Subject: Pegasys 2139-A SGM P2023
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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 CPegasys, 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) and 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 and 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 (CHB) 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
hepatitis D virus [HDV] coinfection)
Authorization of up to 48 weeks total may be granted for
treatment of chronic HBV infection, including HDV
coinfection.
C. Myeloproliferative neoplasm
Authorization of 12 months may be granted for treatment of
myeloproliferative neoplasm (essential thrombocythemia,
polycythemia vera, symptomatic lower-risk myelofibrosis).
D. Systemic mastocytosis
Authorization of 12 months may be granted for treatment of
systemic mastocytosis.
E. Adult T-cell leukemia/lymphoma
Authorization of 12 months may be granted for treatment of
adult T-cell leukemia/lymphoma.
F. Mycosis fungoides/Sezary syndrome
Authorization of 12 months may be granted for 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 treatment
of hairy cell leukemia.
I. Erdheim-Chester disease
Authorization of 12 months may be granted for treatment
of Erdheim-Chester disease.
J. Chronic myeloid leukemia
Authorization of 12 months may be granted for treatment of
chronic myeloid leukemia in pregnancy.
III. CONTINUATION OF THERAPY
A. Chronic HCV infection and chronic HBV infection
(including HDV coinfection)
All members (including new members) requesting
authorization for continuation of therapy must meet all initial
authorization criteria.
B. Myeloproliferative neoplasm
Authorization of 12 months may be granted if the member 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.).
C. Systemic mastocytosis
Authorization of 12 months may be granted if the member 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.).
D. All other indications
Authorization of 12 months may be granted for continued
treatment in members 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® © 2023 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed March 6, 2023.
- Sovaldi [package insert]. Foster City, CA: Gilead Sciences, Inc.; March 2020.
- AASLD/IDSA. HCV guidance: Recommendations for testing, managing, and treating hepatitis C. http://www.hcvguidelines.org. Last changes made October 24, 2022. Accessed March 3, 2023.
- 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 3.2022). http://www.nccn.org. Accessed March 8, 2023.
- National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology™ Systemic Mastocytosis (Version 2.2022). http://www.nccn.org. Accessed March 8, 2023.
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 13, 2023
