CurrentColorado Rocky Mountain Health PlansPolicy CSOH2026D00127.F

Vyjuvek (beramagene geperpavec-svdt) topical therapy for dystrophic epidermolysis bullosa

Policy governs medical benefit coverage and authorization criteria for Vyjuvek topical gene therapy for treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) in the state of Ohio; applies to providers requesting coverage under the payer's Ohio medical benefit drug policy.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyVyjuvek (beramagene geperpavec-svdt) topical therapy for dystrophic epidermolysis bullosa

Policy CodePolicy CSOH2026D00127.F

Change TypeCoverage criteria added and removed

Effective DateFeb 1, 2026

Next Review Date

Key ActionSubmit medical records confirming COL7A1 mutation and required wound characteristics when requesting prior authorization; initial and reauthorization approvals limited to 12 months and up to 52 doses.

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.

12 mo / 52authorization duration / dose limit

J3401HCPCS

Q81.2Diagnosis

Ohio

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Coverage Criteria

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

Initial therapy criteria: Diagnosis of dystrophic epidermolysis bullosa (DEB); submission of medical records confirming a COL7A1 mutation; patient has at least one recurrent or chronic open wound that meets all required wound characteristics; prescribed by or in consultation with a dermatologist with expertise in DEB; not used concurrently with Filsuvez (birch triterpenes) on the same wound(s); provider does not request a planned inpatient admission solely to administer Vyjuvek; dosing per FDA-approved labeling; initial authorization limited to no more than 12 months and 52 doses.

Required wound characteristics: adequate granulation tissue; excellent vascularization; no evidence of active wound infection; no evidence or history of squamous cell carcinoma.

Continuation (Reauthorization) — Covered when ALL of the following are met

Covered when ALL of the following are met:

Continuation criteria: Patient previously treated with Vyjuvek; patient had a positive clinical response to Vyjuvek (e.g., decrease in wound size, increased granulation tissue, or complete wound closure); wound(s) continue to meet required wound characteristics; prescribed by or in consultation with a dermatologist with expertise in DEB; not used concurrently with Filsuvez (birch triterpenes) on the same wound(s); provider does not request a planned inpatient admission solely to administer Vyjuvek; dosing per FDA-approved labeling; reauthorization limited to no more than 12 months and 52 doses.

Required wound characteristics: adequate granulation tissue; excellent vascularization; no evidence of active wound infection; no evidence or history of squamous cell carcinoma.

Use of Vyjuvek in combination with Filsuvez (birch triterpenes) on the same wound(s) is not permitted.

Requests that do not include documentation demonstrating a COL7A1 mutation, lack required wound characteristics, or indicate a planned inpatient admission solely for the purpose of administering Vyjuvek will not meet medical necessity. Required wound characteristics for both initial and continuation therapy include: adequate granulation tissue, excellent vascularization, no evidence of active wound infection, and no evidence or history of squamous cell carcinoma.

Prior authorization is required. Initial and reauthorization approvals are limited to a maximum of 12 months and no more than 52 doses. Dosing must follow the FDA-approved labeling and Vyjuvek must be prescribed by, or in consultation with, a dermatologist experienced in DEB.

Coding and Authorization Limits

Referenced HCPCSHCPCS

J3401

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

Referenced ICD-10 DiagnosisICD-10

Q81.2

Epidermolysis bullosa dystrophica

Authorization limits — inv-07

Maximum authorization duration12 months per authorization

Maximum doses per authorizationNo more than 52 doses per authorization

Applies to initial and reauthorizationLimit of 12 months and 52 doses applies to both initial and continuation (reauthorization) approvals

Prior authorization requiredPrior authorization must be obtained before Vyjuvek is dispensed (see coding and provider actions).

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Vyjuvek. Initial authorizations are limited to a maximum of 12 months and up to 52 doses.

Initial authorization: <= 12 months
Initial authorization: <= 52 doses

Step Therapy

No step therapy requirements are specified for Vyjuvek.

Documentation Required

Documentation and Submission Requirements

Submit complete medical records to support the request, including chart notes and laboratory documentation confirming a COL7A1 mutation and wound details (e.g., granulation, vascularization, signs of infection, history of squamous cell carcinoma). Vyjuvek must be prescribed by or in consultation with a dermatologist experienced in DEB and dosing must follow FDA labeling.

Background

Dystrophic epidermolysis bullosa (DEB) is an ultra-rare genetic connective tissue disorder caused by mutations in the COL7A1 gene leading to deficient type VII collagen. Patients with DEB develop recurrent and chronic skin wounds that carry risks of infection and squamous cell carcinoma.

Vyjuvek (beramagene geperpavec-svdt) is a topical, nonintegrating HSV-1 vector–based gene therapy that delivers a functional copy of COL7A1 episomally to skin cells to enable production of type VII collagen; because the therapy is nonintegrating, repeat dosing is required to maintain effect.

Definitions

DEB — inv-13

Condition nameDystrophic epidermolysis bullosa (DEB)

Genetic causeCaused by mutations in the COL7A1 gene (collagen type VII alpha 1 chain)

PathophysiologyDeficiency or absence of type VII collagen leads to impaired anchoring fibrils at the dermal-epidermal junction, resulting in skin fragility and recurrent wounds

Clinical consequencesRecurrent blistering and wounds, risk of infection, squamous cell carcinoma, limb deformities; may be inherited dominantly or recessively

Vyjuvek — inv-14

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