CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Filsuvez (wound treatment for epidermolysis bullosa) - Coverage Criteria

Covers use of Filsuvez for treatment of wounds in members with dystrophic and junctional epidermolysis bullosa (DEB, JEB) for Neighborhood Health Plan of Rhode Island Medicaid members when specified criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyFilsuvez (wound treatment for epidermolysis bullosa) - Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateNov 1, 2024

Next Review DateN/A

Key ActionSubmit prior authorization showing diagnostic confirmation and wound documentation to request up to a 3-month initial authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3 monthsinitial authorization duration

6 monthsrenewal duration

one 23.4 gmmax daily quantity

≥ 6 monthsminimum age

10–50 cm2target wound size

Coverage Criteria

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.
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 dystrophic epidermolysis bullosa [DEB] or junctional epidermolysis bullosa [JEB] (e.g., COL7A1, LAMA3, LAMB3, LAMC2, COL17A1, ITGA6, ITGB4, ITGA3)).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyFilsuvez (wound treatment for epidermolysis bullosa) - Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateNov 1, 2024

Next Review DateN/A

Key ActionSubmit prior authorization showing diagnostic confirmation and wound documentation to request up to a 3-month initial authorization.

SourceLink

On This Page

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Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required for initial therapy. Authorization of up to 3 months may be granted when the specified clinical criteria are met (member ≥ 6 months, clinical manifestations of EB, laboratory confirmation of DEB or JEB, application frequency and wound eligibility criteria met).

Initial authorization: up to 3 months
Member age: ≥ 6 months
Application: at dressing changes at least once every 4 days, up to once daily

Prior Authorization

Prior Authorization for Renewal

Renewal prior authorization may be granted for up to 6 months when positive clinical response to therapy is documented and the member continues to meet all initial authorization criteria.

Renewal authorization: up to 6 months
Documented positive response required (see renewal documentation)
Member must continue to meet all initial criteria

Denial Risk

Combination Therapy Restriction

Filsuvez must not be used concurrently with other topical skin products including Vyjuvek (beremagene geperpavec), and must not be used on wounds previously treated with Vyjuvek.

Do not administer Filsuvez with Vyjuvek
Do not treat wounds previously treated with Vyjuvek

Denial Risk

Wound Eligibility Risks

Requests for treatment of wounds that are already healed, have active infection, have a history of basal or squamous cell carcinoma, or wounds that do not meet target wound parameters (partial thickness, size 10–50 cm2, present ≥ 3 weeks) are not eligible and may be denied.

Healed wounds are not eligible
Infected wounds are not eligible
Wounds with history of BCC or SCC are not eligible
Target wound requirements: partial thickness; 10–50 cm2; present ≥ 3 weeks

Documentation Required

Diagnostic Documentation

Diagnostic documentation must include evidence of clinical manifestations of epidermolysis bullosa (e.g., extensive skin blistering, erosions, scarring) and laboratory confirmation of diagnosis (genetic testing, immunofluorescence mapping, or transmission electron microscopy confirming a genetic mutation associated with DEB or JEB such as COL7A1, LAMA3, LAMB3, LAMC2, COL17A1, ITGA6, ITGB4, ITGA3).

Clinical manifestations: e.g., extensive skin blistering, erosions, scarring
Laboratory confirmation: genetic testing, IFM, or TEM documenting mutation associated with DEB or JEB (examples listed)

Documentation Required

Renewal Documentation

For renewal requests, document positive clinical response to therapy with one or more of the following: complete wound closure, reduction in wound size, decreased procedural pain, decreased frequency of dressing changes, or decreased total body wound burden. Also document that the member continues to meet all initial authorization criteria.

Acceptable evidence of response: wound closure, size reduction, decreased pain, less frequent dressing changes, decreased total body wound burden
Confirm continued fulfillment of initial criteria

Denial Risk

Indication Limitations

Use of Filsuvez for indications other than FDA‑approved treatment of wounds associated with dystrophic and junctional EB in patients 6 months and older is considered experimental/investigational and is not covered.

Covered indication: wounds associated with dystrophic and junctional EB in adults and pediatric members ≥ 6 months
All other indications: experimental/investigational — not covered

Background

Epidermolysis bullosa (EB) is a genetic blistering disorder characterized by extensive skin blistering, erosions, and scarring. Filsuvez is indicated to treat wounds associated with dystrophic and junctional forms of EB and is applied topically at dressing changes. Initial authorization may be considered when the member is at least 6 months old, has clinical manifestations of EB, and has laboratory confirmation of a causative mutation; target wounds must be partial thickness, measure 10–50 cm2, have been present at least 3 weeks, show no evidence of active infection, and have no history of basal or squamous cell carcinoma. Filsuvez should be applied at dressing changes at least once every 4 days, up to once daily, and must not be used concurrently with or after Vyjuvek.

OpenPayer

Filsuvez (wound treatment for epidermolysis bullosa) - Coverage Criteria

Coverage Criteria

Provider Actions and Requirements

Definitions and Target Wound Criteria

Background