CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Zevaskyn

Defines medical necessity, authorization, dosing, and billing for Zevaskyn topical autologous cellular sheets for treatment of wounds in pediatric and adult patients with genetically confirmed RDEB across Medicaid, Commercial, and Medicare lines.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZevaskyn

Policy CodePolicy N/A

Change TypeNo material change

Effective DateNov 1, 2025

Next Review Date

Key ActionSubmit supporting clinical documentation (medical records, chart notes, lab results, confirmatory diagnostics, genetic/mutational testing) via PA web portal or fax; failure to submit may result in denial due to inability to establish medical necessity.

SourceLink

POLICY UPDATE CHANGES

No material changes to clinical coverage criteria or policy terms (has_material_change = false).

1Covered Indication (RDEB)

12Max Sheets per Surgical Session

6Authorization Duration (months)

6Minimum Age (years)

Coverage Summary

Coverage stance: covered_with_criteria. This policy defines medical necessity, authorization, dosing, and billing for Zevaskyn (prademagene zamikeracel) topical autologous cellular sheets for treatment of wounds in pediatric and adult patients with genetically confirmed recessive dystrophic epidermolysis bullosa (RDEB).

Scope: Applicable across Medicaid, Commercial, and Medicare lines; the policy addresses prior authorization requirements, initial and renewal criteria, authorization duration, and quantity limits for Zevaskyn used to treat RDEB wounds.

Policy thresholds and authorization metrics

Minimum age>= 6 years

Minimum wound duration>= 6 months

Minimum wound area>= 20 cm2 (example: stage 2 wounds)

Max sheets per surgical sessionUp to 12 sheets (supplied as up to 3 containers of up to 4 sheets each)

Authorization duration6 months (initial); may be renewed

81%Wounds ≥50% healed at month 6 with Zevaskyn vs 16% control

-3.07Mean pain reduction with Zevaskyn at month 6 (vs -0.90 control)

Medical-Necessity Criteria

Initial Approval Criteria

Coverage provided when ALL of the following are met:

ALL of the following

Member is at least 6 years of age
Submission of supporting clinical documentation (medical records, chart notes, lab results, confirmatory diagnostics) is provided with the authorization request
Failure to submit documentation may result in denial due to inability to establish medical necessity
Member does not have severe hypersensitivity (i.e., anaphylaxis) to vancomycin or amikacin
Zevaskyn will not be used concurrently, in the same wound, with another disease-modifying therapeutic agent indicated for DEB (examples: Filsuvez, Vyjuvek); use of topicals, dressings, antibiotics etc. is permitted
Member does not show current evidence or have a history of squamous cell carcinoma (SCC) in the area to be treated
Zevaskyn is prescribed by or in consultation with a qualified dermatologist specializing in EB at an enrolled QTC
Genetic confirmation OR parental confirmation
- Diagnosis of recessive dystrophic epidermolysis bullosa (RDEB) established by detection of biallelic mutation(s) in COL7A1 gene on molecular genetic testing
- If unable to confirm a biallelic mutation, confirmation that BOTH parents do not have any evidence of dominant disease is acceptable
Member has cutaneous wound(s) adequate for treatment (example: stage 2 wounds with area ≥20 cm2) that have been present for at least 6 months>= 6 months; area >= 20 cm2 (example)
Medicare members who previously received this medication within the past 365 days are not subject to Step Therapy Requirements365 days

Renewal Criteria

Coverage may be renewed when ALL of the following are met:

ALL of the following

Member continues to meet the indication-specific criteria from Initial Approval
Absence of unacceptable toxicity from the drug (examples include severe hypersensitivity reactions, development of new malignancies, contracting a serious infectious disease or agent)
Member 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
Member requires continued treatment due to new expansion of pre-existing, or development of new (de novo), open wounds

Note: 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

Length of Authorization and Quantity Limits

ALL of the following

Initial authorization duration: six (6) months; may be renewed6 months
Max units per surgical session: Up to twelve (12) C7-expressing cellular sheets supplied as up to 3 containers containing up to 4 sheets eachUp to 12 sheets per session
Dose details: Dose: One sheet covers 41.25 cm2; up to twelve sheets may be manufactured from member biopsies and supplied for potential useOne sheet = 41.25 cm2
Application instructions:

Provider Actions

Prior Authorization

Prior authorization with documentation

Submit supporting clinical documentation (medical records, chart notes, lab results, confirmatory diagnostics, genetic/mutational testing) with the prior authorization request via the PA web portal or by fax. Failure to submit required documentation may result in denial due to inability to establish medical necessity.

Failure to submit medical records may result in denial

Documentation Required

Genetic confirmation requirement

Provide molecular genetic testing demonstrating biallelic COL7A1 mutations to establish a diagnosis of RDEB. If biallelic testing cannot be confirmed, documentation showing that BOTH parents lack evidence of dominant disease is acceptable.

Billing Rule

Quantity and administration reporting

Report up to twelve (12) C7-expressing cellular sheets per surgical session. Sheets are supplied under NDC 84103-0007-xx and should be billed per plan instructions using J3590 (Unclassified biologics).

HCPCS: J3590
NDC: 84103-0007-xx
Max per session: Up to 12 sheets (supplied as up to 3 containers of up to 4 sheets each)

Denial Risk

Concurrent disease-modifying therapy exclusion

Claims may be denied if Zevaskyn is used concurrently, in the same wound, with another disease-modifying therapeutic agent indicated for DEB. Examples of such excluded concurrent therapies include Filsuvez and Vyjuvek.

Documentation Required

Specialist prescriber requirement

Zevaskyn must be prescribed by, or in consultation with, a qualified dermatologist specializing in epidermolysis bullosa at an enrolled qualified treatment center (QTC).

Background & Evidence

Zevaskyn (prademagene zamikeracel) is an autologous, gene-corrected keratinocyte sheet therapy indicated for treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB).

Approval was based on the VIITAL phase 3 randomized, intrapatient-controlled study which demonstrated improved wound healing (81% of wounds achieving ≥50% healing at month 6 with Zevaskyn vs 16% control) and greater pain reduction (mean pain reduction -3.07 vs -0.90) versus standard of care.

Dosage and supply details: one Zevaskyn sheet covers 41.25 cm²; up to twelve (12) sheets may be manufactured from a patient’s biopsies and supplied for potential use, shipped in containers of up to four sheets each.

Outcome	Result
VIITAL trial healing outcome
81% of wounds achieved ≥50% healing at month 6 with Zevaskyn vs 16% control
VIITAL trial pain outcome
Mean pain reduction -3.07 vs -0.90 (Zevaskyn vs control)

Zevaskyn sheet area: One sheet covers 41.25 cm² (5.5 cm × 7.5 cm).

Autologous: Derived from the patient's own tissue (biopsy-derived keratinocyte sheets).

OpenPayer

Zevaskyn

Coverage Summary

Medical-Necessity Criteria

Coding

Provider Actions

Background & Evidence

Revision History