Subject: Harvoni 2134-A, 2677-A SGM P2021
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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 chronic hepatitis C virus (HCV) in
adults and pediatric patients 3 years of age and older who have:|
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, in combination with ribavirin
All other indications are considered experimental/investigational and not
medically necessary.
II. CRITERIA FOR 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 IV).
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 (eg, 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.
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.
III. CONTINUATION OF THERAPY
All members (including new members) requesting authorization for continuation
of therapy must meet all initial authorization criteria.
Special Notes:
IV. 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:
1. Harvoni [package insert]. Foster City, CA: Gilead Sciences; March 2020.
2. AASLD/IDSA/IAS–USA. Recommendations for testing, managing, and treating hepatitis C. https://www.hcvguidelines.org.
Last changes made September 29, 2021. Accessed October 15, 2021.
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 14, 2022
