Wound Care – Essential Formulary

Restricted Product(s)

• Regranex (becaplermin gel 0.01%) 
• Santyl (collagenase ointment)

FDA Approved Use

Regranex

• For the adjunctive treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply.

Santyl

• For the treatment of debriding chronic dermal ulcers and severely burned areas.

Criteria for Approval of Restricted Product(s)

1. The request is for Regranex; AND 
   1. The requested product is being prescribed as treatment of lower extremity diabetic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply; OR 
2. The request is for Santyl; AND
   1. The requested product is being prescribed for the treatment of debriding chronic dermal ulcers or severely burned areas; AND 
3. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
   
   Duration of Approval: 365 days (1 year)

References

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information

May 2023: Original utilization management policy issued.