Subject: Balversa 2965-A SGM P2022

Drug

BALVERSA

erdafitinib  (erdafitinib)

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
                 Balversa is indicated for the treatment of adult patients
                 with locally advanced or metastatic urothelial carcinoma
                 (mUC) that has:
                 1.  susceptible FGFR3 or FGFR2 genetic alterations, and
                 2.  progressed during or following at least one line of prior
                      platinum-containing chemotherapy, including within 12
                      months of neoadjuvant or adjuvant platinum-containing
                      chemotherapy.

            B.  Compendial Use
                 Urothelial Carcinoma
                 1.  Bladder cancer
                 2.  Primary carcinoma of the urethra
                 3.  Upper genitourinary (GU) tract tumors
                 4.  Urothelial carcinoma of the prostate

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

 
     II.  DOCUMENTATION

           Submission of the following information is necessary to initiate
           the prior authorization review: Fibroblast growth factor receptor
           3 (FGFR3) or Fibroblast growth factor receptor 2 (FGFR2)
           mutation status

 
    III.  CRITERIA FOR INITIAL APPROVAL

            A.  Urothelial carcinoma – Bladder cancer
                 Authorization of 12 months may be granted for treatment
                 of bladder cancer with FGFR3 or FGFR2 genetic alterations
                 as a single agent when used as subsequent therapy for any
                 of the following:
                 1.  Stage II disease if tumor is present following
                      reassessment of tumor status 2-3 months after primary
                      treatment with concurrent chemoradiotherapy,
                      radiotherapy alone or transurethral resection of bladder
                      tumor (TURBT)
                 2.  Locally advanced or metastatic disease
                 3.  Metastatic or local recurrence post-cystectomy
                 4.  Muscle invasive local recurrence or persistent disease in
                      a preserved bladder

            B.  Urothelial Carcinoma – Primary Carcinoma of the
                  Urethra
                 Authorization of 12 months may be granted for the
                 treatment of primary carcinoma of the urethra with FGFR3
                 or FGFR2 genetic alterations as a single agent when used
                 as subsequent therapy for locally advanced, recurrent or
                 metastatic disease.

            C.  Urothelial Carcinoma – Upper Genitourinary (GU)
                  Tract Tumors
                 Authorization of 12 months may be granted for the
                 treatment of upper genitourinary (GU) tract tumors with
                 FGFR3 or FGFR2 genetic alterations as a single agent when
                 used as subsequent therapy for locally advanced or
                 metastatic disease.

            D.  Urothelial Carcinoma – Urothelial Carcinoma of the
                  Prostate
                 Authorization of 12 months may be granted for the
                 treatment of urothelial carcinoma of the prostate with
                 FGFR3 or FGFR2 genetic alterations as a single agent when
                 used as subsequent therapy for locally advanced or
                 metastatic disease.

 
     IV.  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 or disease progression while on the
            current regimen.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Balversa [package insert]. Horsham, PA: Janssen Products, LP; April 2022.
2. The NCCN Drugs & Biologics Compendium® © 2022 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed July 6, 2022.

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 29, 2022