CurrentBlue Cross Blue Shield - North CarolinaPolicy N/A

Beremagene geperpavec-svdt (Vyjuvek) topical gene therapy for dystrophic epidermolysis bullosa — Coverage Criteria

Policy governs medical necessity criteria, dosing, site-of-care, and distribution restrictions for beremagene geperpavec-svdt (Vyjuvek) when used to treat wounds in patients with dystrophic epidermolysis bullosa due to COL7A1 mutations; applies to Blue Cross NC members.

Policy Summary

PayerBlue Cross Blue Shield - North Carolina

PolicyBeremagene geperpavec-svdt (Vyjuvek) topical gene therapy — Coverage Criteria

Policy CodePolicy N/A

Change TypeMaterial revisions to age indication and clinical criteriacoding updates

Effective DateApr 1, 2026

Next Review Date2027-04

Key ActionObtain prior authorization confirming diagnostic confirmation, wound eligibility, absence of SCC/infection, specialist involvement, and dosing/quantity within FDA limits.

SourceLink

POLICY UPDATE CHANGES

Added revenue codes 0891 and 0892 associated with HCPCS code(s).

Expanded pediatric age indication to include from birth and adjusted maximum weekly units per updated FDA labeling.

Removed requirement for absence of serum antibodies to type VII collagen and no evidence of systemic infection; added prohibition on concurrent use with Filsuvez or another gene therapy on same treatment area.

J3401HCPCS

Initial 650; Cont 1,300Max units

180d

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Coverage Criteria

Initial Therapy

Covered when ALL of the following are met

Initial Approval Criteria: 1. Diagnosis of dystrophic epidermolysis bullosa (medical record documentation required); AND 2. Diagnosis confirmed by ONE of: a) Immunofluorescence mapping (IFM); OR b) Transmission electron microscopy (TEM); OR c) Genetic testing confirming mutation(s) in COL7A1 (medical record documentation required); AND 3. At least one cutaneous wound that is clean in appearance with adequate granulation tissue, excellent vascularization, and not appearing infected (medical record documentation required); AND 4. No current evidence or history of squamous cell carcinoma in the area undergoing treatment (medical record documentation required); AND 5. No active infection in the area undergoing treatment (medical record documentation required); AND 6. Will NOT be used in combination with Filsuvez (birch triterpenes) or another gene therapy on the same treatment area for the requested indication (medical record documentation required); AND 7. Prescriber is a specialist in the area of the patient's diagnosis (e.g., dermatologist, geneticist) or prescriber has consulted with such a specialist (medical record documentation required); AND 8. Requested dose is within FDA labeled dosing for the indication and requested quantity does NOT exceed the maximum units allowed for the duration of approval (see dosing thresholds) (medical record documentation required); AND 9. For requests for inpatient or outpatient hospital administration, Site of Care Criteria applies (outlined in Site of Care Criteria).see dosing thresholds

Duration of approval: 180 days (6 months)

Continuation Therapy

Covered when ALL of the following are met

Continuation Approval Criteria: 1. Patient was approved through Blue Cross NC initial criteria OR would have met initial criteria at therapy start; AND 2. Clinical benefit demonstrated by improvement in wound healing and/or complete wound closure (medical record documentation required); AND 3. Continues to have at least one incomplete wound that is clean in appearance with adequate granulation tissue, excellent vascularization, and not appearing infected (medical record documentation required); AND 4. No current evidence or history of squamous cell carcinoma in the area undergoing treatment (medical record documentation required); AND 5. No active infection in the area undergoing treatment (medical record documentation required); AND 6. Will NOT be used in combination with Filsuvez (birch triterpenes) or another gene therapy on the same treatment area for the requested indication (medical record documentation required); AND 7. Prescriber is a specialist in the area of the patient's diagnosis (e.g., dermatologist, geneticist) or prescriber has consulted with such a specialist (medical record documentation required); AND 8. Requested dose is within FDA labeled dosing for the indication and requested quantity does NOT exceed the maximum units allowed for the duration of approval (see dosing thresholds) (medical record documentation required); AND 9. For requests for inpatient or outpatient hospital administration, Site of Care Criteria applies (outlined in Site of Care Criteria).see dosing thresholds

Duration of approval: 365 days (1 year)

Site of Care Criteria

Site of Care allowances and exceptions

Inpatient Administration: Inpatient administration allowed if above medical necessity criteria are met AND the inpatient admission is NOT for the sole purpose of administering the medication.

Outpatient Hospital Administration: Outpatient hospital administration allowed if above medical necessity criteria are met AND ONE of the following is met: a) history of a severe adverse event following injection/infusion (e.g., anaphylaxis, seizure, thromboembolism, myocardial infarction, renal failure); OR b) conditions that increase risk for severe adverse event (e.g., unstable renal function, cardiopulmonary conditions, unstable vascular access); OR c) history of mild adverse events not managed with pre-medication; OR d) inability to adhere to the treatment schedule/regimen complexity; OR e) new to therapy (initial administration or <3 months since initial administration); OR f) re-initiation of therapy meeting defined gap criteria; OR g) requirement for a change in product formulation. If Site of Care criteria in #1 or #2 are not met, administration should occur in a home-based or physician office setting with or without supervision by a certified healthcare professional.

Use of the requested agent in combination on the same treatment area with Filsuvez (birch triterpenes) or another gene therapy is explicitly prohibited. Medical record documentation must demonstrate that the treatment will NOT be administered concurrently with Filsuvez or any other gene therapy to the same anatomic treatment area as a condition of approval.

Requests that do not meet the coverage criteria may be considered not medically necessary. Key documentation and eligibility requirements include: confirmed diagnosis of dystrophic epidermolysis bullosa (documentation required) with confirmation by IFM, TEM, or genetic testing showing COL7A1 mutation; at least one cutaneous wound that is clean with adequate granulation tissue, excellent vascularization, and not appearing infected; no current evidence or history of squamous cell carcinoma in the area undergoing treatment; no active infection in the treatment area; prescriber is a specialist or has consulted one; and the requested dose and quantity are within FDA labeled dosing and do not exceed the policy maximum units for the approval period. Failure to document any of these elements may result in denial.

Coding and Dosing

Covered HCPCS CodesHCPCSCovered

J3401

beremagene geperpavec-svdt (Vyjuvek) biological suspension topical

Applicable Revenue CodesRevenue

0891	Special Processed Drugs - FDA Approved Cell Therapy (revenue code)
0892	Special Processed Drugs - FDA Approved Gene Therapy (revenue code)

Maximum weekly dose by age — dosing thresholds and max volume by age group

< 3 years — max weekly dose2 x 10^9 plaque forming units (PFU)

< 3 years — max weekly volume1 mL per week

≥ 3 years — max weekly dose4 x 10^9 plaque forming units (PFU)

≥ 3 years — max weekly volume2 mL per week

Maximum units per approval period — Initial and continuation unit limits

Initial approval — maximum units650 units

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for this therapy. Requests must confirm diagnostic criteria, wound eligibility, absence of squamous cell carcinoma and active infection in the treatment area, specialist involvement or consultation, and that the requested dose and quantity are within FDA‑labeled limits and policy maximums. For inpatient or outpatient hospital administration, Site of Care criteria apply. Approval durations: Initial — 180 days; Continuation — 365 days (when continuation criteria met).

Affected HCPCS: J3401
Duration of approval: Initial 180 days; Continuation 365 days
Site of Care criteria applies for facility administration

Note

Distribution Channel Restriction

Distribution from a specialty pharmacy provider may be required for certain gene and cellular therapies (including beremagene geperpavec-svdt / Vyjuvek) due to cost and distribution channel restrictions. Providers must contact Blue Cross NC to coordinate specialty pharmacy distribution when required.

Background

Dystrophic epidermolysis bullosa (DEB) is a genetic blistering disorder caused by mutations in the COL7A1 gene that impair type VII collagen and lead to defective anchoring fibrils at the dermal-epidermal junction. This pathophysiology results in fragile skin and recurrent wounds; beremagene geperpavec-svdt (Vyjuvek) is a topical gene therapy intended to deliver the corrective genetic material to promote wound healing in patients with DEB due to COL7A1 mutations.

Definitions

Vyjuvek — beremagene geperpavec-svdt product definition and indication summary

Product name (generic)beremagene geperpavec-svdt

Brand nameVyjuvek

Dosage form and routeBiological suspension mixed with excipient gel for topical administration

Indication summaryFor treatment of wounds in adult and pediatric patients (from birth) with dystrophic epidermolysis bullosa with COL7A1 mutations

HCPCS codeJ3401