Barriers to HCV Therapy: Improving Access to Care

1. Barriers to HCV Therapy: Improving Access to Care Michael W. Fried, M.D. Professor of Medicine Director, UNC Liver Center University of North Carolina at Chapel Hill

2. Barriers to Treating HCV • Societal Type of health care system Unemployment Stigma Disadvantaged status Poverty • Community • Healthcare system • Providers • Patient Cost of care Location of clinics Complex system Lack of specialists Alcohol/Drugs Psychiatric disease Non-adherence Unwilling providers Unable to manage co-morbidities

3. Lack of Awareness of HCV Infection • In the U.S., estimated that 75% of infected population are unaware of HCV infection • Variable estimates of awareness in EU • Several reasons • Screening recommendations based on risk • Patients do not admit to risk factors • Primary providers are not familiar with screening guidelines nor next steps in management • Primary providers do not inquire about risk factors • Primary providers may not test for HCV even when risk factors or abnormal ALT are known • 2% of Family Practice survey respondents in US counseled patients that anti-HCV antibody signified immunity to HCV* *Ferrante et al, 2008

4. Inadequate HCV Testing in Patients With Known Risk Factors in Primary Care Almario et al, 2011

5. Institute of Medicine ReportUnited States • There is a lack of knowledge and awareness about hepatitis C on the part of • Health care providers • At-risk populations, • Members of the public and policymakers • There is insufficient understanding about the seriousness of this public health problem • Inadequate resources are allocated to prevention, control and surveillance programs. Consequences: • The full extent of the problem is unknown • At-risk people do not know that they are at risk or how to prevent becoming infected • Chronically infected people do not know that they are infected • Many health care providers do not screen people for risk factors or do not know how to manage infected people. • Infected people often have inadequate access to testing, social support and medical management services.

7. Highlighting Successful National Plans for Hepatitis • French National Plan • Increased proportion of patients aware of HCV-positivity from 24-56% (1994-2004) • Highest treatment rate for HCV in Europe (16%) • Demonstrated impact on morbidity and mortality • Implemented surveilance system • Scottish National Plan • Managed care networks for HCV • National procurement of antivirals • Increased diagnosed and treated • Prisoners treated Hatzakis et al, 2011

8. Awareness of HCV Status in France Jauffret-Roustide M et al, 2009 Meffre C et al, 2010 Delarocque-Astagneau et al, 2010 % Aware of Diagnosis if HCV+ Population Anti-HCV Prevalence= Drug User 60% Metropolitan 0.84% 1994 2004 Population-Based ~1% ~0.71%

9. Public Awareness Campaign Combined with PCP Support Improves Rate of Testing for HCV • Netherlands 2005-2008 • Public Awareness Campaign in all regions • Intervention Region: Support provided to PCPs • Lectures, Peer support • Increased rate of testing and positive results in the intervention group Helsper et al, 2010

10. Rates of HCV Treatment in the United States VA= Veterans Hospital Adapted from McGowan and Fried, 2012

11. HCV in Switzerland Primary Care Practice • 1084 Swiss PCPs responded to confidential survey • 86% had an average of 4 patients with HCV • 20% did not monitor HCV disease • 67% of their patients did not receive HCV treatment • HCV-specialist advice • Patient preference • Normal liver enzymes • Patient factors- • Substance abuse • Psychiatric disease Overbeck et al, 2011

12. Patients’ Perceptions of Barriers to Accessing Care for HCV In U.S. N=126 Evon et al 2010

13. Barriers to Hepatitis C Treatment: A Global Analysis of Physician Perceptions C.E. McGowan, A. Monis, B.R. Bacon, J. Mallolas, F.L. Goncales, I. Goulis, F. Poordad, N. Afdhal, S. Zeuzem, T. Piratvisuth, P. Marcellin, and M.W. Fried

14. Aims • To identify barriers to hepatitis C treatment as perceived by an international sample of HCV treatment providers • To describe regional variations in perceived barriers • To determine the association between physician characteristics and perceived barriers to treatment

15. Central/Eastern Europe • Nordic • Asia/Pacific • Middle East/Africa • United States • Canada • Latin America • Western Europe Methods • International survey study of HCV treatment providers • Study developed by the International Conquer C Coalition (I-C3) • Panel of HCV experts from around the world • Committee and study support provided by Merck • 1400 physicians identified in 8 global regions: • Physicians required to treat a minimum of 5 HCV patients / month

16. Methods • Physicians asked to rate 31 potential barriers divided into patient, provider, government, and payer categories • Each barrier rated on a 10-point Likert scale: • Additional questions addressing physician demographics, practice characteristics, and knowledge of HCV treatment principles • Survey administered by phone interview or online by a professional survey company* 0 5 10 Not a barrier Somewhat of a barrier Large barrier *UGAM Solutions

17. 697 physicians from 8 global regions (27 individual countries) Results Sample Size >50 20-50 <20 Region* US CAN LAT WE CEE NOR AP MEA *US, United States; CAN, Canada; LAT, Latin America; WE, Western Europe; CEE, Central/Eastern Europe; NOR, Nordic; AP, Asia/Pacific; MEA, Middle East/Africa

18. Overall Perception of Barriers by Region 6.3 4.4 2.1 1.7 *results shown for all 31 potential barriers p<0.0001 across regions

19. Regional Barriers by Category • Patient-Level • Fear of side-effects • Treatment duration • Medication expense * * * * * * Highest rated barrier category

20. Regional Barriers by Category • Payer-Level • Lack of coverage • Excessive paperwork * * * Highest rated barrier category

21. Regional Barriers by Category • Government-Level • Insufficient funding • Lack of promotion * * Highest rated barrier category

22. Regional Barriers by Category • Provider-Level • Lack of infrastructure • Insufficient training • Low reimbursement *

23. Summary • Perceived treatment barriers vary significantly by global region • Barriers are least prominent in Nordic and Western European countries and most prominent in Middle East and African countries • Patient-level factors are most frequently and include fear of side effects, treatment duration, and expense • The perception of barriers is significantly associated with physician experience and knowledge level

24. Conclusions • To improve global HCV care, barriers to treatment need to be minimized • Efforts to reduce treatment barriers need to be tailored to each region • Patient fears and concerns should be addressed with appropriate pre-treatment counseling and education • Improving physician education and awareness may influence the delivery of care by reducing perceived treatment barriers

25. 433 Charts reviewed Majority of Patients Are Deferred From Treatment Due to Psychiatric Disease or Substance Abuse 324 (74.8%) Ineligible 109 (25.2%) Eligible Psych 111 (34.3%) Addiction 109 (33.6%) Adv LD 76 (23.5%) Medical 77 (23.8%) Pat Choice 43 (13.3%) MiLD 16 (4.9%) Financial 16 (4.9%) Deferral Reasons Psych 59 (53.2%) Addiction 57 (52.3%) Adv LD 57 (75%) Medical 34 (44.2%) Pat Choice 29 (67.4%) MiLD 5 (31.3%) Financial 10 (62.5%) Attended Follow-up Visits Psych 20 (18%) Addiction 16 (14.7%) Adv LD 2 (2.6%) Medical 11 (14.3%) Pat Choice 8 (18.6%) MiLD 0 Financial 3 (18.8%) Subsequently Treated *More than 1 reason for deferral possible Evon et al, 2007

26. Improving Eligibility for HCV Treatment Multidisciplinary Approach Evon et al, 2011

27. Integrated Care Intervention: Randomized Trial • Determine if 9-month integrated care intervention could improve treatment eligibility for patients with mental health and substance abuse comorbidities compared to standard of care • Intervention • Phone reminders, • Referrals to community resources, • Case management, • Motivational enhancement could increase the proportion of patients with MH/SA comorbidities who become eligible for treatment, compared to patients who received standard medical care • Randomized trial • Providers blinded to intervention assignment Evon et al, 2011

28. Baseline Deferral Reasons N= 101 35% 31% Evon et al, 2011

29. Patients Who Became Eligible for HCV Treatment RR= 2.38; CI (1.21-4.68) P=0.009 % of Patients (21/50) (9/51) Evon et al, 2011

30. Common Challenges During Treatment Nonadherence Drop-Out/LTF Discontinuation Management Difficulties

31. “Shared Patient Management Between Specialists and GPs…… Project Extension for Community Healthcare Outcomes (ECHO) • Academic clinicians co-manage patients with primary care providers • An innovative educational model that uses state-of-the-art “telehealth” technology, best practice protocols, and case-based learning to train and support clinicians

32. Project ECHO: How It Works in New Mexico • Healthcare providers participate in weekly telehealth sessions- “Knowledge Networks” • Specialty provider team (hepatologist, psychologist, social worker, addiction specialist, pharmacist, and others as needed) provide mentorship • Access to mentoring team is available during telehealth sessions and as needed

33. Project ECHO: How It Works in New Mexico • Primary healthcare providers present specific cases to mentoring team in a standardized format: History, physical, labs • Joint decisions are made regarding management from candidate selection to selection of regimen and initiation • PCPs supply weekly updates about patients and discuss any difficult management issues that may arise • Over time: improvement in skills for HCV care

36. Primary Care Providers Managing HCV: Impact of Project ECHO in New Mexico Arora et al, 2011

37. Primary Care Providers Managing HCV: Impact of Project ECHO in New Mexico Arora et al, 2011

38. Primary Care Providers Managing HCV: Impact of Project ECHO in New Mexico Arora et al, 2011

39. Primary Care Providers Managing HCV: Impact of Project ECHO in New Mexico • Primary care providers managed HCV with similar outcomes to specialty providers when teamed with specialty mentors via a telehealth system • Similar rates of SVR • Similar rates of SAEs • Improved self-efficacy- • More confidence to treat HCV • More confidence to serve as an HCV resource • “Force Multiplier”

40. Evolution of HCV Treatment • As all oral regimens develop some, but not all, of these barriers will be diminished • Fewer contraindications based on co-morbidities • More patients will be eligible for treatment • Greater impact on morbidity/mortality and burden of disease as more patients are treated • Greater incentive for society to invest • Costs will be an increasing barrier • Many global regions may be unable to offer newest therapies to those in need

41. Comprehensive Services for Viral Hepatitis Will Decrease Barriers • Community Outreach: • Community-awareness programs • Provider-awareness programs • Encourage patient advocacy programs • Prevention: • Vaccination • Harm reduction Needle exchange, Drug/alcohol treatment) • Identification of Infected Persons: • Risk-factor screening • Serologic testing • Medical Management: • Assessment for and provision of long-term monitoring for viral hepatitis and selection of appropriate persons for treatment (in accordance with AASLD guidelines) • Psychiatric and other mental-health care support • Adherence support IOM Report 2010

42. Key Factors for Successful Management • Reliable epidemiological data to communicate with policy makers • Clinical leadership from specialist centers, public health and social services • Establish quantifiable goals • Example 75% of HCV infected aware of their infection • Concrete goals to extend treatment in line with capacity • Awareness campaigns to increasing testing through GPs • System for referrals to specialists • Shared patient management between specialists and GPs Hatzakis et al, 2011