COVERED USES:

FDA Approved Indications:

• Treatment of hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following anti-estrogen treatment. (174._, 175._)

Requests for a non-FDA approved ("off-label") indication requires the proposed indication be listed in either the American Hospital Formulary System (AHFS), USP-DI, or Drugdex and is considered subject to evaluation of the prescriber's medical rationale, formulary alternatives, the available published evidence-based research and whether the proposed use is determined to be experimental/investigational.

AGE RESTRICTIONS:

NA

PRESCRIBER RESTRICTIONS:

Must be prescribed by an Oncologist

REQUIRED MEDICAL INFORMATION:

For initiation of treatment, a prior authorization and relevant chart notes documenting medical rationale are required and for continuation of therapy, ongoing documentation of successful response to the medication may be necessary.

CRITERIA:

• Failure of anti-estrogen treatment such as tamoxifen
• Women who can't take oral aromatase inhibitors such as anastrozole or exemestane or who have had progression of disease while taking anastrozole (Arimidex®), exemestane (Aromasin®) or other aromatase inhibitors

EXCLUSION CRITERIA:

NA

COVERAGE DURATION:

Initial authorization and reauthorization will be approved for up to 1 year.