CurrentUnitedHealthcarePolicy CS2026D00127J

Vyjuvek (Beramagene Geperpavec-Svdt) Medical Benefit Drug Policy

Defines UnitedHealthcare Medical Benefit Drug Policy coverage, criteria, and billing code guidance for Vyjuvek for treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with COL7A1 mutations. Excludes certain state-specific applicability noted in Application.

Policy Summary

PayerUnitedHealthcare

PolicyVyjuvek (Beramagene Geperpavec-Svdt) Medical Benefit Drug Policy

Policy CodePolicy CS2026D00127J

Change TypeRevised application state language

Effective DateApr 1, 2026

Next Review Date

Key ActionSubmit medical records confirming a mutation in the COL7A1 gene (e.g., chart notes, laboratory values) as part of coverage determination.

SourceLink

POLICY UPDATE CHANGES

Application section removed content/language pertaining to the states of Indiana and Louisiana and archived previous policy version CS2026D00127I.

1Drug Indication (DEB with COL7A1 mutation)

52Max doses per authorization

12 moMax authorization duration

J3401Primary billing code

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Coverage stance: covered_with_criteria. Subject: Vyjuvek (beramagene geperpavec‑svdt). Policy number: CS2026D00127J. Effective date: 2026-04-01; Last review: 2026-04-01. Scope summary: Defines UnitedHealthcare Medical Benefit Drug Policy coverage, criteria, and billing code guidance for Vyjuvek for treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with COL7A1 mutations. Note: state-specific application language for Indiana and Louisiana was removed from the Application and the prior policy version was archived.

Initial Therapy - Medical Necessity Criteria

Covered when ALL of the following are met:

ALL of the following

Diagnosis of dystrophic epidermolysis bullosa (DEB).
Submission of medical records (e.g., chart notes, laboratory values) confirming a mutation in the collagen type VII alpha 1 chain (COL7A1) gene.
Wound criteria (patient has at least one recurrent or chronic open wound that meets all of the following)
- Adequate granulation tissue.
- Excellent vascularization.
- No evidence of active wound infection.
- No evidence or history of squamous cell carcinoma.
Vyjuvek is prescribed by, or in consultation with, a dermatologist with expertise in the treatment of DEB.
Vyjuvek is not being used in combination with Filsuvez (birch triterpenes) on the same wound(s).
Provider does not request a planned inpatient admission for the sole purpose of administering Vyjuvek.
Dosing is in accordance with the United States Food and Drug Administration approved labeling.
Initial authorization will be issued for no more than 12 months and no more than 52 doses.
Authorization limit

Continuation Therapy - Reauthorization Criteria

Covered when ALL of the following are met:

ALL of the following

Patient has been previously treated with Vyjuvek therapy.
Patient had a positive clinical response to Vyjuvek therapy (e.g., decrease in wound size, increase in granulation tissue, complete wound closure).
Wound criteria for treated wounds
- Adequate granulation tissue.
- Excellent vascularization.
- No evidence of active wound infection.

Provider Actions & Authorization Requirements

Documentation Required

Genetic confirmation required

Submit medical records confirming a mutation in the COL7A1 gene (e.g., chart notes, laboratory values) as part of coverage determination.

Chart notes
Genetic test reports
Laboratory values

Prior Authorization

Prior authorization required with limits

Initial authorization limited to no more than 12 months and no more than 52 doses; reauthorization also limited to no more than 12 months and 52 doses.

Initial: no more than 12 months; no more than 52 doses
Reauthorization: no more than 12 months; no more than 52 doses
Affected code: J3401

Documentation Required

Dermatology specialty prescribing/consult requirement

Vyjuvek must be prescribed by, or in consultation with, a dermatologist with expertise in DEB.

Denial Risk

Combination therapy exclusion

Claims may be denied or not approved if Vyjuvek is used in combination with Filsuvez (birch triterpenes) on the same wound(s).

Affected code: J3401

Denial Risk

Inpatient admission exclusion

Requests for planned inpatient admission solely for administering Vyjuvek are not allowed.

Clinical Evidence

67% vs 22%Complete wound closure at 6 months (difference 46 percentage points; 95% CI 24 to 68; p=0.002)

71% vs 20%Complete wound closure at 3 months (difference 51 percentage points; 95% CI 29 to 73; p<0.001)

Pivotal trial results support Vyjuvek’s efficacy: complete wound closure at 6 months 67% with Vyjuvek vs 22% with placebo (difference 46 percentage points; 95% CI 24 to 68; p=0.002), and at 3 months 71% vs 20% (difference 51 percentage points; 95% CI 29 to 73; p<0.001). Mechanism: Vyjuvek is a topical HSV‑1 vector delivering a normal COL7A1 copy to skin cells; the vector genome is deposited episomally and is non‑integrating, therefore repeated application is required to maintain COL7A1 expression and clinical benefit.

Background & Definitions

Background: Dystrophic epidermolysis bullosa (DEB) is caused by mutations in the COL7A1 gene leading to deficient type VII collagen, fragile skin, and chronic wounds. Vyjuvek is a topical gene therapy using an HSV‑1 vector to introduce a normal COL7A1 gene copy into skin cells; the vector genome is deposited episomally so it does not integrate into the patient’s chromosomes. Clinical implication: because the COL7A1 transgene is not integrated, patients require repeated topical administrations per labeled dosing to continue producing functional C7 protein and support wound healing. Applicability note: the policy’s Application removed Indiana and Louisiana language per the policy history.

Term	Definition
DEB
Dystrophic epidermolysis bullosa, a genetic connective tissue disorder caused by COL7A1 mutations.
COL7A1
Collagen type VII alpha 1 chain gene; encodes type VII collagen (C7) important for anchoring fibrils.

Unproven Uses / Exclusions

Exclusions and limits: Use of Vyjuvek in combination with Filsuvez (birch triterpenes) on the same wound(s) is explicitly excluded and may lead to claim denial. Planned inpatient admission requested solely for the purpose of administering Vyjuvek is not allowed. Authorization limits: initial and reauthorization are each limited to no more than 12 months and no more than 52 doses. Applicability note: Indiana and Louisiana-specific application language was removed from the policy.