COVERED USES:

FDA Approved Indications:

1. Reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease (CGD)
2. Delaying time to disease progression in patients with severe, malignant osteopetrosis.

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:

See Covered Uses.

EXCLUSION CRITERIA:

NA:

COVERAGE DURATION:

Initial authorization will be for up to 6 months. Reauthorization will be for up to one year.