Subject: Pegasys 2139-A SGM P2022
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PEGASYS
(peginterferon alfa-2a)
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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.
A. FDA-Approved Indications
1. Chronic Hepatitis C
Pegasys, as part of a combination regimen with other hepatitis C virus (HCV) antiviral drugs,
is indicated for the treatment of adults with chronic hepatitis C (CHC) with compensated liver disease.
Pegasys in combination with ribavirin is indicated for treatment of pediatric patients 5 years of age
and older with CHC and compensated liver disease. Pegasys monotherapy is only indicated for the
treatment of patients with CHC with compensated liver disease if there are contraindications or
significant intolerance to other HCV antiviral drugs.
2. Chronic Hepatitis B
Pegasys is indicated for the treatment of adult patients with HBeAg-positive and HBeAg-negative
chronic hepatitis B infection who have compensated liver disease and evidence of viral replication
and liver inflammation. Pegasys is indicated for the treatment of HBeAG-positive CHB in non-cirrhotic
pediatric patients 3 years of age and older with evidence of viral replication and elevations in serum
alanine aminotransferase (ALT).
B. Compendial Uses
1. Myeloproliferative neoplasm (essential thrombocythemia, polycythemia vera, symptomatic
lower-risk myelofibrosis)
2. Systemic mastocytosis
3. Adult T-Cell Leukemia/Lymphoma
4. Mycosis Fungoides/Sezary Syndrome
5. Primary Cutaneous CD30+ T-Cell Lymphoproliferative Disorders
6. Hairy cell leukemia
7. Erdheim-Chester disease
8. Chronic Myeloid Leukemia
All other indications are considered experimental/investigational and not medically necessary.
II. INITIAL CRITERIA FOR APPROVAL
A. Chronic hepatitis C virus (HCV) infection
Refer to the SGM of requested regimen for the specific criteria for approval and approval durations.
B. Chronic hepatitis B virus (HBV) infection (including HDV coinfection)
Authorization of up to 48 weeks total may be granted for the treatment of chronic HBV infection,
including HDV coinfection.
C. Myeloproliferative neoplasm
Authorization of 12 months may be granted for the treatment of myeloproliferative neoplasm
(essential thrombocythemia, polycythemia vera, symptomatic lower-risk myelofibrosis).
D. Systemic mastocytosis
Authorization of 12 months may be granted for the treatment of systemic mastocytosis.
E. Adult T-Cell Leukemia/Lymphoma
Authorization of 12 months may be granted for the treatment of adult T-cell leukemia/lymphoma.
F. Mycosis Fungoides/Sezary Syndrome
Authorization of 12 months may be granted for the treatment of Mycosis Fungoides/Sezary syndrome.
G. Primary Cutaneous CD30+ T-cell Lymphoproliferative Disorders
Authorization of 12 months may be granted for the treatment of primary cutaneous CD30+ T-cell
lymphoproliferative disorders.
H. Hairy cell leukemia
Authorization of 12 months may be granted for the treatment of hairy cell leukemia.
I. Erdheim-Chester disease
Authorization of 12 months may be granted for the treatment of Erdheim-Chester disease.
J. Chronic Myeloid Leukemia
Authorization of 12 months may be granted for the treatment of chronic myeloid leukemia in pregnancy.
III. CONTINUATION OF THERAPY
A. Myeloproliferative neoplasm
Authorization of 12 months may be granted if the patient is experiencing benefit from therapy as
evidenced by improvement in symptoms and/or disease markers (e.g., morphological response,
reduction or stabilization in spleen size, improvement of thrombocytosis/leukocytosis, etc.)
B. Systemic mastocytosis
Authorization of 12 months may be granted if the patient is experiencing benefit from therapy as
evidenced by improvement in symptoms and/or disease markers (e.g., reduction in serum and urine
metabolites of mast cell activation, improvement in cutaneous lesions, skeletal disease, bone marrow
mast cell burden, etc.)
C. All other indications
Authorization of 12 months may be granted for continued treatment in patients requesting
reauthorization for all other indications in Section II, not previously listed, when there is no evidence
of unacceptable toxicity or disease progression while on the current regimen.
Place of Service:
Outpatient
The above policy is based on the following references:
- Pegasys [package insert]. South San Francisco, CA: Genentech, Inc; March 2021.
- The NCCN Drugs & Biologics Compendium® © 2021 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed March 7, 2022.
- Olysio [package insert]. Titusville, NJ: Janssen Products, LP; November 2017.
- Sovaldi [package insert]. Foster City, CA: Gilead Sciences, Inc.; March 2020.
- AASLD/IDSA/IAS–USA. Recommendations for testing, managing, and treating hepatitis C. http://www.hcvguidelines.org. Last changes made October 5, 2021. Accessed March 7, 2022.
- Terrault NA, Bzowej NH, Chang KM, et al. AASLD guidelines for treatment of chronic hepatitis B. Hepatology. 2016;63(1):261-283.
- National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology™ Myeloproliferative Neoplasms (Version 1.2022). http://www.nccn.org. Accessed March 7, 2022.
- National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology™ Systemic Mastocytosis (Version 3.2021). http://www.nccn.org. Accessed March 7, 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.
August 14, 2022
