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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