HepCure : An innovative web-based toolkit to support the treatment of hepatitis C at community health centers in New York State
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1 HepCure : An innovative web-based toolkit to support the treatment of hepatitis C at community health centers in New York State CHCANYS 15: Statewide Conference & Clinical Forum October 19, 2015 Jeffrey J. Weiss, PhD, MS Associate Professor, Medicine Korin Parrella, MPH HepCure Program Manager Ponni V. Perumalswami, MD Assistant Professor, Medicine
2 Disclosures The following Faculty in a position to control content relevant to this session has disclosed the following relevant financial relationships: Consultant, AbbVie, Inc. (Weiss) The content of my material/presentation in this CME activity will not include discussion of unapproved or investigational uses of products or devices.
3 Overview Importance of focus on HCV in NYS FQHCs - Current HCV screening and treatment landscape Challenges to HCV screening and treatment in FQHCs HepCure project background and development HepCure provider dashboard & patient app demo FQHC collaboration with HepCure
4 Hepatitis C is a Disease of Marginalized Groups Rates of infection: IDU > 10 years of use 90% (Tseng et al. 2007) IDU < 9 years of use 66% (Tseng et al. 2007) Homeless persons 19-69% (Chak et al. 2011) Prisoners 29% (Larney et al. 2013) Severely mentally ill 20% (Rosenberg et al. 2001) US population 2%
5 Gravitz (2011) Nature
6 From: The Increasing Burden of Mortality From Viral Hepatitis in the United States Between 1999 and 2007 Ann Intern Med. 2012;156(4): doi: / Figure Legend: Annual age-adjusted mortality rates from hepatitis B and hepatitis C virus and HIV infections listed as causes of death in the United States between 1999 and Because a decedent can have multiple causes of death, a record listing more than 1 type of infection was counted for each type of infection. Date of download: 7/22/2015 Copyright American College of Physicians. All rights reserved.
7 Number infected HCV is dramatically under-diagnosed Over 75% of patients with HCV are undiagnosed Lack of knowledge & awareness among health care providers Lack of knowledge & awareness among at-risk populations Insufficient understanding about the extent and seriousness of this public health problem 4,000,000 3,000,000 Undiagnosed Diagnosed ~75% 2,000,000 1,000,000 ~21% ~65% 0 HIV HBV HCV
8 10-year Cumulative Incidence Rate SVR (Cure) Associated with Decreased All-Cause Mortality van der Meer et al. JAMA 2012; 308: patients with advanced fibrosis, treated with interferonbased therapy, and followed for 8.4 (IQR ) years
9 CDC Has Revised Screening Recommendations for HCV
10 HCV Screening: Why Us? NYS Governor Signs Health Care Bill October 2013 Hepatitis C Virus Testing (Chapter 425 of the Laws of 2013) This new law requires a hepatitis C virus screening test to be offered to all patients born between 1945 and 1965 who are receiving health services as a hospital inpatient or receiving primary care services and applies to physician, physician assistant, or nurse practitioner. The law further requires that the health care provider refer a patient who receives a positive screening test to another provider to receive confirmatory testing and follow-up care. In effect as of January 1, 2014 and expires on January 1, 2020
11 HCV Treatment Development Interferon (IFN) SVR rates < 10% 1 st Generation Protease Inhibitors SVR rates 65-80% in clinical trials Interferon (IFN) + ribavirin (RBV) SVR Rates 14-22% All oral Direct Acting Antivirals (DAAs) SVR rates %
12 Overview Importance of focus on HCV in NYS FQHCs - Current HCV screening and treatment landscape Challenges to HCV screening and treatment in FQHCs HepCure project background and development HepCure provider dashboard & patient app demo FQHC collaboration with HepCure
13 HCV Public Health Cascade
14 Nearly Three-Quarters of Surveyed Primary Care Physicians are Unfamiliar with Approved Direct Acting Antivirals for Hepatitis C Virus The Majority of Surveyed Primary Care Physicians Expect to Refer HCV Patients to a Specialist for Care, According to Findings from Decision Resources Group June 19, 2014 Burlington, Mass. Decision Resources Group finds that less than one-third of surveyed primary care physicians (PCPs) are familiar with the first-generation hepatitis C virus (HCV) protease inhibitors, Vertex s Incivek and Merck s Victrelis, despite the fact that these direct acting antivirals have been marketed in the U.S. since Furthermore, approximately three-quarters of surveyed PCPs are unaware that Janssen/Medivir s Olysio and Gilead s Sovaldi recently received FDA approval for the treatment of HCV infections, highlighting an opportunity for drug marketers to increase their prescriber pool by raising awareness of the current HCV treatment options among PCPs.
15 HCV Provider Shortage A key element will be to recruit trained, mid-level providers and Primary care physicians as new treaters, in addition to expanding the capacity of gastroenterologists, hepatologists, and infectious disease specialists. Aronsohn & Jensen, Expanding Access to Hepatitis C Virus Care: A Call to Deconstruct Individualized Therapy, (2014) Hepatology 59: 13-15
16 Project ECHO Launched in 2003 to address the lack of providers treating HCV in New Mexico Tele-education model to expand provider capacity and share knowledge A study published in NJEM in 2011 showed that the quality of hepatitis C care provided by project ECHO trained clinicians was equal to that of care provided by clinicians at academic medical centers Now project ECHO works in a variety of disease types, not just HCV.
17 HCV Linking to Care
18 Experienced Hepatitis C Provider NYSDOH AIDS Institute Definition of HCV Experienced Provider Providers must meet all three criteria: Category Criteria 1. Clinical Experience Management AND treatment of at least 10 patients with HCV infection within the past 12 months. -OR- HCV preceptorship, who Management and treatment of at least 10 patients with infection in partnership (defined as consultation, or via telemedicine) with an experienced HCV provider meets the above criteria. 2. CME At least 10 HCV-related CME credits within the last 12 months 3. Licensure Current, valid MD, DO, PA, or NP New York State license.
19 Cost is limiting access
20 Prior Authorization Process Time consuming Non-billable Medical & Psychosocial Criteria Different rules per insurer Appeals Process Dedicated Staff Specialty Pharmacy Collaboration
21 Overview Importance of focus on HCV in NYS FQHCs - Current HCV screening and treatment landscape Challenges to HCV screening and treatment in FQHCs HepCure project background and development HepCure provider dashboard & patient app demo FQHC collaboration with HepCure
22 New York State Department of Health AIDS Institute Colleen Flanigan, RN, MS Director Viral Hepatitis Section Primary Care Hepatitis C Care and Treatment Programs Improving Linkage and Access to Hepatitis C Care and Treatment Programs CHCANYS Demonstration Project Six FQHCs throughout NYS Build capacity for HCV treatment HCV care and treatment Quality Indicators Tele-consultation
23 Psychosocial Readiness Evaluation and Preparation for hepatitis C treatment (PREP-C) Background Developed in response to lack of guidelines and screening tools to meet clinicians needs for assessing patient s psychosocial readiness to begin chronic HCV therapy by NYCDOHMH HCV Task Force Working Group (Nirah Johnson & Carolyn Licht) Description Clinical interview (20-30 minutes) Assessment of 9 areas of psychosocial functioning based on research findings and clinical experience Implementation Piloted at Mount Sinai and revised Web based version now available PrepC.org Full and Abbreviated versions
24 Motivation Information Medication Adherence PrepC.org Self- Efficacy Social Support and Stability Alcohol and Substance Use Psychiatric Stability Psychosocial Readiness HCV Treatment Adherence Energy Level Cognitive Functioning
25 Provider Dashboard, Patient App, Tele-Education HepCure.org
26 HepCure HCV Innovation HepCure is a quality improvement initiative partnership of: Icahn School of Medicine at Mount Sinai The New York State Department of Health AIDS Institute CHCANYS Primary funding from NYS Health foundation with supplemental funding from Merck Foundation, Boehringer Ingelheim Foundation, Gilead Foundation
27 HepCure Goals Engage patients Patients are primary stakeholders in their health HepCure is patient-centered to improve adherence and quality of care Expand the workforce Train primary care and other subspecialty providers to screen, evaluate and treat patients with HCV Enable improved outcomes linking health-care providers from community practices with specialists experienced in treating hepatitis C provide weekly case conferencing create knowledge networks and training modules real time quality improvement dashboard
28 HepCure HCV Innovation Creating a state-of-the-art innovative web application that will improve access to quality health care for persons infected with HCV, support providers and lead to cost savings For providers and HCV patients HepCure Dashboard for providers HepCure Mobile app for patients HepCure Webinars (Tuesday 4:30-5:30 PM EST) hepcure@mountsinai.org
29 Overview Importance of focus on HCV in NYS FQHCs - Current HCV screening and treatment landscape Challenges to HCV screening and treatment in FQHCs HepCure project background and development HepCure provider dashboard & patient app demo FQHC collaboration with HepCure
30 HepCure Provider Dashboard Features Organize HCV patient panel systematically Treatment decision support based on patient characteristics Population health quality indicators Link to patients on app View patient adherence and symptom data Release labs to patient Treatment visit tracker Case submission for expert consultation Resources and webinars
31 HepCure Patient Patient app features Enter pre-treatment information See suggested regimens Assess treatment readiness Set adherence reminders Enter appointments in native calendar Track Adherence & Symptoms Enter Labs Link to Provider Dashboard Provider can view adherence & symptom data & release labs Resources Section iphone 7:11 PM Home My Status My Team My Cure
32 Overview Importance of focus on HCV in NYS FQHCs - Current HCV screening and treatment landscape Challenges to HCV screening and treatment in FQHCs HepCure project background and development HepCure provider dashboard & patient app demo FQHC collaboration with HepCure
33 Security Windows Azure Services Cloud platform Secure SSL encryption, HIPAA Adherent platform Data is not stored in devices to prevent loss if stolen Review and sign a business associate agreement with Mount Sinai Terms of Use and Privacy Policy available Plan for integration into top EMRs in New York State
34 Learn HepCure.org
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