COVERED USES:

FDA Approved Indications: Chronic lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have adequate blood tissue supply.

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

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:

For initiation, must submit the following:

1. Documentation of adequate blood tissue supply to the effected area; AND
2. The record must demonstrate use of good ulcer care for a minimum of 8 weeks prior to request for initiation of therapy. Good ulcer care will generally include documentation of the following:
   • Establishment of adequate blood supply as indicated above
   • Determination of adequate nutritional status with a serum albumin level of greater than 2g/dL
   • Appropriate debridement to remove dead tissue with ongoing debridement as necessary
   • No weight on affected area to relieve pressure points
   • Systemic treatment of wound infections if present
   • Maintenance of a moist wound environment (dressing changes including alginates, foams, hydrocolloids, hydro gels, and transparent films).

For reauthorization for a second 90 day course must submit documentation showing an adequate response defined by a 30% reduction or greater in ulcer size. There is no medical evidence to justify ongoing treatment after 180 days of Regranex® treatment.

EXCLUSION CRITERIA:

NA

COVERAGE DURATION:

Initial authorization will be approved for 90 days. Reauthorization will be approved for a second 90 days.