Subject: Ribavirin 2140-A SGM P2021
| RIBAVIRIN PRODUCTS |
|
COPEGUS
(ribavirin capsules and tablets)
|
|
MODERIBA
(ribavirin capsules and tablets)
|
|
REBETOL
(ribavirin capsules and tablets)
|
|
RIBASPHERE
(ribavirin capsules and tablets)
|
|
RIBASPHERE RIBAPAK
(ribavirin capsules and tablets)
|
|
RIBATAB
(ribavirin capsules and tablets)
|
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
Copegus
Copegus is indicated for the treatment of chronic hepatitis C (CHC) virus infection in
combination with Pegasys in patients 5 years of age and older with compensated liver
disease not previously treated with interferon alpha, and in adult CHC patients coinfected
with HIV.
Moderiba
Moderiba is indicated for the treatment of chronic hepatitis C (CHC) virus infection in
combination with peginterferon alfa-2a in patients 5 years of age and older with compensated
liver disease not previously treated with interferon alpha, and in adult CHC patients
coinfected with HIV.
Rebetol
Rebetol is indicated in combination with interferon alfa-2b (pegylated and nonpegylated) for
the treatment of chronic hepatitis C (CHC) in patients 3 years of age and older with
compensated liver disease.
Ribasphere/RibaPak
Ribasphere is indicated for the treatment of chronic hepatitis C (CHC) virus infection in
combination with peginterferon alfa-2a in patients 5 years of age and older with compensated
liver disease not previously treated with interferon alpha, and in adult CHC patients
coinfected with HIV.
All other indications are considered experimental/investigational and are not medically
necessary.
II. EXCLUSIONS
Exclusions to other antiviral drugs being used in combination with the requested drug apply.
Refer to the SGM policy for each drug in the treatment regimen for applicable exclusions.
III. CRITERIA FOR APPROVAL
Hepatitis C virus (HCV) infection
Refer to the SGM of requested regimen for the specific criteria for approval and approval
durations.
Place of Service:
Outpatient
The above policy is based on the following references:
- Copegus [package insert]. South San Francisco, CA: Genentech USA, Inc.; August 2015.
- Moderiba [package insert]. North Chicago, IL: AbbVie Inc.; December 2017.
- Rebetol [package insert]. Whitehouse Station, NJ: Merck & Co., Inc.; January 2020.
- Ribasphere/Ribapak [package insert]. Warrendale, PA: Kadmon Pharmaceuticals, LLC; September 2017.
- AASLD/IDSA/IAS–USA. Recommendations for testing, managing, and treating hepatitis C. https://www.hcvguidelines.org. Last changes made on September 29, 2021. Accessed October 15, 2021.
- Sovaldi [package insert]. Foster City, CA: Gilead Sciences, Inc.; March 2020.
- Viekira Pak [package insert]. North Chicago, IL: AbbVie Inc.; December 2019.
- Zepatier [package insert]. Whitehouse Station, NJ: Merck & Co., Inc.; December 2019.
- Epclusa [package insert]. Foster City, CA: Gilead Sciences, Inc.; June 2021.
- Vosevi [package insert]. Foster City, CA: Gilead Sciences, Inc.; November 2019.
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 25, 2022
