CurrentEmblemHealthPolicy MG.MM.PH.391

Vyjuvek (beremagene geperpavec-svdt) topical gel

Medical policy governing coverage and authorization criteria for Vyjuvek topical gel for treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with COL7A1 mutations; applies to EmblemHealth and ConnectiCare members and their providers seeking prior authorization or reimbursement.

Policy Summary

PayerEmblemHealth

PolicyVyjuvek (beremagene geperpavec-svdt) topical gel

Policy CodePolicy MG.MM.PH.391

Change TypeRevised dosing limitsage indication updatedexclusion removed

Effective DateJul 28, 2023

Next Review DateOct 8, 2025

Key ActionSubmit prior authorization with documentation of COL7A1 mutation(s), wound status, and specialty prescribing/consultation.

SourceLink

POLICY UPDATE CHANGES

Updated age from in patients ≥ 6 months of age to now read in adult and pediatric patients.

Updated Dosing Limits with charts and dosing table content were added/clarified.

Removed requirement that squamous cell carcinoma has been ruled out for the target wound(s).

Title language changed from 'suspension' to 'gel'.

6 monthsinitial length of authorization

J3401applicable HCPCS/J-code

82194-0510-02applicable NDC

Q81.2

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Coverage and Medical Necessity Criteria

Initial Therapy

Covered when ALL of the following are met:

Initial Coverage Criteria for Vyjuvek: 1) Patient has not received a skin graft in the area to be treated within the prior 3 months; AND 2) Will not be used concurrently in the same wound with another disease-modifying therapeutic agent indicated for DEB (this exclusion does not apply to routine wound management products such as topicals, dressings, or antibiotics); AND 3) Diagnosis of dystrophic epidermolysis bullosa (DEB) as evidenced by detection of mutation(s) in the COL7A1 gene on molecular genetic testing; AND 4) Patient has at least one clinical feature of DEB; AND 5) Provider attestation of at least one cutaneous wound that is clean in appearance with adequate granulation tissue, has excellent vascularization, and does not appear infected; AND 6) Medication is prescribed by or in consultation with a dermatologist or wound care specialist.

Includes FDA-approved indication requirement

Continuation Therapy

Continuation/renewal coverage when ALL of the following are met:

Continuation Criteria: A) Patient continues to meet the indication-specific relevant criteria identified in Initial Criteria; AND B) Absence of unacceptable toxicity from the drug (examples include severe medication reactions warranting discontinuation); AND C) Disease response with treatment as defined by improvement (healing) of treated wound sites and/or reduction in skin infections as attested by the physician; AND D) Patient requires continued treatment due to new or existing open wound.

Renewal coverage provided; length of authorization is 6 months and may be renewed

Vyjuvek must not be used concurrently in the same wound with another disease-modifying therapeutic agent indicated for DEB. Routine wound care products and adjunctive agents (for example, topical agents, dressings, and antibiotics) are not considered disease‑modifying DEB therapies and are not included in this restriction. Providers should ensure that concurrent use of other investigational or approved disease-modifying agents for the same wound is avoided when requesting authorization.

Administrative updates were made to simplify diagnostic mapping and remove prior prescriptive requirements. The policy removed the former requirement for specific diagnostic mapping methods (immunofluorescence mapping, transmission electron microscopy, or antigenic mapping) and the older prescriber/consultation language that mandated involvement of a geneticist, dermatologist, or histopathologist. The revision history also documents removal of prior DEB continuation wording and adds the current requirement that the patient "has not received a skin graft in the area to be treated within the prior 3 months."

Billing Codes and Limits

Applicable Procedure CodesHCPCSCovered

J3401

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

Applicable NDCsNDCCovered

82194-0510-02

Vyjuvek topical Gel 2.5mL

Applicable ICD-10 DiagnosesICD-10Covered

Q81.2

Epidermolysis bullosa

inv-08: Maximum weekly billable units

Maximum weekly billable units25 billable units every 7 days

Maximum weekly PFU (<3 yrs)2 x 10^9 PFU

Maximum weekly volume (<3 yrs)1 mL after mixing with excipient gel

Maximum weekly PFU (≥3 yrs)4 x 10^9 PFU

Maximum weekly volume (≥3 yrs)2 mL after mixing with excipient gel

Prior Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Vyjuvek (beremagene geperpavec-svdt) topical gel. The treating physician or primary care provider must submit the clinical evidence that the member meets the policy criteria prior to treatment. Requests without required documentation will not be reviewed for prior authorization or post-payment review.

Submit full clinical records demonstrating the diagnosis and molecular testing results (see Documentation Required callout).
Include specialty consultation documentation when applicable (dermatologist or wound care specialist).
Do not initiate therapy prior to receiving an authorization decision.

Denial Risk

Concurrent Disease-Modifying Therapy Restriction

Vyjuvek must not be used concurrently in the same wound with another disease-modifying therapy indicated for dystrophic epidermolysis bullosa (DEB) (for example, birch triterpenes). This restriction does not apply to routine wound care measures (topical emollients, dressings, topical antibiotics, or other non–disease-modifying wound management).

Product and Disease Definitions

inv-14: Vyjuvek (beremagene geperpavec-svdt) topical gel

ProductVyjuvek (beremagene geperpavec-svdt) topical gel

Mechanism (high-level)Topical gene therapy vector that transduces keratinocytes and fibroblasts to deliver COL7A1, enabling production and secretion of collagen VII which forms anchoring fibrils

Indication (high-level)Treatment of wounds in adult and pediatric patients with dystrophic epidermolysis bullosa (DEB) due to COL7A1 mutations

inv-15: Dystrophic epidermolysis bullosa (DEB)

DiseaseDystrophic epidermolysis bullosa (DEB)

Genetic basisCaused by mutation(s) in the COL7A1 gene leading to reduced or absent functional collagen VII and defective or absent anchoring fibrils

Documentation Required

Documentation Required for Review

Provide the following clinical documentation with the prior authorization request to allow a complete review: molecular genetic testing confirming COL7A1 mutation(s); clinical documentation demonstrating at least one cutaneous wound meeting policy criteria (clean appearance, adequate granulation tissue, excellent vascularization, not appearing infected); documentation that no skin graft was performed in the treatment area within the prior 3 months; provider attestation that Vyjuvek will not be used concurrently in the same wound with another disease-modifying DEB therapy; and documentation that the medication is prescribed by or in consultation with a dermatologist or wound care specialist.

Molecular genetic testing report confirming COL7A1 mutation(s).
Clinical wound documentation (photographs, wound measurements, description of granulation tissue and vascularization, infection status).
Operative notes or records showing no skin graft in the treatment area within the prior 3 months.
Provider attestation regarding concurrent disease-modifying DEB therapies.
Consultation notes from a dermatologist or wound care specialist.
Medication prescription details (dose, frequency, planned duration).