Subject: Sovaldi 2141-A, 2680-A SGM P2022
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 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, in combination with
peginterferon alfa (PEG-IFN) and ribavirin (RBV)1
1. Genotype 1 infection
Authorization of up to 12 weeks total may be granted for
adult members who are treatment-naïve.
2. Genotype 4 infection
Authorization of up to 12 weeks total may be granted for
adult 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
adult members who have documented interferon (IFN)
ineligibility (see Section VI).
2. Genotype 2 infection
Authorization of up to 12 weeks total may be granted for
members 3 years of age and older 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 3 years of age and older 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 adult 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 3 years of age or older who are
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.
IV. CONTINUATION OF THERAPY
All members (including new members) requesting authorization
for continuation of therapy must meet all initial authorization
criteria.
V. OTHER
A. Some elements outlined in this policy may not be enforced
for certain plans due to regulatory guidelines.
B. 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: 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 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.
March 28, 2023
