CurrentCignaPolicy IP0635

Filsuvez

Defines clinical coverage, medical necessity criteria, duration, exclusions, and prescribing requirements for Filsuvez topical gel for treatment of wounds associated with dystrophic epidermolysis bullosa (DEB) and related continuation therapy for previously treated wounds for Cigna-administered plans.

Policy Summary

PayerCigna

PolicyFilsuvez

Policy CodePolicy IP0635

Change TypeAnnual revision (no criteria changes)

Effective DateApr 15, 2025

Next Review Date

Key ActionPrescriber must attest to criteria and provide documentation of DEB features, target wound measurements and age, wound cleanliness and cancer ruled out; approvals are for 3 months.

POLICY UPDATE CHANGES

New policy created with Date = 07/15/2024 then underwent annual revision with no criteria changes on 4/15/2025.

1Covered FDA Indication (DEB)

3Covered approval duration (months)

6Minimum patient age (months)

2Explicit not-covered uses (JEB; combo with Vyjuvek)

Coverage Summary

Coverage stance: Covered with criteria — Filsuvez (birch triterpenes topical gel) is covered for the FDA‑approved indication of wounds associated with dystrophic epidermolysis bullosa (DEB) when the medical necessity criteria are met. Policy effective/last review date: Effective 04/15/2025; Last review 04/15/2025 (policy IP0635; new policy 07/15/2024 with annual revision 04/15/2025, no criteria changes).

Explicit not‑covered uses (short):

- Junctional EB (JEB) (efficacy not proven vs placebo).

- Combination use with Vyjuvek (beremagene geperpavec) — not studied and considered experimental/investigational/unproven.

Initial Therapy Criteria (FDA‑Approved Indication)

Medical Necessity Criteria - FDA-Approved Indication (Dystrophic Epidermolysis Bullosa)

Filsuvez is considered medically necessary when the following is met:

One of

A) Initial Therapy
- i. Patient age: Patient is ≥ 6 months of age.≥ 6 months
- ii. Clinical features and target wound
  - a) Clinical feature: Patient has at least one clinical feature of dystrophic epidermolysis bullosa.
  - b) Open wound(s): Patient has one or more open wound(s) that will be treated (i.e., 'target wound[s]').
    Definition: target wound involves loss of the epidermis; extension into dermis allowed.
  - c) Target wound(s) meet ALL of the following according to the prescriber: Target wound(s) meet ALL of the following according to the prescriber10 cm2 - 50 cm2; ≥ 21 days and < 9 months
    (1) clean/not infected; (2) surface area 10 cm2 to 50 cm2; (3) wound age ≥ 21 days and < 9 months; (4) squamous cell and/or basal cell carcinoma has been ruled out for the target wound(s).
- iii. Prescriber specialty: The medication is prescribed by or in consultation with a dermatologist or wound care specialist.

B) Patient Currently Receiving Filsuvez on Previously Treated Wound(s)

i. Target wound remains open: According to the prescriber, the target wound(s) remains open.
ii. Wound decreased from baseline: According to the prescriber, the target wound(s) has decreased in size from baseline.
Baseline size must be documented for continuation requests.
iii. Prescriber specialty: The medication is prescribed by or in consultation with a dermatologist or wound care specialist.

Continuation Therapy Criteria (Previously Treated Wound[s])

Patient Currently Receiving Filsuvez on Previously Treated Wound(s)

B) Patient Currently Receiving Filsuvez on Previously Treated Wound(s)

i. Target wound remains open: According to the prescriber, the target wound(s) remains open.
ii. Wound decreased from baseline: According to the prescriber, the target wound(s) has decreased in size from baseline.
iii. Prescriber specialty: The medication is prescribed by or in consultation with a dermatologist or wound care specialist.

Unproven Uses and Exclusions

Coverage Exclusions / Not Covered Uses

Exclusions (Not Covered)

Junctional Epidermolysis Bullosa (JEB): Use for Junctional Epidermolysis Bullosa (JEB) is not covered (efficacy not proven better than placebo).
Not covered.
Combination with Vyjuvek: Combination use with Vyjuvek (beremagene geperpavec-svdt topical gel) is not covered as it has not been studied and patients who had undergone gene therapy were excluded from pivotal trials.
Not covered.
Other non-DEB uses: Any other indication or combination use outside of DEB (not listed above) is considered experimental/investigational and not covered.
Not covered.

EASE trial exclusions: patients who had undergone prior gene therapy or stem cell transplant for inherited EB were excluded from enrollment, and patients with current and/or former malignancy (including basal cell carcinoma and squamous cell carcinoma) were also ineligible.

Clinical criteria requirement: for target wounds to qualify, squamous cell and/or basal cell carcinoma must be ruled out for the target wound(s) (see target wound criteria).

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization / approval duration

Approval is for 3 months for both Initial Therapy and for continuation on previously treated wounds. The prescriber must attest that the patient meets age and clinical criteria, that target wound characteristics meet size and age thresholds, that squamous/basal cell carcinoma has been ruled out for the target wound, and that the medication is prescribed by or in consultation with a dermatologist or wound care specialist.

Approval duration: 3 months for Initial Therapy and for Previously Treated Wound(s).
Prescriber attestation must include: age, wound characteristics, wound size/age, cancer ruled out, and specialty (dermatologist or wound care specialist).

Documentation Required

Clinical documentation required

Required documentation includes: clinical feature(s) of dystrophic epidermolysis bullosa (examples: blistering, wounds, scarring); target wound measurements (surface area 10 cm2 to 50 cm2) and target wound age (≥ 21 days and < 9 months); documentation that the target wound is clean in appearance and not infected; documentation that squamous cell and/or basal cell carcinoma has been ruled out for the target wound; and for continuation requests, documentation of baseline wound size for comparison.

Clinical features of DEB (e.g., blistering, wounds, scarring).
Target wound measurements: 10 cm2 to 50 cm2.
Target wound age: ≥ 21 days and < 9 months.
Target wound is clean/not infected.
Squamous cell and/or basal cell carcinoma ruled out for the target wound.
Baseline wound size documented for continuation requests.

Denial Risk

Coverage exclusions / denial conditions

Use of Filsuvez for any indication other than dystrophic epidermolysis bullosa (DEB) is considered experimental, investigational, or unproven and is not covered. Specifically, combination use with Vyjuvek and use in junctional EB (JEB) are listed as not covered and will be denied.

Combination use with Vyjuvek is not covered (not studied).
Junctional EB (JEB) use is not covered — efficacy not proven and trial data did not show benefit.

Clinical Evidence

Key evidence — EASE Phase III pivotal trial (randomized, double‑blind, placebo‑controlled; n=223) demonstrated a statistically significant increase in complete target wound closure at Day 45: 41.3% with Filsuvez vs 28.9% with placebo (P = 0.013).

Subtype results: the benefit was driven by the RDEB subgroup (Day 45 complete closure 44.0% vs 26.2% for placebo; P = 0.008); the JEB subgroup showed no benefit (18.6% Filsuvez vs 26.7% placebo).

Trial population exclusions reiterated: the study excluded patients with prior stem cell transplant or gene therapy and those with current or former malignancy (including basal cell and squamous cell carcinoma).

Trial Highlights (EASE Phase III)

Primary endpoint (Day 45) - overallComplete wound closure: 41.3% (Filsuvez) vs 28.9% (placebo); P = 0.013

RDEB subgroup (Day 45)44.0% (Filsuvez) vs 26.2% (placebo); relative risk 1.72; 95% CI: 1.14-2.59; P = 0.008

JEB subgroup (Day 45)18.6% (Filsuvez) vs 26.7% (placebo); no benefit demonstrated