CurrentViva HealthPolicy IC-0796

Zevaskyn (prademagene zamikeracel) (Topical)

Medical policy governing prior authorization, coverage criteria, dosing, and billing for Zevaskyn topical cell-sheet therapy for treatment of recessive dystrophic epidermolysis bullosa (RDEB) for Viva Health members.

Policy Summary

PayerViva Health

PolicyZevaskyn (prademagene zamikeracel) (Topical)

Policy CodePolicy IC-0796

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionPrior authorization is required; initial authorization is valid for 6 months and may be renewed every 6 months with required clinical documentation submitted at time of request.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial prior authorization validity

1 unitHCPCS units per treatment

up to 12max sheets per lot

age ≥ 6 yearsminimum patient age

Q81.2covered diagnosis

Coverage Criteria for Zevaskyn (prademagene zamikeracel)

Initial Therapy

Covered when ALL of the following are met

Age: Patient is at least 6 years of age>= 6 years

Hypersensitivity: Patient does not have severe hypersensitivity (i.e., anaphylaxis) to vancomycin or amikacin

Concurrent therapy: Will not be used concurrently, in the same wound, with another disease-modifying therapeutic agent indicated for DEB (this does not include topical/wound management agents such as dressings or antibiotics)

No SCC:

Policy Summary

PayerViva Health

PolicyZevaskyn (prademagene zamikeracel) (Topical)

Policy CodePolicy IC-0796

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionPrior authorization is required; initial authorization is valid for 6 months and may be renewed every 6 months with required clinical documentation submitted at time of request.

SourceLink

On This Page

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Renewal Criteria

Renewal when ALL of the following are met

Continued indication: Patient continues to meet the indication-specific relevant criteria identified in initial approval (section III)

Toxicity: Absence of unacceptable toxicity from the drug (examples include severe hypersensitivity reactions, new malignancies, serious infections)

Clinical response: Patient shows disease response to treatment as defined by improvement (healing) of treated wound sites and/or reduction in skin infections, as attested by the treating physician

Need for continued treatment: Patient requires continued treatment due to new expansion of pre-existing or development of new open wounds

Zevaskyn is intended as a one-time treatment per area; re-treatment of wounds that were previously grafted is considered investigational and may not be renewed.

Coverage excludes concurrent application of Zevaskyn with another disease-modifying therapeutic agent indicated for DEB in the same wound. The policy language explicitly excludes simultaneous use with other DEB gene- or cell-based disease-modifying therapies (examples cited in the source include birch triterpenes and beremagene geperpavec), but does not prohibit use of routine topical wound care products such as dressings, topical antimicrobials, or other local wound-management measures.

Providers should document prior treatments and the clinical rationale when requesting authorization so it is clear that Zevaskyn will not be used concurrently in the same wound with another disease-modifying DEB agent. This restriction applies to initial authorization and renewals; failure to demonstrate compliance may affect coverage determinations.

Re-treatment of wounds that have previously been grafted with Zevaskyn (or otherwise previously grafted) is considered investigational and may not be renewed. The policy specifies that Zevaskyn is intended as a one-time treatment per area, and renewal is limited to situations where the patient meets renewal criteria for new or expanding open wounds, not for re-treating previously grafted sites.

When submitting a renewal request, clinicians must demonstrate ongoing need based on new expansion of pre-existing wounds or development of de novo open wounds and provide documentation of treatment response and absence of unacceptable toxicity; requests to re-treat previously grafted areas should be anticipated to be denied as investigational.

Coding and Billing

HCPCS CodesHCPCS

J3389	Topical administration, prademagene zamikeracel, per treatment; 1 billable unit = 1 treatment (Effective 01/01/2026)
J3590	Unclassified biologics (Discontinue use on 01/01/2026)

NDCNDC

84103-0007-xx

Zevaskyn sheets of 41.25 cm² (5.5 cm × 7.5 cm); all available sheets per manufactured lot supplied under this NDC (up to twelve sheets per lot)

Covered Diagnosis CodesICD-10Covered

Q81.2

Epidermolysis Bullosa Dystrophic

Wound area and duration — key clinical thresholds

Minimum wound areaWounds adequate for treatment (example: stage 2 wounds) with area ≥ 20 cm2

Minimum wound durationWounds present for at least 6 months

Sheet coverageOne Zevaskyn sheet covers 41.25 cm2 (used to calculate number of sheets per wound)

Maximum sheets availableUp to 12 sheets may be manufactured from patient biopsies and supplied for potential use

Provider Actions, Authorization, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for initial requests. Initial authorizations are valid for 6 months. Authorizations may be renewed at 6‑month intervals per clinical need and supporting documentation.

Initial prior authorization validity: 6 months
Renewal cadence: may be renewed every 6 months

Denial Risk

Concurrent Disease‑Modifying Therapy Restriction

Therapy must not be used concurrently in the same wound with another disease‑modifying agent indicated for dystrophic epidermolysis bullosa (DEB). This restriction does not apply to routine wound care items such as topical agents, dressings, or antibiotics.

Do not use concurrently in the same wound with another disease‑modifying DEB agent (e.g., birch triterpenes, beremagene geperpavec).
Concurrent use of topical wound care, dressings, or antibiotics is permitted.

Documentation Required

Required Clinical Documentation

Submission of supporting clinical documentation is REQUIRED on all authorization requests. Records will be reviewed at the time of submission as part of the evaluation. Provide documentation related to diagnosis, any required step therapy, and relevant clinical markers (for example genetic or mutational testing) when applicable.

Acceptable documentation: medical records, chart notes, lab results, confirmatory diagnostics.
Include documentation supporting diagnosis and clinical indications for initiation.
Provide genetic/mutational testing results when applicable.

Documentation Required

Documentation Submission Required

Failure to submit the required supporting clinical documentation may result in denial of the request or non‑renewal due to inability to establish medical necessity.

Submit documentation via direct upload through the PA web portal or by fax.
Incomplete or missing records may lead to denial or non‑renewal.

Background

Zevaskyn is an autologous, gene-corrected keratinocyte sheet therapy indicated for treatment of wounds in recessive dystrophic epidermolysis bullosa (RDEB). Dosing is based on wound surface area, with each sheet covering 41.25 cm2 and manufacturing allowing up to 12 sheets per patient biopsy collection (supplied in transport containers).

The product is billed using HCPCS codes (notably J3389 effective 01/01/2026 for topical administration, per treatment, where 1 billable unit = 1 treatment) and each treatment requires prior authorization. Coverage is limited to patients meeting specific criteria including genetic confirmation of RDEB, age threshold (≥ 6 years), appropriate wound size and duration, absence of severe hypersensitivity to component antibiotics, and no current or prior squamous cell carcinoma in the treatment area.

OpenPayer

Zevaskyn (prademagene zamikeracel) (Topical)

Coverage Criteria for Zevaskyn (prademagene zamikeracel)

Coding and Billing

Provider Actions, Authorization, and Documentation Requirements

Background

Definitions