Subject: gefitinib-Iressa 1660-A SGM P2023a

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^® © 2023 National Comprehensive Cancer Network, Inc. Available at: https://www.nccn.org. Accessed March 4, 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.

June 11, 2023