CurrentUnitedHealthcarePolicy IEXD0127.06

Vyjuvek (beramagene geperpavec-svdt) topical gene therapy

Defines UnitedHealthcare's medical benefit coverage criteria, required documentation, prescribing requirements, dosing limits, applicable codes, and background for Vyjuvek for treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with COL7A1 mutations.

Policy Summary

PayerUnitedHealthcare

PolicyVyjuvek (beramagene geperpavec-svdt) topical gene therapy

Policy CodePolicy IEXD0127.06

Change TypeSupporting information update

Effective DateJun 1, 2025

Next Review Date

Key ActionSubmit medical records confirming COL7A1 mutation and wound documentation (granulation, vascularization, absence of infection and squamous cell carcinoma); authorizations limited to 12 months and up to 52 doses.

SourceLink

POLICY UPDATE CHANGES

Updated References section to reflect the most current information and archived previous policy version IEXD00127.05.

6 months+Minimum eligible age

52Authorization dose cap per 12-month period

COL7A1Genetic confirmation required

Coverage Summary

Scope: Defines UnitedHealthcare's medical benefit coverage criteria, required documentation, prescribing requirements, dosing limits, applicable codes, and background for Vyjuvek for treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with COL7A1 mutations. Coverage stance: covered_with_criteria. Policy Number: IEXD0127.06. Subject: Vyjuvek (beramagene geperpavec-svdt) topical gene therapy. High-level approval statement: Approved for treatment of wounds in patients aged >= 6 months with DEB and confirmed COL7A1 mutation when all coverage criteria are met. Effective date: June 1, 2025. Last review: June 1, 2025.

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Initial Therapy Criteria

Initial Therapy

Covered when ALL of the following are met:

Patient is aged at least 6 months and older>= 6 months

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) geneCOL7A1 mutation required

Wound criteria (ALL of the following)

Patient has at least one recurrent or chronic open wound
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)

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 dosesInitial / Reauthorization duration <= 12 months; Dose limit per authorization <= 52 doses

Authorization limit: 12 months; maximum 52 doses

Continuation (Reauthorization) Criteria

Continuation Therapy

Covered when ALL of the following are met:

Patient has previously been 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 (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)

Dosing is in accordance with the United States Food and Drug Administration approved labeling

Reauthorization will be issued for no more than 12 months and no more than 52 dosesInitial / Reauthorization duration <= 12 months; Dose limit per authorization <= 52 doses

Reauthorization limit: 12 months; maximum 52 doses

Provider Actions & Billing Rules

Prior Authorization

Authorization required with documentation

Submit medical records confirming a COL7A1 mutation and wound documentation (granulation, vascularization, absence of infection and squamous cell carcinoma). Initial and reauthorization limited to 12 months and up to 52 doses.

J3401
Q81.2
Initial and reauthorization: up to 12 months; up to 52 doses

Documentation Required

Specialist prescribing requirement

Vyjuvek must be prescribed by, or in consultation with, a dermatologist with expertise in the treatment of DEB; document the consultation or prescriber specialty in the medical record.

Billing Rule

Dosing per FDA labeling

Dosing must follow United States Food and Drug Administration approved labeling. Authorization and reimbursement are limited to no more than 52 doses per 12-month authorization period.

J3401
Limit: ≤ 52 doses per 12-month authorization period

Denial Risk

Combination therapy exclusion

Claims may be denied if Vyjuvek is used in combination with Filsuvez (birch triterpenes) on the same wound(s).

Clinical Evidence

58% had ≥1 AE58% had ≥1 adverse event; mostly mild/moderate

3 SCC in untreated woundsThree squamous-cell carcinoma cases occurred in wounds not treated with drug

Evidence summary: The pivotal study was a randomized, double-blind, intra-subject placebo-controlled trial enrolling 31 subjects with genetically confirmed COL7A1 mutations; two comparable wounds per subject were randomized to Vyjuvek or placebo and treated weekly for 26 weeks. The primary efficacy outcome was the proportion of wounds with durable complete (100%) wound closure at 24 weeks confirmed at two consecutive visits two weeks apart (assessed at Weeks 22/24 or 24/26); Vyjuvek achieved substantially higher closure rates than placebo. Safety findings: 58% of subjects had ≥1 adverse event, mostly mild/moderate; five serious adverse events in three patients were judged unrelated to treatment, one mild erythema was considered related, and three cases of squamous-cell carcinoma occurred in wounds not exposed to study drug.

Background

Background: Vyjuvek is an HSV-1 vector–based topical gene therapy that delivers a functional copy of COL7A1 to skin cells, enabling production and secretion of functional C7 (type VII collagen) protein necessary for anchoring fibril formation. Indication: topical treatment of wounds in patients aged 6 months and older with dystrophic epidermolysis bullosa (DEB) and mutation(s) in the COL7A1 gene. Product notes: the vector genome is deposited episomally (does not integrate into patient chromosomes), and because it does not incorporate into host DNA, repeated treatment is required. Applicable code: HCPCS J3401 (Beremagene geperpavec-svdt for topical administration, containing nominal 5 x 10^9 pfu/ml vector genomes, per 0.1 ml).

Definitions

Policy thresholds