Pharmacy Prior Authorization Criteria

Regranex (becaplermin)

For diagnosis of Diabetic Neuropathic Ulcers
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 Gel 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, 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.

Prior Authorization

Length of Approval: 5 Months [1, A]

AND

Treatment will be given in combination with ulcer wound care (e.g., debridement, infection control, and/or pressure relief) [1]

2024-07-31, 2023-07-03, 2022-07-06, 2021-06-30, 2021-05-21, 2020-07-13

Regranex Prescribing Information. Smith & Nephew, Inc. Fort Worth, TX. August 2019.

Fifty percent of patients will achieve complete healing within 20 weeks with Regranex. Reassessment is required for further therapy. [1] If the ulcer does not decrease in size by approximately 30% after 10 weeks of treatment or complete healing has not occurred in 20 weeks, continued treatment with Regranex should be reassessed. Postmarketing studies have demonstrated an increased risk of mortality secondary to malignancy observed in patients treated with greater than or equal to 3 tubes of Regranex gel. [1]