CurrentUnitedHealthcarePolicy CSOH2O25D00127.E

Vyjuvek (beramagene geperpavec-svdt) topical gene therapy — Ohio Medical Benefit Drug Policy (DEB)

Medical benefit coverage policy for Vyjuvek topical gene therapy for treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) in Ohio; applies to requests evaluated under Ohio Administrative Code 5160-1-01.

Policy Summary

PayerUnitedHealthcare

PolicyVyjuvek (beramagene geperpavec-svdt) topical gene therapy — Ohio Medical Benefit Drug Policy (DEB)

Policy CodePolicy CSOH2O25D00127.E

Change TypeSupporting information updated

Effective Date2025

Next Review Date

Key ActionObtain prior authorization with documentation of COL7A1 mutation, patient age ≥6 months, wound eligibility, prescribing dermatologist involvement, and dosing per FDA label.

SourceLink

POLICY UPDATE CHANGES

Supporting Information Updated References section to reflect the most current information; archived previous policy version CSOH2O24D00127.D.

6 monthsminimum patient age for therapy

52 doses/12 moinitial authorization limit

J3401HCPCS code

Q81.2diagnosis code

Coverage Criteria for Vyjuvek (beramagene geperpavec-svdt)

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Initial Therapy

Covered when ALL of the following are met

Initial therapy - patient and wound eligibility: Patient is aged at least 6 months; diagnosis of dystrophic epidermolysis bullosa (DEB); submission of medical records confirming a mutation in the collagen type VII alpha chain (COL7A1; documented in source as COLZA1) gene; patient has at least one recurrent or chronic open wound with adequate granulation tissue, no evidence of active wound infection, and excellent vascularization; no evidence or history of squamous cell carcinoma at the treatment site; Vyjuvek is not being used in combination with Filsuvez (birch triterpenes) on the same wound(s); Vyjuvek is prescribed by, or in consultation with, a dermatologist with expertise in the treatment of DEB; dosing is in accordance with the United States Food and Drug Administration approved labeling.age >= 6 months

Submission of supporting medical records (e.g., chart notes, laboratory values) confirming COL7A1 mutation is required.

Continuation Therapy

Covered for continuation when ALL of the following are met

Continuation therapy: Patient previously treated with Vyjuvek; initial authorization was issued for no more than 12 months and no more than 52 doses; treated wound(s) show a positive clinical response to Vyjuvek (e.g., decrease in wound size, increase in granulation tissue, complete wound closure); 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; dosing is in accordance with the United States Food and Drug Administration approved labeling; Vyjuvek is not being used in combination with Filsuvez (birch triterpenes) on the same wound(s).initial authorization <= 12 months & <= 52 doses

Documentation of prior response (clinical notes, wound measurements/photographs) and original authorization details should be submitted.

Use of Vyjuvek in combination with Filsuvez (birch triterpenes) on the same wound(s) is excluded and will not be covered. This exclusion applies when both products are applied to the same wound site, consistent with the policy language that Vyjuvek must not be used concurrently with Filsuvez on the same wound(s).

Treatment with Vyjuvek is not covered when the target wound demonstrates any of the following: active wound infection, inadequate granulation tissue, poor vascularization, or evidence or a history of squamous cell carcinoma at the treatment site. These wound conditions must be absent to meet medical necessity criteria for initial or continued therapy.

Provider Actions, Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Submit documentation of genetic confirmation of a COL7A1 mutation, patient age (≥ 6 months), wound characteristics, prescribing clinician qualifications, and proposed dosing. Initial authorization will be issued for no more than 12 months and no more than 52 doses.

Ages: patient ≥ 6 months
Genetic confirmation: medical records confirming COL7A1 mutation
Wound criteria: at least one recurrent or chronic open wound with adequate granulation tissue, excellent vascularization, and no active wound infection
Prescriber: prescribed by or in consultation with a dermatologist experienced in DEB
Dosing: must follow FDA-approved labeling
Limit: Initial authorization ≤ 12 months and ≤ 52 doses
Combination therapy: not to be used on the same wound(s) with Filsuvez (birch triterpenes)

Documentation Required

Documentation Requirements

Submit medical records (e.g., chart notes, laboratory values) confirming a mutation in the collagen type VII alpha chain (COL7A1) gene and documentation of wound characteristics and treatment response as applicable.

Genetic test result demonstrating COL7A1 mutation (note: source text contains 'COLZA1' typographical error; the required gene is COL7A1)
Wound documentation: description of wound(s), presence of adequate granulation tissue, vascularization status, and absence of active infection
For continuation: documentation of prior Vyjuvek treatment and positive clinical response (decreased wound size, increased granulation tissue, or complete wound closure)
Documentation that there is no evidence or history of squamous cell carcinoma for treated wound(s)

Denial Risk

Denial Risk / Not Covered Conditions

Applications lacking required documentation or meeting exclusionary conditions risk denial.

Missing or absent genetic confirmation of COL7A1 mutation — denial risk
Active wound infection present — denial risk
Inadequate granulation tissue or poor vascularization — denial risk
Evidence or history of squamous cell carcinoma at the wound site — denial risk
Concurrent use of Vyjuvek and Filsuvez on the same wound(s) — denial risk

Step Therapy

No step therapy requirements are specified in this policy.

Key Definitions

inv-12: Vyjuvek (beramagene geperpavec-svdt) — product definition and indication summary

Product name (generic and brand)beramagene geperpavec-svdt (Vyjuvek)

Therapy typeTopical HSV-1 vector–based gene therapy delivering a functional COL7A1 gene episomally to transduced skin cells

Indication summaryFor treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with COL7A1 mutations; enables production of functional type VII collagen to support formation of anchoring fibrils

Mechanism & durabilityVector deposits genome episomally in nuclei of transduced cells to produce COL7A1 transcripts; does not integrate into chromosomes, so repeat applications are required to maintain effect

Minimum patient age (policy)6 months

Key clinical considerationsRequires dermatologic management of wounds; not a one-time curative integration therapy—ongoing repeated dosing per label is necessary

inv-13: DEB — Dystrophic epidermolysis bullosa definition summary

Condition nameDystrophic epidermolysis bullosa (DEB)

Genetic causeMutations in the collagen type VII alpha 1 chain gene (COL7A1, written in source as COLZA1)

PathophysiologyDefective or deficient type VII collagen (C7) disrupts anchoring fibrils at the epidermal basement membrane, causing fragile skin, recurrent blistering and chronic wounds

Clinical consequencesRecurrent wounds, risk of life‑threatening infections, fibrosis, limb deformities, and increased long‑term risk of squamous cell carcinoma

Inheritance & prevalenceMay be dominant or recessive (RDEB typically more severe); affects ~9,000 people globally (~3,000 in the U.S.)

Background

Dystrophic epidermolysis bullosa (DEB) is an ultra-rare genetic connective tissue disorder caused by mutations in the COL7A1 gene (documented in portions of the source as COLZA1), which result in deficiency of type VII collagen and defective anchoring fibrils. Clinically, DEB produces fragile skin with recurrent blistering and chronic wounds and can be inherited in dominant or recessive forms. Patients with DEB are at increased risk for wound infections and squamous cell carcinoma. Vyjuvek is a topical herpes simplex virus type 1 (HSV-1) vector–based gene therapy that delivers a functional COL7A1 gene episomally to transduced skin cells to enable type VII collagen production; because the delivered gene does not integrate into chromosomes, repeated applications are required per the FDA label.