CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Filsuvez

Defines coverage criteria, quantity limits, and authorization durations for Filsuvez for treatment of wounds in dystrophic and junctional epidermolysis bullosa (EB) in members >=6 months. States other indications are investigational/not medically necessary.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyFilsuvez

Policy CodePolicy N/A

Change TypeClarified (review dates noted)

Effective Date

Next Review Date2025-08

Key ActionObtain initial authorization for 3 months and document laboratory confirmation of DEB/JEB and specialist involvement; renewals limited to 6 months with documented positive clinical response.

SourceLink

POLICY UPDATE CHANGES

Reviewed: 08/2024, 08/2025 noted in references/review line.

1Covered Indication (EB types listed)

3 monthsInitial Authorization Duration

6 monthsRenewal Authorization Duration

1 tube/dayDaily Quantity Limit

Coverage Summary

Filsuvez is covered for the treatment of wounds associated with dystrophic epidermolysis bullosa (DEB) and junctional epidermolysis bullosa (JEB) in patients aged >= 6 months when the policy criteria are met (initial authorization up to 3 months, renewal up to 6 months). Coverage is restricted to the labeled indication and requires diagnostic confirmation (genetic testing, IFM, or TEM) and that the medication be prescribed by or in consultation with a wound care specialist experienced in EB.

FDA-Approved Indication / Initial Authorization (3 months)

Authorization of 3 months may be granted when ALL of the following are met:

ALL of the following

Member is 6 months of age or older>= 6 months
Documentation that member has clinical manifestations of disease (e.g., extensive skin blistering, skin erosions, scarring)
Documentation that member has laboratory test results confirming diagnosis (i.e., genetic testing, immunofluorescence mapping [IFM], or transmission electron microscopy [TEM] confirming a genetic mutation associated with DEB or JEB [e.g., COL7A1, LAMA3, LAMB3, LAMC2, COL17A1, ITGA6, ITGB4, ITGA3])
Includes genetic testing, IFM, or TEM
Filsuvez will be prescribed by or in consultation with a wound care specialist who specializes in the treatment of EB
Filsuvez will be applied at dressing changes at least once every four days, up to once dailyat least once every 4 days, up to once daily
Filsuvez will not be administered to wound(s) that are currently healed
Filsuvez will not be administered in combination with other topical skin products, e.g., Vyjuvek (beremagene geperpavec) or Zevaskyn (prademagene zamikeracel), or in wounds previously treated with Vyjuvek (beremagene geperpavec) or Zevaskyn (prademagene zamikeracel)
Target wound(s) must meet all of the following
- Are partial thickness
- Are 10-50 cm2 in size10-50 cm2
  size units specified as cm2
- Have been present for a minimum of 3 weeks>= 3 weeks
- Have no evidence of active infection
- Have no history of basal or squamous cell carcinoma (SCC)

Renewal / Continued Therapy (6 months)

Authorization of 6 months may be granted when ALL of the following are met:

ALL of the following

ALL of the following
- ONE or more of
  - Complete wound closure
  - Reduction in wound size
  - Decreased procedural pain
  - Decreased frequency of dressing changes
  - Decreased total body wound burden
Member continues to meet all initial criteria

Other Indications / Exclusions

Other Indications

Non-FDA or compendial uses

All other indications are considered experimental/investigational and not medically necessary

Exclusions include wounds that were previously treated with or are being treated concurrently with Vyjuvek (beremagene geperpavec) or Zevaskyn (prademagene zamikeracel), wounds that are currently healed, and target wounds with a history of basal or squamous cell carcinoma (SCC).

Provider Actions

Prior Authorization

Authorization required

Initial authorization limited to 3 months; renewal authorization limited to 6 months contingent on documented positive clinical response and continued meeting of initial criteria.

Documentation Required

Diagnostic confirmation required

Submit documentation of laboratory confirmation (genetic testing, IFM, or TEM) showing mutation associated with DEB or JEB and clinical manifestations (e.g., blistering, erosions, scarring).

Documentation Required

Specialist involvement

Prescription must be by or in consultation with a wound care specialist experienced in EB; include consultation note or specialist attestation.

Billing Rule

Quantity limit enforcement

Claims will be limited to dispensing one 23.4 gm tube per day.

One 23.4 gm tube per day

Denial Risk

Excluded uses and combinations

Claims for Filsuvez for indications other than DEB/JEB or for wounds previously treated with or concurrently treated with Vyjuvek or Zevaskyn are considered not medically necessary and may be denied.

Background & Definitions

Indication summary: Filsuvez is indicated for treatment of wounds associated with dystrophic and junctional EB in patients aged >= 6 months. Use is restricted to this labeled indication; all other indications are considered experimental/investigational and not medically necessary. Diagnostic confirmation by genetic testing, immunofluorescence mapping (IFM), or transmission electron microscopy (TEM) demonstrating a mutation associated with DEB or JEB is required, and prescription must be by or in consultation with a wound care specialist experienced in EB.

Term	Definition
{"text":"DEB","status":""},{"text":"Dystrophic epidermolysis bullosa","status":""}
{"text":"JEB","status":""},{"text":"Junctional epidermolysis bullosa","status":""}
{"text":"IFM","status":""},{"text":"Immunofluorescence mapping","status":""}
{"text":"TEM","status":""},{"text":"Transmission electron microscopy","status":""}