CurrentModa HealthPolicy IC-0796

Zevaskyn (prademagene zamikeracel) (Topical)

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Defines Moda Health coverage, prior authorization, dosing, and medical necessity criteria for topical Zevaskyn to treat wounds from recessive dystrophic epidermolysis bullosa (RDEB) for covered members and providers submitting PA requests.

Policy Summary

PayerModa Health

PolicyZevaskyn (prademagene zamikeracel) (Topical)

Policy CodePolicy IC-0796

Change TypeNo material changes

Effective DateJun 5, 2025

Last ReviewJun 5, 2025

Next Review DateJun 5, 2025

Key ActionSubmit prior authorization with supporting clinical documentation; initial PA valid for 6 months and may be renewed every 6 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial prior authorization length

6 monthsrenewal prior authorization interval

1 unitbillable unit per treatment

41.25 cm2area per sheet

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CurrentModa HealthPolicy IC-0796

Zevaskyn (prademagene zamikeracel) (Topical)

Customize your policy alerts

Sign up for Moda Health Policy IC-0796 alerts

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Policy Summary

PayerModa Health

PolicyZevaskyn (prademagene zamikeracel) (Topical)

Policy CodePolicy IC-0796

Change TypeNo material changes

Effective DateJun 5, 2025

Last ReviewJun 5, 2025

Next Review DateJun 5, 2025

Key ActionSubmit prior authorization with supporting clinical documentation; initial PA valid for 6 months and may be renewed every 6 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial prior authorization length

6 monthsrenewal prior authorization interval

1 unitbillable unit per treatment

41.25 cm2area per sheet

Coverage Criteria for Zevaskyn (prademagene zamikeracel)

Initial Approval Criteria

Covered when ALL of the following are met

Initial and universal criteria: Patient is at least 6 years of age; AND patient does not have severe hypersensitivity (e.g., anaphylaxis) to vancomycin or amikacin; AND therapy will not be used concurrently in the same wound with another disease-modifying therapeutic agent indicated for DEB (this does not include routine wound care topicals, dressings, or antibiotics); AND patient does not show current evidence of, nor have a history of, squamous cell carcinoma in the area to be treated; AND submission of supporting clinical documentation (medical records, chart notes, lab results, confirmatory diagnostics) is REQUIRED on all requests; records will be reviewed at time of submission and failure to provide may result in denial.

Provide documentation via PA web portal or fax; records reviewed at time of submission

RDEB-specific criteria: Diagnosis of recessive dystrophic epidermolysis bullosa (RDEB) established by detection of biallelic COL7A1 mutation(s) on molecular genetic testing (if unable to confirm biallelic mutation, confirmation that BOTH parents do not have evidence of dominant disease is acceptable); AND presence of cutaneous wound(s) adequate for treatment (for example, stage 2 wounds) with total area ≥ 20 cm2 that have been present for at least 6 months.wound area >= 20 cm2; duration >= 6 months

FDA-approved indication

Dosing limit: Maximum 1 billable HCPCS unit per treatment, where 1 treatment equals up to twelve C7-expressing cellular sheets (supplied as up to three containers with up to four sheets each).<= 1 unit per treatment

One Zevaskyn sheet covers 41.25 cm2; up to 12 sheets may be supplied per treatment

Renewal Criteria

Renewal is allowed when ALL of the following are met

Continuation criteria: Patient continues to meet the indication-specific criteria from the initial approval; AND there is absence of unacceptable toxicity from the drug (examples include severe hypersensitivity reactions, development of new malignancies, or serious infections); AND patient demonstrates clinical response (healing of treated wound sites and/or reduction in skin infections) as attested by the treating physician; AND patient requires continued treatment due to expansion of pre-existing wounds or development of new open wounds.

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

Coverage excludes concurrent application of Zevaskyn in the same wound with another disease-modifying therapeutic agent indicated for DEB (for example, birch triterpenes or beremagene geperpavec). Routine wound care items such as topical emollients, dressings, or systemic/topical antibiotics are not considered disease-modifying agents and are not included in this exclusion. Submission of supporting clinical documentation is required with prior authorization requests and records will be reviewed at time of submission; failure to provide required documentation may result in denial.

Zevaskyn is intended as a one-time treatment per area. Accordingly, re-treatment of wounds that were previously grafted is considered investigational at this time and may not be renewed under the policy’s renewal criteria.

Billing and Coding

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) with up to four sheets provided in a single transport container, and with up to three containers per manufactured lot (up to twelve sheets) supplied under this NDC: 84103-0007-xx.

Covered ICD-10 CodesICD-10Covered

Q81.2

Epidermolysis Bullosa Dystrophic

Provider Requirements and Authorization

Prior Authorization

Prior authorization required — initial and renewal intervals

Prior authorization is required for Zevaskyn. Initial PA is valid for 6 months; renewals may be issued every 6 months. Documentation to support medical necessity must be submitted with the PA request.

Initial: PA valid for 6 months
Renewal: may be renewed every 6 months
Submit supporting documentation with request (see required clinical documentation)

Step Therapy

No concurrent disease‑modifying agents in the same wound

Do not use Zevaskyn concurrently in the same wound with another disease‑modifying therapeutic agent indicated for DEB.

Prohibition applies to concurrent use in the same wound with other disease‑modifying DEB agents (examples: birch triterpenes, beremagene geperpavec)
This exclusion does not apply to routine wound care products (topicals, dressings, antibiotics, etc.)

Background

Zevaskyn (prademagene zamikeracel) is an autologous, gene-corrected topical cellular therapy intended to treat wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB). Sheets are produced from a patient biopsy and applied to wound sites in a single treatment session; post-application immobilization (typically several days) is used as clinically indicated. Prior authorization is required before treatment and supporting clinical documentation must be submitted for review.

Definitions and Product Details

Zevaskyn sheet — specifications and NDC

Sheet size (area)41.25 cm2 (5.5 cm × 7.5 cm)

Sheets per transport containerUp to 4 sheets per container

Containers per manufactured lotUp to 3 containers per lot (total up to 12 sheets)

NDC linkageAll sheets supplied per manufactured lot under NDC 84103-0007-xx

Per-treatment useApply all selected sheets in a single surgical session; do not trim or overlap sheets

Shipping and handlingShipped directly to the qualified treatment center sealed in transport packaging