Subject: Vosevi 2176-A, 2683-A SGM P2021
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VOSEVI
(sofosbuvir/velpatasvir/voxilaprevir)
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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. 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 (eg, 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 (eg, 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 (eg, 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 (eg, 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 (eg, 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
(eg, 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 (eg, 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.
IV. CONTINUATION OF THERAPY
All members (including new members) requesting authorization for continuation of therapy must meet all initial authorization criteria.
Place of Service:
Outpatient
The above policy is based on the following references:
- Vosevi [package insert]. Foster City, CA: Gilead Sciences, Inc.; November 2019.
- 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.
January 20, 2022
