Currentsierra health and lifePolicy 2026D0127G

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

Coverage and medical necessity criteria for Vyjuvek topical gene therapy for wounds in patients with dystrophic epidermolysis bullosa (DEB) with COL7A1 mutations, applicable to Sierra Health and Life members under the referenced benefit document.

Policy Summary

Payersierra health and life

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

Policy CodePolicy 2026D0127G

Change TypeMaterial revisions to coverage criteria (added inpatient admission prohibitionremoved prior age floor)

Effective DateJan 1, 2026

Next Review Date

Key ActionSubmit prior authorization with COL7A1 mutation documentation, dermatologist involvement, wound assessments, and dosing per FDA labeling.

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.

52max doses / auth

12 monthsmax duration

J3401HCPCS

Q81.2

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Vyjuvek

inv-01: Initial Therapy — Covered when ALL of the following are met for initial therapy

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

Initial therapy criteria: Diagnosis of dystrophic epidermolysis bullosa (DEB); submission of medical records confirming a mutation in the COL7A1 gene; 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; 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); provider does not request a planned inpatient admission for the sole purpose of administering Vyjuvek; dosing is in accordance with FDA‑approved labeling; initial authorization for no more than 12 months and no more than 52 doses.

inv-02: Continuation Therapy — Covered when ALL of the following are met for continuation of therapy

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

Continuation therapy criteria: Patient previously treated with Vyjuvek; patient had a positive clinical response to Vyjuvek (e.g., decrease in wound size, increase in granulation tissue, or complete wound closure); 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; 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); provider does not request a planned inpatient admission for the sole purpose of administering Vyjuvek; dosing is in accordance with FDA‑approved labeling; reauthorization for no more than 12 months and no more than 52 doses.

Vyjuvek must not be used in combination with Filsuvez (birch triterpenes) on the same wound(s).

Planned inpatient admission solely for the purpose of administering Vyjuvek is not an approval criterion and may be considered not medically necessary; providers should arrange administration in an outpatient setting (office, infusion center) rather than requesting hospitalization solely to deliver the product.

Initial Therapy Criteria

inv-15: Initial therapy criteria — 1 top-level node

Initial therapy criteria: Indicated for patients with genetically confirmed COL7A1 mutation(s) and at least one wound meeting wound criteria (adequate granulation tissue, excellent vascularization, no evidence of active wound infection, and no evidence or history of squamous cell carcinoma); prescribed by, or in consultation with, a dermatologist with expertise in DEB; not combined with Filsuvez on the same wound(s); dosing per FDA labeling; authorization up to 12 months and up to 52 doses.

Reauthorization / Continuation Criteria

inv-16: Reauthorization criteria — 1 top-level node

Reauthorization criteria: See Coverage.criteria_sets Continuation Therapy: patient previously treated with Vyjuvek with documented positive clinical response (e.g., decrease in wound size, increased granulation tissue, or closure); treated wound(s) continue to meet wound criteria (adequate granulation tissue, excellent vascularization, no active infection, no evidence or history of squamous cell carcinoma); prescribed by, or in consultation with, a dermatologist with expertise in DEB; not combined with Filsuvez on the same wound(s); provider does not request planned inpatient admission solely for administration; dosing per FDA labeling; reauthorization up to 12 months and up to 52 doses.

Coding and Authorization Details

Applicable HCPCS CodesHCPCS

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

Authorization duration and dose cap

Authorization durationUp to 12 months per authorization

Dose cap per authorizationUp to 52 doses per authorization

ApplicabilityApplies to initial approvals and reauthorizations as specified in criteria

Provider Requirements and Actions

Prior Authorization

Prior authorization requirements

Prior authorization is required. Requests must document a COL7A1 gene mutation, be prescribed by or in consultation with a dermatologist with expertise in DEB, describe wound characteristics (adequate granulation tissue, excellent vascularization, no active wound infection, and no evidence/history of squamous cell carcinoma), confirm no concurrent use of Filsuvez on the same wound(s), and indicate dosing is in accordance with FDA labeling; initial approvals are limited to no more than 12 months and no more than 52 doses.

Submission of medical records confirming COL7A1 mutation
Prescribed by or in consultation with a dermatologist with expertise in DEB
Wound meets: adequate granulation tissue; excellent vascularization; no active wound infection; no evidence/history of squamous cell carcinoma
Not used in combination with Filsuvez on the same wound(s)
Dosing per FDA labeling; initial authorization ≤12 months and ≤52 doses

Step Therapy

Concurrent therapy restriction — no Filsuvez on same wound(s)

Site of Care Guidance

Note

Site-of-care: inpatient admission solely for administration is prohibited

Planned inpatient admission solely for the purpose of administering Vyjuvek is not acceptable; site of care should be office, infusion center, or outpatient settings and providers should not seek inpatient admission solely to deliver the drug.

Do not request a planned inpatient admission solely for administration of Vyjuvek
Preferred sites of care: office, infusion center, outpatient

Quantity Limits and Product

Vyjuvek (beramagene geperpavec-svdt) — quantity limit

Quantity limit (doses per year)52 doses per year

Per-authorization capMaximum of 52 doses per authorization period (see authorization duration)

Coding referenceListed HCPCS code J3401 applies to product billing

Key Definitions

Dystrophic epidermolysis bullosa (DEB) — definition

DefinitionDystrophic epidermolysis bullosa (DEB) is an ultra-rare genetic connective tissue disorder caused by mutations in the COL7A1 gene leading to deficient or absent type VII collagen and resulting in fragile skin with recurrent wounds.

GeneticsCaused by mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene; may be inherited in dominant or recessive patterns

Clinical featuresSkin fragility, multiple recurring wounds, risk of squamous cell carcinoma, infections, and limb deformities

Vyjuvek mechanism

Mechanism of actionTopical HSV-1 vector gene therapy that delivers a functional COL7A1 copy to patients' skin cells; the vector genome is deposited episomally and generates COL7A1 transcripts to produce functional type VII collagen without integrating into the patient’s chromosomes.

Administration

Background

Dystrophic epidermolysis bullosa (DEB) is an ultra-rare genetic connective tissue disorder caused by mutations in the COL7A1 gene resulting in deficient type VII collagen and fragile skin with recurrent wounds, risk of infection, and potential for squamous cell carcinoma. Vyjuvek is a topical HSV-1 vector gene therapy that delivers a functional copy of COL7A1 episomally to skin cells to produce functional type VII collagen and is intended for repeat topical treatment of eligible DEB wounds.