Subject: Iressa 1660-A SGM P2021
Policy:
- 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 Indication
Iressa is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.
Limitation of Use: Safety and efficacy of Iressa have not been established in patients who have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations.
B. Compendial Use
1. EGFR mutation-positive recurrent, advanced, or metastatic NSCLC
2. Brain metastases from sensitizing EGFR mutation-positive NSCLC
All other indications are considered experimental/investigational and not medically necessary.
-
REQUIRED DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review: EGFR mutation testing results.
- CRITERIA FOR INITIAL APPROVAL
Non-small cell lung cancer (NSCLC)
Authorization of 12 months may be granted for treatment of recurrent, advanced, or metastatic NSCLC (including brain metastases from NSCLC) in members with sensitizing EGFR mutation-positive disease as a single agent.
- CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in Section III when there is no evidence of unacceptable toxicity.
Place of Service:
Outpatient
The above policy is based on the following references:
- Iressa [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; May 2019.
- The NCCN Drugs & Biologics Compendium® © 2021 National Comprehensive Cancer Network, Inc. Available at: https://www.nccn.org. Accessed March 1, 2021.
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.
July 30, 2021
