CurrentEmblemHealthPolicy MG.MM.PH.391

Medical Policy: Vyjuvek (beremagene geperpavec-svdt) topical gel

Defines medical necessity criteria, dosing limits, authorization length, applicable codes and continuation requirements for Vyjuvek topical gel for treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with COL7A1 mutations.

Policy Summary

PayerEmblemHealth

PolicyMedical Policy: Vyjuvek (beremagene geperpavec-svdt) topical gel

Policy CodePolicy MG.MM.PH.391

Change TypeRevisions and additions (multiple dates)

Effective DateJul 28, 2023

Next Review Date

Key ActionSubmit clinical documentation (diagnostic genetic testing showing COL7A1 mutation, provider attestation of wound characteristics, specialist consultation) for preauthorization or post-payment review.

SourceLink

POLICY UPDATE CHANGES

Updated age wording from 'in patients ≥ 6 months of age' to 'in adult and pediatric patients'; updated dosing limits charts; removed requirement that squamous cell carcinoma has been ruled out for target wound(s).

Updated title from 'suspension' to 'gel' and added initial criteria including clinical feature requirement, SCC rule-out, and specialist prescriber requirement.

Removed 'diagnosis of recessive' from Initial criteria and updated NDCs.

Initial policy creation with criteria requiring COL7A1 mutation detection for DEB diagnosis and related initial criteria.

Removed prior multi-method requirement for demonstrating two copies of COL7A1 mutation by immunofluorescence mapping, TEM, or antigenic mapping and removal of requirement for geneticist/histopathologist involvement.

1Covered Indication (DEB)

25 units/7 daysMax Billable Units Frequency

Authorization Duration

J3401Primary Procedure Code

Coverage Summary

This policy (MG.MM.PH.391) provides medical necessity criteria for Vyjuvek (beremagene geperpavec-svdt) topical gel for treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with COL7A1 mutations. Effective date/origin: 07/28/2023; last review/revision: 10/08/2025. Policy number: MG.MM.PH.391. The scope defines authorization length, dosing limits, applicable codes, and continuation requirements for Vyjuvek topical gel in adult and pediatric patients with DEB due to COL7A1 mutations.

Authorization & Billing Snapshot

Authorization Duration6 months (may be renewed)

Max Billable Units25 billable units every 7 days

Primary Procedure CodeJ3401

Covered IndicationTreatment of wounds in adult and pediatric patients with dystrophic epidermolysis bullosa (DEB) with COL7A1 mutations

Medical-Necessity Criteria

Initial Authorization / Medical Necessity Criteria

Coverage is provided when ALL of the following conditions are met:

ALL of the following

Patient has not received a skin graft in the area to be treated within the prior 3 months
This exclusion does not include disease/wound management incidentals like topicals, dressings, antibiotics, etc.
Will not be used concurrently in the same wound with another disease-modifying therapeutic agent indicated for DEB (e.g., birch triterpenes, etc.)
This exclusion does not include disease/wound management incidentals like topicals, dressings, antibiotics, etc.
Dystrophic Epidermolysis Bullosa (DEB) diagnosis: Diagnosis of DEB as evidenced by detection of mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene on molecular genetic testing

Coding

Applicable Procedure Code (HCPCS/J-code)HCPCSCovered

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

Provider Actions & Billing

Prior Authorization

Submit clinical documentation for review

The treating physician or primary care provider must submit clinical evidence that the member meets policy criteria for preauthorization or post-payment review. Required documentation includes diagnostic genetic testing demonstrating COL7A1 mutation, provider attestation regarding wound characteristics, and documentation of specialist consultation.

Affected codes: J3401; NDC 82194-0510-02; ICD-10 Q81.2
Required documents: genetic testing showing COL7A1 mutation; provider attestation of wound characteristics (clean, adequate granulation, excellent vascularization, not infected); specialist consultation/confirmation

Documentation Required

Specialist involvement required

Medication must be prescribed by, or in consultation with, a dermatologist or wound care specialist. Provider attestation is required that at least one treated wound is clean in appearance, has adequate granulation tissue, has excellent vascularization, and does not appear infected.

Background & Definitions

Vyjuvek is a topical gene therapy indicated to treat wounds in adult and pediatric patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene. Upon topical application to wounds, Vyjuvek can transduce keratinocytes and fibroblasts, enabling production and secretion of collagen VII to form anchoring fibrils that help restore skin integrity. This policy and criteria are based on the manufacturer package insert and regulatory labeling.

Term	Definition
{"text":"DEB","status":""},{"text":"Dystrophic epidermolysis bullosa caused by mutation(s) in the COL7A1 gene resulting in reduced or absent biologically active collagen VII and impaired anchoring fibrils.","status":""}
{"text":"PFU","status":""},{"text":"Plaque forming units (measure of viral vector dose)","status":""}

Vyjuvek package insert, Krystal Biotech, Inc.; September 2025 (accessed September 2025).

Revision History

2025-10-08revision (material)Latest

2025-01-02revision (material)

Updated title from 'suspension' to 'gel' and added initial criteria including requirement for at least one clinical feature of DEB, squamous cell carcinoma ruled-out for target wound(s), and specialist prescriber/consultation requirement.

2024-02-26revision (material)

Policy Summary

PayerEmblemHealth

PolicyMedical Policy: Vyjuvek (beremagene geperpavec-svdt) topical gel

Policy CodePolicy MG.MM.PH.391

Change TypeRevisions and additions (multiple dates)

Effective DateJul 28, 2023

Next Review Date

SourceLink

On This Page

Patient has at least one clinical feature of dystrophic epidermolysis bullosa

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

Medication is prescribed by or in consultation with a dermatologist or wound care specialist

Continuation (Renewal) Criteria

Coverage renewal is provided when ALL of the following are met:

ALL of the following

Patient continues to meet the indication-specific relevant criteria identified in Initial Criteria
Absence of unacceptable toxicity from the drug
Examples include any severe medication reactions warranting therapy discontinuation
Disease response with treatment as defined by improvement (healing) of treated wound sites and/or reduction in skin infections as attested by the treating physician
Patient requires continued treatment due to new or existing open wound

Dosing / Volume Thresholds (PFU and mL)

<3 years old - Max weekly dose (PFU)2 x 10^9 PFU

<3 years old - Max weekly volume1 mL

≥3 years old - Max weekly dose (PFU)4 x 10^9 PFU

≥3 years old - Max weekly volume2 mL

<20 kg dose4 x 10^8 PFU (0.2 mL)

20 to <40 kg dose8 x 10^8 PFU (0.4 mL)

40 to 60 kg dose1.2 x 10^9 PFU (0.6 mL)

Billing Rule

Unit reporting

Report up to 25 billable units every 7 days per dosing limits. Follow HCPCS billing guidance using J3401 for topical administration of Vyjuvek.

J3401

Denial Risk

Concurrent disease-modifying therapy exclusion

Claims may be denied if Vyjuvek is used concurrently in the same wound with another disease-modifying therapeutic agent indicated for DEB.

Documentation Required

Prior skin graft exclusion

Claims may be denied if the target area received a skin graft within the 3 months prior to treatment of the wound.

Removed 'diagnosis of recessive' from Initial criteria and updated NDCs.

2023-07-28addition (initial policy)

Initial policy creation with criteria requiring detection of mutation(s) in COL7A1 for DEB diagnosis and related initial criteria.

variousremovals across updates (summary)

Removed prior multi-method requirement to demonstrate two copies of COL7A1 mutation by immunofluorescence mapping, transmission electron microscopy, or antigenic mapping, and removed requirement for geneticist/histopathologist involvement across revision history.