Subject: Epclusa 2137-A, 2676-A SGM P2022
|
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. 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, 2, 3, 4, 5 or 6 infection
i. 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).
ii. Authorization of up to 12 weeks may be granted
for members less than 18 years of age without
cirrhosis or with compensated cirrhosis who failed
prior treatment with an interferon-based regimen
with or without ribavirin and who have not
received an NS3/4A protease inhibitor or NS5A
inhibitor.
iii. Authorization of up to 12 weeks may be granted
for members less than 18 years of age without
cirrhosis or with compensated cirrhosis who failed
prior treatment with a sofosbuvir-based regimen
and who have not received an NS3/4A protease
inhibitor or NS5A inhibitor.
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 in those on a tenofovir disoproxil fumarate
(TDF)-containing regimen with an eGFR less than
60 ml/min
ii. HBsAG positive
iii. Current pregnancy
iv. Known or suspected hepatocellular carcinoma
v. 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 VI).
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.
IV. CONTINUATION OF THERAPY
All members (including new members) requesting
authorization for continuation of therapy must meet all initial
authorization criteria.
V. OTHER
A. 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
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.; April 2022.
- AASLD/IDSA/IAS–USA. Recommendations for testing, managing, and treating hepatitis C. https://www.hcvguidelines.org. Last changes made October 24, 2022. Accessed December 1, 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
