Subject: Intron A 1703-A SGM P2022
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INTRON A
(interferon alfa-2b)
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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. Malignant melanoma
2. Condylomata acuminata
3. Hairy cell leukemia
4. AIDS-related Kaposi sarcoma
5. Chronic hepatitis B virus infection
6. Chronic hepatitis C virus infection
7. Follicular non-Hodgkin’s lymphoma
B. Compendial Uses
1. Adult T-cell leukemia/lymphoma (ATLL)
2. Mycosis fungoides (MF)/Sezary syndrome (SS)
3. Renal cell carcinoma
4. Chronic myeloid leukemia (CML)
5. Giant cell tumor of the bone
6. Ocular surface neoplasia (conjunctival and corneal neoplasm)
All other indications are considered experimental/investigational and not medically necessary.
II. CRITERIA FOR INITIAL APPROVAL
A. Malignant melanoma
Authorization of 12 months may be granted for treatment of malignant melanoma.
B. Adult T-cell leukemia/lymphoma (ATLL)
Authorization of 12 months may be granted for treatment of adult T-cell leukemia/lymphoma (ATLL) when the requested medication is
used in combination with zidovudine.
C. Mycosis fungoides (MF)/Sezary syndrome (SS)
Authorization of 12 months may be granted for treatment of mycosis fungoides (MF)/Sezary syndrome (SS).
D. Hairy cell leukemia
Authorization of 12 months may be granted for treatment of hairy cell leukemia.
E. Follicular lymphoma
Authorization of 12 months may be granted for treatment of follicular lymphoma (clinically aggressive).
F. Renal cell carcinoma
Authorization of 12 months may be granted for treatment of renal cell carcinoma when the requested medication will be used in
combination with bevacizumab.
G. Condylomata acuminata
Authorization of 12 months may be granted for treatment of condylomata acuminata.
H. AIDS-related Kaposi sarcoma
Authorization of 12 months may be granted for treatment of AIDS-related Kaposi sarcoma
I. Chronic myeloid leukemia (CML)
Authorization of 6 months may be granted for treatment of CML.
J. Giant cell tumor of the bone
Authorization of 12 months may be granted for treatment of giant cell tumor of the bone.
K. Chronic hepatitis C virus infection
Authorization of 16 weeks may be granted for treatment of chronic hepatitis C virus infection.
L. Chronic hepatitis B (including hepatitis D virus co-infection) virus infection
Authorization of 16 weeks may be granted for treatment of chronic hepatitis B (including hepatitis D virus co-infection) virus infection.
M. Ocular surface neoplasia (conjunctival and corneal neoplasm)
Authorization of 12 months may be granted for treatment of ocular surface neoplasia (conjunctival and corneal neoplasm).
III. CONTINUATION OF THERAPY
A. Chronic Hepatitis C
Authorization of 52 weeks, up to a total of 96 weeks, may be granted for continued treatment of chronic hepatitis C when the member is
receiving clinical benefit and there is no evidence of unacceptable toxicity while on the current regimen.
B. Chronic Hepatitis B
Authorization of up to a total of 24 weeks may be granted for continued of chronic hepatitis B when the member is receiving clinical benefit
and there is no evidence of unacceptable toxicity while on the current regimen.
C. All Other Indications
Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in Section II,
other than chronic hepatitis C and chronic hepatitis B, 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:
- Intron A [package insert]. Whitehouse Station, NJ: Merck Sharp & Dohme Corp.; November 2021.
- The NCCN Drugs & Biologics Compendium® © 2022 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed April 5, 2022.
- Micromedex Solutions [database online]. Truven Health Analytics, Greenwood Village, Colorado, USA. Available at: http://www.micromedexsolutions.com/. Accessed April 5, 2022.
- Lexicomp Online®, AHFS® Drug Information, Hudson, Ohio: Wolters Kluwer Clinical Drug Information, Inc.; http://online.lexi.com [available with subscription]. Accessed April 5, 2022.
- Shah SU, Kaliki S, Kim HJ, Lally SE, Shields JA, Shields CL. Topical Interferon Alfa-2b for Management of Ocular Surface Squamous Neoplasia in 23 Cases: Outcomes Based on American Joint Committee on Cancer Classification. Arch Ophthalmol. 2012;130(2):159–164.
- Avastin [package insert]. South San Francisco, CA: Genentech, Inc.; January 2021.
- American Academy of Ophthalmology (AAO). Ocular surface squamous neoplasia. EyeWiki. San Francisco, CA: AAO; last modified on November 8, 2017
- Karp CL, Galor A, Chhabra S, Barnes SD, Alfonso EC. Subconjunctival/perilesional recombinant interferon alpha2b for ocular surface squamous neoplasia: a 10-year review. Ophthalmology. 2010;117(12):2241–6.
- Shields CL, Kaliki S, Kim HJ, Al-Dahmash S, Shah SU, Lally SE, et al. Interferon for ocular surface squamous neoplasia in 81 cases: outcomes based on the American Joint Committee on Cancer classification. Cornea. 2013;32(3):248–56.
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.
October 22, 2022
