COVERED USES:

FDA Approved Indications:

Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS)

All FDA-approved indications not otherwise excluded from Part D.

AGE RESTRICTIONS:

May be approved for adults and children 12 years and older.

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:

Member must meet all criteria below for initial approval:

1. Diagnosis of Cryopyrin-Associated Periodic Syndrome (CPS) confirmed by:
   1. Laboratory evidence of genetic mutation NLRP-3 (Nucleotide-binding domain, leucine rich family (NLR) pyrin domain containing 3) or CIAS1 (Cold-Induced Auto-inflammatory Syndrome-1), and
   2. Classic symptoms associated with Familial Cold Auto-Inflammatory Syndrome (FCAS) or Muckle-Wells Syndrome (MWS) - recurrent intermittent fever and rash typically associated with natural or artificial cold, and
2. Evidence of significant impairment of Activities of Daily Living (ADL) due to condition.

Reauthorization: Documentation submitted that ADLs have improved significantly from baseline.

EXCLUSION CRITERIA:

NA

COVERAGE DURATION:

Initial authorization will be approved for up to 6 months. Ongoing authorizations may be approved for up to one year.