suppressing the hepatitis c virus, barriers to care american public health association apha 143 rd...
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Suppressing the Hepatitis C virus, Barriers to Care American Public Health Association APHA
143rd Annual Meeting&Expo October 31-November 4,2015, Chicago, IL Session 4194 November 3, 12:30pm-1:30pm, Abstract 332709
Linda D. Green, MD Nune Karamyan, MD Leopoldine Kenmogne, MD
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Introduction
• In the United States, an estimated 2.7–3.9 million persons (1.0%–1.5%) are living with hepatitis C virus (HCV) infection of which 75% are “baby boomers”.• In 2014 FDA approved effective and less toxic oral medications to eradicate
Hepatitis C. This is now challenging physicians to identify and treat patients.• Since July 2012 faculty and residents at an internal medicine community
clinic have screened patients and developed a registry of 170 patients with Hepatitis C. The baby boomer prevalence of 8.1% is three times the national average .• The patients are tracked for access to treatment and progression to
cirrhosis and hepatocellular carcinoma.
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Registry Data Lost from study; 10Deceased; 7
Eligible for Rx re-ferred to GI; 80
Rxed and SVR at-
tained, 20
Rxed deferred, 10
Sponta-neously Serocon-verted; 6
Confirmatory workup; 37
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Registry data. Liver related mortalityLiver related mortality Number Percentage
Liver Cirrhosis 20 11.76%
Deceased 7 4.12%Liver Transplant 5 2.94%
Hepatocellular carcinoma 4 2.35%
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Registry data. Other Co-morbidities
Other- Co Morbidities Number Percentage
Hypertension 93 (54.70%) 54.70%
Diabetes Mellitus 40 (23.53%) 23.53%
Anemia 33 (19.41%) 19.41%
Vitamin D deficiency 31 (18.23%) 18.23%
Thrombocytopenia 29 (17.06%) 17.06%
Chronic Kidney Disease 18 (10.59%) 10.59%
HIV 9 (5.29%) 5.29%
Hepatitis B 4 (2.35%) 2.35%
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Methods
170 patients80 patients
14 patients
Completed medical work up
Referred to GI Seen by GI Prior Authorization
submitted
Completed medical work up
Referred to GI
Registry of 170 patients with Hepatitis C
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Methods
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Total of 14 PA submitted
Total PA submitted Initial PA approved Initial PA denied, 2nd PA approved PA denied twice, approved with free program
PA denied twice0
2
4
6
8
10
12
14
14 Prior Authorization (PA) submitted
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Discussion The experience in working with this cohort has identified barriers to care in the clinic which include:• Patients are untested or unaware of their diagnosis.• Fear of toxicity of treatment based on experiences with interferon based regimens.• Cost of new medications including insurance deductibles and copays,• Insurance companies’ requirements for staging severity by fibrosis scores (F0-4)
before approving medications only for advanced disease (F3,4) despite broader recommendations from professional societies.
• Insurance companies’ requirements that only subspecialists in Gastroenterology and Infectious Disease can prescribe the medications.
• Completing treatment of comorbid conditions and surgeries prior to committing to 3 months of treatment.
• Need to develop a support network with specialty pharmacies and alcohol and substance abuse programs.
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Patient outcomes. Initial PA approved CBC, CMP, VLFibrosure, U tox
Rx Start date Week 4 , 6, 8CBC, CMP, VL
End of Rx CBC, CMP, VL
SVR 12VL
Insurance/Barriers
Rx exp, F4,VL<6m, 24 wks 05/25/2015 Wk 4- VL<15
Wk 6- VL 011/16/2015Not done
02/08-02/15/16Pending
UHC-Medicaid EGD, wk 6 re- PA
Rx exp, F4 VL<6m, 24 wks 06/18/2015 Wk 4- VL 0 12/03/2015
Pending 02/25-03/03/16Pending
MedicareEGD
Rx naïve, F4VL<6m, 12 wks 07/02/2015 Wk 4 –VL 0 09/02/2015
Not done12/01-12/08/15Pending
Medicare EGD, GI app wait
Rx naïve, F4VL<6m, 12 weeks 03/12/2015 Wk 4 – VL 0 05/28/2015
VL 008/27-09/03/15Not done UHC-Medicaid
Rx naïve, F3VL<6m, 8 wks 05/21/2015 Wk 4- VL 0 07/16/2015
Not done10/08-10/15/15Not done
UHC-Medicaid B-blocker, AICD
Rx naïve, F2VL>6m, 12 wks 04/09/2015 Wk 4- VL 0 07/02/2015
Not done09/24-10/01/15Not done
Medicare
Rx exp, F2, VL<6mln, 12 wks
01/21/2015 Wk 4- VL 0 07/13/2015VL 0
07/08-07/15/15<100 copies BCBS Care First
Co-pay
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Patient outcomes.Initial PA denied, second PA approvedCBC, CMP, VLFibrosure, U tox
Rx Start date Week 4 , 6, 8CBC, CMP, VL
End of Rx CBC, CMP, VL
SVR 12VL
Insurance/Barriers
Rx naive, F3,VL<6m, 8wks
05/14/15 Wk 4-VL 0 07/09/2015VL 0
10/01-10/08/15Not done
MedicareUtox positive
Rx naive, F3,VL<6m, 8 wks
07/03/2015 Wk 4- VL 0 08/28/2015Not done
01/20-01/27/15Pending
UHC-MedicaidUtox positive
Rx naive, F2,VL<6m, 8 wks
04/16/2015 Wk 4-VL 0 06/17/2015VL 0
09/03-09/10/15Not done
UHC-MedicaidUtox positive
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Patient outcomes: PA denied twice, approved with free drug Program CBC, CMP, VLFibrosure, U tox
Rx Start date Week 4 , 6, 8CBC, CMP, VL
End of Rx CBC, CMP, VL
SVR 12VL
Insurance/Barriers
Rx naive, F2,VL>6m, 12wks
04/08/2015 Wk 4- VL 0 07/01/2015VL 0
09/23-09/30/15Not done
BCBS-Care firstLow fibrosis
Rx naive, F2,VL<6m, 8wks
06/25/2015 Wk 4- VL 0 08/20/2015Not done
11/12-11/19/15Pending
UCH-MedicaidLow fibrosis
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Patient outcomes:PA denied twice. Pending new PA process CBC, CMP, VLFibrosure, U tox
Rx Start date Week 4 , 6, 8CBC, CMP, VL
End of Rx CBC, CMP, VL
SVR 12VL
Insurance/Barriers
Rx naive, F3,VL<6m, 8wks
Pending UHC-MedicaidU tox
Rx naive, F2,VL<6m, 8wks
Pending PP-Medicaid Lost insurance
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Conclusion • Identifying and assessing a patient for treatment requires a complex
assessment of the medical conditions, severity of fibrosis and necrosis and psychosocial issues.• A patient who is ready for treatment has required 6-10 encounters prior
to starting medication.• Treatment by a specialist further delays the start of treatment. Experts
predict that there are not enough specialists to treat the 2-4 million patients expected to be eligible over the next 5-10 years.• Integrating the management of Hepatitis C into primary care training is
thus essential to the future management of uncomplicated cases.• Designated staff person or committed volunteer with nursing or medical
or public health background is needed to guarantee the program.