Subject: Regranex PA with Limit 186-C P07-2025

Drug

REGRANEX  (becaplermin)

Policy:

Indications

FDA-approved Indications

Regranex is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply, when used as an adjunct to, and not a substitute for, good ulcer care practices including initial sharp debridement, pressure relief and infection control.

Limitations of Use

The efficacy of Regranex has not been established for the treatment of pressure ulcers and venous stasis ulcers and has not been evaluated for the treatment of diabetic neuropathic ulcers that do not extend through the dermis into subcutaneous tissue [Stage I or II, International Association of Enterostomal Therapy (IAET) staging classification] or ischemic diabetic ulcers.

The effects of becaplermin on exposed joints, tendons, ligaments, and bone have not been established in humans.

Regranex is not intended to be used in wounds that close by primary intention.

Coverage Criteria

Lower Extremity Diabetic Neuropathic Ulcer

Authorization may be granted when the requested drug is being prescribed for the treatment of a lower extremity diabetic neuropathic ulcer that extends into the subcutaneous tissue or beyond AND has an adequate blood supply when ALL of the following criteria are met:

• Good ulcer care practices including initial sharp debridement, pressure relief, and infection control will be performed.
• If additional quantities are being requested, then the requested drug is being prescribed to treat an ulcer greater than 2.5 square inches in size OR multiple ulcers.

Quantity Limits Apply

30 grams per 25 days.

For multiple ulcers or an ulcer greater than 2.5 square inches in size: 60 grams per 25 days.

The duration of 25 days is used for a 30-day fill period to allow time for refill processing.

This drug is for short-term acute use; therefore, the intent is for prescriptions of the requested drug to be filled one month at a time; there should be no 3-month supplies filled.

Duration Of Approval (DOA)

• 186-C: DOA: 20 weeks

Place of Service:

Outpatient

The above policy is based on the following references:

1. Regranex [package insert]. Fort Worth, TX: Smith & Nephew Inc.; August 2019.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2025. https://online.lexi.com.Accessed June 10, 2025.
3. Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 06/10/2025).

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

December 12, 2025