Description
Fulvestrant (Faslodex) is an estrogen receptor antagonist indicated for the treatment of hormone receptor-positive (HR-positive), human epidermal growth receptor 2-negative (HER2-negative) breast cancer. Fulvestrant (Faslodex) binds to the estrogen receptor (ER) in a competitive manner with affinity comparable to that of estradiol and down-regulates the ER protein in human breast cancer cells.
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
- When used as treatment for HR-positive, human epidermal growth receptor-2 negative (HER2-negative) advanced disease in postmenopausal women not previous treated with endocrine therapy; or
- When used as treatment for HR-positive advanced disease in postmenopausal women with disease progression following endocrine therapy; or
- When used as treatment for HR-positive, HER2-negative advanced or metastatic breast cancer in women with disease progression after endocrine therapy, in combination with ANY ONE of the following:
- Palbociclib (Ibrance); or
- Abemaciclib (Verzenio)
- Therapy as a single agent for postmenopausal women* or for premenopausal women treated with ovarian ablation/suppression who have recurrent or stage IV HR-positive non-visceral or asymptomatic visceral disease characterized as (preferred**):
- HER2-negative disease; or
- HER2-positive disease
- Therapy for recurrent or stage IV HR-positive non-visceral or asymptomatic visceral disease in combination with everolimus for HER2-negative disease in postmenopausal women* who have had prior endocrine therapy within one (1) year or for premenopausal women treated with ovarian ablation/suppression who have had prior endocrine therapy within one (1) year (preferred**); or
- When used in combination with trastuzumab (Herceptin) for the treatment of recurrent or stage IV HR-positive, HER2-positive non-visceral or asymptomatic visceral disease in postmenopausal women* or premenopausal women treated with ovarian ablation/suppression; or
- For the treatment of recurrent or metastatic HR-positive, HER2-negative disease that has progressed on or after prior adjuvant or metastatic endocrine therapy for postmenopausal women* or premenopausal women receiving ovarian suppression with an LHRH agonist, in combination with ANY ONE of the following (preferred**):
- Palbociclib (Ibrance); or
- Abemaciclib (Verzenio)
Endometrial Carcinoma
- When used as primary treatment as single-agent hormone therapy for grade one (1) or two (2) endometrioid histologies, preferably in individuals with small tumor volume or an indolent growth pace
- May be considered for select individuals with disease limited to the uterus that is not suitable for primary surgery; or
- With or without sequential external beam radiation therapy (EBRT) and brachytherapy for diseases not suitable for primary surgery in individuals with suspected or gross cervical involvement; or
- With or without sequential EBRT and with or without brachytherapy for extrauterine pelvic disease; or
- With or without systemic therapy and/or EBRT for distant visceral metastases, or
- As adjuvant treatment for surgically staged individuals as single-agent hormone therapy for grade one (1) or two (2) endometrioid histologies, preferably in individuals with small tumor volume or an indolent growth pace
- With sequential EBRT with or without brachytherapy for stage III disease; or
- With or without EBRT and vaginal brachytherapy for stage IV disease, or
- When used as hormone therapy for grade one (1) or two (2) endometrioid histologies, preferably in individuals with small tumor volume or an indolent growth pace
- May be considered for isolated metastases; or
- For disseminated metastases; or
- With sequential EBRT with or without brachytherapy for local/regional recurrence in individuals with disease confined to the vagina or in pelvic lymph nodes; or
- With sequential EBRT for local/regional recurrence in individuals with disease in para-aortic or common iliac lymph nodes; or
- With or without sequential tumor-directed EBRT for local-regional recurrence in individuals with microscopic residual upper abdominal or peritoneal disease; or
- With or without sequential palliative EBRT for local/regional recurrence in individuals who have received prior EBRT to site of recurrence.
*Men with breast cancer should be treated in a similar manner as postmenopausal women.
The use of an aromatase inhibitor is ineffective without simultaneous suppression of testicular steroidogenesis.
The use of Fulvestrant for any other indication is considered not medically necessary.
Procedure Codes