Subject: Balversa 2965-A SGM P2023
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 bladder preserving
chemoradiotherapy, and maximal 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:
- Balversa [package insert]. Horsham, PA: Janssen Products, LP; January 2023.
- The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed August 1, 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.
January 06, 2024
