CurrentColorado Rocky Mountain Health PlansPolicy IEXD0127.07

Vyjuvek (beramagene geperpavec-svdt) topical gene therapy coverage criteria

Medical benefit drug policy governing coverage criteria and authorization requirements for Vyjuvek for treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) for Individual Exchange plans (excludes MA, NV, NY).

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyVyjuvek (beramagene geperpavec-svdt) topical gene therapy coverage criteria

Policy CodePolicy IEXD0127.07

Change TypeMaterial updates to coverage criteria (added inpatient-admission restrictionremoved age minimum)

Effective DateJan 1, 2026

Next Review Date

Key ActionObtain and submit medical records confirming a COL7A1 mutation for initial authorization.

SourceLink

POLICY UPDATE CHANGES

Added requirement that 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.

≤52max doses / 12 months

J3401HCPCS

Q81.2ICD-10

All except MA,NV,NYapplicability

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Coverage Criteria

Initial Therapy

Covered when ALL of the following are met for initial therapy:

Diagnosis of dystrophic epidermolysis bullosa (DEB)

Genetic confirmation: Submission of medical records confirming a mutation in the COL7A1 gene

Example: chart notes, laboratory values

Wound characteristics: Patient has at least one recurrent or chronic open wound with: adequate granulation tissue; excellent vascularization; no evidence of active wound infection; and no evidence or history of squamous cell carcinoma

All wound subcriteria must be met

Prescriber: Vyjuvek is prescribed by, or in consultation with, a dermatologist with expertise in the treatment of DEB

Concomitant use: Vyjuvek is not being used in combination with Filsuvez (birch triterpenes) on the same wound(s)

Inpatient admission: 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

Authorization limits: Initial authorization will be issued for no more than 12 months and no more than 52 doses

Continuation Therapy

Covered when ALL of the following are met for continuation of therapy:

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: Wound(s) being treated have: adequate granulation tissue; excellent vascularization; no evidence of active wound infection; and no evidence or history of squamous cell carcinoma

All subcriteria must be met

Prescriber: Vyjuvek is prescribed by, or in consultation with, a dermatologist with expertise in the treatment of DEB

Use of Vyjuvek in combination with Filsuvez (birch triterpenes) on the same wound(s) is excluded from coverage under these criteria.

Wounds that do not meet specified wound bed requirements are not medically necessary for treatment with Vyjuvek. Specifically, coverage is limited to wounds that have adequate granulation tissue, excellent vascularization, no evidence of active wound infection, and no evidence or history of squamous cell carcinoma. Wounds lacking any of these elements do not meet the medical necessity criteria and are excluded from coverage.

Initial Vyjuvek Therapy Criteria

Initial Vyjuvek therapy

Covered when ALL of the following are met for initial therapy:

Diagnosis of dystrophic epidermolysis bullosa (DEB)

Genetic confirmation: Submission of medical records confirming a mutation in the COL7A1 gene

Example: chart notes, laboratory values

All wound subcriteria must be met

Prescriber: Vyjuvek is prescribed by, or in consultation with, a dermatologist with expertise in the treatment of DEB

Continuation / Reauthorization Criteria

Vyjuvek continuation

Reauthorization criteria

Prior Vyjuvek treatment: Patient previously treated with Vyjuvek

Clinical benefit: Positive clinical response to therapy (e.g., decrease in wound size, increased granulation, or complete wound closure)

Wound requirements: Wound(s) being treated have adequate granulation tissue, excellent vascularization, no evidence of active wound infection, and no evidence or history of squamous cell carcinoma

Limits: Reauthorization for no more than 12 months and no more than 52 doses

Coding

Covered HCPCSHCPCSCovered

J3401

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

Relevant Diagnosis CodesICD-10

Q81.2

Epidermolysis bullosa dystrophica

Provider Actions and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial authorizations will be issued for no more than 12 months and no more than 52 doses; reauthorization will be issued for no more than 12 months and no more than 52 doses.

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

Step Therapy

No Step Therapy

No step therapy or required prior failures with other topical products is required for Vyjuvek.

Documentation Required

Genetic Confirmation Required

Site of Care

Note

Site of care — no planned inpatient admission solely for administration

Planned inpatient admission solely for the purpose of administering Vyjuvek is prohibited by the coverage criteria; otherwise site of care follows usual benefit rules (office, outpatient, or home).

Allowed sites per policy: office, outpatient, home.

Quantity Limits

Vyjuvek quantity limit

Maximum doses (per authorization)Up to 52 doses per authorization (no more than 12 months)

Authorization durationInitial and reauthorization limited to no more than 12 months

Reauthorization limitReauthorization issued for no more than 52 doses per 12 months

Background

Dystrophic epidermolysis bullosa (DEB) is an ultra‑rare genetic disorder caused by mutations in the COL7A1 gene, which encodes type VII collagen and leads to recurrent skin wounds. Vyjuvek (beramagene geperpavec-svdt) is an HSV-1 vector–based topical gene therapy that delivers a functional COL7A1 copy to skin cells to treat wounds in patients with genetically confirmed DEB. Because the vector remains episomal, repeated topical administrations are required to maintain effect.

Definitions

Definition: COL7A1

GeneCOL7A1 (collagen type VII alpha 1 chain)

Role in DEBCodes for type VII collagen (C7), a major component of anchoring fibrils that bind the dermis and epidermis; mutations disrupt adhesion leading to recurrent skin wounds and DEB

Clinical consequenceMutations result in absent or deficient COL7A1, causing skin fragility, recurring wounds, and increased risk of squamous cell carcinoma

Definition: Vyjuvek

ProductVyjuvek (beramagene geperpavec-svdt)

DescriptionTopical herpes simplex virus type 1 (HSV-1) vector-based gene therapy that delivers a functional COL7A1 copy to skin cells; vector genome remains episomal requiring repeated treatments