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:
Food and Drug Administration (FDA) Indications:
Breast Cancer
- Fulvestrant (Faslodex) is indicated 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.
- Fulvestrant (Faslodex) is indicated for the treatment of HR-postive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy; or
- Fulvestrant (Faslodex) is indicated for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancerin postmenopausal women in combination with ribociclib, as initial endocrine based therapy or following disease progression on endocrine therapy; or
- Fulvestrant (Faslodex) is indicated 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
National Comprehensive Cancer Network (NCCN) Recommendations:
Breast Cancer, Invasive
- When used as treatment for recurrent or stage IV (M1) hormone receptor (HR)-positive, in postmenopausal women* or for premenopausal women treated with ovarian ablation/suppression.
- As first-line or second-line therapy and beyond as a single agent for human epidermal growth factor receptor 2 (HER2)-negative disease with no visceral crisis (preferred regimen); or
- As first-line therapy in combination with a non-steroidal aromatase inhibitor (anastrozole or letrozole) for HER2-negative disease with no visceral crisis (preferred regimen); or
- As first-line therapy in combination with a CDK 4/6 inhibitor (abemaciclib, palbociclib or ribociclib) for HER2-negative disease with no visceral crisis (all preferred regimens); or
- As second-line therapy and beyond in combination with everolimus for HER2-negative disease with no visceral crisis (preferred regimen); or
- As a second-line therapy and beyond in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib or ribociclib) for HER-2 negative disease with no visceral crisis if a CDK4/6 inhibitor was not previously used (preferred regimen); or
- As second-line therapy and beyond in combination with alpelisib for HER2-negative disease with no visceral crisis if PIK3CA mutation positive (preferred regimen**)
- Therapy as a single agent for HER2-positive disease;
- When used in combination with trastuzumab (Herceptin) for the treatment of HER2-positive disease; or
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 in ANY of the following:
- 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 that is not suitable for primary surgery; or
- With or without systemic therapy and/or EBRT for distant 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 IIIA-IVA disease; or
- With or without vaginal brachytherapy for stage IIIA-IVA disease; or
- With or without subsequential 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 in ANY of the following:
- 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.; or
Epithelial Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer
- Useful in certain circumstances, as recurrence therapy for low-grade serous carcinoma.
Uterine Sarcoma
- When used as therapy for low-grade endometrial stromal sarcoma (ESS) or estrogen receptor/progesterone receptor positive (ER/PR+) uterine leiomyosarcoma (uLMS):
- For disease that is not suitable for primary surgery; or
- Following total hysterectomy with or without bilateral salpingo-oophorectomy for stage II-IV low-grade ESS or for stage I-IV ER/PR+ uLMS; or
- For a radiologically isolated vaginal/pelvic recurrence; or
- For isolated metastases. Consider postoperative therapy for resectable isolated metastases; or
- For disseminated metastases.
The use of Fulvestrant for any other indication is considered not medically necessary.
Procedure Codes