CurrentNeighborhood Health Plan of Rhode IslandPolicy 186-C

becaplermin (Regranex) topical gel — coverage criteria and limits

Covers clinical authorization and limits for becaplermin (Regranex) topical gel prescribed as adjunctive therapy for lower-extremity diabetic neuropathic ulcers in members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCoverage criteria for becaplermin (Regranex) topical gel

Policy CodePolicy 186-C

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization and document that the ulcer is a lower‑extremity diabetic neuropathic ulcer extending into subcutaneous tissue with adequate blood supply and that good ulcer care will be provided.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

30 gstandard qty limit / 25 days

60 gqty limit — multiple or >2.5 in²

20 wksmaximum duration

Stage ≥ IIIrequired ulcer depth

Coverage Criteria for becaplermin (Regranex)

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCoverage criteria for becaplermin (Regranex) topical gel

Policy CodePolicy 186-C

Change TypeNo material change

Effective Date

Next Review Date

SourceLink

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Quantity and Duration Limits

Quantity limit

Standard quantity limit30 grams per 25 days (standard)

Quantity limit for multiple ulcers60 grams per 25 days for multiple ulcers

Quantity limit for large single ulcer60 grams per 25 days for an ulcer greater than 2.5 square inches

Fill period note25-day duration used to represent a 30-day fill period to allow refill processing; no 3-month supplies

Duration of approval

Maximum duration of approval20 weeks

Intended supply frequencyPrescriptions intended to be filled one month at a time (no 3-month supplies)

Drug use classificationShort-term acute use

Prior Authorization, Documentation, and Related Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approval is granted only when the requested therapy is for a lower extremity diabetic neuropathic ulcer that extends into the subcutaneous tissue or beyond and the ulcer has adequate blood supply, AND the clinical criteria below are met.

Authorization requires documentation that good ulcer care practices (including initial sharp debridement, pressure relief, and infection control) will be performed.
Quantity limits apply (see policy): typically 30 g per 25 days; 60 g per 25 days for multiple ulcers or an ulcer >2.5 sq in.

Step Therapy

Step Therapy / Care Sequencing

No formal multi‑step drug sequencing is required, but prior authorization will only be considered when concurrent standard ulcer care has been attempted/ planned as described in documentation requirements.

Ensure documentation shows good ulcer care (debridement, pressure relief, infection control) before or concurrent with therapy.

Documentation Required

Required Clinical Documentation

Requests must include clinical documentation that supports the ulcer type, depth, blood supply, and concurrent standard ulcer care. Insufficient documentation may result in denial.

Confirm the ulcer is a lower extremity diabetic neuropathic ulcer extending into subcutaneous tissue or beyond.
Document assessment of blood supply to the affected extremity (e.g., palpable pulses, ABI, vascular studies as appropriate).
Document planned or completed good ulcer care: initial sharp debridement, pressure off‑loading/relief, and infection control measures.
If requesting additional quantity, document ulcer size (>2.5 square inches) or presence of multiple ulcers.
Include prior treatment history and rationale for becaplermin as adjunctive therapy.

Denial Risk

Non‑Indicated Wound Types

Therapy is not supported for certain wound types or healing scenarios.

Not indicated for pressure ulcers or venous stasis ulcers.
Not indicated for ischemic diabetic ulcers or diabetic neuropathic ulcers that do NOT extend through the dermis into subcutaneous tissue (e.g., Stage I or II).
Not evaluated for wounds with exposed joints, tendons, ligaments, or bone.
Not intended for wounds that close by primary intention.

Key Definitions

Lower extremity diabetic neuropathic ulcer — definition and required ulcer depth (extends into subcutaneous tissue or deeper)

DefinitionAn ulcer on the lower extremity in a patient with diabetes associated with neuropathy that extends into the subcutaneous tissue or deeper and has adequate blood supply.

Required depthExtends into the subcutaneous tissue or beyond (not Stage I or II)

Relation to stagingStage I or II (do not extend through dermis into subcutaneous tissue) are not supported indications

Background and Regulatory Status

Becaplermin (Regranex) is a topical growth factor gel approved for use as an adjunctive treatment of lower‑extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have adequate blood supply. It is intended to be used alongside standard ulcer care (for example, sharp debridement, pressure relief, and infection control). The product’s efficacy has not been established for pressure ulcers, venous stasis ulcers, ischemic ulcers, wounds that close by primary intention, or wounds with exposed joints/tendons/ligaments/bone.