CurrentCignaPolicy IP0572

Vyjuvek (beremagene geperpavec-svdt) topical gel

Cigna coverage policy for Vyjuvek topical gene therapy for wounds in dystrophic epidermolysis bullosa (DEB), specifying prior authorization, clinical criteria, dosing, and documentation requirements for patients and providers.

Policy Summary

PayerCigna

PolicyVyjuvek (beremagene geperpavec-svdt) topical gel - Coverage criteria for DEB wounds

Policy CodePolicy IP0572

Change TypeMaterial clinical revisions and documentation clarifications (includes added genetic testing requirement)

Effective Date7/10/2025

Next Review DateN/A

Key ActionObtain prior authorization and provide genetic testing documentation confirming a pathogenic COL7A1 variant when requesting coverage.

SourceLink

POLICY UPDATE CHANGES

Updated diagnostic requirement language to specify confirmation by genetic testing showing a pathogenic variant in COL7A1.

Removed prescriber attestation that 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.

Modified 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 monthsmin age

6 monthsinitial/continuation approval

1.6 mL

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.

max weekly dose ≥3 yrs

0.8 mLmax weekly dose 6mo–<3 yrs

Coverage Criteria for Vyjuvek (beremagene geperpavec-svdt)

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) patient has at least one clinical feature of dystrophic epidermolysis bullosa [documentation required]; (b) patient has one or more open target wound(s) to be treated; (c) target wound(s) meet ALL of: (1) target wound(s) is clean in appearance and does not appear to be infected; (2) target wound(s) has adequate granulation tissue and vascularization; (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.

Approval duration: 6 months.

Continuation Therapy

Approve for 6 months if ALL of the following are met

Patient Currently Receiving Vyjuvek on Previously Treated Wound(s): (i) According to the prescriber, the target wound(s) remains open; AND (ii) according to the prescriber, the target wound(s) has decreased in size from baseline; AND (iii) the medication is prescribed by or in consultation with a dermatologist or wound care specialist.

If treating a new or reopened wound(s), refer to Initial Therapy.

Use of Vyjuvek (beremagene geperpavec-svdt) for any indication other than wounds in dystrophic epidermolysis bullosa as specified in this policy is considered not medically necessary.

Specifically, the combination of Vyjuvek with other therapies not described in the coverage criteria is not supported by evidence and is therefore considered not medically necessary.

Combination use of Vyjuvek and Filsuvez (birch triterpenes topical gel) is considered not medically necessary because the combination has not been studied and there is insufficient evidence to support safety or effectiveness of concurrent use.

Coding, Dosing, and Dose Limits

Considered Medically NecessaryHCPCSCovered

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

Age group≥ 6 months to < 3 years

Maximum weekly volume0.8 mL (after mixing with excipient gel)

Maximum weekly PFUs1.6 x 10^9 plaque forming units (PFUs)

Age group≥ 3 years

Maximum weekly volume1.6 mL (after mixing with excipient gel)

Maximum weekly PFUs3.2 x 10^9 plaque forming units (PFUs)

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior authorization required

Prior Authorization Required. Approvals are provided for the durations specified in the Policy Statement when all Criteria and Dosing requirements are met. Requests for doses outside the established dosing will be reviewed case-by-case by a clinician. Approvals are provided for the duration noted; when expressed in months, 1 month = 30 days. Vyjuvek must be prescribed by or in consultation with a dermatologist or wound care specialist.

Approval duration: 6 months for Initial Therapy or for patients currently receiving therapy when criteria met
Documentation required for diagnosis and clinical features as specified

Denial Risk

Combination restriction — do not combine with Filsuvez

Combination therapy with Filsuvez (birch triterpenes topical gel) is considered not medically necessary. Concurrent use has not been studied and is excluded by the policy.

Definitions

Dystrophic Epidermolysis Bullosa (DEB)

DefinitionDystrophic epidermolysis bullosa (DEB) is a form of epidermolysis bullosa caused by mutations in the COL7A1 gene resulting in reduced or absent biologically active type VII collagen and fragility of skin and mucosa.

PathophysiologyMutations in COL7A1 lead to decreased production of type VII collagen, impairing formation of anchoring fibrils that maintain epidermal-dermal integrity.

Clinical featuresPresents with skin blistering and scarring (including mucosal surfaces); may be recessive (RDEB) or dominant (DDEB).

Vyjuvek (beremagene geperpavec-svdt)

Generic nameBeremagene geperpavec-svdt

DescriptionA live, replication-defective herpes simplex virus type-1 (HSV-1)–based topical vector genetically modified to encode human COL7A1.

Background

Dystrophic epidermolysis bullosa (DEB) is caused by mutations in the COL7A1 gene leading to reduced or absent type VII collagen and resultant skin and mucosal fragility with blistering, chronic wounds, and scarring. DEB typically presents early in life and can be inherited in recessive or dominant forms; clinical course often includes recurrent wound formation, delayed healing, and complications such as infection and aggressive squamous cell carcinoma in chronic wounds.

Vyjuvek is a topical, replication-defective herpes simplex virus type‑1 (HSV‑1) based gene therapy designed to deliver the human COL7A1 coding sequence to wound sites to restore type VII collagen production, promote anchoring fibril formation, and support wound healing in patients with DEB.

Revision History and Policy Changes

2025-07-10policy_revisionLatest

Modified criterion wording: 'Squamous cell carcinoma has been ruled out for the target wound(s)' changed to 'Squamous cell carcinoma has been considered for the target wound(s).', recorded as part of the annual revision.

2024-10-01policy_revision

Updated diagnostic requirement language to specify confirmation by genetic testing showing a pathogenic variant in COL7A1; removed prescriber attestation requirement; added documentation requirements and added requirement that medication be prescribed by or in consultation with a dermatologist or wound care specialist for continuation approvals.

Policy Summary

PayerCigna

PolicyVyjuvek (beremagene geperpavec-svdt) topical gel - Coverage criteria for DEB wounds

Policy CodePolicy IP0572

Change TypeMaterial clinical revisions and documentation clarifications (includes added genetic testing requirement)

Effective Date7/10/2025

Next Review DateN/A

Key ActionObtain prior authorization and provide genetic testing documentation confirming a pathogenic COL7A1 variant when requesting coverage.

SourceLink

On This Page

Reference Dose by Wound Size

Wound surface area < 20 cm^20.2 mL (4 x 10^8 PFUs)

Wound surface area 20–<40 cm^20.4 mL (8 x 10^8 PFUs)

Wound surface area 40–60 cm^20.6 mL (1.2 x 10^9 PFUs)

Combination of Vyjuvek with Filsuvez is not allowed

Documentation Required

Required documentation and specialist prescribing/consultation

Documentation is required to support medical necessity. Required documentation includes genetic testing confirming a pathogenic COL7A1 variant and clinical evidence of dystrophic epidermolysis bullosa (e.g., blistering, wounds, scarring), chart notes, prescription records, and other relevant records. Prescribing must be by or in consultation with a dermatologist or wound care specialist; this specialist involvement is required for initial and continuation approvals.

Genetic testing showing a pathogenic COL7A1 variant [documentation required]
Documentation of at least one clinical feature of dystrophic EB [documentation required]
Prescriber is a dermatologist or wound care specialist or consultation documented
Target wound documentation: clean appearance, adequate granulation and vascularization, and that squamous cell carcinoma has been considered

Denial Risk

Denial triggers and billing notes

Claims lacking required covered codes or necessary documentation may be denied. Providers must bill using the appropriate covered code for Vyjuvek (J3401) and include supporting documentation; services billed with non-covered or deleted codes or without required documentation are subject to denial.

Covered HCPCS code: J3401 — Beremagene geperpavec-svdt topical (per 0.1 ml)
Claims without covered codes or without required documentation may be denied
Deleted or ineffective codes at time of service may not be eligible for reimbursement

Mechanism of actionApplication to wounds results in transcription of the encoded human COL7A1, production and secretion of type VII collagen, and formation of anchoring fibrils to support wound healing.

Indication ageIndicated for treatment of wounds in patients with DEB with COL7A1 mutation(s) aged ≥ 6 months.