www.merckaccessprogram-zepatier.com/hcp/patient-support-tools/
Outline
• Brief HCV refresher• HCV treatment financial landscape• Navigating the system
– Patients with prescription insurance– Patients without prescription insurance
• Tools – Manufacturer patient support– HCV treatment access resources
• Access on the horizon
Medicaid Access: 2014 to 2017• Liver damage restrictions:
• Sobriety requirements:
• Prescriber Restrictions:
Known criteria No minimum requirement At least F3 fibrosis
2014 34 states (67%) 0 states 31/34 states (91%) surveyed
2017 50 states (+PR and DC, 100%) 18 states (35%) 12 states (23%)
Known criteria No requirement 6 months 1 year
2014 37 states (73% surveyed) 0 states 18 states (49% surveyed) 2 states (5%) surveyed
2017 50 states (+PR,DC, 100%) 10 states (19%) 18 states (35%) 2 states (4%)
Known criteria Specialist Prescribe or Consult Specialist Prescribe Only
2014 22 states (42%) 22 states (100%) surveyed 14 states (48%) surveyed
2017 1 state (2%) 14 states (27%) 9 states (18%)NVHR/Harvard Law School, 2017
Access on the Horizon
• Current state of treatment access– Overall improved with few Pharmacy Benefit Managers denying
treatment– Barriers remain
• Hopeful in the near future– Decreased cost– Increased competition– Increased access
Other Access Resources• HCV Treatment Access (HIVMA/IDSA)
– http://hcvtreatmentaccess.org/• National Viral Hepatitis Roundtable
– NVHR.org/hepatitis-c-treatment-access• Hepatitis C New Drug Research
– http://hepatitiscnewdrugresearch.com/hcv-drugs-financial-support.html• American Liver Foundation
– http://hepc.liverfoundation.org/resources/what-if-i-need-financial-assistance-to-pay-for-treatment/
• Life Beyond Hepatitis C– http://www.lifebeyondhepatitisc.com/medical-information/financial-assistance/
Treatment Access Pearls
• Develop a relationship with a specialty pharmacy• Complete prior authorization forms completely• Identify staff to become familiar with requirements• Try to obtain necessary work-up and signatures at first visit• Incorporate a discussion of the access process in first visit
counseling• Document approval dates• Ensure 4 week lab completion
Summary• Though costly, the price of HCV treatment should not limit
prescribing of these medications.• Complete documentation and supplementary support can improve
PA approval rates.• Do not give up after initial PA denial!• Uninsured patients with low income are the MOST likely to get
approved for treatment.• Manufacturer support is available to assist prescribers and their
staff.