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UnitedHealthcare Pharmacy
Clinical Pharmacy Programs
Program Number
Program
Medication
2016 P 2052-6
Prior Authorization/Medical Necessity
Harvoni™ (ledipasvir/sofosbuvir)
P&T Approval Date
Effective Date
4/2015, 8/2015, 11/2015, 8/2016, 12/2016
3/1/2017;
Oxford only: 3/1/2017
1. Background:
Harvoni™ (ledipasvir/sofosbuvir) is a fixed-dose combination of ledipasvir, a hepatitis C virus
(HCV) NS5A inhibitor, and sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor, and
is indicated for the treatment of chronic hepatitis C (CHC) genotype 1, 4, 5, or 6 infection in adults.1
2. Coverage Criteriaa,b, c:
A. For the treatment of chronic hepatitis C genotype 1 infection in treatment-naïve patients
without cirrhosis who have pre-treatment HCV RNA less than 6 million IU/mL, Harvoni
will be approved based on all of the following criteria:
1.
Submission of medical records (e.g., chart notes, laboratory values) documenting
diagnosis of chronic hepatitis C genotype 1 infection
-AND-
2. Submission of medical records documenting stage of liver disease (e.g., APRI score,
FibroSure score, Fibroscan score, or other methods)
-AND3. Patient is treatment-naive [patient has not experienced treatment failure (defined as viral
relapse, breakthrough while on therapy, or nonresponder to therapy) with peginterferon
plus ribavirin or peginterferon plus ribavirin plus an HCV protease inhibitor (e.g.,
Incivek, Olysio, Victrelis) or Sovaldi (sofosbuvir)]
-AND4. Submission of laboratory report documenting a pre-treatment HCV RNA less than 6
million IU/mL
-AND5. Prescribed by one of the following:
a.
b.
c.
d.
Hepatologist
Gastroenterologist
Infectious Disease Specialist
HIV Specialist Certified through the American Academy of HIV Medicine
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-AND6. Both of the following:
a. Physician/provider has evaluated the treatment readiness of the patient using one of
the following scales/assessment tools:
(1) Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment
(PREP-C) – available at www.prepc.org
-OR(2) SAMHSA-HRSA Center for Integrated Health Solutions – Drug & Alcohol
Screening Tools - available at http://www.integration.samhsa.gov/clinicalpractice/screening-tools#drugs. Physician/provider must indicate the name of
the SAMHSA-HRSA drug and alcohol screening tool used
-ANDb. Physician/provider asserts patient demonstrates treatment readiness, including the
ability to adhere to the treatment regimen
-AND7. Patient is not receiving Harvoni in combination with another HCV direct acting antiviral
agent [e.g., Sovaldi (sofosbuvir), Olysio (simeprevir)]
Authorization will be issued for 8 weeks.
B. For the treatment of chronic hepatitis C genotype 1 infection in treatment-naïve patients
without cirrhosis who have pre-treatment HCV RNA equal to or greater than 6 million
IU/mL OR Post Transplant OR on immunosuppressants OR co-infected with HIV,
Harvoni will be approved based on all of the following criteria:
1.
Submission of medical records (e.g., chart notes, laboratory values) documenting
diagnosis of chronic hepatitis C genotype 1 infection
-AND-
2. Submission of medical records documenting stage of liver disease (e.g., APRI score,
FibroSure score, Fibroscan score, or other methods)
-AND3. Patient is treatment-naive [patient has not experienced treatment failure (defined as viral
relapse, breakthrough while on therapy, or nonresponder to therapy) with peginterferon
plus ribavirin or peginterferon plus ribavirin plus an HCV protease inhibitor (e.g.,
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Incivek, Olysio, Victrelis) or Sovaldi (sofosbuvir)]
-AND4. One of the following:
a. Submission of laboratory report documenting a pre-treatment HCV RNA equal to or
greater than 6 million IU/mL
-ORb. Patient is taking immunosuppressant therapy following organ transplantation or for
another condition
-ORc. Patient is co-infected with HIV
-AND5. Prescribed by one of the following:
a.
b.
c.
d.
Hepatologist
Gastroenterologist
Infectious Disease Specialist
HIV Specialist Certified through the American Academy of HIV Medicine
-AND-
6. Both of the following:
a. Physician/provider has evaluated the treatment readiness of the patient using one of
the following scales/assessment tools:
(1) Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment
(PREP-C) – available at www.prepc.org
-OR(2) SAMHSA-HRSA Center for Integrated Health Solutions – Drug & Alcohol
Screening Tools - available at http://www.integration.samhsa.gov/clinicalpractice/screening-tools#drugs. Physician/provider must indicate the name of
the SAMHSA-HRSA drug and alcohol screening tool used
-ANDb. Physician/provider asserts patient demonstrates treatment readiness, including the
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ability to adhere to the treatment regimen
-AND7. Patient is not receiving Harvoni in combination with another HCV direct acting antiviral
agent [e.g., Sovaldi (sofosbuvir), Olysio (simeprevir)]
Authorization will be issued for 12 weeks.
C. For the treatment of chronic hepatitis C genotype 1 infection in treatment-naïve patients
with cirrhosis, Harvoni will be approved based on all of the following criteria:
1. Submission of medical records (e.g., chart notes, laboratory
diagnosis of chronic hepatitis C genotype 1 infection
values) documenting
-AND2. Submission of medical records (eg, chart notes, laboratory values) documenting that the
patient has cirrhosis
-AND3. Patient is treatment-naive [patient has not experienced treatment failure (defined as viral
relapse, breakthrough while on therapy, or nonresponder to therapy) with peginterferon
plus ribavirin or peginterferon plus ribavirin plus an HCV protease inhibitor (e.g.,
Incivek, Olysio, Victrelis) or Sovaldi (sofosbuvir)]
-AND4. Prescribed by one of the following:
a.
b.
c.
d.
Hepatologist
Gastroenterologist
Infectious Disease Specialist
HIV Specialist Certified through the American Academy of HIV Medicine
-AND-
5. Both of the following:
a. Physician/provider has evaluated the treatment readiness of the patient using one of
the following scales/assessment tools:
(1) Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment
(PREP-C) – available at www.prepc.org
-OR-
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(2) SAMHSA-HRSA Center for Integrated Health Solutions – Drug & Alcohol
Screening Tools - available at http://www.integration.samhsa.gov/clinicalpractice/screening-tools#drugs. Physician/provider must indicate the name of
the SAMHSA-HRSA drug and alcohol screening tool used
-ANDb. Physician/provider asserts patient demonstrates treatment readiness, including the
ability to adhere to the treatment regimen
-AND6. Patient is not receiving Harvoni in combination with another HCV direct acting antiviral
agent [e.g., Sovaldi (sofosbuvir), Olysio (simeprevir)]
Authorization will be issued for 12 weeks.
D. For the treatment of chronic hepatitis C genotype 1 infection in treatment-experienced
patients without cirrhosis, Harvoni will be approved based on all of the following criteria:
1.
Submission of medical records (e.g., chart notes, laboratory values) documenting
diagnosis of chronic hepatitis C genotype 1 infection
-AND-
2. Submission of medical records documenting stage of liver disease (eg, APRI score,
FibroSure score, Fibroscan score, or other methods)
-AND3. Prescribed by one of the following:
a.
b.
c.
d.
Hepatologist
Gastroenterologist
Infectious Disease Specialist
HIV Specialist Certified through the American Academy of HIV Medicine
-AND-
4. Both of the following:
a. Physician/provider has evaluated the treatment readiness of the patient using one of
the following scales/assessment tools:
(1) Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment
(PREP-C) – available at www.prepc.org
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-OR(2) SAMHSA-HRSA Center for Integrated Health Solutions – Drug & Alcohol
Screening Tools - available at http://www.integration.samhsa.gov/clinicalpractice/screening-tools#drugs. Physician/provider must indicate the name of
the SAMHSA-HRSA drug and alcohol screening tool used
-ANDb. Physician/provider asserts patient demonstrates treatment readiness, including the
ability to adhere to the treatment regimen
-AND5. Patient has experienced treatment failure, defined as viral relapse/breakthrough while on
therapy or non-responder to therapy, with a previous treatment regimen that included
peginterferon plus ribavirin or an HCV protease inhibitor (e.g. Incivek, Olysio,
Victrelis) plus peginterferon plus ribavirin or Sovaldi (sofosbuvir)
-AND6. Patient is not receiving Harvoni in combination with another HCV direct acting antiviral
agent [e.g., Sovaldi (sofosbuvir), Olysio (simeprevir)]
Authorization will be issued for 12 weeks.
E. For the treatment of chronic hepatitis C genotype 1 infection in treatment-experienced
patients with cirrhosis, Harvoni in combination with ribavirin will be approved based on
all of the following criteria:
1.
Submission of medical records (e.g., chart notes, laboratory values) documenting
diagnosis of chronic hepatitis C genotype 1 infection assessment, liver biopsy)
-AND-
2. Submission of medical records (e.g., chart notes, laboratory values) documenting that
the patient has cirrhosis
-AND3. Used in combination with ribavirin
-AND4. Prescribed by one of the following:
a. Hepatologist
b. Gastroenterologist
c. Infectious Disease Specialist
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d. HIV Specialist Certified through the American Academy of HIV Medicine
-AND5. Both of the following:
a. Physician/provider has evaluated the treatment readiness of the patient using one of
the following scales/assessment tools:
(1) Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment
(PREP-C) – available at www.prepc.org
-OR(2) SAMHSA-HRSA Center for Integrated Health Solutions – Drug & Alcohol
Screening Tools - available at http://www.integration.samhsa.gov/clinicalpractice/screening-tools#drugs. Physician/provider must indicate the name of
the SAMHSA-HRSA drug and alcohol screening tool used
-ANDb. Physician/provider asserts patient demonstrates treatment readiness, including the
ability to adhere to the treatment regimen
-AND6. Patient has experienced treatment failure, defined as viral relapse/breakthrough while on
therapy or non-responder to therapy, with a previous treatment regimen that included
peginterferon plus ribavirin or an HCV protease inhibitor (e.g. Incivek, Olysio,
Victrelis) plus peginterferon plus ribavirin or Sovaldi (sofosbuvir)
-AND7. Patient is not receiving Harvoni in combination with another HCV direct acting antiviral
agent [e.g., Sovaldi (sofosbuvir), Olysio (simeprevir)]
Authorization will be issued for 12 weeks.
F. For the treatment of chronic hepatitis C genotype 1 infection in treatment-experienced
patients with cirrhosis, Harvoni will be approved based on all of the following criteria:
1.
Submission of medical records (e.g., chart notes, laboratory values) documenting
diagnosis of chronic hepatitis C genotype 1 infection assessment, liver biopsy)
-AND-
2. Submission of medical records (e.g., chart notes, laboratory values) documenting that
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the patient has cirrhosis
-AND3. Prescribed by one of the following:
a.
b.
c.
d.
Hepatologist
Gastroenterologist
Infectious Disease Specialist
HIV Specialist Certified through the American Academy of HIV Medicine
-AND-
4. Both of the following:
a. Physician/provider has evaluated the treatment readiness of the patient using one of
the following scales/assessment tools:
(1) Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment
(PREP-C) – available at www.prepc.org
-OR(2) SAMHSA-HRSA Center for Integrated Health Solutions – Drug & Alcohol
Screening Tools - available at http://www.integration.samhsa.gov/clinicalpractice/screening-tools#drugs. Physician/provider must indicate the name of
the SAMHSA-HRSA drug and alcohol screening tool used
-ANDb. Physician/provider asserts patient demonstrates treatment readiness, including the
ability to adhere to the treatment regimen
-AND5. Patient has experienced treatment failure, defined as viral relapse/breakthrough while on
therapy or non-responder to therapy, with a previous treatment regimen that included
peginterferon plus ribavirin or an HCV protease inhibitor (e.g. Incivek, Olysio,
Victrelis) plus peginterferon plus ribavirin or Sovaldi (sofosbuvir)
-AND6. Patient is not receiving Harvoni in combination with another HCV direct acting antiviral
agent [e.g., Sovaldi (sofosbuvir), Olysio (simeprevir)]
-AND-
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7. One of the following:
a. Both of the following:
(1) History of intolerance or contraindication to ribavirin therapy
-AND(2) History of intolerance or contraindication to Epclusa (sofosbuvir/velpatasvir)
therapy
-ORb. Patient is currently on Harvoni therapy
Authorization will be issued for 24 weeks.
G. For the treatment of chronic hepatitis C genotype 4, 5 or 6 infection, Harvoni will be
approved based on all of the following criteria:
1.
Submission of medical records (e.g., chart notes, laboratory values) documenting
diagnosis of chronic hepatitis C genotype 4, 5 or 6 infection
-AND-
2. Submission of medical records documenting stage of liver disease (eg, APRI score,
FibroSure score, Fibroscan score, or other methods)
-AND3. Prescribed by one of the following:
a.
b.
c.
d.
Hepatologist
Gastroenterologist
Infectious Disease Specialist
HIV Specialist Certified through the American Academy of HIV Medicine
-AND-
4. Both of the following:
a. Physician/provider has evaluated the treatment readiness of the patient using one of
the following scales/assessment tools:
(1) Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment
(PREP-C) – available at www.prepc.org
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-OR(2) SAMHSA-HRSA Center for Integrated Health Solutions – Drug & Alcohol
Screening Tools - available at http://www.integration.samhsa.gov/clinicalpractice/screening-tools#drugs. Physician/provider must indicate the name of
the SAMHSA-HRSA drug and alcohol screening tool used
-ANDb. Physician/provider asserts patient demonstrates treatment readiness, including the
ability to adhere to the treatment regimen
-AND5. Patient is not receiving Harvoni in combination with another HCV direct acting antiviral
agent [e.g., Sovaldi (sofosbuvir), Olysio (simeprevir)]
Authorization will be issued for 12 weeks.
a
For Maryland, requests for continuation of therapy may also be approved if the provider
confirms the patient has been on the medication in the past 180 days and that the medication is
effective in treating the patient’s condition. Please see Maryland Continuation of Care guideline
b
For Indiana (effective 7/1/16) and West Virginia (effective 1/1/17), step therapy requirements
may be approved if the patient has previously received either a documented step one
prescription drug or another prescription drug that has the same mechanism of action as a
preceding prescription drug, and the prescription drug was discontinued due to lack of efficacy
or effectiveness, diminished effect, or an adverse event. For West Virginia (effective 1/1/17)
members only, coverage may also be provided for continuation of therapy if the member is
currently stabilized on the requested medication for the same medical condition.
c
For California, requests for continuation of therapy may also be approved if the
provider confirms the patient has been on the medication, it is appropriately prescribed,
and that the medication is considered safe and effective in treating the patient’s
condition.
3. Additional Clinical Rules:
Supply Limits may be in place.
4. References:
1. Harvoni [package insert]. Foster City, CA: Gilead Sciences, Inc.; June 2016.
2. American Association for the Study of Liver Diseases and the Infectious Diseases Society of
America. Recommendations for Testing, Managing, and Treating Hepatitis C.
http://www.hcvguidelines.org/full-report-view. Accessed July 29, 2016
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Program
4/2015
8/2015
11/2015
8/2016
11/2016
12/2016
Prior Authorization/Medical Necessity - Harvoni (ledipasvir/sofosbuvir)
Change Control
Coverage requirements for State of New Jersey effective 5/18/2015.
Added criteria for genotype 4 infection
Changed program title to include all lines of business, added genotypes 5
and 6, and updated language regarding documentation of liver fibrosis.
Revised treatment-experienced with cirrhosis criteria to include ribavirin
and Epclusa.
Added California coverage information.
Removed abstinence-based criteria and replaced with treatment readiness
screening criteria. Added Maryland, Indiana and West Virginia
coverage information.
Confidential and Proprietary, © 2016 United HealthCare Services, Inc.
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