Subject: Vosevi 2176-A 2683-A SGM P2022
|
VOSEVI
(sofosbuvir/velpatasvir/voxilaprevir)
|
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
Vosevi is indicated for the treatment of adult patients with
chronic hepatitis C virus (HCV) infection without cirrhosis or
with compensated cirrhosis (Child-Pugh A) who have:
A. Genotype 1, 2, 3, 4, 5, or 6 infection and have previously
been treated with an HCV regimen containing an NS5A
inhibitor
B. Genotype 1a or 3 infection and have previously been treated
with an HCV regimen containing sofosbuvir without an NS5A
inhibitor
Additional benefit of Vosevi over sofosbuvir/velpatasvir was
not shown in adults with genotype 1b, 2, 4, 5, or 6 infection
previously treated with sofosbuvir without an NS5A inhibitor.
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 1a, 1b, and 2 infection
i. Authorization of up to 12 weeks total may be
granted for members who failed prior treatment
with a sofosbuvir-containing regimen.
ii. Authorization of up to 12 weeks total may be
granted for members who failed prior treatment
with an HCV NS5A inhibitor-containing regimen
(except glecaprevir/pibrentasvir [Mavyret]).
iii. Authorization of up to 12 weeks total may be
granted for members without cirrhosis who failed
initial treatment with glecaprevir/pibrentasvir
(Mavyret).
2. Genotype 3 infection
i. Authorization of up to 12 weeks total may be
granted for members without cirrhosis who failed
prior treatment with any direct-acting antiviral
regimen (e.g., NS5A- or sofosbuvir-containing
regimen), including glecaprevir/pibrentasvir
[Mavyret]).
ii. Authorization of up to 12 weeks total may be
granted for members with compensated cirrhosis
who are treatment-naïve and have the Y93H
substitution associated with velpatasvir resistance.
3. Genotype 4, 5, or 6 infection
i. Authorization of up to 12 weeks total may be
granted for members who failed prior treatment
with any direct-acting antiviral regimen (e.g.,
NS5A- or sofosbuvir-containing regimen except
glecaprevir/pibrentasvir [Mavyret]).
ii. Authorization of up to 12 weeks total may be
granted for members without cirrhosis who failed
initial treatment with glecaprevir/pibrentasvir
(Mavyret).
4. Recurrent HCV infection post liver transplantation
Authorization of up to 12 weeks total may be granted
for members with recurrent HCV genotype 1, 2, 3, 4, 5
or 6 infection who failed prior treatment with any direct-
acting antiviral regimen (e.g., NS5A- or sofosbuvir-
containing regimen).
5. Kidney transplant recipients
Authorization of up to 12 weeks total may be granted
for members who have genotype 1, 2, 3, 4, 5 or 6
infection and failed prior treatment with any direct-
acting antiviral regimen (e.g., NS5A- or sofosbuvir-
containing regimen).
B. Hepatitis C virus infection, in combination with
ribavirin
1. Genotype 3 infection
Authorization of up to 12 weeks total may be granted for
members with compensated cirrhosis who failed prior
treatment with any direct-acting antiviral regimen (e.g.,
NS5A- or sofosbuvir-containing regimen), including
glecaprevir/pibrentasvir [Mavyret]).
2. Direct-acting antiviral treatment failure
Genotype 1, 2, 3, 4, 5, or 6 infection
i. Authorization of up to 12 weeks total may be
granted for members with compensated cirrhosis
who failed initial treatment with
glecaprevir/pibrentasvir (Mavyret).
ii. Authorization of up to 24 weeks total may be
granted for members with or without compensated
cirrhosis who failed initial treatment with
sofosbuvir/velpatasvir/voxilaprevir (Vosevi).
3. Recurrent HCV infection post liver transplantation
Authorization of up to 12 weeks total may be granted
for members with recurrent HCV genotype 1, 2, 3, 4, 5
or 6 infection who failed prior treatment with any direct-
acting antiviral regimen (e.g., NS5A- or sofosbuvir-
containing regimen).
4. Kidney transplant recipients
Authorization of up to 12 weeks total may be granted
for members who have genotype 1, 2, 3, 4, 5 or 6
infection and failed prior treatment with any direct-
acting antiviral regimen (e.g., NS5A- or sofosbuvir-
containing regimen).
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. This medication will be approved for use in adult members
only.
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:
1. Vosevi [package insert]. Foster City, CA: Gilead Sciences, Inc.;
November 2019.
2. 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
