Subject: Sovaldi 2141-A, 2680-A SGM P2021
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.
A. FDA-Approved Indications
Sovaldi is indicated for the treatment of:
1. Adult patients with chronic hepatitis C virus (HCV) infection as a component of a combination
antiviral treatment regimen
a. genotype 1 or 4 infection without cirrhosis or with compensated cirrhosis for use in combination
with pegylated interferon and ribavirin
b. genotype 2 or 3 infection without cirrhosis or with compensated cirrhosis for use in combination with ribavirin.
2. Chronic HCV genotype 2 or 3 infection in pediatric patients 3 years of age and older without cirrhosis or with
compensated cirrhosis for use in combination with ribavirin.
B. Compendial Uses
Hepatitis C genotype 5 or 6 infection (refer to Mavyret SGM)
All other indications are considered experimental/investigational and are not medically necessary.
II. CRITERIA FOR INITIAL APPROVAL
A. Hepatitis C virus infection, in combination with peginterferon alfa (PEG-IFN) and ribavirin (RBV)
1. Genotype 1 infection
Authorization of up to 12 weeks total may be granted for members who are treatment-naïve.
2. Genotype 4 infection
Authorization of up to 12 weeks total may be granted for members who are treatment-naïve.
B. Hepatitis C virus infection, in combination with ribavirin
1. Genotype 1 infection
Authorization of up to 24 weeks total may be granted for members who have documented interferon (IFN)
ineligibility (see Section IV).
2. Genotype 2 infection
Authorization of up to 12 weeks total may be granted for members who are treatment-naïve or failed
prior treatment with PEG-IFN and RBV.
3. Genotype 3 infection
Authorization of up to 24 weeks total may be granted for members who are treatment-naïve or failed
prior treatment with PEG-IFN and RBV.
4. Members with hepatocellular carcinoma awaiting liver transplantation
Authorization of up to 48 weeks total or until liver transplantation, whichever occurs first, may be granted
for members with genotype 1, 2, 3, or 4 infection and hepatocellular carcinoma who meet the MILAN criteria,
defined as the following:
i. Tumor size 5 cm or less in diameter with single hepatocellular carcinomas OR 3 tumor nodules or less,
each 3 cm or less in diameter with multiple tumors AND
ii. No extrahepatic manifestations of the cancer or evidence of vascular invasion of tumor
C. Hepatitis C virus infection, in combination with Mavyret (with ribavirin)
Authorization of up to 24 weeks total (as applicable) may be granted for members prescribed Sovaldi in
combination with Mavyret (with ribavirin) who meet the criteria for approval for the requested regimen.
Refer to the Mavyret SGM for the specific criteria for approval and approval durations.
D. 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, B, or C 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: INTERFERON INELIGIBLITY
IFN ineligible is defined as one or more of the below:
- Intolerance to IFN
- Autoimmune hepatitis and other autoimmune disorders
- Hypersensitivity to PEG-IFN or any of its components
- Major uncontrolled depressive illness
- A baseline neutrophil count < 1,500/mcL
- A baseline platelet count < 90,000/mcL
- A baseline hemoglobin < 10 g/dL
- History of pre-existing cardiac disease
Place of Service:
Outpatient
The above policy is based on the following references:
- Sovaldi [package insert]. Foster City, CA: Gilead Sciences, Inc.; March 2020.
- 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
