Highmark Commercial Medical Policy - Pennsylvania
Medical Policy: I-123-005
Topic: Fulvestrant (Faslodex)
Section: Injections
Effective Date: April 30, 2018
Issue Date: April 30, 2018
Last Reviewed: April 2018

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.

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Policy Position Coverage is subject to the specific terms of the member’s benefit plan.

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:

o    Palbociclib (Ibrance); or

o    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**):

o    HER2-negative disease; or

o    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**):

o    Palbociclib (Ibrance); or

o    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

o    May be considered for select individuals with disease limited to the uterus that is not suitable for primary surgery; or

o    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

o    With or without sequential EBRT and with or without brachytherapy for extrauterine pelvic disease; or

o    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

o    With sequential EBRT with or without brachytherapy for stage III disease; or

o    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

o    May be considered for isolated metastases; or

o    For disseminated metastases; or

o    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

o    With sequential EBRT for local/regional recurrence in individuals with disease in para-aortic or common iliac lymph nodes; or

o    With or without sequential tumor-directed EBRT for local-regional recurrence in individuals with microscopic residual upper abdominal or peritoneal disease; or

o    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
J9395


Dosage recommendations per the FDA label.

**Note: Language derived from National Comprehensive Cancer Network (NCCN) guidelines.



Place of Service: Outpatient

The administration of Fulvestrant (Faslodex) is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.


The policy position applies to all commercial lines of business


Denial Statements

Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

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Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

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The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer: If you need these services, contact the Civil Rights Coordinator.

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

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