Specialty Pharmacy Benefit Management Discussion – Hepatitis C April 2, 2013.

Specialty Pharmacy Benefit Management Discussion –

Hepatitis C

April 2, 2013

Panel ParticipantsName Title Organization

Matt Mitchell, PharmD, MBA Manager of Pharmacy Services

SelectHealth

Cheryl Allen, BSPharm, MBA Vice President, Business Development & Industry Relations

Diplomat Specialty Pharmacy

David Coury, PharmD Director of Business Development

ACRO Pharmaceutical Services

Erik Halstrom, MHA VP, Specialty Pharmacy Solutions

MHA Specialty Pharmacy

Coy Stout VP Managed Markets Gilead Sciences

Debbie Stern, RPh President Rxperts

Defining Hepatitis C (HCV)• Hepatitis C is an infection caused by a virus that attacks the liver and

leads to inflammation. • Most people infected with the hepatitis C virus (HCV) have no

symptoms. And most people don't know they have the hepatitis C infection until liver damage shows up, decades later, during routine medical tests.

Definition

• Exposure to blood contaminated with HCV:• A health care worker who has been exposed to infected blood• Illicit drug use• Received a blood transfusion or organ transplant before 1992, or clotting

factor concentrates before 1987• Child born to a woman with a hepatitis C infection

Risk Factors

• Approximately 3.2 million persons in the United States have chronic HCV infection.

• Most prevalent among those born during 1945–1965, the majority of whom were likely infected during the 1970s and 1980s when rates were highest.

• About 25% of individuals infected with HIV in the US are also infected with HCV

Prevalence

Chronic HCV Leads to Many Liver-related Complications

Chronic

HCV

Hepatocellularcarcinoma

Decompensated cirrhosis

Liver Transplant

Death

CIRR

HO

SIS

HCV Infection is #1 cause of liver transplants in the U.S.

While sustained virologic response (SVR) rates in patients with cirrhosis are reduced, those that achieve SVR have lower rates of hepatitis C virus (HCV)-associated complications compared with non-responders.

Treatment Success = SVR … However, Other Outcomes are Possible

0 4 8 12 242016 484032 24 weeks post -treatment

56

Start of treatment End of treatment

HCV

RN

A (lo

g 10 IU

/mL)

Weeks

Undetectable HCV RNA in plasma

Viral Eradication

Breakthrough

SVR

RelapserNull

Partial

Ghany MG, Strader DB, Thomas DL, Seeff LB. Diagnosis, management and treatment of Hepatitis C: An update. Hepatology. 2009;49(4):1335-1374.

PANEL PARTICIPANTS

Matthew Mitchell PharmD, MBAManager, Pharmacy Services

SelectHealth

SelectHealth/Intermountian Healthcare• Non-profit Integrated Health Care System• Facilities

– 25 hospitals and 150 medical facilities and physician offices located throughout Utah and Idaho

• Physicians– 900 employed physicians – 2,500 affiliated physicians

• Health Plan– 635,000 enrollees

• Home care and Specialty Pharmacy

Specialty Steering CommitteeStrategic direction and planning

Fee schedule Maintain appropriate group of providers

Discussion of incentive programs or special fee arrangements

Evaluate product procurement/administration Includes need for specialty pharmacy

Determine preferred products

Establish coverage criteria Pre Authorization, Step Therapy, Duration of Therapy, Quantity

Limits, Specialist Only Prescribing, Case Management Priorities,

etc.

Specialty Activities Injectable/Specialty Trends

Members, Units, Allowed Cost, %increase/qtr,

%increase/year, PMPM Evaluate warehousing of HCV patients

Pipeline review

Therapeutic class reviews

Coordination with clinical program teams/key

providers Create and maintains Specialty Steering Committees i.e.

Rheumatology, Neurology, Oncology

Timely Topics

HCV Specific Management• Preferred treatment agents

– Different per line of business• Prior Authorization

– Help ensure appropriate genotype, drug selection, and duration

• Care management coordination– Auto generated reports and personal referrals

• Specialty pharmacy coordination– Includes compliance and rates of viral response

Cheryl Allen, BSPharm, MBAVice President, Business Development &

Industry Relations

Diplomat Specialty Pharmacy

Position: The nation's largest privately-held specialty pharmacy.

Mission: Being a customer focused and innovative partner, providing medication management and clinical services in a caring, cost-effective, supportive environment; keeping patients healthier longer… one patient at a time.

Diplomat’s Mission

DiplomatSpecialtyPharmacy

Pharmaceutical Manufacturers

Prescribers

Patients Payors/Exchanges

Retailers*

Health Systems/

Hospitals*

Evolving Specialty Pharmacy Partnerships

14

Core Medication Management

Prescriber Communication and Collaboration

Clinical Interventions and Drug Optimization

Health Plan Coverage and Utilization Management

Manufacturer Reporting and Strategy

Adherence &

Persistency

Clinical Intervention ScheduleIntervention Frequency Description

HCV Baseline Assessment Week 0 Collect/verify labs (e.g. weight, VL, biopsy, Hgb) and previous HCV therapy, duration, and outcome

Pharmacist PV1 Verification New RXs Evaluate therapy by genotype, treatment history, effectiveness, and safety; resolve actual or potential drug-related problems

Care Plan Week 0, PRN Identify treatment goals and document care plan

Medical Assessment Week 0, monthly Collect/verify allergies, co-morbidities, concomitant meds; clinician triage

Patient Education and Training Week 0, PRN Clinician initial consult (drug, disease, expectations, AE mgmt, adherence); HCV educational packet; injection training

Support Program Referral Week 0, PRN Facilitate enrollment in manufacturer programs and other supportive organizations

Depression Screening Months 0, 1, 3, 6 Patient Health Questionnaire-2/9 with prescriber contact and/or transfer to suicide hotline

Side Effect Management Week 0, PRN HCV Care Kits, side effect management guides, and clinician counseling

Adherence and Distribution Calls

At least monthly Outbound call by patient care coordinator to arrange refills, evaluate side effects, education needs, and administration

Futility Rules and Treatment Outcomes

Varies by regimen Collect VL and provide recommendations for treatment plan; outreach to obtain SVR results

• Hydrocortisone cream, carrying case, chapstick, magnet

Rash tip card with instructions for use, non-drug management techniques, when to contact HCP

New patients receive HCV Basics, HCV Side Effect Management, and HCV Specialty Care Overview

Additional side effect management brochures available: Anemia, Flu-like symptoms, Fatigue, Headache, Nausea and Vomiting, Rash, Etc.

HCV Care Kit Patient Education Packets

Enhanced Clinical Services

Facilitate patient support program

enrollment

Strategic interventions customized to

drug profile

Innovations in technology to optimize adherence

David Coury, PharmDDirector of Business DevelopmentAcro Pharmaceutical Services

19

Acro is a Pharmacy Care Management company with a specific focus on the distribution and clinical aspects

of high cost pharmaceutical products.

Who Is Acro?

Who Is Acro?

• Acro Pharmaceutical Services is owned by Lincare Holdings, a subsidiary of The Linde Group

• Revenue 2012 ~ $2 billion• Over 11,000 employees• 1100+ sales people• Over 500 Nurses on Staff• 30 closed door pharmacies across United States

– 26 infusion + 4 mail order + Acro Specialty Pharmacy (HUB)– Over 85 RNs and 102 Pharmacists

20

21

Acro/Lincare Pharmacy Services

Staffing Includes: 102+ Pharmacists and 85+ Nurses

Lincare Pharmacy LocationsBoca Raton, FL Little Rock, AR

Casper, WY Livonia, MI

Charlotte, NC Louisville, KY

Chesapeake, VA Madison Heights, MI

Clinton, NY Marietta, GA

Fayetteville, AR Montgomery, AL

Flowood, MS Orlando, FL

Fort Smith, AR Pelham, AL

Grand Rapids, MI Sharon Hill, PA (ACRO)

Huntsville, AL Somerset, KY

Indianapolis, IN Syracuse, NY

Jonesboro, AR Tempe, AZ

Lexington, KY Hammonton, NJ

Southhaven, MS* Clearwater, FL*

Kansas City, MO* Carlsbad, CA*

* Mail Order Pharmacy

Acro HCV Pharmacy Experience• Patients: Majority are Managed Medicaid• Referrals Prescriptions Sent to Acro by Payer Prior authorization

Depts.• Reauthorization Scripts Sent to Acro or upon Acro request to plan• Provide Necessary Clinical / Financial Support

– 24/7 clinical pharmacist availability– Refer patients to clinical and Financial support programs

• Provide Automatic Live outreach calls to members for refill scripts– Any patient not contacted for refills, physician office is

notified due to compliance concerns

Acro HCV Pharmacy ExperienceKey Challenges:- Transient Patients – Lose patients due to changing health

plan also gain patients from health plans already into therapy

- Complex prior authorization process for payers and necessary coordination with specialty pharmacy– Treatment regimens vary not set until initial HCV responses are

assessed, up to 3 reauthorization points– Not always apparent how long the patient should be on therapy

based on authorization notices because patient history is not always known

Erik HalstromVice President, Specialty Pharmacy SolutionsManaged Health Care Associates, Inc:

MHA is a leading health care service company that helps alternate site health care providers compete in their

respective markets

24 Confidential - Do Not Distribute

MHA – A Health Care Service Company

MHA

Group Purchasing

Organization

ConsultantPharmacy Software

Reimbursement Services

Pharmaceutical Data

Services

MHA Specialty Pharmacy Solutions

Legislative Advocacy

Managed Care Network

Confidential - Do Not Distribute 25

Group Purchasing Business Units

Group Purchasing Organizatio

n

NavigatorLTC Facilities

MHA Alternate Site Care Division

MHA LTC Pharmacy

Division

The MED Group

Confidential - Do Not Distribute

>830 Exclusive LTC Pharmacy providers>1,500 sites of service

>500 Rehab, DME, Sleep and Respiratory providers>1,600 locations

>4,700 Nursing Home providers>11,000 locations

>530 Home Infusion & Specialty pharmacies>1,200 sites of service

26

MHA Specialty Sales for Top 7 Therapeutic Areas $6.8B in Total Sales

Transplant

IVIG

HEP C

Oncology

HIV

MS

Inflammatory Conditions

All 7 Conditions Total

$0

$1,000,000,000

$2,000,000,000

$3,000,000,000

$4,000,000,000

$5,000,000,000

$6,000,000,000

$7,000,000,000

$8,000,000,000

All active members (excluding Omnicare & Pharmerica); Annualized Sales Q4 2011 – Q3 2012Contracted & Non contracted SalesAll COTs: Retail, Specialty Pharmacy/HI, HMO Staff Model, Clinics, LTC and all others.Source: Midas SQL Trak

Comprehensive clinical patient-focused program designed to help patients achieve optimal outcomes of their prescribed treatment regimen

Facilitates guided communication with patient, payer, and physician’s office

Program is based upon identified outreaches to the patient at key intervals to provide timely:

• Education• Treatment support• Individualized patient counseling

Outreaches are based on individual patient needs

– Review key patient demographics– Evaluate knowledge of disease state and therapy– Assess medication history and identify barriers to

treatment success– Review goals of therapy and treatment

expectations

28

Provides a clinical support pathway to enhance patient care and facilitates the collection of clinical and dispensing metrics for specialty reporting.

Clinical Support Pathway

Confidential - Do Not Distribute

Confidential - Do Not Distribute 29

Coy StoutVP, Managed Markets

Gilead Sciences

Disclaimer• Gilead has a development pipeline for Hepatitis

C therapies but does not have an approved product for Hepatitis C treatment at this time

• This presentation and speaker comments are based on general discussion around current and potential future Hepatitis C therapies but do not specifically refer to any particular Gilead pipeline product or products

Gilead Sciences• Gilead Sciences, Inc. is a research-based biopharmaceutical company that

discovers, develops and commercializes innovative medicines in areas of unmet need. With each new discovery and experimental drug candidate, we seek to improve the care of patients suffering from life-threatening diseases.

• Gilead’s primary areas of focus include HIV/AIDS, liver disease, serious cardiovascular and respiratory conditions, oncology and inflammation.

• Founded in 1987 in Foster City, California, Gilead has become a leading biopharmaceutical company with a rapidly expanding product portfolio and growing pipeline of investigational drugs.

• In 2012, Gilead attained $9.7 billion in annual global revenues and employs over 5,000 people

Evolving HCV Treatment Dynamics• Past

– 48 weeks of therapy (injectable + oral)– Low response rates in GT1

• Present– 24-48 weeks of therapy (injectable + oral)

• Response guided therapy considerations– Better response rates in GT1, not indicated for GT 2/3– Side effect management considerations

• Potential Future Treatments (many candidates in pipeline from multiple companies)– Shortened duration of therapy – Reduce or eliminate injectable component of therapy– Pan-genotypic regimens possible– No response guided therapy– Well-tolerated (less focus on side effect management)

Manufacturer Considerations• With new therapies, does the current distribution paradigm

change?– Need for payer network compatibility– Institutional access (e.g., corrections, VA)– Capacity

• What patient support programs are needed in the future for short-duration, all oral therapy?

• Specialty pharmacies play an important role in patient education, coordination of benefits, linkage to patient support programs…where else can we work together to ensure appropriate use and goals of therapy are reached?

HEPATITIS C OVERVIEW

HCV Therapy Challenges

36Mitra D, et al. Treatment Patterns and Adherence among patients with chronic hepatitis C virus in a US managed care population. Value in Health. 2010; 13(4): 479-486

Silent Disease

Adverse Events

Complex Treatment Regimens

Low Adherence

Adherence is Critical According to HCV Guidelines

NIH Consensus Statement on the Management of Hepatitis C (2002)1:• “Patient adherence is critical to the success of HCV treatment.” Physicians are encouraged to help

patients maximize adherence by managing their side effects, depression and substance abuse.

American Association for the Study of Liver Diseases (AASLD )Practice Guidelines: Diagnosis, Management, and Treatment of Hepatitis C: An Update (2009)2: • Patients “should also be queried about adherence to treatment.”

Institute of Medicine (IOM) Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C (2009)3: • Components of Comprehensive Viral Hepatitis Services: “Adherence Support”

1Management of Hepatitis C: 2002. National Institutes of Health Consensus Conference Statement. NIH Consensus Development Program. June 10-12, 2002. http://consensus.nih.gov/2002/2002HepatitisC2002116html.htm. Accessed 6/2011. 2Ghany MG, Strader DB, Thomas DL, Seeff LB. Diagnosis, management and treatment of Hepatitis C: An update. Hepatology. 2009;49(4):1335-13743 Colvin HM, Mitchell AE. Hepatitis a and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C. National Academy of Sciences. 2010. http://www.nap.edu/catalog.php?record_id=12793. Accessed 6/2011.

All patients -- PegIFN α-2b + 1.5 ug/kg Ribavirin

Genotype 1 -- PegIFN α-2b + 1.5 ug/kg Ribavirin

0

20

40

60

80

100 63

5152

34

PegIFNα-2b + Ribavirin: Effect of Adherence on SVR

>80/>80/>80 <80/<80/>80

Su

sta

ine

d V

iro

lgo

ic R

esp

on

se (

%)

80/80/80 Rule is Goal for HCV Treatment

80% of interferon dose80% of ribavirin dose

80% of prescribed treatment regimenMcHutchison JG, et al. Adherence to combination therapy enhances sustained response in genotype-1-infected patients with chronic hepatitis C. Gastroenterology. 2002;123:1068.

Hepatitis C Non-Adherence

2011 Express Scripts Specialty Drug Trend Report

Adverse Events Impact Adherence

Standard of Care

Peg-InterferonFlu-like Symptoms

Emotional and Cognitive EffectsBone Marrow Suppression

RibavirinHemolytic Anemia

Protease Inhibitors

Boceprivir:Anemia

NeutropeniaNausea and vomiting

Alteration of taste

Telapravir:Pruritis and rash, including Stevens-

Johnson syndromeFatigue, anemia, nausea and vomiting,

diarrhea, anorectal discomfort

Pill Burden and Complex Treatment Regimens Impact Adherence

VICTRELIS: 4 tabs 3x a day

WEEKLY

RIBAVIRIN: 3 tabs 2x a day

INCIVIK: 2 tabs 3x a day

OR

-PLUS-

DAILY

PLUS

Peg-IFN injection

Predictors of Poor Response to TherapyEthnicity

• African American vs. Caucasians• Higher rates of G1 infection• Higher rates of complications and mortality

Presence of psychiatric illnesses

• Depression or other psychiatric illnesses

Obesity

• Insulin resistance• Visceral fat tissue causing inflammation in liver

Co-infection with HIV

Active drug or alcohol use

McHutchison JG, et al. Adherence to combination therapy enhances sustained response in genotype-1-infected patients with chronic hepatitis C. Gastroenterology. 2002;123:1068.

HCV Ranks #7 In top 10 Specialty Therapy Classes2011 Express Scripts Specialty Drug Trend Report

HCV Pipeline• Novel therapies in Phase II and III – targeted launch in 2014 and

beyond:– New MOAs– New combinations– Dual/triple therapy– Novel interferons– Therapy without interferon

2011 Express Scripts Specialty Drug Trend Report

New CDC Recommendations: Hepatitis C Testing for Anyone Born During 1945-1965

• There are high rates of Hepatitis C in people born during 1945-1965. – People born during 1945 through 1965 are 5 times more likely than other adults to be

infected. – 75% of adults with Hepatitis C were born in these years

• Testing can help prevent deaths from Hepatitis C. – It is estimated that one-time testing of everyone born during 1945 through 1965 will prevent

more than 120,000 deaths.

• There is a lack of awareness.– One-time testing of everyone born during 1945 through 1965 would find an estimated

800,000 undiagnosed Hepatitis C cases.

• There have been recent advances in treatment.– For many people with Hepatitis C, medical treatment can result in the virus no longer being

detected in the blood.

AUDIENCE QUESTIONS