CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Regranex (becaplermin) topical prior authorization for wound care

Defines prior authorization criteria and quantity limits for Regranex (becaplermin) topical gel when prescribed for lower-extremity diabetic neuropathic ulcers; intended for providers seeking coverage for this agent.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRegranex (becaplermin) topical prior authorization for wound care

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and document that the ulcer extends into subcutaneous tissue, has adequate blood supply, and that initial sharp debridement, pressure relief, and infection control have been performed.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

60maximum quantity for multiple ulcers or ulcer > 2.5 in^2

30quantity limit (single ulcer / standard limit)

1FDA‑approved treatment indication covered

Criteria for Regranex (becaplermin) Coverage

Coverage Criteria for Regranex (becaplermin)

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ALL of the following

The drug is prescribed for a lower-extremity diabetic neuropathic ulcer that extends into the subcutaneous tissue or beyond
Matches FDA-approved indication; ulcer must extend through the dermis into subcutaneous tissue
The ulcer has an adequate blood supply
Provider must assess vascular status prior to treatment
Good ulcer care practices will be performed
Initial sharp debridement, pressure relief, and infection control measures as part of standard wound management.
Quantity/size condition
- If additional quantities are requested, the drug is prescribed to treat an ulcer greater than 2.5 square inches in size> 2.5 square inches
- For multiple ulcers

What Providers Must Do

Prior Authorization

Prior authorization required

Prior authorization is required for Regranex (becaplermin) topical gel; coverage only granted when the documented clinical criteria are met (see criteria tree).

Documentation Required

Document wound characteristics and care

Providers must document that the ulcer extends into subcutaneous tissue or beyond, evidence of adequate blood supply, performance of initial sharp debridement, pressure relief measures, and infection control.

Ulcer extends into the subcutaneous tissue or beyond
Evidence of adequate blood supply
Performance of initial sharp debridement
Pressure relief measures
Infection control

Prior Authorization

Quantity limits

Quantity limits apply: standard 30 g/month; for multiple ulcers or an ulcer greater than 2.5 square inches in size the limit is 60 g/month.

Standard limit: 30 grams per month
Increased limit: 60 grams per month for multiple ulcers or an ulcer > 2.5 square inches

Clinical Background

Regranex (becaplermin) is FDA‑approved as an adjunctive topical therapy for lower‑extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and that have an adequate blood supply. It is intended to be used in addition to standard wound care, not as a substitute for good ulcer care practices such as initial sharp debridement, pressure relief, and infection control.

Regranex has not been shown effective for the treatment of pressure ulcers or venous stasis ulcers, for diabetic neuropathic ulcers that do not extend through the dermis into subcutaneous tissue, for ischemic diabetic ulcers, or for wounds that close by primary intention.

Defined Terms

Definitions

Good ulcer care practicesInitial sharp debridement, pressure relief, and infection control measures as part of standard wound management.

FDA‑approved treatment indicationLower‑extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond, with adequate blood supply; used as adjunctive therapy, not a substitute for good ulcer care practices.

Not effective for other ulcer typesEfficacy not established for pressure ulcers, venous stasis ulcers, ischemic diabetic ulcers, or ulcers that do not extend through the dermis into subcutaneous tissue.

Not for wounds closing by primary intentionRegranex is not intended to be used in wounds that close by primary intention.