CurrentBaylor Scott & White Health PlanPolicy 320

Beremagene geperpavec-svdt (Vyjuvek) Coverage

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This policy governs prior authorization and medical-necessity coverage for topical beremagene geperpavec-svdt (Vyjuvek) in members with dystrophic epidermolysis bullosa (DEB). Unless otherwise indicated, it applies across lines of business, subject to the applicable benefit plan and federal or state requirements.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyBeremagene geperpavec-svdt (Vyjuvek) Coverage

Policy CodePolicy 320

Change TypeNo material change

Effective DateOct 1, 2026

Last ReviewSep 24, 2026

Next Review DateSep 24, 2027

Key ActionSubmit prior authorization documentation demonstrating that all policy criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥6 moMinimum age

1 yrAuthorization duration

67%Wound healing at 6 months

71%Wound healing at 3 months

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CurrentBaylor Scott & White Health PlanPolicy 320

Beremagene geperpavec-svdt (Vyjuvek) Coverage

Customize your policy alerts

Sign up for baylor_scott_and_white_health_plan Policy 320 alerts

Get alerted when Policy 320 changes without checking for updates manually.

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Policy Summary

PayerBaylor Scott & White Health Plan

PolicyBeremagene geperpavec-svdt (Vyjuvek) Coverage

Policy CodePolicy 320

Change TypeNo material change

Effective DateOct 1, 2026

Last ReviewSep 24, 2026

Next Review DateSep 24, 2027

Key ActionSubmit prior authorization documentation demonstrating that all policy criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥6 moMinimum age

1 yrAuthorization duration

67%Wound healing at 6 months

71%Wound healing at 3 months

Coverage Criteria

Initial Therapy

Baylor Scott & White Health Plan may consider beremagene geperpavec-svdt (Vyjuvek®) medically necessary when all universal criteria below are met and the listed exclusionary conditions and prior wound-treatment restrictions do not apply.

ALL of the following

Confirmed dystrophic epidermolysis bullosa (DEB) requires BOTH of the following
- Skin biopsy for immunohistochemistry (IHC) with fluorescence-labelled secondary antibodies (immunofluorescence mapping, IFM).
- Confirmed COL7A1 (collagen type VII alpha 1) gene mutation and Collagen VII (CVII) deficiency or absence by genetic test.
Member has an appropriate clinical presentation, such as skin blistering, erosions, slow-healing chronic wounds, scarring, milia, and itchy or painful skin.
Provider has ruled out other related skin disorders with a similar clinical presentation.
Member is at least 6 months old.>= 6 months
Beremagene geperpavec-svdt (Vyjuvek®) is prescribed by or in consultation with a dermatologist experienced in treating patients with DEB.
Beremagene geperpavec-svdt (Vyjuvek®) will be dosed and administered according to FDA-approved labeling.

Continuation Therapy

Renewal requests are covered when all continuation criteria are met.

ALL of the following

Member meets all universal criteria for therapy, including the applicable exclusionary conditions and prior wound-treatment restrictions.
Member has manageable or no side effects.
Member's previously beremagene-treated wounds show a positive clinical response, such as reduction in wound area size or improvement in skin appearance.

Other Indications

Beremagene geperpavec-svdt (Vyjuvek®) for all other indications is not covered under this policy.

Treatment of all other indications is considered experimental and investigational because the effectiveness of this strategy has not been established.

Authorization duration is 1 year. All requests will be reviewed by a clinical pharmacist and medical director.

Coverage requires that the member does not have any of the following: systemic infection such as hepatitis B or C or human immunodeficiency virus (HIV); squamous cell carcinoma lesions at or near candidate wounds; planned application of birch bark triterpenes (Filsuvez®) or investigational gene or cell therapies onto candidate wounds leading up to the first application or afterward; planned application of beremagene geperpavec-svdt (Vyjuvek®) on wounds previously treated with prademagene zamikeracel (Zevaskyn®); or a skin graft within the past three months.

Initial Vyjuvek Therapy

Initial therapy requires ALL universal criteria.

Universal initial-therapy criteria

Confirmed dystrophic epidermolysis bullosa diagnosis
- Skin biopsy for immunohistochemistry with fluorescence-labelled secondary antibodies (immunofluorescence mapping, or IFM).
- Confirmed COL7A1 gene mutation with Collagen VII deficiency or absence by genetic testing.
Appropriate clinical presentation and provider requirements
- Member has an appropriate clinical presentation, such as skin blistering, erosions, slow-healing chronic wounds, scarring, milia, or itchy painful skin.

Vyjuvek Renewal

Renewal requests require ALL continuation criteria.

Vyjuvek renewal criteria

Member continues to meet all universal initial-therapy criteria.
Member has manageable or no side effects.
Previously beremagene-treated wounds show a positive clinical response, such as a reduction in wound area size or improvement in skin appearance.
Document the clinical response in previously treated wounds.

Coding Information

CPT CodesHCPCS

J3401

Beremagene geperpavec-svdt for topical administration, containing

Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. BSWHP may consider beremagene geperpavec-svdt (Vyjuvek®) medically necessary only when documentation demonstrating that all applicable criteria are met is submitted. Requests are reviewed by a clinical pharmacist and medical director.

For Medicare plans, apply the appropriate Medicare NCD or LCD; if none applies, use the criteria below.
For Medicaid plans, confirm coverage under the Texas Medicaid Provider Procedures Manual (TMHP/TMPPM); Texas Mandate HB154 applies.
Authorization duration: 1 year.

Documentation Required

Initial Authorization Documentation

Submit documentation for initial therapy showing that the member meets all universal medical-necessity criteria for Vyjuvek® treatment of confirmed dystrophic epidermolysis bullosa (DEB).

Clinical Background

Dystrophic epidermolysis bullosa (DEB) is a severe inherited form of epidermolysis bullosa caused by mutations in the COL7A1 gene. These mutations result in deficient or absent Collagen VII, which impairs formation of the anchoring filaments that attach the epidermis to underlying tissue. The resulting skin fragility can cause blistering, scarring, and chronic non-healing wounds.

Beremagene geperpavec-svdt (Vyjuvek) is a topical HSV-1 vector-based gene therapy that induces COL7A1 expression and formation of anchoring filaments in treated wounds. It is applied weekly to candidate wounds until healing. Because it does not permanently correct the underlying COL7A1 mutation, ongoing administration may be needed for wound management.

Key Definitions

Immunofluorescence mapping (IFM)

DefinitionA diagnostic skin biopsy for immunohistochemistry using fluorescence-labelled secondary antibodies to map tissue components.

Role in diagnosisImmunofluorescence mapping supports confirmation of dystrophic epidermolysis bullosa (DEB).

Policy requirementA skin biopsy with immunofluorescence mapping is required as part of the confirmed DEB diagnosis.

COL7A1

DefinitionCOL7A1 is the gene encoding collagen type VII alpha 1.

Diagnostic requirementA confirmed COL7A1 gene mutation is required for the policy diagnosis of DEB.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyBeremagene geperpavec-svdt (Vyjuvek) Coverage

Policy CodePolicy 320

Change TypeNo material change

Effective DateOct 1, 2026

Last ReviewSep 24, 2026

Next Review DateSep 24, 2027

Key ActionSubmit prior authorization documentation demonstrating that all policy criteria are met.

SourceLink

On This Page

Other related skin disorders with a similar clinical presentation have been ruled out.

Member is at least 6 months old.>= 6 months

Vyjuvek is prescribed by or in consultation with a dermatologist experienced in treating patients with dystrophic epidermolysis bullosa.

FDA-approved administration and exclusion criteria

Vyjuvek will be dosed and administered according to FDA-approved labeling.
Member does not have a systemic infection such as hepatitis B or C or HIV.
Member does not have squamous cell carcinoma lesions at or near candidate wounds.
Member will not apply birch bark triterpenes (Filsuvez), investigational gene therapies, or investigational cell therapies onto candidate wounds leading up to or after the first application.
Vyjuvek will not be applied to wounds previously treated with prademagene zamikeracel (Zevaskyn).
Member has not received a skin graft within the past three months.skin graft not within prior 3 months

Confirmed DEB diagnosis supported by skin biopsy for immunohistochemistry with fluorescence-labelled secondary antibodies (immunofluorescence mapping) and confirmed COL7A1 gene mutation with Collagen VII (CVII) deficiency or absence by genetic testing.

Appropriate clinical presentation, such as skin blistering, erosions, slow-healing chronic wounds, scarring, milia, or itchy, painful skin.

Other related skin disorders with a similar clinical presentation have been ruled out.

Member is 6 months of age or older.

Vyjuvek® is prescribed by or used in consultation with a dermatologist experienced in treating patients with DEB.

Treatment will be dosed and administered according to FDA-approved labeling.

Documentation confirms none of the exclusionary conditions or prohibited prior wound treatments listed below.

Documentation Required

Renewal Documentation

For continuation requests, submit updated documentation showing that the member continues to meet the universal criteria and that prior treatment remains clinically appropriate.

The member continues to meet all universal criteria.
Side effects are absent or manageable.
Previously Vyjuvek®-treated wounds show a positive clinical response, such as reduced wound area or improved skin appearance.

Denial Risk

Renewal Response Requirement

Renewal requests may be denied when continuation criteria are not met, side effects are not manageable, or previously treated wounds do not demonstrate a positive clinical response.

Document ongoing satisfaction of all universal criteria.
Document that side effects are manageable or absent.
Document objective or clinically described improvement in previously treated wounds, including reduction in wound area size or improvement in skin appearance.

Denial Risk

Non-DEB Indications

Requests for Vyjuvek® to treat indications other than dystrophic epidermolysis bullosa are considered experimental and investigational because the effectiveness of this treatment strategy for other indications has not been established.

Non-DEB treatment requests are not medically necessary under this policy.

Denial Risk

Exclusionary Conditions and Prior Wound Treatment

Do not apply Vyjuvek® to candidate wounds when any of the following exclusionary conditions or prior wound treatments apply.

Systemic infection, including hepatitis B or C or human immunodeficiency virus (HIV).
Squamous cell carcinoma lesions at or near candidate wounds.
The member will apply birch bark triterpenes (Filsuvez®) or investigational gene or cell therapies to candidate wounds leading up to the first application or afterward.
The member will apply Vyjuvek® to wounds previously treated with prademagene zamikeracel (Zevaskyn®).
The member received a skin graft within the past 3 months.

Documentation Required

Clinical and Prescribing Requirements

The prescribing provider must document the diagnosis, clinical presentation, exclusion of similar disorders, and appropriate specialist oversight before treatment is authorized.

Diagnosis must be confirmed DEB with immunofluorescence mapping and genetic confirmation of a COL7A1 mutation with Collagen VII deficiency or absence.
Document compatible clinical findings, including skin blistering, erosions, slow-healing chronic wounds, scarring, milia, or itchy, painful skin.
Rule out other related skin disorders with a similar clinical presentation.
Vyjuvek® must be prescribed by or in consultation with a dermatologist experienced in treating patients with DEB.
Use the FDA-approved dose and administration schedule.
The member must be at least 6 months old.

Additional finding required

Genetic testing must also confirm Collagen VII deficiency or absence.

Beremagene geperpavec-svdt (Vyjuvek)

DefinitionBeremagene geperpavec-svdt (Vyjuvek) is a topical gene therapy supplied as a once-weekly biological suspension.

Vector typeHSV-1 (herpes simplex type 1) vector-based gene therapy.

IndicationTreatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) and mutation(s) in the COL7A1 gene.

Eligible populationAdults and pediatric patients with DEB and COL7A1 mutation(s).