CurrentBlue Cross Blue Shield - IowaPolicy N/A

Vyjuvek (beremagene geperpavec) — Coverage Criteria for Dystrophic Epidermolysis Bullosa Wounds

Covers prior authorization, documentation, eligibility, dosing limits, and billing guidance for Vyjuvek topical gene therapy for treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with COL7A1 mutations for Wellmark/Blue Cross and Blue Shield members.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyVyjuvek (beremagene geperpavec) — Coverage Criteria for DEB wounds

Policy CodePolicy N/A

Change TypeNo material change

Effective DateDecember 19, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with medical records and genetic test results confirming a COL7A1 mutation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6initial auth (months)

6continuation auth (months)

4/28dqty limit

J3401HCPCS

COL7A1genetic confirm

Coverage criteria for Vyjuvek (beremagene geperpavec)

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyVyjuvek (beremagene geperpavec) — Coverage Criteria for DEB wounds

Policy CodePolicy N/A

Change TypeNo material change

Effective DateDecember 19, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with medical records and genetic test results confirming a COL7A1 mutation.

SourceLink

On This Page

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Initial Therapy

Covered when ALL of the following are met:

Initial Approval for Vyjuvek: A. Member has a diagnosis of dystrophic epidermolysis bullosa (DEB). B. Member has clinical manifestations of disease (e.g., extensive skin blistering, skin erosions, scarring). C. Member has genetic test results confirming a mutation in the COL7A1 gene. D. Member does not have current evidence or a history of squamous cell carcinoma in the affected wound(s) that will receive treatment. E. Member does not have an active infection in the affected wound(s) that will receive treatment. F. Vyjuvek will not be used in combination with Filsuvez (birch triterpenes) or Zevaskyn (prademagene zamikeracel).

Authorization of 6 months may be granted when all criteria met.

Continuation Therapy

Covered when ALL of the following are met:

Continuation of Therapy for Vyjuvek: A. Member achieves or maintains a positive clinical response to Vyjuvek therapy (e.g., decrease in wound size, increase in granulation tissue, complete wound closure). B. Member does not have current evidence or a history of squamous cell carcinoma in the affected wound(s) that will receive treatment. C. Member does not have an active infection in the affected wound(s) that will receive treatment. D. Vyjuvek will not be used in combination with Filsuvez (birch triterpenes) or Zevaskyn (prademagene zamikeracel).

Authorization of 6 months may be granted when all criteria met. Vyjuvek is considered not medically necessary for members who do not meet these criteria.

Vyjuvek will not be used in combination with Filsuvez (birch triterpenes) or Zevaskyn (prademagene zamikeracel).

Vyjuvek is considered not medically necessary for members who do not meet the specified initial or continuation coverage criteria.

Coding and quantity limits

Billing HCPCS / Unclassified codesHCPCS

J3401	Beremagene geperpavec-svdt for topical administration, containing nominal 5 x 10^9 pfu/ml vector genomes, per 0.1 ml (effective 1/1/2024)
J3490	Unclassified drugs (when specified as [Vyjuvek] (beremagene geperpavec-svdt))
J3590	Unclassified biologics (when specified as [Vyjuvek] (beremagene geperpavec-svdt))
C9399	Unclassified drugs or biologicals

Quantity limit (standard)

Standard quantity limit4 cartons per 28 days (Vyjuvek 5×10^9 PFU carton)

Product form referencedVyjuvek 5×10^9 PFU carton

Dosing frequency (FDA-recommended)Apply to selected wound(s) once a week

What providers must do

Prior Authorization

Prior Authorization Required

Prior authorization is required for Vyjuvek. When criteria are met, initial authorization may be approved for up to 6 months.

Initial approval: up to 6 months when all Initial Approval criteria are satisfied.
Continuation approval: up to 6 months when all Continuation of Therapy criteria are satisfied.

Step Therapy

No step therapy sequence is specified for this therapy.

Documentation Required

Required Documentation

Submit the following documentation to initiate prior authorization review.

Medical records documenting clinical manifestations of dystrophic epidermolysis bullosa (e.g., extensive skin blistering, erosions, scarring).
Genetic test results confirming a mutation in the COL7A1 gene.
For continuation requests: chart notes or medical record documentation demonstrating a positive clinical response to Vyjuvek (e.g., decrease in wound size, increased granulation tissue, complete wound closure).

Denial Risk

Triggers for Denial

Denial may be issued if any of the following apply.

No documented diagnosis of dystrophic epidermolysis bullosa (DEB).
Lack of genetic confirmation of a COL7A1 mutation.
Absence of medical records documenting clinical manifestations consistent with DEB.
Current evidence or history of squamous cell carcinoma in the wound(s) to be treated.
Active infection in the wound(s) to be treated.
Concurrent or planned use of contraindicated/ excluded therapies (e.g., Filsuvez or Zevaskyn in combination with Vyjuvek).
For continuation requests: insufficient documentation of positive clinical response to therapy.

OpenPayer

Vyjuvek (beremagene geperpavec) — Coverage Criteria for Dystrophic Epidermolysis Bullosa Wounds

Coverage criteria for Vyjuvek (beremagene geperpavec)

Coding and quantity limits

What providers must do

Definitions

Background