Subject: Zepatier 2145-A 2684-A SGM P2022
|
ZEPATIER
(elbasvir and grazoprevir)
|
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
Zepatier is indicated for the treatment of chronic hepatitis C
virus (HCV) genotype 1 or 4 infection in adult and pediatric
patients 12 years of age and older or weighing at least 30 kg.
Zepatier is indicated for use with ribavirin in certain patient
populations.
All other indications are considered experimental/investigational
and not medically necessary.
II. EXCLUSIONS
Coverage will not be provided for members with decompensated
cirrhosis/moderate or severe hepatic impairment (Child Turcotte
Pugh Class B or C).
Note: When the requested drug is being used in a combination
therapy regimen, exclusions to the other antiviral drugs also
apply.
III. PRESCRIBER SPECIALTIES
This medication must be prescribed by or in consultation with a
prescriber specializing in infectious disease, gastroenterology,
hepatology, or transplant.
IV. CRITERIA FOR INITIAL APPROVAL
A. Hepatitis C virus infection, in combination with
ribavirin (RBV)
1. Genotype 1a infection
i. Authorization of up to 16 weeks total may be
granted for members with baseline NS5A
resistance-associated substitutions
(RASs)/polymorphisms (see Section VII) who are
either of the following:
a. Treatment-naïve
b. Failed prior treatment with peginterferon alfa
(PEG-IFN) and RBV with or without an HCV
protease inhibitor (boceprevir, simeprevir or
telaprevir)
ii. Authorization of up to 12 weeks total may be
granted for members without baseline NS5A
resistance-associated substitutions
(RASs)/polymorphisms (see Section VII) who have
failed prior treatment with PEG-IFN and RBV with
an HCV protease inhibitor (boceprevir, simeprevir
or telaprevir).
2. Genotype 1b infection
Authorization of up to 12 weeks total may be granted for
members who failed prior treatment with PEG-IFN and
RBV with an HCV protease inhibitor (boceprevir,
simeprevir or telaprevir).
3. Genotype 4 infection
Authorization of up to 16 weeks total may be granted for
members who failed prior treatment with PEG-IFN and
RBV.
B. Hepatitis C virus infection, without RBV
1. Genotype 1a infection
Authorization of up to 12 weeks total may be granted for
members without baseline NS5A resistance-associated
substitutions (RASs)/polymorphisms who are either of
the following:
i. Treatment-naïve
ii. Failed prior treatment with PEG-IFN and RBV
without an HCV protease inhibitor (boceprevir,
simeprevir or telaprevir)
2. Genotype 1b infection
Authorization of up to 12 weeks total may be granted for
members who are either of the following:
i. Treatment-naïve
ii. Failed prior treatment with PEG-IFN and RBV
without an HCV protease inhibitor (boceprevir,
simeprevir or telaprevir)
3. Genotype 4 infection
Authorization of up to 12 weeks total may be granted
for members who are treatment-naïve.
4. Kidney transplant recipients
Authorization of up to 12 weeks total may be granted
for members without baseline NS5A resistance-
associated substitutions (RASs)/polymorphisms (see
Section VII) who have HCV genotype 1 or 4 infection
and are treatment-naïve or who have not failed prior
treatment with a direct-acting antiviral.
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.
V. CONTINUATION OF THERAPY
All members (including new members) requesting authorization
for continuation of therapy must meet all initial authorization
criteria.
VI. OTHER
A. Member must be 12 years of age or older or weigh at least
30 kg.
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
VII. APPENDIX: NS5A RESISTANCE-ASSOCIATED
SUBSTITUTIONS (POLYMORPHISMS)
NS5A resistance-associated substitutions (polymorphisms) at
amino acid positions M28, Q30, L31 or Y93. Examples include
M28A/T, Q30H/R, L31M/V, and Y93C/H/N.
Place of Service:
Outpatient
The above policy is based on the following references:
- Zepatier [package insert]. Whitehouse Station, NJ: Merck & Co., Inc.; May 2022.
- 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
