Prior authorization criteria for:

Regranex®


(becaplermin)

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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.

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:

For initiation, must submit the following:

  1. Adequate blood tissue supply must be demonstrated by one of the following:
    • Transcutaneous oxygen pressure of TCPO2 greater than 30mm, OR
    • Demonstrated flow by Doppler
  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 for up to 90 days. Reauthorization will be for a second 90 days.

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