from prescription to patient · 2018. 5. 30. · treatment selection • treatment consists of only...

114
From Prescription to Patient: Navigating Barriers to HCV Treatment Initiation Autumn Zuckerman, PharmD, BCPS, AAHIVP, CSP Vanderbilt Specialty Pharmacy Vanderbilt University Medical Center

Upload: others

Post on 22-Aug-2020

0 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

From Prescription to Patient:Navigating Barriers to HCV Treatment Initiation

Autumn Zuckerman, PharmD, BCPS, AAHIVP, CSPVanderbilt Specialty Pharmacy

Vanderbilt University Medical Center

Page 2: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

Disclosures

• Dr. Zuckerman has no financial or ethical disclosures• No manufacturer or medication preference

Page 3: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 4: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 5: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 6: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 7: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

HCV and Mortality in the USA

Ly KN et al. Ann Int Med 2012. // Ly KN et al. Clin Infect Dis 2016.

Page 8: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

https://hepvu.org/map/.

Incidence of Positive HCV Antibody

Page 9: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 10: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 11: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 12: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

Estimating HCV in Hispanics

Puerto Rican• 11.6%

Mexican • 1.9%

Dominican • 1.5%

Central American• 1%

South American• 0.4%

Cuban• 0.8%

Page 13: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 14: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 15: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 16: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 17: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

Natural History of HCV Infection

Thornton K UW/IDSA Hepatitis C Online Course, 2013.

Page 18: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 19: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 20: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 21: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 22: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 23: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 24: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 25: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 26: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 27: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 28: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 29: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 30: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 31: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

• 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

Page 32: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

• 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

Page 33: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

*

Page 34: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 35: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

Medicaid Liver Disease Restrictions

10% with known criteria limited access to F474% with known criteria limited access to F3 Barua, Ann Int Med, 2015

Page 36: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

Substance Abuse Restrictions

50% required periods of abstention ranging from 1 to 12 monthsBarua, Ann Int Med, 2015

Page 37: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

Hepatitis C State of Medicaid Access

https://stateofhepc.org/

Page 38: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 39: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 40: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 41: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 42: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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)

Page 43: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 44: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 45: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

Insured Medication Access Process

Page 46: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 47: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

Cover My Meds

Page 48: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 49: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

Patient Case 1: Gabriel

Page 50: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer
Page 51: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer
Page 52: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

Patient Case 2: Lucas

Page 53: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer
Page 54: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer
Page 55: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer
Page 56: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

Patient Case 1: Gabriel APPROVED!

Document and monitor

dates of approval.

Page 57: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 58: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 59: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 60: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 61: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 62: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

Grant Funding

• Complete grant funding application• Yearly household income• Household size• Retired• File taxes• Submit application online

Page 63: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 64: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

Back to cases

Page 65: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

Patient Case 2: Lucas

Page 66: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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.)

Page 67: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

Appeal Elements

https://www.mavyret.com/hcp/appealing-prescription-coverage

Page 68: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 69: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

Appeal Support

HIVMA/IDSA: http://hcvtreatmentaccess.org/drug-appeals/#section2

Page 70: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

Appeal Support

• Mavyret® Medical Exception Request

Page 71: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

Patient Case 2: Lucas Appeal

Page 72: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

• Reason for request• State denial reason• Relevant medical history

Lucas Appeal

Page 73: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

Lucas Appeal• Address denial

Lucas Appeal

Page 74: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

• Describe outcome with treatment

• Summary statement

• List inclusions • References

Lucas Appeal

Page 75: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

Case 2: Lucas approved!

Page 76: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

Special Denials

Page 77: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 78: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

Child Bearing

Page 79: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

AASLD/IDSA Guidelines Guidance on Ongoing Alcohol/Illicit Substance Use

Page 80: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

Centers for Medicare/Medicaid Services (CMS) Guidance

Page 81: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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.”

Page 82: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

https://prepc.org/

Psychosocial Readiness Evaluation to Prepare for hepatitis C treatment (PREP-C)

Page 83: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 84: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 85: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 86: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 87: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

Proof of Income

• Letter stating income if no other option is available

• Proof of residency is similar

Page 88: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 89: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

Patient signature required

Page 90: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 91: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 92: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

Back to patient case 2: LucasWhat if he had been denied?

Page 93: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 94: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

EmiliaAPPROVED!

Page 95: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 96: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

On-Treatment Considerations

Page 97: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 98: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 99: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

MyMedSchedule.Com

Page 100: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 101: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 102: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

Provider Support: Gilead Support Path

https://supportpathconsent.iassist.com

Page 103: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

Provider Support: Gilead Support Path

https://supportpathconsent.iassist.com

Page 104: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 105: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 106: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 107: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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/

Page 108: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 109: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 110: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 111: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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/

Page 112: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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

Page 113: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

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.

Page 114: From Prescription to Patient · 2018. 5. 30. · Treatment Selection • Treatment consists of only DAAs – 1 DAA from at least 2 different DAA classes – Interferon is no longer

Thank you!

Questions?

[email protected]