Barriers to HCV Therapy: Improving Access to Care

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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

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

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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
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Awareness of HCV Status in France
Aware of Diagnosis if HCV
Population Anti-HCV Prevalence
Drug User 60
Metropolitan 0.84
1994
2004
Population-Based
1
0.71
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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
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Rates of HCV Treatment in the United States
Author Year Cohort/Setting Of Patients Treatment Rate ()
Grebely6 2009 Community-based inner city cohort 1,360 1.1
Butt53 2010 VA National Database 134,934 11.9
Cawthorne17 2002 St. Louis VA 557 13.8
Rocca37 2004 Olmstead County Hepatitis C Registry 366 15.0
Bini54 2005 24 VA medical centers 4,084 17.7
Groom18 2008 Minneapolis VA 520 23.8
Evon32 2007 Academic medical center 433 25.2
Morrill36 2005 Primary care clinic 208 27.4
Falck-Ytter19 2002 Teaching county hospital 293 28.3
Butt16 2005 Pittsburgh VA 354 29.4
Rowan7 2004 Houston VA 580 30.0
Cheung 2010 US Ambulatory Database 16 million 9.1
VA Veterans Hospital
Adapted from McGowan and Fried, 2012
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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
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Patients Perceptions of Barriers to Accessing
Care for HCV In U.S.
N126
Evon et al 2010
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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
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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

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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

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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

UGAM Solutions
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Results
697 physicians from 8 global regions (27
individual countries)
Sample Size
gt50
20-50
lt20
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
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Overall Perception of Barriers by Region
6.3
4.4
2.1
1.7
results shown for all 31 potential barriers
plt0.0001 across regions
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Regional Barriers by Category

• Patient-Level
• Fear of side-effects
• Treatment duration
• Medication expense

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Regional Barriers by Category

• Payer-Level
• Lack of coverage
• Excessive paperwork

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Regional Barriers by Category

• Government-Level
• Insufficient funding
• Lack of promotion

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Regional Barriers by Category

• Provider-Level
• Lack of infrastructure
• Insufficient training
• Low reimbursement

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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

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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

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Majority of Patients Are Deferred From Treatment
Due to Psychiatric Disease or Substance Abuse
433 Charts reviewed
324 (74.8) Ineligible
109 (25.2) Eligible
Psych 111 (34.3)
Medical 77 (23.8)
Adv LD 76 (23.5)
Addiction 109 (33.6)
MiLD 16 (4.9)
Pat Choice 43 (13.3)
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
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Improving Eligibility for HCV Treatment
Multidisciplinary Approach
Evon et al, 2011
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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
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Baseline Deferral Reasons
N 101
35
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Evon et al, 2011
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Patients Who Became Eligible for HCV Treatment
RR 2.38 CI (1.21-4.68)
P0.009
of Patients
(21/50)
(9/51)
Evon et al, 2011
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Common Challenges During Treatment
Nonadherence Drop-Out/LTF Discontinuation Ma
nagement Difficulties
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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

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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

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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

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

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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

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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
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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