ModifiedUnitedHealthcarePolicy 2026D0127G

Vyjuvek® (Beramagene Geperpavec-Svdt) – Commercial Medical Benefit Drug Policy

Defines UnitedHealthcare commercial medical-benefit coverage criteria, initial and continuation authorization limits, prescribing and usage constraints, and applicable billing codes for Vyjuvek (beramagene geperpavec-svdt) for treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with COL7A1 mutation(s).

Policy Summary

PayerUnitedHealthcare

PolicyVyjuvek® (Beramagene Geperpavec-Svdt) – Commercial Medical Benefit Drug Policy

Policy CodePolicy 2026D0127G

Change TypeCoverage criteria revised

Effective DateJan 1, 2026

Next Review Date

Key ActionProvider must submit medical records confirming COL7A1 mutation and wound characteristics to support initial authorization and reauthorization.

SourceLink

POLICY UPDATE CHANGES

Added criterion requiring the provider does not request a planned inpatient admission for the sole purpose of administering Vyjuvek.

Removed criterion requiring the patient is aged at least 6 months or older for initial therapy.

Updated FDA and References sections to reflect the most current information and archived previous policy version 2025D0127F.

DEB w/ COL7A1Covered Indications

12 monthsMax authorization duration

52Max doses per authorization

RemovedAge restriction

Coverage Summary

Defines UnitedHealthcare commercial medical-benefit coverage criteria for Vyjuvek (beramagene geperpavec-svdt) as treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with confirmed COL7A1 mutation(s), requiring submission of medical records confirming the mutation and wound characteristics (adequate granulation tissue, excellent vascularization, no active infection, no evidence/history of squamous cell carcinoma). Prescribing constraints require Vyjuvek to be prescribed by or in consultation with a dermatologist experienced in DEB and not used on the same wound(s) as Filsuvez; the provider must not request a planned inpatient admission solely for administration. Authorization limits follow FDA labeling with initial and reauthorization authorizations issued for no more than 12 months and no more than 52 doses. Applicable billing and diagnosis codes include HCPCS J3401 and ICD-10 Q81.2.

Initial Therapy — Proven / Medically Necessary

Vyjuvek is proven and medically necessary for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) who meet ALL of the following criteria:

Diagnosis and genetic confirmation
- Diagnosis of dystrophic epidermolysis bullosa (DEB).
- Genetic confirmation: Submission of medical records (e.g., chart notes, laboratory values) confirming a mutation in the collagen type VII alpha 1 chain (COL7A1) gene.
Wound characteristics
- Wound subgroup criteria
  - Granulation: Adequate granulation tissue
  - Vascularization: Excellent vascularization
  - Infection: No evidence of active wound infection
  - SCC: No evidence or history of squamous cell carcinoma
Prescribing and combination restrictions
- Dermatology involvement: Vyjuvek is prescribed by, or in consultation with, a dermatologist with expertise in the treatment of DEB.
- No Filsuvez combination: Vyjuvek is not being used in combination with Filsuvez (birch triterpenes) on the same wound(s).
- No planned inpatient admission solely for administration: Provider does not request a planned inpatient admission for the sole purpose of administering Vyjuvek.
Dosing and authorization limits
- Dosing per FDA labeling: Dosing is in accordance with the United States Food and Drug Administration approved labeling.
- Authorization limits: Initial authorization will be issued for no more than 12 months and no more than 52 doses.

Continuation Therapy — Proven / Medically Necessary

Reauthorization is approved when ALL of the following are met:

Prior treatment and response
- Prior treatment: Patient has previously been treated with Vyjuvek therapy.
- Clinical response: Patient had a positive clinical response to Vyjuvek therapy (e.g., decrease in wound size, increase in granulation tissue, complete wound closure).
Wound characteristics for reauthorization
- Granulation:

Applicable Codes

Drug J-code for VyjuvekHCPCSCovered

J3401

Beremagene geperpavec-svdt for topical administration, containing nominal 5 x 10^9 PFU/ml vector genomes, per 0.1 ml

Relevant Diagnosis CodeICD-10

Q81.2

Epidermolysis bullosa dystrophica

Provider Actions / Prior Authorization & Documentation

Prior Authorization

Authorization and documentation submission

Provider must submit medical records (e.g., chart notes, laboratory values) confirming a COL7A1 mutation and wound characteristics — including adequate granulation tissue, excellent vascularization, absence of active wound infection, and no evidence or history of squamous cell carcinoma — to support initial authorization and reauthorization.

J3401
Q81.2

Documentation Required

Dermatology specialist involvement

Vyjuvek must be prescribed by, or in consultation with, a dermatologist with expertise in the treatment of dystrophic epidermolysis bullosa (DEB). Documentation of specialist involvement must be provided to support authorization.

Clinical Evidence

58%Patients with ≥1 adverse event

10%Most common AEs: pruritus, chills, squamous-cell carcinoma (each)

mostly mild/modMajority of AEs were mild or moderate

Efficacy was demonstrated in a randomized, double-blind, intra-subject placebo-controlled trial in which two comparable wounds per subject were randomized to Vyjuvek gel or placebo and treated weekly for 26 weeks, showing significantly higher rates of complete (durable) wound closure with Vyjuvek versus placebo; note that repeated treatment is required because the HSV-1 vector genome is deposited episomally and does not integrate into patients' chromosomes.

Background & Definitions

Vyjuvek is a topical HSV-1 vector-based gene therapy that delivers a normal copy of the COL7A1 gene to patients' skin cells, enabling production and secretion of functional type VII collagen to form anchoring fibrils and restore dermal-epidermal adhesion; because the vector genome remains episomal (does not incorporate into chromosomes), patients must be treated repeatedly to maintain production of healthy skin.

Term	Definition
DEB	Dystrophic epidermolysis bullosa, genetic disorder caused by COL7A1 mutations leading to skin fragility and recurrent wounds.
Complete wound closure	100% wound closure confirmed at two consecutive study visits two weeks apart (durable closure).

Revision History

2026-01-01policy_effectiveLatest

Policy effective date set to January 1, 2026 (Policy Number 2026D0127G).

2026-01-01material_change_addedLatest

Added criterion requiring the provider does not request a planned inpatient admission for the sole purpose of administering Vyjuvek.

2026-01-01material_change_removed

Policy Summary

PayerUnitedHealthcare

PolicyVyjuvek® (Beramagene Geperpavec-Svdt) – Commercial Medical Benefit Drug Policy

Policy CodePolicy 2026D0127G

Change TypeCoverage criteria revised

Effective DateJan 1, 2026

Next Review Date

Key ActionProvider must submit medical records confirming COL7A1 mutation and wound characteristics to support initial authorization and reauthorization.

SourceLink

On This Page

Adequate granulation tissue

Vascularization: Excellent vascularization

Infection: No evidence of active wound infection

SCC: No evidence or history of squamous cell carcinoma

Prescribing and combination restrictions

Dermatology involvement: Vyjuvek is prescribed by, or in consultation with, a dermatologist with expertise in the treatment of DEB.
No Filsuvez combination: Vyjuvek is not being used in combination with Filsuvez (birch triterpenes) on the same wound(s).
No planned inpatient admission solely for administration: Provider does not request a planned inpatient admission for the sole purpose of administering Vyjuvek.

Dosing and authorization limits

Dosing per FDA labeling: Dosing is in accordance with the United States Food and Drug Administration approved labeling.
Authorization limits: Reauthorization will be issued for no more than 12 months and no more than 52 doses.

Billing Rule

Dosing per FDA labeling

Dosing must be consistent with the United States Food and Drug Administration approved labeling for Vyjuvek. Claims or dosing requests that are inconsistent with FDA-approved labeling may be denied.

J3401

Denial Risk

Inpatient admission exclusion

Claims may be denied if a provider requests a planned inpatient admission solely for the purpose of administering Vyjuvek; do not request inpatient admission for that sole purpose.

Documentation Required

No combination on same wound with Filsuvez

Vyjuvek must not be used in combination with Filsuvez (birch triterpenes) on the same wound(s). Providers should document that concurrent use on the same wound(s) is not occurring.

Removed criterion requiring the patient be at least 6 months of age or older for initial therapy (minimum age requirement removed).

2026-01-01non_material_updateLatest

Updated FDA and References sections to reflect current information and archived previous policy version 2025D0127F.