Subject: Harvoni 2134-A 2677-A SGM P2022
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HARVONI
(ledipasvir and sofosbuvir)
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Policy:
I. INDICATIONS
The indications below including FDA-approved indications and
compendial uses are considered a covered benefit provided
that all the approval criteria are met and the member has no
exclusions to the prescribed therapy.
FDA-Approved Indications
Harvoni is indicated for the treatment of adults and pediatric
patients 3 years of age and older with chronic hepatitis C virus
(HCV):
A. genotype 1, 4, 5, or 6 infection without cirrhosis or with
compensated cirrhosis
B. genotype 1 infection with decompensated cirrhosis, for use
in combination with ribavirin
C. genotype 1 or 4 infection who are liver transplant recipients
without cirrhosis or with compensated cirrhosis, for use in
combination with ribavirin
All other indications are considered
experimental/investigational and not medically necessary.
II. PRESCRIBER SPECIALTIES
This medication must be prescribed by or in consultation with a
prescriber specializing in infectious disease, gastroenterology,
hepatology, or transplant.
III. CRITERIA FOR INITIAL APPROVAL
A. Hepatitis C virus infection, without ribavirin
1. Genotype 1 infection
i. Authorization of up to 12 weeks total may be
granted for treatment-naïve members with
compensated cirrhosis.
ii. Authorization of up to 12 weeks total may be
granted for treatment-naïve members without
cirrhosis who have any of the following: HIV co-
infection, or are less than 18 years of age, or have
pre-treatment HCV RNA greater than or equal to 6
million IU/mL.
iii. Authorization of up to 8 weeks total may be
granted for treatment-naive members without
cirrhosis who have pre-treatment HCV RNA below 6
million IU/mL and are HIV-uninfected.
iv. Authorization of up to 12 weeks total may be
granted for members without cirrhosis who failed
prior treatment with peginterferon alfa (PEG-IFN)
with or without ribavirin (RBV) with or without an
HCV protease inhibitor (telaprevir, boceprevir, or
simeprevir).
v. Authorization of up to 24 weeks total may be
granted for members with compensated cirrhosis
who failed prior treatment with PEG-IFN with or
without RBV with or without an HCV protease
inhibitor.
2. Genotype 4 or 5
Authorization of up to 12 weeks total may be granted
for members without cirrhosis or with compensated
cirrhosis who are treatment-naïve or who failed prior
treatment with PEG-IFN with or without RBV with or
without an HCV protease inhibitor.
3. Genotype 6 infection
Authorization of up to 12 weeks total may be granted
for members without cirrhosis or with compensated
cirrhosis when either of the following criteria are met:
i. Member is treatment-naïve and does not have
genotype 6e subtype
ii. Member has failed prior treatment with PEG-IFN
with or without RBV with or without an HCV
protease inhibitor
4. Decompensated cirrhosis (CTP class B or C)
Authorization of up to 24 weeks total may be granted
for members with HCV genotype 1, 4, 5 or 6 infection
and documented anemia (baseline Hgb below 10 g/dL)
or RBV ineligibility (see Section VI).
5. Recurrent HCV infection post liver transplantation
Authorization of up to 12 weeks total may be granted
for members without cirrhosis or with compensated
cirrhosis and recurrent HCV genotype 1, 4, 5 or 6
infection post liver transplantation.
6. Kidney transplant recipients
Authorization of up to 12 weeks total may be granted
for members without cirrhosis or with compensated
cirrhosis who have HCV genotype 1, 4, 5 or 6 infection
and are treatment-naïve or who have not failed prior
treatment with a direct-acting antiviral.
B. Hepatitis C virus infection, in combination with
ribavirin
1. Genotype 1 infection
Authorization of up to 12 weeks total may be granted
for members with compensated cirrhosis who failed
prior treatment with PEG-IFN with or without RBV with
or without an HCV protease inhibitor.
2. Genotype 4 infection
Authorization of up to 12 weeks total may be granted
for members with compensated cirrhosis who failed
prior treatment with PEG-IFN with or without RBV with
or without an HCV protease inhibitor.
3. Decompensated cirrhosis (CTP class B or C)
i. Authorization of up to 12 weeks total may be
granted for members with HCV genotype 1, 4, 5 or
6 infection.
ii. Authorization of up to 24 weeks total may be
granted for members with HCV genotype 1, 4, 5 or
6 infection who failed prior treatment with a
sofosbuvir-based regimen (e.g., sofosbuvir and
RBV, sofosbuvir plus PEG-IFN and RBV, sofosbuvir
plus simeprevir with or without RBV).
4. Recurrent HCV infection post liver transplantation
i. Authorization of up to 12 weeks total may be
granted for treatment-naïve members with
recurrent HCV genotype 1, 4, 5 or 6 infection post
liver transplantation and decompensated cirrhosis.
ii. Authorization of up to 24 weeks total may be
granted for treatment experienced members with
recurrent HCV genotype 1, 4, 5 or 6 infection post
liver transplantation and decompensated cirrhosis.
iii. Authorization of up to 12 weeks total may be
granted for treatment-naïve members with HCV
genotype 1 or 4 infection post liver transplantation
without cirrhosis or with compensated cirrhosis.
iv. Authorization of up to 12 weeks total may be
granted for members with HCV genotype 1 or 4
infection post liver transplantation without cirrhosis
or with compensated cirrhosis who failed prior
treatment with peginterferon alfa (PEG-IFN) with or
without ribavirin (RBV) with or without an HCV
protease inhibitor.
C. HCV and HIV coinfection
Authorization may be granted for members with HCV and
HIV coinfection when the criteria for approval of the
requested regimen in Section A or B above are met.
IV. CONTINUATION OF THERAPY
All members (including new members) requesting
authorization for continuation of therapy must meet all initial
authorization criteria.
V. OTHER
A. The member must be 3 years of age or older.
B. Some elements outlined in this policy may not be enforced
for certain plans due to regulatory guidelines.
C. The following information may be requested to support
regulatory requirements and will not be used to decision
individual requests:
1. Treatment status (i.e., treatment-naïve or retreatment)
2. For initial treatment: confirmation of member readiness
3. For retreatment: reason for the need for retreatment
(e.g., prior treatment failure, reinfection), confirmation
of member readiness, and ability to adhere to proposed
treatment plan
4. Hepatitis B screening results
5. Metavir/Fibrosis score
VI. APPENDIX: RIBAVIRIN INELIGIBILITY
RBV ineligibility is defined as one or more of the below:
• Intolerance to RBV
• Pregnant female or male whose female partner is pregnant
• Hemoglobinopathy
• Coadministration with didanosine
• History of significant or unstable cardiac disease
Place of Service:
Outpatient
The above policy is based on the following references:
- Harvoni [package insert]. Foster City, CA: Gilead Sciences; March 2020.
- AASLD/IDSA/IAS–USA. Recommendations for testing, managing, and treating hepatitis C. https://www.hcvguidelines.org. Last changes made October 5, 2021. Accessed August 9, 2022.
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
February 12, 2023
