MHN Vyjuvek (beremagene) Coverage Update

Coverage Criteria

Initial Therapy

Covered when ALL of the following are met:

Initial DEB criteria: 1) Diagnosis of dystrophic epidermolysis bullosa (DEB) with COL7A1 gene mutation confirmed by genetic testing; 2) Prescribed by or in consultation with a geneticist, dermatologist, or histopathologist; 3) Provider attestation that target wounds are clean with adequate granulation tissue, well vascularized, and not infected; 4) Documentation of baseline target wound size; 5) Provider attestation that member is receiving standard of care preventative or treatment wound therapies; 6) No current evidence or history of squamous cell carcinoma in the treatment area; 7) Vyjuvek is not prescribed concurrently with Filsuvez or Zevaskyn on the same target wound; 8) Dose does not exceed age-based maximums: a) Age < 3 years: 2 x 10^9 PFU (1 mL) weekly; b) Age ≥ 3 years: 4 x 10^9 PFU (2 mL) weekly.

Continuation Therapy

Continued coverage when ALL of the following are met:

Continuation DEB criteria: 1) Member currently receiving medication via the benefit, previously met initial approval, or is in a state/product with continuity of care; 2) Member is responding positively to therapy as evidenced by decreased wound size or decreased pain with dressing changes; 3) Provider attestation that target wounds continue to have incomplete closures that are clean with adequate granulation tissue and vascularization and are not infected, and that Vyjuvek is not applied to target wounds that have completely healed; 4) Vyjuvek is not prescribed concurrently with Filsuvez or Zevaskyn on the same target wound; 5) If request is for a dose increase, new dose does not exceed age-based maximums (Age < 3 years: 2 x 10^9 PFU/1 mL weekly; Age ≥ 3 years: 4 x 10^9 PFU/2 mL weekly).

Approval duration: 6 months

Label change / Off-label routing

Other indications/label changes: If the drug label has changed recently and the policy is not yet updated, route requests per the specified formulary/no-coverage or non-formulary policies for the relevant line of business; if the requested use is not listed under section III and the label-change routing does not apply, refer to the off-label use policy for the applicable line of business.

Refer to CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16, CP.CPA.09, HIM.PA.154, CP.PMN.53 as applicable.

Covered with Criteria

Coverage is subject to documented diagnostic confirmation and adherence to dosing and exclusion rules.

Initial Approval Core Requirements: Member has diagnosis of DEB with COL7A1 mutation confirmed by genetic testing; baseline documentation of target wound size; planned dosing within labeled maximums; absence of contraindicated concurrent therapy on the same target wound (e.g., Filsuvez, Zevaskyn).ALL

Administration and Setting: Vyjuvek gel should be prepared at the pharmacy and may be applied by a healthcare professional, patient, or caregiver in a clinic or home setting per instructions for use.ALL

Dosing Limits: Dosing regimen by age: Age < 3 years: 2 x 10^9 PFU (1 mL) topically once weekly; Age ≥ 3 years: 4 x 10^9 PFU (2 mL) topically once weekly. Maximum weekly doses correspond to these age-based limits.ALL

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized for coverage unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with the payer's off‑label use policies (see applicable off‑label policies for Commercial, Marketplace, and Medicaid lines of business).

Vyjuvek must not be prescribed concurrently with Filsuvez® or Zevaskyn™ when both products are intended for use on the same target wound; concomitant application to the same wound is an exclusion to coverage.

Therapy is considered not medically necessary if dosing exceeds the labeled age‑based maxima (Age <3 years: 2 x 10^9 PFU/1 mL weekly; Age ≥3 years: 4 x 10^9 PFU/2 mL weekly), or if there is current evidence or history of squamous cell carcinoma in the treatment area. Concurrent application of Vyjuvek with excluded topical products on the same target wound (e.g., Filsuvez, Zevaskyn) or failure to provide required documentation (including genetic confirmation and baseline target wound size) also renders the request unsupported under these criteria.

For continued therapy, Vyjuvek must not be applied to target wounds that have completely healed; continued coverage requires provider attestation that target wounds remain incompletely closed, are clean with adequate granulation tissue and vascularization, and are not infected.

Initial Therapy Criteria

Initial Therapy

Initial approval requires genetic confirmation and specialist involvement plus wound and treatment conditions.

Genetic and specialist confirmation: 1) Confirmation of COL7A1 gene mutation via genetic testing (see Appendix E); 2) Prescribed by or in consultation with a geneticist, dermatologist, or histopathologist.

Wound condition and documentation: 1) Provider attestation that target wounds are clean with adequate granulation tissue and excellent vascularization and not infected; 2) Documentation of baseline target wound size (see Appendix F); 3) Provider attestation that member is receiving concurrent standard of care wound therapies.

Appendix F provides per-wound dose guidance by wound size.

Exclusions and dosing limits: 1) No current evidence or history of squamous cell carcinoma in the treatment area; 2) No concurrent prescription of Vyjuvek with Filsuvez or Zevaskyn on the same target wound; 3) Planned dose must conform to age-based maximums (Age < 3 years: 2 x 10^9 PFU/1 mL weekly; Age ≥ 3 years: 4 x 10^9 PFU/2 mL weekly) and per-wound dosing in Appendix F.

Continuation and Continued Therapy Criteria

Continuation Therapy

Continuation requires evidence of positive response and ongoing appropriate wound status.

Response and wound status: 1) Member is responding positively to therapy as evidenced by improvement such as decreased wound size or decreased pain with dressing changes; 2) Provider attestation that target wounds continue to have incomplete closures that are clean with adequate granulation tissue, well vascularized, and not infected; 3) Vyjuvek is not applied to target wounds that have completely healed.

If requesting dose increase, new dose must not exceed age-based maximums.

Continued Therapy

Continued therapy requires ongoing documentation that target wounds remain eligible and that dosing and exclusion rules are followed.

Ongoing eligibility and documentation: 1) Documentation of ongoing clinical benefit for the treated target wounds (e.g., reduced size or pain) and that wounds remain eligible for treatment (not completely healed); 2) Continued adherence to dosing limits and per-wound dosing guidance; 3) Documentation confirming Vyjuvek is not being applied concurrently on the same target wound with excluded therapies (Filsuvez, Zevaskyn); 4) Required records (office notes, genetic testing, wound measurements) are maintained and available for prior authorization or claims documentation.

Coding and Dose Tables

Policy identifiersmixed

CP.PHAR.592

Policy reference number (internal)

Referenced HCPCS CodesHCPCS

J3401

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

Dose by wound size (Appendix F)

Wound size <20 cm^2Dose = 4 x 10^8 PFU; Volume = 0.2 mL

Wound size 20 to <40 cm^2Dose = 8 x 10^8 PFU; Volume = 0.4 mL

Wound size 40 to 60 cm^2Dose = 1.2 x 10^9 PFU; Volume = 0.6 mL

Maximum weekly dose by age

Age <3 years — maximum weekly dose2 x 10^9 PFU (1 mL) once weekly

Age ≥3 years — maximum weekly dose4 x 10^9 PFU (2 mL) once weekly

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must obtain prior authorization and submit supporting clinical documentation demonstrating that the member meets the initial or continuation criteria (including genetic confirmation of COL7A1 mutation for DEB and specialist prescriber requirements) before Vyjuvek (beremagene geperpavec-svdt) will be approved.

Prior authorization required for initiation and continuation of therapy
Initial criteria require COL7A1 genetic confirmation and prescriber specialty (geneticist, dermatologist, or histopathologist)
Continuation requires documentation of response and adherence to continuation criteria

Denial Risk

Documentation Required — Denial Risk if Incomplete

Providers must submit complete clinical documentation with the prior authorization request. Failure to provide required documentation may result in denial of the request.

Quantity Limits and Product Dosing

Vyjuvek dosing overview

Per-wound dosingDose varies by wound size per Appendix F (see dose tiers: 0.2–0.6 mL corresponding to 4 x10^8–1.2 x10^9 PFU)

Age-based weekly maximumsMaximum weekly dose limits apply: Age <3 = 2 x10^9 PFU/week (1 mL); Age ≥3 = 4 x10^9 PFU/week (2 mL)

Documentation requirementBaseline target wound size must be documented to determine per-wound dosing

Beremagene geperpavec-svdt (Vyjuvek) presentation and weekly vial mapping

Product presentationSingle‑dose vial: 1 mL extractable biological suspension mixed into excipient gel at nominal 5 x 10^9 PFU/mL

Age-based vial/week mapping — Age <3Weekly maximum: 2 x10^9 PFU equals 1 mL (one 1 mL vial) once weekly

Site of Care and Administration

Note

Site-of-care: no explicit restriction; provider responsibilities for wound evaluation

There is no explicit site-of-care restriction; providers remain responsible for evaluating target wounds and considering practical aspects of wound evaluation and topical application when planning therapy.

Provider should document wound evaluation and suitability for topical application.

Note

Site-of-care: application in clinic or at home by patient/caregiver per instructions

Application of Vyjuvek gel may be performed in a healthcare professional setting or at home when applied by the patient or caregiver per the instructions for use; pharmacy preparation and appropriate instruction should be documented.

Document who applied the gel (HCP, patient, or caregiver) and the setting (clinic or home).

Definitions and Product Information

Key abbreviations

COL7A1Collagen type VII alpha 1 chain (gene mutated in DEB)

DEBDystrophic epidermolysis bullosa

PFUPlaque forming units

HSV-1Herpes simplex virus type 1

Product formulation

Vial typeBiological suspension in a single‑dose vial with 1 mL extractable volume

PreparationVial contents are mixed into excipient gel to create Vyjuvek topical gel

Step Therapy Considerations

Requirement	Details
Concurrent standard wound care required
Member must be receiving standard of care preventative or treatment wound therapies (examples: polymeric membrane, super‑absorbent dressings, soft‑silicone foam, enzyme alginogel, protease; see Appendix G)
No mandated prior failure of a specific product
Provider attestation
Provider must attest target wounds are clean, have adequate granulation tissue, are well vascularized, and not appear infected

Step therapy element	Policy statement
Presence of step therapy sequence
No explicit step therapy sequence is described in this policy segment; treatment is governed by prior authorization criteria and required documentation
Exclusions and prior authorization
Exclusions (e.g., concurrent use with Filsuvez or Zevaskyn on the same target wound) and prior authorization requirements apply instead of a step sequence

Revision History

2026-03-16clarificationLatest

Clarified that exclusions for concomitant use with Filsuvez and Zevaskyn apply when therapies are used on the same target wound (updated initial and continued therapy language).

2025-09-24labeling_update

RT4: removed the lower age limit (previously 6 months), increased maximum weekly doses from 1.6 and 3.2 x10^9 PFU to 2 and 4 x10^9 PFU per week, and added administration information allowing application by patient or caregiver per updated instructions for use.

2024-05-13

Background

Dystrophic epidermolysis bullosa (DEB) is an ultra‑rare subtype of epidermolysis bullosa caused by mutations in the COL7A1 gene. Vyjuvek (beremagene geperpavec‑svdt) is a topical HSV‑1 vector–based gene therapy supplied as a biological suspension (nominally mixed into gel at 5 x 10^9 PFU/mL) and is approved to treat wounds in patients with DEB with confirmed COL7A1 mutations. Labeled dosing is age‑based with maximum weekly doses of 2 x 10^9 PFU (1 mL) for patients <3 years and 4 x 10^9 PFU (2 mL) for patients ≥3 years, and the product may be prepared at the pharmacy and applied by a healthcare professional, patient, or caregiver per the instructions for use.

OpenPayer

Beremagene geperpavec (Vyjuvek) coverage for dystrophic epidermolysis bullosa