Starting an HCV Clinic Authored and Presented by: LCDR Jonathan Owen, PharmD Neelam Gazarian, MS, PharmD Quentin N. Burdick Memorial Health Care Facility Indian Health Service Belcourt, ND

Conflict of Interest Disclosure Statement None

Objectives Learn the tools to appreciate the scope of hepatitis C in their service area At the end of this presentation, participants will have the knowledge and tool set to start a hepatitis c clinic at their service unit number of people infected, awareness?

Prior to HCV Clinic With Insurance (Pvt./Federal) Without Insurance Referred to Medical Specialists $10,000/referral Distance Lost to follow-up Without Insurance Very Few Options Rationing Care Poor outcomes Lost to follow up/less documentation No tracking of patients

Identifying Patients with Hepatitis C iCare 168 patients 25% screening rate VGEN 155 patients Getting a sense of how many patients with diagnosis of hcv. Jessica and David huge help Patients with visit in past year Screening rate with a denominator of patients born between 1945 and 1965 (baby boomers) From reports from vay, based on old labs. Often patients deceased, moved away

Inter-collaborative Approach Primary Care Provider Pharmacist Behavioral Health Public Health Laboratory Services Patient Policy making Education and awareness

Challenges in Starting Clinic Labs do not exist in system NS5A Resistance Test Fibrosure Test Outsourced help to create this lab, currently working on NS5A resistance test More info on this later

EHR Documentation Initial Visit Comprehensive visit End of Treatment PHQ-9 screen AUDIT-C Order labs from Hep C Menu Comprehensive visit Project ECHO recommendations Start Medication Authorization End of Treatment Follow-up labs ordered throughout the process SVR Patient is cured! Counsel about re-infection and prevention Comprehensive visit usually done on the phone.

Managing Patients Hepatitis C Patient Panel List Excel document for patient management Created by Jessica Leston, Brigg Reilley, and David Stephens Automatically calculates APRI, FIB 4 scores Excellent for helping to prioritize patients based on liver function and viral load Respective stages for fibrosis or cirrhosis Excellent for helping to prioritizing patients based on liver function and viral load

Managing Patients Hepatitis C Patient Panel List New panel created by Neelam ‘Nelly’ to help manage patients referred to the clinic Spin-off of previous panel, automatically calculates APRI, FIB 4 scores Organized by stage in the treatment processes Reminders for labs while in treatment, immunizations, notes Respective stages for fibrosis or cirrhosis Excellent for helping to priorityzing patients based on liver function and viral load

Managing Patients Snapshot of stage in treatment process drop down menus (these can be adjusted) Reminders for labs while in treatment, immunizations

Managing Patients Reminders for labs while in treatment, immunizations

Managing Patients Reminders for labs while in treatment, immunizations

Stage of fibrosis score Navigating Insurance Stage of fibrosis score APRI, FIB 4 Abstinence Differs by state

Patient Assistance Program Gilead’s Support Path Sovaldi®, Harvoni®, Epclusa® AbbVie Patient Assistance Foundation Viekira Pak®, Mavyret® Type 1: Epclusa ( sofosbuvir/velpatasvir, with ribavirin in cases of decompensated cirrhosis) , Harvoni (ledipasvir/sofosbuvir), viekira pak, zepatier Type 2: Epclusa, sovaldi (sofosbuvir) with ribavirin Type 3: Epclusa only given with ribavirin in cases of decompensated cirrhosis Type 4: Epclusa, Harvoni, zepatier Type 5: Epclusa, Harvoni Type 6: Epclusa, Harvoni Mavyret (glecaprevir/pibrentasvir): 1, 2, 3, 4, 5, 6 Mavyret still not on abbvie patient assistance program list, soon hopefully? ND Medicaid just added as preferred non-formulary

Current Status 13 4 5 2 Pending Project Echo ETR SVR “cure” Treatment Appointment with PCP, more labs pending (possible self clearers) ETR: end of treatment response 3 months First scvr labs due in November

Screening Rates

Investment Cost Analysis Acquiring the medication Case presentation Education Consultation request from provider Approximately 2 hours needed per patient total

$110,046 $546,666 Direct cost of medications, Includes patients that received medciations ….point of sale

Next Steps POC Testing (>14 years) Behavioral Health Public Health Clinic Pharmacy Dental Emergency Room Public health: community events

Next Steps Leading efforts in the Great Plains, Bemidji and Billings Areas Sharing experiences and resources with other service units

Success Story Lobbied ND Medicaid 12-months abstinence requirements Drop minimum fibrosure score requirements Zepatier; Elbasvir; Grazoprevir Elbasvir: Not Predicted Ledipasvir: Not Predicted HARVONI; Ledipasvir; Sofosbuvir $630, takes 1 to 2 weeks No NS5A resistance test required unless prescribing Zepatier®

Acknowledgement Quentin N. Burdick Memorial Health Care Facility Eliminate Hepatitis C Team: Neelam Gazarian, PharmD. MS Pharmacology/Toxicology LCDR Jonathan Owen, PharmD. USPHS Thanks to: Molly Steen, PharmD. Pharmacy Clinical Services Director CDR Tyler Lannoye, PharmD. Chief of Pharmacy, USPHS

Special Thanks Jessica Leston , HCV/HIV/STI Clinical Programs Director for the Northwest Portland Area Indian Health Board Brigg Reilley, National HIV/AIDS Program David Stephens, BSN, RN, Case Manager for the Northwest Portland Area Indian Health Board.

Questions

Thank you Contact Info: Neelam.Gazarian@ihs.gov Jonathan.Owen@ihs.gov 701-477-6111 Ext 8426