COVERED USES:

FDA Approved Indications:

Boniva® is indicated for the treatment and prevention of osteoporosis in postmenopausal women.

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:

NA

REQUIRED MEDICAL INFORMATION:

For initiation of treatment, a prior authorization form 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:

Boniva® is covered for post-menopausal women who meet the following:

• Documented clinical diagnosis of osteoporosis (defined as a non-traumatic, non-pathologic spinal fracture OR spine or hip bone mineral density (BMD) T-score ≤-2.5.)
OR
• Documented risk of osteoporosis (defined as BMD T-score between -2.0 and -2.5 AND one of the following risk factors: non-traumatic fracture since menopause, history of hip or spine fracture in first degree relative, weight <127 lbs.)
AND
• Documented intolerance OR non-adherence OR trial and failure of 1 oral bisphosphonate.

EXCLUSION CRITERIA:

NA

COVERAGE DURATION:

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