This document summarizes coverage criteria and guidelines for various alpha interferon products used to treat conditions such as chronic hepatitis B, chronic hepatitis C, melanoma, and myeloproliferative neoplasms. It provides details on covered medications, their uses, prior authorization rationale and criteria, benefit design, and coverage duration and renewal. References include clinical practice guidelines and studies supporting the use of pegylated interferons for hepatitis C and interferon for other conditions.
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Alpha Interferon Products for Hepatitis and Cancer Treatment
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Alpha Interferon Products
To Initiate a Coverage Review, Call 1-800-753-2851
Covered Medications
Interferon alfacon-1 (Infergen )
Interferon alpha-2b (Intron-A )
Peginterferon alfa-2b (Sylatron )
Interferon alpha-n3 (Alferon N )
What they do and how they are used
Interferons are a family of proteins that may enhance or suppress the immune system. They have complex
antiviral, antineoplastic (anti-cancer), and immunomodulating activities. Interferons are often referred to as
biologic response modifiers. They are used in the treatment of various neoplasms and viral infections.
Interferon alfacon-1 (Infergen) is comprised of the most frequently repeating amino acid pairs occurring in
the natural alpha interferon subtypes and is used to treat chronic hepatitis B and chronic hepatitis C.
Evidence and clinical practice guidelines support the use of pegylated interferons over non-pegylated
interferons in treatment of chronic hepatitis C, with higher adherence and sustained virologic response
(SVR) rates.
Peginterferon alfa-2b has been specifically formulated in single use, self-administered injections as
Sylatron for the weekly treatment of advanced melanoma to be given for up to five years.
Chronic hepatitis C (CHC) is caused by a RNA virus that infects the liver. CHC infection can lead to
cirrhosis, liver failure, and liver cancer. Treatment of hepatitis C virus (HCV) is aimed at reducing the
progression of the disease to cirrhosis and decreasing the risk of liver cancer by achieving a decrease in
the hepatitis C viral level.
All treatment-naïve patients with compensated chronic liver disease related to HCV who are willing to be
treated and have no contraindication to peginterferon alfa or ribavirin should be considered for therapy.
Rationale for prior authorization
To provide coverage for alpha interferon products for the treatment of conditions for which they have shown to
be effective and to help prevent their use for conditions for which the effectiveness is not known. The coverage
review process is also intended to limit exposure to excessive duration of coverage outside that which is
referenced in widely accepted clinical treatment guidelines.
Benefit design
Coverage is determined through prior authorization for every claim.
Coverage authorization criteria
Coverage for Interferon alfa-2b (Intron-A ) is provided for treatment of the following:
Chronic hepatitis B
Hairy cell leukemia
Kaposi’s sarcoma (in the presence of CD4 T-cell count ≥ 200 cells/mm
3
or asymptomatic patients with no
history of serious opportunistic infection)
Malignant melanoma
Multiple myeloma
Non-Hodgkin’s lymphoma
Renal cell carcinoma
Condyloma acuminata (genital warts) in situations where conventional therapy has not been effective
Myeloproliferative neoplasms (chronic myeloid leukemia, essential thrombocytosis, myelofibrosis, and
polycythemia vera)
Folicular lymphoma
Chronic hepatitis C
Acute hepatitis C (if it has been at least 8 weeks since onset)
Bone cancer, giant cell tumor of the bone
Central nervous system (CNS) Cancers (i.e., leptomenigeal metastases and meningioma)
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Chronic myeloid leukemia (CML) in patients unable to tolerate tyrosine kinase inhibitors (TKIs) or for use
in post-transplant patients
Carcinoid Tumors
Soft tissue sarcoma – desmoids tumors (aggressive fibromatosis)
Neoplasm of conjunctiva or neoplasm of cornea
Coverage for Interferon alfacon-1 (Infergen ) is provided for treatment of the following:
Chronic hepatitis B
Chronic hepatitis C
Coverage for Peginterferon alfa-2b (Sylatron ) is provided for the following:
Stage III, resected melanoma
Stage IIB or C melanoma
Bone cancer, giant cell tumor of the bone
Coverage for Interferon alpha-n3 (Alferon N ) is provided for the following::
Condyloma acuminata (genital warts) in situations where conventional therapy has not been effective
Chronic hepatitis C
Coverage duration:
Coverage for Intron A is provided for 12 months.
Coverage for Infergen is provided for 12 months.
Coverage for Sylatron is provided for 12 months. Coverage may be renewed.
Coverage for Alferon N is provided for 12 months.
References
Product Information
Boceprevir (Victrelis™) Prescribing Information. Whitehouse Station, NJ: Merck and Co., May 2011.
Interferon alfa-n3 (Alferon N). Prescribing information. Hemispherx Biopharma. Accessed 24 June 2011. Available
from URL: http://www.hemispherx.net/content/products/alferon_insert.htm#TOP
Interferon alpha – 2b (Intron A) Whitehouse Station, NJ: Schering, 2008.
Interferon alfacon-1 (Infergen ). Prescribing information. Warrendale, PA: Three Rivers, LLC, June, 2010.
Peginterferon alfa-2b (Sylatron ). Prescribing information. Kenilworth, NJ: Schering, March, 2011.
Telaprevir (Incivek™) Prescribing Information Cambridge, MA: Vertex Pharmaceuticals, Inc., May 2011.
Chronic Hepatitis B
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Chronic Hepatitis C
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Chronic Myelogenous Leukemia
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Myeloproliferative Neoplasms
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Renal Cell Carcinoma
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