CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

regranex_prior_authorization_criteria

Defines prior authorization and quantity limit criteria for topical Regranex (becaplermin) for treatment of lower extremity diabetic neuropathic ulcers in members covered by the plan. Specifies clinical indications, required concurrent wound care, and monthly quantity limits including higher limits for larger or multiple ulcers.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

Policyregranex_prior_authorization_criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrior authorization is required; coverage permitted only when criteria are met (see criteria_trees).

POLICY UPDATE CHANGES

No material changes to clinical coverage or criteria.

1FDA-approved indication (diabetic neuropathic lower extremity ulcers)

30 g/moStandard monthly quantity limit

60 g/moMonthly limit for multiple ulcers or >2.5 sq in

2Limitations of use listed

Coverage Summary

Regranex (becaplermin) is covered with prior authorization when ALL criteria are met: it must be prescribed for a lower extremity diabetic neuropathic ulcer that extends into the subcutaneous tissue or beyond and has an adequate blood supply; good ulcer care practices (initial sharp debridement, pressure relief, infection control) will be performed. Quantity limits apply: 30 grams per month standard; 60 grams per month for multiple ulcers or an ulcer > 2.5 square inches. Prior authorization is required and coverage is permitted only when these criteria are documented.

Quantity limits and FDA indication

Standard quantity limit30 grams per month

Increased quantity threshold (ulcer size)> 2.5 square inches

Increased quantity limit60 grams per month

FDA‑approved indicationTreatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond with adequate blood supply, used as an adjunct to good ulcer care practices

Initial Therapy Criteria (Prior Authorization)

Initial Prior Authorization / Coverage Criteria

The requested drug will be covered with prior authorization when ALL of the following are met:

ALL of the following

Indication: 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
Concurrent wound care: Good ulcer care practices including initial sharp debridement, pressure relief, and infection control will be performed
Quantity exception: 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 ulcersUlcer size > 2.5 square inches
Applies when member requests quantities above standard monthly limit (standard 30 g/month; 60 g/month for multiple ulcers or ulcer >2.5 sq in)

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization is required; coverage permitted only when criteria are met (see criteria).

Documentation Required

Document wound characteristics and care

Provider must document that the ulcer is a lower extremity diabetic neuropathic ulcer extending into subcutaneous tissue or beyond, that the ulcer has adequate blood supply, and that good ulcer care practices (initial sharp debridement, pressure relief, and infection control) will be performed.

Billing Rule

Quantity limits

Apply quantity limits as specified.

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

Clinical Evidence & References

Primary reference: Regranex package insert, Smith & Nephew, August 2019.

Efficacy not established for the treatment of pressure ulcers and venous stasis ulcers, not evaluated for diabetic neuropathic ulcers that do not extend through the dermis into subcutaneous tissue (Stage I/II), or for ischemic diabetic ulcers.

Background

Regranex is FDA‑approved as an adjunct treatment for lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply. It is intended to be used as an adjunct to, not a substitute for, good ulcer care practices including initial sharp debridement, pressure relief, and infection control. Regranex is not intended for wounds that close by primary intention. The efficacy of Regranex has not been established for pressure ulcers or venous stasis ulcers, has not been evaluated for superficial (Stage I/II) diabetic ulcers that do not extend into subcutaneous tissue, or for ischemic diabetic ulcers.

Good ulcer care practices: Includes initial sharp debridement, pressure relief, and infection control.