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    v1.0.28
    OpenPayerPolicy UpdatesDermatologymoda_health_plan_inc Zevaskyn Coverage & Prior Aut…
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    Currentmoda_health_plan_incPolicy IC-0796

    Zevaskyn (prademagene zamikeracel) topical therapy coverage

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    Policy governing prior authorization, dosing, billing, and medical necessity criteria for Zevaskyn topical autologous cellular sheets for treatment of recessive dystrophic epidermolysis bullosa (RDEB) for Moda Health Plan members.

    Policy Summary
    Payermoda_health_plan_inc
    PolicyZevaskyn (prademagene zamikeracel) topical therapy coverage
    Policy CodePolicy IC-0796
    Change TypeNo material clinical or coverage changes
    Effective DateJun 5, 2025
    Last ReviewJul 1, 2026
    Next Review DateJul 1, 2026
    Key ActionObtain prior authorization; initial approval is valid for 6 months and may be renewed every 6 months thereafter.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    6 monthsinitial prior authorization validity
    J3389HCPCS billing code
    up to 12sheets per treatment
    ≥6 yrsminimum age

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    Q81.2
    covered ICD-10

    Coverage Criteria for Zevaskyn (RDEB)

    Zevaskyn must not be used concurrently in the same wound with another disease-modifying therapeutic agent indicated for dystrophic epidermolysis bullosa (DEB). Routine wound-care measures such as topical dressings, non–disease-modifying antibiotics, or other local wound management products are not considered disease-modifying agents and are excluded from this restriction.

    Zevaskyn is intended as a one-time treatment per anatomic area. Re-treatment of wounds that were previously grafted is considered investigational and may not be renewed under the renewal criteria.

    Use of Zevaskyn is contraindicated in members with severe hypersensitivity (e.g., anaphylaxis) to vancomycin or amikacin; presence of such hypersensitivity renders treatment not appropriate.

    Coding, Units, and Diagnosis Codes

    Covered HCPCS CodesHCPCSCovered
    J3389Topical administration, prademagene zamikeracel, per treatment; 1 billable unit = 1 treatment
    NDCNDC
    84103-0007-xxZevaskyn sheets of 41.25 cm² (5.5 cm × 7.5 cm) with up to four sheets provided in a single transport container, and with up to three containers per manufactured lot, for a total of up to twelve sheets. All available sheets per manufactured lot are supplied under the same NDC: 84103-0007-xx
    Covered ICD-10 CodesICD-10Covered
    Q81.2Epidermolysis Bullosa Dystrophic
    inv-09: Minimum wound size for treatment — e.g. wound area threshold and duration
    Wound area thresholdWound area ≥ 20 cm2
    Minimum wound durationWound(s) present for at least 6 months
    Example wound stageAdequate for treatment e.g., stage 2 wounds
    inv-10: Minimum age — age threshold for coverage
    Minimum age for coverage>= 6 years
    Authorization noteMember must meet other clinical criteria in addition to age (see full criteria)
    Documentation requirementAge must be documented in submitted clinical records

    Provider Requirements and Actions

    Prior Authorization

    Prior authorization validity

    Prior authorization is required. Initial authorization is valid for 6 months (180 days) and may be renewed every 6 months (180 days) thereafter.

    Step Therapy

    No concurrent disease‑modifying therapy in same wound

    Zevaskyn must not be used concurrently, in the same wound, with another disease-modifying therapeutic agent indicated for dystrophic epidermolysis bullosa; routine wound care products (topicals, dressings, antibiotics) are not included in this exclusion.

    Documentation Required

    Required clinical documentation

    Background

    Zevaskyn (prademagene zamikeracel) is an autologous topical cellular-sheet therapy

    Definitions and Product Details

    inv-16: Sheet — one Zevaskyn sheet area and maximum sheets per manufactured lot
    Area covered per sheetOne Zevaskyn sheet = 41.25 cm2 (5.5 cm × 7.5 cm)
    Maximum sheets per manufactured lotUp to 12 sheets may be manufactured from member biopsies and supplied per lot
    Packaging detailSheets shipped sealed in transport packaging to treatment center
    Application instructionApply all selected sheets in a single surgical session; do not trim or overlap sheets
    inv-17: RDEB diagnostic confirmation — molecular testing criteria for biallelic COL7A1 variants
    Primary diagnostic requirementDetection of biallelic pathogenic (or likely pathogenic) variants in COL7A1 on molecular genetic testing
    Policy Summary
    Payermoda_health_plan_inc
    PolicyZevaskyn (prademagene zamikeracel) topical therapy coverage
    Policy CodePolicy IC-0796
    Change TypeNo material clinical or coverage changes
    Effective DateJun 5, 2025
    Last ReviewJul 1, 2026
    Next Review DateJul 1, 2026
    Key ActionObtain prior authorization; initial approval is valid for 6 months and may be renewed every 6 months thereafter.
    SourceLink
    On This Page
    Coverage Criteria for Zevaskyn (RDEB)Coding, Units, and Diagnosis CodesProvider Requirements and ActionsBackgroundDefinitions and Product Details

    Submission of supporting clinical documentation is REQUIRED on all authorization requests; records will be reviewed at the time of submission.

    • Medical records and chart notes documenting diagnosis and treated wound characteristics
    • Lab results and confirmatory diagnostics (e.g., genetic/mutational testing for COL7A1)
    • Documentation supporting step‑therapy and clinical markers as applicable
    • Provide documentation via PA web portal upload or by fax
    Denial Risk

    Denial risk for missing documentation

    Failure to submit the required supporting clinical documentation may result in denial due to inability to establish medical necessity.

    Alternative when biallelic testing unavailableIf unable to confirm biallelic variant, confirmation that BOTH parents have no evidence of dominant disease is acceptable
    Indication tied to diagnosisDiagnosis of recessive dystrophic epidermolysis bullosa (RDEB) must be established per above molecular criteria