CurrentCignaPolicy IP0572

Vyjuvek (beremagene geperpavec) topical gel coverage policy

Cigna's coverage policy for Vyjuvek, a topical HSV-1 vector-based gene therapy for treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with COL7A1 mutations; governs prior authorization, clinical criteria, dosing, and coding for affected members and providers.

Policy Summary

PayerCigna

PolicyVyjuvek (beremagene geperpavec) topical gel coverage policy

Policy CodePolicy IP0572

Change TypeRevision with material coverage updates

Effective DateJul 10, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation including genetic testing confirming a pathogenic COL7A1 variant and evidence of at least one clinical feature of DEB.

SourceLink

POLICY UPDATE CHANGES

Updated diagnostic criterion language to require genetic testing showing a pathogenic variant in COL7A1 (changed from pathogenic or likely pathogenic).

Removed prescriber attestation that the individual is receiving concomitant standard of care wound prevention and/or treatment.

Added requirement that medication be prescribed by or in consultation with a dermatologist or wound care specialist for patients currently receiving Vyjuvek on previously treated wounds.

Changed criterion from 'Squamous cell carcinoma has been ruled out for the target wound(s)' to 'Squamous cell carcinoma has been considered for the target wound(s).'

≥6 monthsMinimum patient age for treatment

6 monthsInitial approval duration

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Max weekly dose (6 mo–<3 yr)

1.6 mLMax weekly dose (≥3 yr)

Coverage Criteria for Vyjuvek (beremagene geperpavec)

Initial Therapy

Approve for 6 months if ALL of the following are met

Initial Therapy: Patient is ≥ 6 months of age; AND the diagnosis is confirmed by genetic testing showing a pathogenic variant in the collagen type VII alpha 1 chain (COL7A1) gene [documentation required]; AND patient meets ALL of the following (a, b, and c): (a) patient has at least one clinical feature of dystrophic epidermolysis bullosa [documentation required]; AND (b) patient has one or more open target wound(s) that will be treated; AND (c) each target wound meets ALL of the following: (1) target wound(s) is clean in appearance and does not appear to be infected; AND (2) target wound(s) has adequate granulation tissue and vascularization; AND (3) squamous cell carcinoma has been considered for the target wound(s); AND the medication is prescribed by or in consultation with a dermatologist or wound care specialist.all conditions required

Approve for 6 months.

Patient Currently Receiving Vyjuvek on Previously Treated Wound(s)

Approve for 6 months if ALL of the following are met

Currently Receiving Vyjuvek: According to the prescriber, the target wound(s) remains open; AND according to the prescriber, the target wound(s) has decreased in size from baseline; AND the medication is prescribed by or in consultation with a dermatologist or wound care specialist.all conditions required

If treating a new or reopened recurrent wound, patient should meet Initial Therapy criteria instead.

Combination use of Vyjuvek with Filsuvez (birch triterpenes topical gel) is considered not medically necessary. The policy states that combination use has not been studied and therefore is excluded from coverage under this policy.

Use of Vyjuvek for any indication not explicitly described in this policy is considered not medically necessary. The policy notes that the list of non‑covered uses may not be all‑inclusive and will be updated as new published data become available.

Coding and Dosage Information

Considered medically necessary HCPCSHCPCSCovered

J3401

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

Maximum weekly dose by age — dosing caps for age groups

Ages ≥ 6 months to < 3 yearsMaximum weekly volume: 0.8 mL (maximum weekly dose: 1.6 x 10^9 PFUs)

Ages ≥ 3 yearsMaximum weekly volume: 1.6 mL (maximum weekly dose: 3.2 x 10^9 PFUs)

Dosing frequencyApplied topically once weekly; continue application to selected wound(s) until closed

Reference dose by wound size — dose guidance by wound surface area

Wound < 20 cm²Reference volume: 0.2 mL (Dose: 4 x 10^8 PFUs)

Wound 20–<40 cm²Reference volume: 0.4 mL (Dose: 8 x 10^8 PFUs)

Provider Actions, Documentation, and Prior Authorization

Prior Authorization

Prior Authorization Recommended

Prior Authorization is recommended — formal approval is required when the member meets the coverage Criteria and Dosing in this policy. Requests for doses outside the established dosing will be reviewed case-by-case by a clinician. Approvals are provided for the duration noted in the policy. Because specialized skills are required for evaluation and monitoring, Vyjuvek must be prescribed by or in consultation with a physician who specializes in the condition being treated.

Prior authorization recommended for Vyjuvek (see Policy Statement).
Requests for doses outside established dosing considered on a case-by-case basis by clinician.
Approvals provided for the duration noted; 1 month = 30 days.

Step Therapy

No Step Therapy Specified

No step therapy or prerequisite trial requirements are specified in this policy for Vyjuvek.

Background on Disease and Therapy

Dystrophic epidermolysis bullosa (DEB) is an inherited blistering disorder caused by pathogenic variants in COL7A1 that result in reduced or absent type VII collagen, leading to fragile skin with recurrent blistering, erosions, and scarring. Vyjuvek (beremagene geperpavec) is an HSV‑1 vector–based topical gene therapy designed to deliver COL7A1 to wounds to restore collagen VII and improve anchoring fibril formation; efficacy was demonstrated in a randomized intrapatient Phase III trial showing higher complete wound healing versus placebo.

Definitions and Abbreviations

DEB — definition of dystrophic epidermolysis bullosa

DefinitionDystrophic epidermolysis bullosa (DEB) — a form of epidermolysis bullosa caused by mutations in the COL7A1 gene resulting in reduced or absent type VII collagen, leading to fragile skin with blistering, wounds, and scarring.

Genetic basisAssociated with pathogenic variants in COL7A1 leading to deficient anchoring fibrils and impaired dermal-epidermal cohesion.

Clinical featuresCharacterized by skin blistering, chronic wounds, scarring, and susceptibility to nonhealing wounds; wound appearance for treatment should be clean with adequate granulation and vascularization.

PFU — plaque forming units used to quantify viral vector dose

DefinitionPlaque forming units (PFUs) — a measure of replication-competent viral particles used to quantify the viral vector dose in Vyjuvek; dosing and maximum weekly doses are expressed in PFUs.

Policy Summary

PayerCigna

PolicyVyjuvek (beremagene geperpavec) topical gel coverage policy

Policy CodePolicy IP0572

Change TypeRevision with material coverage updates

Effective DateJul 10, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation including genetic testing confirming a pathogenic COL7A1 variant and evidence of at least one clinical feature of DEB.

SourceLink

On This Page

Reference volume: 0.6 mL (Dose: 1.2 x 10^9 PFUs)

Documentation Required

Documentation is required to support medical necessity. Required documentation includes genetic testing confirming a pathogenic variant in the COL7A1 gene and evidence of clinical features of dystrophic epidermolysis bullosa (e.g., blistering, wounds, scarring). Documentation may include, but is not limited to, chart notes, genetic test reports, prescription records, and other clinical records. For initial therapy, documentation must show the diagnosis by genetic testing and at least one clinical feature; for continuing therapy, documentation must support ongoing treatment of the previously treated wound(s).

Genetic testing documentation confirming a pathogenic COL7A1 variant [documentation required].
Evidence of at least one clinical feature of dystrophic epidermolysis bullosa (e.g., blistering, wounds, scarring) [documentation required].
Chart notes, genetic test reports, prescription claims/receipts, and other relevant clinical records may be used.

Denial Risk

Claims and Billing Guidance — Denial Risk

Claims submitted with invalid, deleted, or non-covered codes may be denied. Denials may also occur for doses administered outside the established dosing guidance in this policy.

Use most appropriate and active codes as of the date of service.
Denial risk for doses outside established dosing guidance.

Vyjuvek concentrations and reference doses are reported both as volume (mL) after mixing with excipient gel and as PFUs (e.g., 0.2 mL = 4 x 10^8 PFUs).

Use in dosing limitsMaximum weekly doses by age and reference doses by wound size are specified in PFUs to define dosing caps (e.g., 1.6 x 10^9 PFUs for ages 6 months to <3 years).