CurrentCignaPolicy IP0635

Filsuvez

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This policy governs prior authorization and medical-necessity coverage for Filsuvez (birch triterpenes topical gel) used to treat wounds associated with dystrophic epidermolysis bullosa under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyFilsuvez

Policy CodePolicy IP0635

Change TypeMaterial revision

Effective DateNov 1, 2026

Last ReviewFeb 13, 2025

Next Review DateN/A

Key ActionObtain prior authorization and prescribe Filsuvez by or in consultation with a dermatologist or wound care specialist.

SourceLink

POLICY UPDATE CHANGES

The approval duration for initial therapy and treatment of previously treated wounds was increased from 3 months to 12 months.

The target-wound squamous cell carcinoma criterion was revised to require the prescriber to attest that there is no evidence or clinical suspicion of squamous cell carcinoma at the target wound.

≥ 6 monthsMinimum patient age for initial therapy

12 monthsApproval duration

10–50 cm²Target-wound size

≥21 days; <9 monthsTarget-wound age

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CurrentCignaPolicy IP0635

Filsuvez

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Policy Summary

PayerCigna

PolicyFilsuvez

Policy CodePolicy IP0635

Change TypeMaterial revision

Effective DateNov 1, 2026

Last ReviewFeb 13, 2025

Next Review DateN/A

Key ActionObtain prior authorization and prescribe Filsuvez by or in consultation with a dermatologist or wound care specialist.

SourceLink

POLICY UPDATE CHANGES

The approval duration for initial therapy and treatment of previously treated wounds was increased from 3 months to 12 months.

The target-wound squamous cell carcinoma criterion was revised to require the prescriber to attest that there is no evidence or clinical suspicion of squamous cell carcinoma at the target wound.

≥ 6 monthsMinimum patient age for initial therapy

12 monthsApproval duration

10–50 cm²Target-wound size

≥21 days; <9 monthsTarget-wound age

41.3% vs 28.9%Complete wound closure at Day 45

Medical Necessity and Non-Covered Uses

FDA-Approved Indication: Dystrophic Epidermolysis Bullosa

Filsuvez is medically necessary for the FDA-approved indication when the patient meets either the initial-therapy or previously treated-wound criteria.

Covered pathway

Initial Therapy
- Patient age and diagnosis: The patient is at least 6 months of age and has at least one clinical feature of dystrophic epidermolysis bullosa.Age ≥ 6 months
  Documentation is required for the clinical feature. Examples include blistering, wounds, and scarring.
- Target wound requirements: The patient has one or more open wounds to be treated, and the target wound(s) are clean in appearance, do not appear infected, measure 10 cm² to 50 cm², and are at least 21 days but less than 9 months old.10–50 cm²; ≥21 days and <9 months old
  The prescriber must attest that there is no evidence or clinical suspicion of squamous cell carcinoma at the target wound(s).
- Specialist prescribing: Filsuvez is prescribed by or in consultation with a dermatologist or wound care specialist.
Currently Receiving Filsuvez on Previously Treated Wound(s)
- Ongoing wound status and response: According to the prescriber, the target wound(s) remains open and has decreased in size from baseline.Target wound remains open and is smaller than baseline
- Specialist prescribing: Filsuvez is prescribed by or in consultation with a dermatologist or wound care specialist.

Conditions Not Covered

Filsuvez for the following uses is considered not medically necessary.

Not medically necessary uses

Combination with Vyjuvek: Filsuvez is used in combination with Vyjuvek (beremagene geperpavec-svdt topical gel).
Combination use of Vyjuvek and Filsuvez has not been studied.
Junctional epidermolysis bullosa: The patient has junctional epidermolysis bullosa.
Efficacy has not been proven to be better than placebo.

Combination use of Filsuvez with Vyjuvek (beremagene geperpavec-svdt topical gel) is not covered. Combination use has not been studied, and patients who had undergone gene therapy for inherited epidermolysis bullosa were excluded from the pivotal EASE trial.

Filsuvez for junctional epidermolysis bullosa (JEB) is considered not medically necessary. Efficacy has not been proven better than placebo; in the pivotal EASE trial, complete wound closure at Day 45 was greater with placebo than with Filsuvez in patients with JEB (26.7% vs. 18.6%).

Filsuvez used in combination with Vyjuvek is considered not medically necessary. Combination use has not been studied, and patients who had undergone gene therapy for inherited epidermolysis bullosa were excluded from the pivotal EASE trial.

Authorization, Documentation, and Denial Risks

Prior Authorization

Prior Authorization and Specialist Involvement

Prior authorization is required for benefit coverage of Filsuvez. Approval requires the medication to be prescribed by or in consultation with a physician who specializes in the condition being treated, including a dermatologist or wound care specialist.

Approvals are provided for the duration specified in the applicable criteria.
When approval is authorized in months, 1 month equals 30 days.

Documentation Required

Patient-Specific Supporting Documentation

Submit patient-specific documentation supporting the request when the criteria identify documentation as required. Records may include chart notes, laboratory tests, medical test results, claims records, prescription receipts, and/or other relevant information.

All documentation must include patient-specific identifying information.

Product and Clinical Context

Filsuvez is a sterile botanical topical gel containing birch triterpenes in an oil base. It is indicated for wounds associated with inherited epidermolysis bullosa, including wounds associated with dystrophic epidermolysis bullosa in patients at least 6 months of age. The gel is applied to cleansed wounds during wound dressing changes until healing; treatment should be discontinued if a treated wound becomes infected until the infection resolves. Dystrophic epidermolysis bullosa is characterized by extreme skin fragility, blistering, and scarring.

Clinical Terms and Product Definition

Dystrophic epidermolysis bullosa (DEB)

DefinitionAn inherited epidermolysis bullosa disorder characterized by extreme skin fragility.

Genetic basisAll DEB subtypes are caused by mutations in COL7A1, the gene coding for type VII collagen; DEB may be recessive or dominant.

Clinical manifestationsBlisters on the skin and mucosal surfaces characteristically heal with scarring.

Junctional epidermolysis bullosa (JEB)

DefinitionAn epidermolysis bullosa disorder characterized by skin blistering through the lamina lucida of the cutaneous basement membrane zone.

InheritanceJEB is an autosomal recessive disorder.

Policy Summary

PayerCigna

PolicyFilsuvez

Policy CodePolicy IP0635

Change TypeMaterial revision

Effective DateNov 1, 2026

Last ReviewFeb 13, 2025

Next Review DateN/A

Key ActionObtain prior authorization and prescribe Filsuvez by or in consultation with a dermatologist or wound care specialist.

SourceLink

On This Page

Unsupported block type: documentation

Documentation Required

Target-Wound Malignancy Attestation

For initial therapy, the prescriber must attest that there is no evidence or clinical suspicion of squamous cell carcinoma identified at the target wound(s).

The attestation is part of the target-wound requirements for initial therapy.

Documentation Required

Continuation Response Documentation

For continuation therapy on a previously treated wound, document that the target wound remains open and has decreased in size from baseline. Requests for a new wound or a reopened recurrent wound must be evaluated under the initial-therapy criteria.

Continuation approval is for 12 months when all applicable criteria are met.
The medication must be prescribed by or in consultation with a dermatologist or wound care specialist.

Denial Risk

Combination Use with Vyjuvek

Concurrent use of Vyjuvek (beremagene geperpavec-svdt topical gel) and Filsuvez is considered not medically necessary and is not covered under this policy.

Combination use has not been studied.
Patients who had undergone gene therapy for inherited epidermolysis bullosa were excluded from the pivotal EASE trial with Filsuvez.

Denial Risk

Junctional Epidermolysis Bullosa

Filsuvez for junctional epidermolysis bullosa (JEB) is considered not medically necessary and is not covered under this policy because efficacy has not been proven to be better than placebo.

In the pivotal EASE trial, patients with JEB comprised 11% of the total population (n = 26).
At Day 45 (± 7 days), complete wound closure was greater with placebo than Filsuvez in patients with JEB (26.7% vs. 18.6%).
In the open-label extension trial, 12.2% of the total population (n = 25) had JEB; the data did not break down results by epidermolysis bullosa type.

Denial Risk

Missing Covered Coding or Criteria

Claims may be denied as not covered when they are submitted without applicable covered diagnosis and/or procedure code(s), or when the requested use does not meet the policy criteria. Providers must use the most appropriate codes in effect on the submission date.

Reimbursement is not allowed for services billed for conditions or diagnoses that are not covered under this policy.
Claims for services not accompanied by covered code(s) under the applicable policy will be denied as not covered.

Anatomical site of blisteringBlistering occurs through the lamina lucida of the cutaneous basement membrane zone; wounds frequently affect the face, occipital area, diaper area, and extremities.

Filsuvez

Product typeFilsuvez is a sterile botanical drug product for topical use.

Active botanical constituentsIt contains birch triterpenes, a botanical drug substance composed of a mixture of pentacyclic triterpenes.

FormulationThe birch triterpenes are contained in an oil base.

UseFilsuvez is applied to cleansed wounds with wound dressing changes until the wound is healed.