Subject: Epclusa 2137-A, 2676-A SGM P2021
|
EPCLUSA
(sofosbuvir and velpatasvir)
|
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
Epclusa is indicated for the treatment of adults and pediatric patients 3
years of age and older with chronic hepatitis C virus (HCV) genotype 1,
2, 3, 4, 5 or 6 infection:
A. without cirrhosis or with compensated cirrhosis
B. with decompensated cirrhosis for use in combination with ribavirin
All other indications are considered experimental/investigational and
not medically necessary.
II. CRITERIA FOR INITIAL APPROVAL
A. Hepatitis C virus infection, without ribavirin
1. Genotype 1, 2, 3, 4, 5 or 6 infection
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
peginterferon alfa (PEG-IFN) and ribavirin (RBV) with or without
an HCV protease inhibitor (boceprevir, simeprevir or telaprevir).
2. Unknown genotype/genotype could not be determined
Authorization of up to 12 weeks total may be granted for
members with unknown or undetermined genotype without
cirrhosis who are treatment-naïve and do not have any of the
following characteristics:
i. HIV or HBsAG positive
ii. Current pregnancy
iii. Known or suspected hepatocellular carcinoma
iv. Prior liver transplantation
Note: Genotype testing is required for members with any of the
characteristics listed.
3. Decompensated cirrhosis (Child Turcotte Pugh [CTP] class
B or C)
Authorization of up to 24 weeks total may be granted for
members with genotype 1, 2, 3, 4, 5 or 6 infection who have
decompensated cirrhosis and documented anemia (baseline
hemoglobin [Hgb] below 10 g/dL) or RBV ineligibility (see Section
IV).
4. 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, 2, 3, 4, 5 or 6 infection post liver
transplantation.
5. 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, 2, 3, 4, 5 or 6 infection and are treatment-
naïve or who have not failed prior treatment with a direct-acting
antiviral.
6. Organ recipient from HCV-viremic donor
Authorization of up to 12 weeks total may be granted for
members who have received a liver or non-liver organ transplant
from an HCV-viremic donor.
B. Hepatitis C virus infection, in combination with ribavirin
1. Genotype 3 infection
Authorization of up to 12 weeks total may be granted for
treatment naïve members with compensated cirrhosis who have
the Y93H substitution associated with velpatasvir resistance.
2. Decompensated cirrhosis (CTP class B or C)
i. Authorization of up to 12 weeks total may be granted for
members with genotype 1, 2, 3, 4, 5 or 6 infection and
decompensated cirrhosis.
ii. Authorization of up to 24 weeks total may be granted for
members with genotype 1, 2, 3, 4, 5 or 6 infection and
decompensated cirrhosis who failed prior treatment with a
sofosbuvir- or NS5A inhibitor-based regimen.
3. Recurrent HCV infection post liver transplantation
i. Authorization of up to 12 weeks total may be granted for
treatment-naïve members with decompensated cirrhosis and
recurrent HCV genotype 1, 2, 3, 4, 5 or 6 infection post liver
transplantation.
ii. Authorization of up to 24 weeks total may be granted for
treatment experienced members with decompensated
cirrhosis and recurrent HCV genotype 1, 2, 3, 4, 5 or 6
infection post liver transplantation.
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.
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:
- Epclusa [package insert]. Foster City, CA: Gilead Sciences, Inc.; June 2021.
- 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
