Subject: fulvestrant-Faslodex 2903-A SGM P2022
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FASLODEX
(fulvestrant)
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fulvestrant
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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
Faslodex is indicated for the treatment of:
1. Hormone receptor (HR)-positive, human epidermal
growth factor receptor 2 (HER2)-negative advanced
breast cancer in postmenopausal women not previously
treated with endocrine therapy.
2. HR-positive advanced breast cancer in postmenopausal
women with disease progression following endocrine
therapy.
3. HR-positive, HER2-negative advanced or metastatic
breast cancer in postmenopausal women in combination
with ribociclib, as initial endocrine based therapy or
following disease progression on endocrine therapy.
4. HR-positive, HER2-negative advanced or metastatic
breast cancer in combination with palbociclib or
abemaciclib in women with disease progression after
endocrine therapy
B. Compendial Uses
1. Breast cancer
2. Low grade serous ovarian carcinoma
3. Endometrial carcinoma
4. Uterine sarcoma
All other indications are considered experimental/investigational
and not medically necessary.
II. DOCUMENTATION
Submission of hormone receptor (HR) status is necessary to
initiate the prior authorization review, where applicable.
III. CRITERIA FOR INITIAL APPROVAL
A. Breast Cancer
Authorization of 12 months may be granted for treatment
recurrent, advanced, or metastatic HR-positive breast
cancer.
B. Low Grade Serous Ovarian Carcinoma
Authorization of 12 months may be granted for treatment of
persistent disease or recurrence of low-grade serous ovarian
carcinoma as a single agent.
C. Endometrial carcinoma
Authorization of 12 months may be granted for treatment
of endometrial carcinoma as a single agent.
D. Uterine sarcoma
Authorization of 12 months may be granted for treatment
of low-grade endometrial stromal sarcoma, adenosarcoma
without sarcomatous overgrowth, or estrogen receptor/
progesterone receptor positive (ER/PR+) uterine sarcomas
as a single agent.
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:
- Faslodex [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; September 2020.
- The NCCN Drugs & Biologics Compendium® © 2021 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed December 7, 2021.
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 26, 2022
