Subject: Mavyret 2242-A, 2678-A SGM P2022
|
MAVYRET
(glecaprevir and pibrentasvir)
|
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
Mavyret is indicated for the treatment of adult and pediatric
patients 3 years and older with:
A. Chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6
infection without cirrhosis or with compensated cirrhosis
(Child-Pugh A)
B. HCV genotype 1 infection, who previously have been
treated with a regimen containing an HCV NS5A inhibitor or
an NS3/4A protease inhibitor (PI), but not both.
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, without ribavirin
1. Genotype 1 infection
i. Authorization of up to 8 weeks total may be
granted for treatment-naive members without
cirrhosis or with compensated cirrhosis.
ii. Authorization of up to 16 weeks total may be
granted for members without cirrhosis or with
compensated cirrhosis who failed prior treatment
with an NS5A inhibitor (excluding
glecaprevir/pibrentasvir) and who have not
received an NS3/4A protease inhibitor.
iii. Authorization of up to 12 weeks total may be
granted for members without cirrhosis or with
compensated cirrhosis who failed prior treatment
with an NS3/4A protease inhibitor (e.g., simeprevir,
boceprevir or telaprevir in combination with
peginterferon and ribavirin, simeprevir with
sofosbuvir) and who have not received an NS5A
inhibitor.
iv. Authorization of up to 8 weeks total may be
granted for members without cirrhosis who failed
prior treatment with an interferon-based regimen
with or without ribavirin (RBV) and who have not
received an NS3/4A protease inhibitor or NS5A
inhibitor.
v. Authorization of up to 12 weeks total may be
granted for members with compensated cirrhosis
who failed prior treatment with an interferon-based
regimen with or without RBV and who have not
received an NS3/4A protease inhibitor or NS5A
inhibitor.
vi. Authorization of up to 16 weeks total may be
granted for members without cirrhosis or with
compensated cirrhosis who failed prior treatment
with a sofosbuvir-based regimen (e.g., sofosbuvir
and ribavirin with or without interferon,
sofosbuvir/ledipasvir [Harvoni],
sofosbuvir/velpatasvir [Epclusa]) and who have not
had prior exposure to an NS5A inhibitor plus NS3/4A
protease inhibitor regimen (e.g., elbasvir/grazoprevir
[Zepatier]).
2. Genotype 3 infection
i. Authorization of up to 8 weeks total may be
granted for treatment-naive members without
cirrhosis or with compensated cirrhosis.
ii. Authorization of up to 16 weeks total may be
granted for members less than 18 years of age
without cirrhosis or with compensated cirrhosis
who failed prior treatment with an NS5A inhibitor
(excluding glecaprevir/pibrentasvir) and who have
not received an NS3/4A protease inhibitor.
iii. Authorization of up to 12 weeks total may be
granted for members less than 18 years of age
without cirrhosis or with compensated cirrhosis
who failed prior treatment with an NS3/4A
protease inhibitor (e.g., simeprevir, boceprevir or
telaprevir in combination with peginterferon and
ribavirin, simeprevir with sofosbuvir) and who
have not received an NS5A inhibitor.
iv. Authorization of up to 16 weeks total may be
granted for members without cirrhosis or with
compensated cirrhosis who failed prior treatment
with an interferon-based regimen with or without
RBV and who have not received an NS3/4A
protease inhibitor or NS5A inhibitor.
v. Authorization of up to 16 weeks total may be
granted for members without cirrhosis or with
compensated cirrhosis who failed prior treatment
with a sofosbuvir-based regimen (e.g., sofosbuvir
and ribavirin with or without interferon) without
sofosbuvir/NS5A inhibitor experience (e.g.,
sofosbuvir/ledipasvir [Harvoni],
sofosbuvir/velpatasvir [Epclusa]) or prior exposure
to a NS5A inhibitor plus NS3/4A protease inhibitor
regimen (e.g., elbasvir/grazoprevir [Zepatier]).
3. Genotype 4 infection
i. Authorization of up to 8 weeks total may be
granted for treatment-naive members without
cirrhosis or with compensated cirrhosis.
ii. Authorization of up to 12 weeks total may be
granted for treatment naïve members with
compensated cirrhosis and HIV coinfection.
iii. Authorization of up to 16 weeks total may be
granted for members less than 18 years of age
without cirrhosis or with compensated cirrhosis
who failed prior treatment with an NS5A inhibitor
(excluding glecaprevir/pibrentasvir) and who have
not received an NS3/4A protease inhibitor.
iv. Authorization of up to 12 weeks total may be
granted for members less than 18 years of age
without cirrhosis or with compensated cirrhosis
who failed prior treatment with an NS3/4A
protease inhibitor (e.g., simeprevir, boceprevir or
telaprevir in combination with peginterferon and
ribavirin, simeprevir with sofosbuvir) and who
have not received an NS5A inhibitor.
v. Authorization of up to 8 weeks total may be
granted for members without cirrhosis who failed
prior treatment with an interferon-based regimen
with or without RBV and who have not received
an NS3/4A protease inhibitor or NS5A inhibitor.
vi. Authorization of up to 12 weeks total may be
granted for members with compensated cirrhosis
who failed prior treatment with an interferon-
based regimen with or without RBV and who have
not received an NS3/4A protease inhibitor or
NS5A inhibitor.
vii. Authorization of up to 16 weeks total may be
granted for members without cirrhosis or with
compensated cirrhosis who failed prior treatment
with a sofosbuvir-based regimen (e.g., sofosbuvir
and ribavirin with or without interferon,
sofosbuvir/ledipasvir [Harvoni],
sofosbuvir/velpatasvir [Epclusa]) and who have
not had prior exposure to an NS5A inhibitor plus
NS3/4A protease inhibitor regimen (e.g.,
elbasvir/grazoprevir [Zepatier]).
4. Genotype 2, 5, or 6 infection
i. Authorization of up to 8 weeks total may be
granted for treatment-naive members without
cirrhosis or with compensated cirrhosis.
ii. Authorization of up to 16 weeks total may be
granted for members less than 18 years of age
without cirrhosis or with compensated cirrhosis
who failed prior treatment with an NS5A inhibitor
(excluding glecaprevir/pibrentasvir) and who have
not received an NS3/4A protease inhibitor.
iii. Authorization of up to 12 weeks total may be
granted for members less than 18 years of age
without cirrhosis or with compensated
cirrhosis who failed prior treatment with an
NS3/4A protease inhibitor (e.g., simeprevir,
boceprevir or telaprevir in combination with
peginterferon and ribavirin, simeprevir with
sofosbuvir) and who have not received an NS5A
inhibitor.
iv. Authorization of up to 8 weeks total may be
granted for members without cirrhosis who failed
prior treatment with an interferon-based regimen
with or without RBV and who have not received
an NS3/4A protease inhibitor or NS5A inhibitor.
v. Authorization of up to 12 weeks total may be
granted for members with compensated cirrhosis
who failed prior treatment with an interferon-
based regimen with or without RBV and who have
not received an NS3/4A protease inhibitor or NS5A
inhibitor.
vi. Authorization of up to 16 weeks total may be
granted for members without cirrhosis or with
compensated cirrhosis who failed prior treatment
with a sofosbuvir-based regimen (e.g., sofosbuvir
and ribavirin with or without interferon,
sofosbuvir/ledipasvir [Harvoni],
sofosbuvir/velpatasvir [Epclusa]) and who have
not had prior exposure to an NS5A inhibitor plus
NS3/4A protease inhibitor regimen (e.g.,
elbasvir/grazoprevir [Zepatier]).
5. Unknown genotype/genotype could not be
determined
Authorization of up to 8 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.
6. Recurrent HCV infection post liver
transplantation
i. 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.
ii. Authorization of up to 16 weeks total may be
granted for members with recurrent HCV
genotype 1 infection post liver transplantation
without cirrhosis or with compensated cirrhosis
who failed prior treatment with an NS5A inhibitor
(excluding glecaprevir/pibrentasvir) and who
have not received an NS3/4A protease inhibitor.
iii. Authorization of up to 16 weeks total may be
granted for members with recurrent HCV
genotype 3 infection post liver transplantation
without cirrhosis or with compensated cirrhosis
who failed prior treatment with PEG-IFN and RBV
and who have not received an NS3/4A protease
inhibitor or NS5A inhibitor.
iv. Authorization of up to 16 weeks total may be
granted for members with recurrent HCV
genotype 3 infection post liver transplantation
without cirrhosis or with compensated cirrhosis
who failed prior treatment with sofosbuvir
(Sovaldi) and RBV with or without PEG-IFN and
who have not received an NS3/4A protease
inhibitor or NS5A inhibitor.
7. Kidney transplant recipients
i. 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.
ii. Authorization of up to 16 weeks total may be
granted for members with HCV genotype 1
infection without cirrhosis or with compensated
cirrhosis who failed prior treatment with an
NS5A inhibitor (excluding
glecaprevir/pibrentasvir) and who have not
received an NS3/4A protease inhibitor.
iii. Authorization of up to 16 weeks total may be
granted for members with HCV genotype 3
infection without cirrhosis or with compensated
cirrhosis who failed prior treatment with PEG-
IFN and RBV and who have not received an
NS3/4A protease inhibitor or NS5A inhibitor.
iv. Authorization of up to 16 weeks total may be
granted for members with HCV genotype 3
infection without cirrhosis or with compensated
cirrhosis who failed prior treatment with
sofosbuvir (Sovaldi) and RBV with or without
PEG-IFN and who have not received an NS3/4A
protease inhibitor or NS5A inhibitor.
8. Organ recipient from HCV-viremic donor
i. Authorization of up to 12 weeks total may be
granted for members who have received a liver
transplant from an HCV-viremic donor.
ii. Authorization of up to 8 weeks total may be
granted for members who have received a non-
liver organ transplant from an HCV-viremic
donor when treatment is initiated in the first
week after transplant.
iii. Authorization of up to 12 weeks total may be
granted for members who have received a non-
liver organ transplant from an HCV-viremic
donor when treatment is initiated more than
one week after transplant.
B. Hepatitis C virus infection, in combination with
Sovaldi and ribavirin Genotype 1, 2, 3, 4, 5, or 6
infection
1. Authorization of up to 16 weeks total may be granted for
members without cirrhosis or with compensated cirrhosis
who failed prior treatment with glecaprevir/pibrentasvir
(Mavyret). An additional 8 weeks may be granted
following failure with sofosbuvir (Sovaldi) and Mavyret.
2. Authorization of up to 16 weeks total may be granted for
members without cirrhosis or with compensated cirrhosis
who failed prior treatment with
sofosbuvir/velpatasvir/voxilaprevir (Vosevi).
Authorization of up to 24 weeks may be granted for
members with extremely difficult cases (e.g., genotype 3
with cirrhosis).
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 Sections 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 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
Place of Service:
Outpatient
The above policy is based on the following references:
- Mavyret [package insert]. North Chicago, IL: AbbVie Inc.; September 2021.
- 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
