Subject: Fruzaqla 6246-A SGM P2023a

Drug

FRUZAQLA  (fruquintinib)

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
               Fruzaqla is indicated for the treatment of adult patients with
               metastatic colorectal cancer (mCRC) who have been
               previously treated with fluoropyrimidine-, oxaliplatin-, and
               irinotecan-based chemotherapy, an anti-vascular endothelial
               growth factor (VEGF) therapy, and, if RAS wild-type and
               medically appropriate, an anti-epidermal growth factor
               receptor (EGFR) therapy.

          B.  Compendial Uses
               1.  Advanced or metastatic colon cancer
               2.  Advanced or metastatic rectal cancer

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


  III.  CRITERIA FOR INITIAL APPROVAL

          Colorectal Cancer (CRC)
          Authorization of 12 months may be granted for treatment of
          advanced or metastatic colorectal cancer, including appendiceal
          adenocarcinoma and anal adenocarcinoma, when the member
          has been previously treated with all the following regimens
          unless the member has a contraindication or intolerance:
               1.  Fluoropyrimidine-, oxaliplatin- and irinotecan-based
                    chemotherapy (with or without bevacizumab); and
               2.  If RAS wild type and medically appropriate, an anti-
                    epidermal growth factor receptor (EGFR) therapy


  III.  CONTINUATION OF THERAPY

          Authorization of 12 months may be granted for continued
          treatment in members requesting reauthorization for an
          indication listed in Section II 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:

1. Fruzaqla [package insert]. Lexington, MA: Takeda Pharmaceuticals America, Inc.; November 2023.
2. The NCCN Drugs & Biologics Compendium™ © 2023 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed November 24, 2023.
3. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Anal Carcinoma. Version 3.2023. Accessed November 24, 2023. https://www.nccn.org/professionals/physician_gls/pdf/anal.pdf
4. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Colon Cancer. Version 4.2023. Accessed November 24, 2023. https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf

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.

December 31, 2023