CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Filsuvez (topical therapy) for epidermolysis bullosa wounds — Coverage Criteria

Coverage policy governing use of Filsuvez for treatment of wounds in members with dystrophic and junctional epidermolysis bullosa (DEB, JEB); defines prescriber requirements, eligibility, dosing frequency, wound characteristics, and authorization durations for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyFilsuvez (topical therapy) for epidermolysis bullosa wounds — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date11/01/2024

Next Review DateN/A

Key ActionObtain prior authorization: initial approvals for 3 months; renewals for 6 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3 monthsinitial authorization duration

6 monthsmaximum renewal authorization duration

1 tube/dayquantity limit

>=6 mominimum member age

10-50 cm2target wound size

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Coverage Criteria for Filsuvez (EB wounds)

Initial therapy (3-month authorization)

Covered when ALL of the following are met for DEB or JEB wounds:

Eligibility: Member is 6 months of age or older

Clinical manifestations: Documentation that member has clinical manifestations of disease (e.g., extensive skin blistering, skin erosions, scarring)

Laboratory confirmation: Documentation of laboratory test results confirming diagnosis (genetic testing, immunofluorescence mapping [IFM], or transmission electron microscopy [TEM]) confirming a genetic mutation associated with DEB or JEB (examples: COL7A1, LAMA3, LAMB3, LAMC2, COL17A1, ITGA6, ITGB4, ITGA3)

Application and dosing: Filsuvez will be applied at dressing changes at least once every four days, up to once daily

Treatment exclusion - healed wounds: Filsuvez will not be administered to wound(s) that are currently healed

Product exclusivity: Filsuvez will not be administered in combination with other topical skin products including Vyjuvek (beremagene geperpavec), or on wounds previously treated with Vyjuvek

Target wound(s) criteria: Target wound(s) meet all the following: are partial thickness; are 10-50 cm2 in size; have been present for a minimum of 3 weeks; have no evidence of active infection; have no history of basal or squamous cell carcinoma (SCC)

Renewal therapy (6-month authorization)

Renewal covered when ALL of the following are met:

Clinical response: Documentation of positive clinical response to therapy evidenced by one or more of: complete wound closure; reduction in wound size; decreased procedural pain; decreased frequency of dressing changes; or decreased total body wound burden

Ongoing eligibility: Member continues to meet all initial criteria

Filsuvez is covered only for the FDA-approved indication: treatment of wounds associated with dystrophic epidermolysis bullosa (DEB) or junctional epidermolysis bullosa (JEB) in members 6 months of age or older. All other indications outside these FDA‑approved EB subtypes are considered experimental/investigational and not medically necessary.

Filsuvez is not medically necessary and will be denied when requested for any of the following scenarios: wounds that are currently healed; wounds with active infection; wounds with a history of basal cell or squamous cell carcinoma; wounds that do not meet the size requirement of 10–50 cm2 or the duration requirement of being present for at least 3 weeks; use in combination with other topical skin products including Vyjuvek (beremagene geperpavec); or application to wounds previously treated with Vyjuvek.

Key Coding & Eligibility Metrics

Minimum patient age

Minimum patient ageMember is 6 months of age or older

ApplicabilityApplies to DEB and JEB wounds only

Authorization noteInitial approvals are for 3 months when criteria met

Target wound size

Target wound sizeWound(s) 10-50 cm2 in size

CountSize requirement applies per target wound

ExclusionWounds outside 10-50 cm2 are not medically necessary

Prior Auth, Documentation, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization required. Initial approvals are for 3 months; renewals are for 6 months when continuation criteria are met.

Applies to treatment of wounds associated with dystrophic (DEB) and junctional (JEB) epidermolysis bullosa in members ≥ 6 months of age.
Filsuvez application schedule: at dressing changes at least once every four days, up to once daily.

Step Therapy

Step Therapy / Continuation

No step therapy is specified. Continuation/renewal requests require documentation of a positive clinical response and that the member continues to meet all initial criteria.

Evidence of positive clinical response may include complete wound closure, reduction in wound size, decreased procedural pain, decreased frequency of dressing changes, or decreased total body wound burden.
Renewal duration: 6 months when criteria are met.

Clinical Background

Epidermolysis bullosa (EB) comprises genetic blistering disorders; the policy addresses the dystrophic (DEB) and junctional (JEB) subtypes. Affected patients develop extensive skin blistering, erosions, and scarring that can lead to chronic, nonhealing wounds. Laboratory confirmation of the subtype is required (genetic testing, immunofluorescence mapping [IFM], or transmission electron microscopy [TEM] demonstrating a mutation associated with DEB or JEB). Filsuvez is applied to target wounds at dressing changes — at least once every four days, up to once daily — and must be used only on qualifying partial‑thickness wounds that are 10–50 cm2, present ≥ 3 weeks, free of active infection, and without a history of basal or squamous cell carcinoma.

Definitions and Target Wound Criteria

Laboratory confirmation of DEB or JEB

Accepted testsGenetic testing confirming mutation associated with DEB or JEB

Accepted testsImmunofluorescence mapping (IFM) confirming DEB or JEB

Accepted testsTransmission electron microscopy (TEM) confirming DEB or JEB

Examples of genesExamples: COL7A1, LAMA3, LAMB3, LAMC2, COL17A1, ITGA6, ITGB4, ITGA3

Target wound criteria

DepthTarget wounds must be partial thickness

Size

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyFilsuvez (topical therapy) for epidermolysis bullosa wounds — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date11/01/2024

Next Review DateN/A

Key ActionObtain prior authorization: initial approvals for 3 months; renewals for 6 months when criteria are met.

SourceLink

On This Page

Minimum wound duration

Minimum wound durationWound(s) present for a minimum of 3 weeks

Duration applies toEach target wound must meet the ≥3 weeks requirement

Renewal considerationContinued eligibility requires ongoing meeting of initial criteria including duration

Documentation Required

Required Documentation

Documentation must include clinical manifestations of EB and laboratory confirmation of diagnosis. Provide specific test results.

Clinical documentation: signs such as extensive skin blistering, skin erosions, scarring.
Laboratory confirmation: genetic testing, immunofluorescence mapping (IFM), or transmission electron microscopy (TEM) confirming a genetic mutation associated with DEB or JEB (examples: COL7A1, LAMA3, LAMB3, LAMC2, COL17A1, ITGA6, ITGB4, ITGA3).
Include wound-specific details: wound depth (partial thickness), size (10–50 cm²), duration (present ≥ 3 weeks), absence of active infection, and no history of basal or squamous cell carcinoma (SCC).

Denial Risk

Indication‑Based Denial Risk

Use for indications other than FDA‑approved EB (DEB or JEB) is considered experimental/investigational and not medically necessary.

Filsuvez is indicated only for wounds associated with dystrophic and junctional EB in adults and pediatric members ≥ 6 months.
Requests for other diagnoses should be denied as not medically necessary/experimental.

Denial Risk

Wound Characteristic Denial Risk

Applications may be denied if target wounds do not meet specified characteristics or pose safety concerns.

Do not request for healed wounds or wounds with active infection.
Do not request for wounds with a history of basal or squamous cell carcinoma (SCC).
Target wounds must be partial thickness, 10–50 cm² in size, present for at least 3 weeks, and have no evidence of active infection.

DurationPresent for a minimum of 3 weeks

Infection statusNo evidence of active infection

Cancer historyNo history of basal or squamous cell carcinoma in the wound