Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Fulvestrant (Faslodex) may be considered medically necessary for ANY ONE of the follow indications:
Breast Cancer
- For the treatment of hormone receptor (HR)-positive, human epidermal growth receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy; or
- For the treatment of HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy; or
- For the treatment of 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; or
- For the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy; or
Compendia Sources
Fulvestrant (Faslodex) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.
The use of fulvestrant (Faslodex) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
Procedure Codes
The above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.
*Men with breast cancer should be treated in a similar manner as postmenopausal women, except that use of an aromatase inhibitor is ineffective without concomitant suppression of testicular steroidogenesis
