Subject: Talzenna 2782-A SGM P2023a
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
1. Breast Cancer
Talzenna is indicated as a single agent for the treatment
of adult patients with deleterious or suspected deleterious
germline breast cancer susceptibility gene (BRCA)-
mutated (gBRCAm) human epidermal growth factor
receptor 2 (HER2)-negative locally advanced or
metastatic breast cancer. Select patients for therapy
based on an FDA-approved companion diagnostic for
Talzenna.
2. Prostate Cancer
Talzenna is indicated in combination with enzalutamide
for the treatment of adult patients with homologous
recombination repair (HRR) gene-mutated metastatic
castration-resistant prostate cancer (mCRPC).
B. Compendial Uses
1. Human epidermal growth factor receptor 2 (HER2)-
negative, BRCA 1/2-germline mutated breast cancer
2. HER2-positive BRCA 1/2-germline mutated breast cancer
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: BRCA mutation or HRR gene
testing results.
III. CRITERIA FOR INITIAL APPROVAL
1. Breast Cancer
Authorization of 12 months may be granted for treatment of
breast cancer with no response to preoperative systemic
therapy, or for locally advanced, recurrent, or metastatic
breast cancer as a single agent in members with deleterious
or suspected deleterious germline BRCA mutations.
2. Metastatic Castration-Resistant Prostate Cancer
Authorization of 12 months may be granted for treatment of
metastatic castration-resistant prostate cancer when all of
the following criteria are met:
i. The member has homologous recombination repair
(HRR)-gene mutation which includes ATM, ATR, BRCA1, BRCA2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN,
PALB2, or RAD51C
ii. The requested medication will be used in combination
with enzalutatmide (Xtandi)
iii. The member has had a bilateral orchiectomy or will be
using the requested medication in combination with a
gonadotropin-releasing hormone (GnRH) analog.
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:
- Talzenna [package insert]. New York, NY: Pfizer Inc.; June 2023.
- The NCCN Drugs & Biologics Compendium 2022 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed December 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.
July 29, 2023
