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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty Drugsmoda_health_plan_inc Vyjuvek Coverage & Prior Auth…
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    Currentmoda_health_plan_incPolicy IC-0709

    Vyjuvek (beremagene geperpavec-svdt) topical policy

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    Defines prior authorization, dosing limits, coverage criteria, renewal rules, billing codes, and documentation requirements for Vyjuvek topical therapy for dystrophic epidermolysis bullosa (DEB) for Moda Health Plan members.

    Policy Summary
    Payermoda_health_plan_inc
    PolicyVyjuvek (beremagene geperpavec-svdt) topical policy
    Policy CodePolicy IC-0709
    Change TypeNo material change
    Effective DateJul 5, 2023
    Last ReviewJul 1, 2026
    Next Review DateJul 1, 2026
    Key ActionSubmit prior authorization with supporting clinical documentation; initial approval is for 12 months and may be renewed every 12 months.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    12 monthsinitial prior authorization validity
    25maximum billable units (HCPCS) per 7 days
    J3401HCPCS code for Vyjuvek
    Q81.2Covered diagnosis code (DEB - dystrophic)

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    NDC 82194-0510-02 / 82194-0501-01Vyjuvek product NDCs

    Coverage Criteria for Vyjuvek (beremagene geperpavec‑svdt)

    Initial Approval Criteria

    Covered when ALL of the following are met

    Universal criteria: Will not be used concurrently in the same wound with another disease-modifying DEB therapeutic; member does not have current evidence or history of squamous cell carcinoma (SCC) in the area to be treated; member does not have an active infection on the area to be treated.
    Indication-specific criteria (DEB): Member has a diagnosis of dystrophic epidermolysis bullosa (DEB) established by detection of mutation(s) in the COL7A1 gene on molecular genetic testing; AND member has open cutaneous wound(s).
    Documentation: Submission of supporting clinical documentation including medical records, chart notes, laboratory results, and confirmatory diagnostics (e.g., genetic/mutational testing) is required at the time of authorization request.

    Renewal Criteria

    Renewal approval requires ALL of the following

    Continued eligibility: Member continues to meet the universal and indication-specific criteria; absence of unacceptable toxicity from the drug (e.g., severe medication reactions warranting discontinuation); member has demonstrated clinical benefit (improvement/healing of treated wound sites and/or reduction in skin infections); member requires continued treatment due to new or existing open wounds.

    Vyjuvek must not be used concurrently in the same wound with another disease‑modifying therapeutic agent indicated for dystrophic epidermolysis bullosa (DEB). This exclusion applies to other topical or systemic disease‑modifying DEB therapies (for example, prademagene zamikeracel or birch triterpenes) but does not prohibit concurrent use of routine wound‑management items such as dressings, topical wound care products, or antibiotics. The policy also requires that the member does not have current evidence or a history of squamous cell carcinoma in the area to be treated and that the treatment site is free of active infection before initiation.

    Requests for Vyjuvek that propose concurrent application in the same wound with another disease‑modifying DEB agent will not be approved. The policy explicitly excludes combination use of two disease‑modifying therapies on the same wound (this exclusion is separate from and does not restrict use of non‑disease‑modifying wound care measures).

    Initial Therapy — Dosage and Administration

    Initial Therapy — Dosage/Administration overview and dosing rules

    Dose and administration overview and dosing rules

    Dosing frequency and application: Vyjuvek gel is applied topically to selected wound(s) once weekly; apply in droplets spaced approximately 1 cm apart within the wound. It may not be possible to treat all wounds at each visit; prioritize previously treated wounds if they re-open. If a dose is missed, apply as soon as possible and resume weekly dosing. The gel prepared at the pharmacy may be applied by an HCP, member, or caregiver in a clinic or at home.
    Age- and area-based maximum weekly dose: Maximum weekly dose varies by age and wound area. For individuals <3 years: maximum weekly PFU and volume per policy table; for individuals ≥3 years: higher maximum weekly PFU and volume per policy table. For wound area <=60 cm^2, use the table (e.g., <20 cm^2 = 0.2 mL; 20–<40 = 0.4 mL; 40–60 = 0.6 mL). For wound area >60 cm^2, calculate the total dose per policy guidance.
    Preparation and safety: Prepare Vyjuvek biological suspension mixed with excipient gel to achieve the specified maximum weekly volume. Pregnant individuals should not prepare or apply Vyjuvek gel and should avoid direct contact with treated wounds or dressings.

    Continuation Therapy and Renewal Requirements

    Continuation Therapy / Renewal

    Renewal requirements

    Renewal nodes: Member continues to meet universal and indication-specific criteria; absence of unacceptable toxicity; demonstrated clinical benefit (healing/improvement of treated wounds and/or reduced skin infections); continued need for treatment due to new or existing open wounds.

    Coding — HCPCS, ICD-10, and NDCs

    Covered HCPCS CodesHCPCSCovered
    J3401Beremagene geperpavec-svdt for topical administration, containing nominal 5 x 10^9 pfu/ml vector genomes, per 0.1 ml; 1 billable unit = 0.1 mL
    Covered Diagnosis Codes (DEB)ICD-10Covered
    Q81.2Epidermolysis Bullosa Dystrophic
    Product NDCsNDC
    82194-0510-02Vyjuvek 1.0 mL extractable volume outer carton (NDC)
    82194-0501-01Vyjuvek 1.0 mL extractable volume inner drug vial (NDC)
    inv-08: HCPCS units per period
    HCPCS unit limitMax 25 billable units every 7 days
    Unit definition1 billable unit = 0.1 mL (per HCPCS code J3401)
    Measurement periodLimit assessed per rolling 7-day period

    Quantity Limits

    inv-19: Vyjuvek (beremagene geperpavec-svdt)
    ProductVyjuvek (beremagene geperpavec-svdt)
    Quantity limit25 billable units per 7 days
    Billable unit definition1 billable unit = 0.1 mL (per J3401)

    Provider Actions and Documentation Requirements

    Prior Authorization

    Prior authorization required; initial approval 12 months

    Prior authorization is required for Vyjuvek. Initial approval is provided for 12 months (365 days) and may be renewed every 12 months (365 days). Supporting clinical documentation must be provided at the time of submission.

    • HCPCS code: J3401 (used for PA requests)
    Step Therapy

    Do not use concurrently in same wound with another disease‑modifying DEB agent

    Therapy must not be used concurrently in the same wound with another disease‑modifying DEB agent; this restriction applies to disease‑modifying therapeutics (does not include dressings, topical wound care, antibiotics, etc.).

    Step Therapy / Exclusions

    StepRequirement / Restriction
    {"text":"1","status":""}|{"text":"Vyjuvek must not be used concurrently in the same wound with another disease-modifying therapeutic agent indicated for dystrophic epidermolysis bullosa (DEB) (this exclusion does not apply to topical dressings, routine wound care products, or antibiotics).","status":"not_covered"}

    Site of Care for Application

    Note

    Home application permitted

    The Vyjuvek gel prepared at the pharmacy may be applied by a healthcare professional, the member, or a caregiver in a home setting; application at home is an approved site of care when prepared by the pharmacy.

    Note

    Office/clinic application permitted

    Vyjuvek gel may be applied in a healthcare professional setting (e.g., clinic) by an HCP, member, or caregiver; clinic/office application is an approved site of care.

    Diagnostic and Definition Requirements

    inv-15: Dystrophic epidermolysis bullosa (DEB) diagnostic requirement
    Diagnostic requirementDEB diagnosis must be established by detection of mutation(s) in the COL7A1 gene on molecular genetic testing
    Associated conditionDiagnosis applies to dystrophic epidermolysis bullosa (DEB)
    Supporting documentationMolecular genetic testing results must be submitted with authorization request

    Background

    Dystrophic epidermolysis bullosa (DEB) is an inherited blistering disorder caused by mutations in the COL7A1 gene leading to fragility of the skin and mucous membranes. Vyjuvek (beremagene geperpavec‑svdt) is a topical gene therapy indicated for treatment of open cutaneous wounds in members with DEB. Per the policy, diagnosis of DEB must be confirmed by detection of mutation(s) in the collagen type VII alpha 1 chain (COL7A1) on molecular genetic testing, and Vyjuvek is applied to eligible open wounds only when the treatment site is free of active infection and has no current or past squamous cell carcinoma in the area to be treated.

    Policy Summary
    Payermoda_health_plan_inc
    PolicyVyjuvek (beremagene geperpavec-svdt) topical policy
    Policy CodePolicy IC-0709
    Change TypeNo material change
    Effective DateJul 5, 2023
    Last ReviewJul 1, 2026
    Next Review DateJul 1, 2026
    Key ActionSubmit prior authorization with supporting clinical documentation; initial approval is for 12 months and may be renewed every 12 months.
    SourceLink
    On This Page
    Coverage Criteria for Vyjuvek (beremagene geperpavec‑svdt)Initial Therapy — Dosage and AdministrationContinuation Therapy and Renewal RequirementsCoding — HCPCS, ICD-10, and NDCsQuantity LimitsProvider Actions and Documentation RequirementsStep Therapy / ExclusionsSite of Care for ApplicationDiagnostic and Definition RequirementsBackground
    Documentation Required

    Submit medical records, chart notes, labs, and confirmatory diagnostics

    Submit supporting clinical documentation with all authorization requests. Required materials include medical records, chart notes, laboratory results, and confirmatory diagnostics demonstrating diagnosis, applicable genetic/mutational testing, and any step‑therapy history.

    • Provide documentation via direct upload through the PA web portal or by fax.
    • Documentation will be reviewed at time of submission as part of the evaluation.
    Denial Risk

    Failure to provide required documentation may result in denial or delay

    Failure to submit the required supporting clinical documentation (medical records, chart notes, lab results, confirmatory diagnostics) may result in denial or delay due to inability to establish medical necessity.

    • Records must be provided with the PA request; lack of records can lead to denial per policy guidelines.
    Denial Risk

    Concurrent disease‑modifying therapy in same wound will not be approved

    Requests for concurrent use in the same wound with another disease‑modifying DEB therapeutic will not be approved; concurrent disease‑modifying therapy in the same wound is an exclusion to coverage.