Subject: gefitinib-Iressa 1660-A SGM P2024

Drug

IRESSA  (gefitinib)

gefitinib

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 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
               EGFR mutation-positive recurrent, advanced, or metastatic NSCLC

          All other indications are considered experimental/investigational and not medically necessary.


    II.  REQUIRED DOCUMENTATION

          Submission of the following information is necessary to initiate the prior authorization review:
          EGFR mutation testing results.


   III.  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 in members with sensitizing EGFR mutation-positive disease as a single agent.


   IV.  CONTINUATION OF THERAPY

          Authorization of 12 months may be granted for continued treatment in members requesting
          reauthorization for EGFR positive NSCLC when either of the following criteria are met:
          1.  There is no evidence of unacceptable toxicity or disease progression while on the current
               regimen.
          2.  Disease is T790M negative and there is no evidence of unacceptable toxicity.

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Iressa [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; February 2023.
2. Gefitinib [package insert]. Orlando, FL: Ingenus Pharmaceuticals, LLC; April 2023.
3. The NCCN Drugs & Biologics Compendium^® © 2024 National Comprehensive Cancer Network, Inc. Available at: https://www.nccn.org. Accessed March 4, 2024. 

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 18, 2024