CurrentCignaPolicy IP0747

Zevaskyn Coverage for Recessive Dystrophic Epidermolysis Bullosa

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This policy governs prior authorization and benefit coverage for Zevaskyn (prademagene zamikeracel gene-modified cellular sheets) for wounds associated with recessive dystrophic epidermolysis bullosa in adult and pediatric patients. Coverage is limited to a single application when the genetic, clinical, wound, specialist, and dosing criteria are met.

Policy Summary

PayerCigna

PolicyZevaskyn Coverage for Recessive Dystrophic Epidermolysis Bullosa

Policy CodePolicy IP0747

Change TypeMaterial revision

Effective DateSep 1, 2026

Last ReviewJul 23, 2026

Next Review DateN/A

Key ActionObtain prior authorization and submit documentation confirming that each target wound meets the coverage criteria.

SourceLink

POLICY UPDATE CHANGES

The policy added a requirement that the prescriber attest Zevaskyn has not previously been applied to the target wound(s).

The squamous-cell-carcinoma criterion was revised to require prescriber attestation that there is no evidence or clinical suspicion of squamous cell carcinoma at the target wound(s).

The policy clarified that approvals are for one single application and have a six-month duration to allow time to administer Zevaskyn.

The coding section removed HCPCS codes C9399, J3490, and J3590 and retained HCPCS code J3389 for Zevaskyn.

1 applicationMaximum approved treatment applications

Up to 12Maximum cellular sheets per application

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CurrentCignaPolicy IP0747

Zevaskyn Coverage for Recessive Dystrophic Epidermolysis Bullosa

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Get alerted when Policy IP0747 changes without checking for updates manually.

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Policy Summary

PayerCigna

PolicyZevaskyn Coverage for Recessive Dystrophic Epidermolysis Bullosa

Policy CodePolicy IP0747

Change TypeMaterial revision

Effective DateSep 1, 2026

Last ReviewJul 23, 2026

Next Review DateN/A

Key ActionObtain prior authorization and submit documentation confirming that each target wound meets the coverage criteria.

SourceLink

POLICY UPDATE CHANGES

The policy added a requirement that the prescriber attest Zevaskyn has not previously been applied to the target wound(s).

The squamous-cell-carcinoma criterion was revised to require prescriber attestation that there is no evidence or clinical suspicion of squamous cell carcinoma at the target wound(s).

The policy clarified that approvals are for one single application and have a six-month duration to allow time to administer Zevaskyn.

The coding section removed HCPCS codes C9399, J3490, and J3590 and retained HCPCS code J3389 for Zevaskyn.

1 applicationMaximum approved treatment applications

Up to 12Maximum cellular sheets per application

≥ 6 monthsRequired target wound duration

6 monthsApproval duration

81% vs 16%Month-6 healing rate

Coverage Criteria

Initial therapy - FDA-approved indication

Approve a single application of up to 12 sheets when ALL of the following are met.

Covered recessive dystrophic epidermolysis bullosa indication

Genetic confirmation: The diagnosis is confirmed by genetic testing showing a pathogenic variant in both alleles of the COL7A1 gene.
Documentation required.
Clinical and target-wound requirements
- Target-wound characteristics: Each target wound is clean in appearance and does not appear to be infected; has adequate granulation tissue and vascularization; and is a chronic wound present for at least 6 months.Present ≥ 6 months
- Target-wound attestations: The prescriber attests that there is no evidence or clinical suspicion of squamous cell carcinoma at the target wound and that Zevaskyn has not previously been applied to the target wound.
  Prescriber attestations are required.
Specialist involvement: Zevaskyn is prescribed by or provided in consultation with a dermatologist or wound care specialist.

Dosing and approval duration

Dosing and authorization limits apply.

Approved dosing and authorization duration: Approve one application of up to 12 gene-modified cellular sheets.1 application; up to 12 sheets

The approval duration is 6 months to allow adequate time to administer Zevaskyn. Requests for doses outside the established dosing may be considered case by case by a clinician. Extended approvals may be allowed when the patient continues to meet the criteria and dosing requirements.

Uses outside the covered recessive dystrophic epidermolysis bullosa indication are not covered under this policy.

Coverage is not available for a target wound with evidence or clinical suspicion of squamous cell carcinoma. The prescriber must attest that neither is present at the target wound(s).

A target wound previously treated with Zevaskyn does not meet the coverage criteria. The prescriber must attest that Zevaskyn has not previously been applied to the target wound(s).

Zevaskyn for any other use is considered not medically necessary under this policy.

Coding and Policy Limits

Considered Medically Necessary when criteria in the applicable policy statements listed above are met: HCPCS CodesHCPCSCovered

J3389

Topical administration, prademagene zamikeracel, per treatment

Target Wound Chronicity

Minimum durationAt least 6 months

Applies toEach target wound selected for treatment

Policy descriptionA chronic wound present for at least 6 months

Cellular Sheet Limit

Maximum per applicationUp to 12 gene-modified cellular sheets

Approved dosingOne application

Sheet sizeEach sheet may measure 41.25 cm²

Provider Requirements and Decision Risks

Prior Authorization

Prior Authorization Required

Prior authorization is required for benefit coverage of Zevaskyn.

Billing Rule

Single-Application Approval

Approvals are limited to one single application with an approval duration of 6 months to allow adequate time for administration.

Documentation Required

Clinical Background

Recessive dystrophic epidermolysis bullosa (RDEB) is an inherited disorder associated with pathogenic variants in both alleles of the COL7A1 gene. The disorder is characterized by severe skin fragility, with clinical features that may include blistering, wounds, and scarring involving the skin and mucosal surfaces.

Key Definitions

Zevaskyn

Therapy typeAutologous cell sheet-based gene therapy

Cell sourcePatient-derived cells isolated from skin punch biopsies

Genetic modificationCells are transduced ex vivo with a replication-incompetent retroviral vector containing the full-length COL7A1 gene

Recessive Dystrophic Epidermolysis Bullosa

ConditionThe recessive form of dystrophic epidermolysis bullosa

Genetic basisPathogenic variants in both alleles of the COL7A1 gene

Confirmation

Policy Summary

PayerCigna

PolicyZevaskyn Coverage for Recessive Dystrophic Epidermolysis Bullosa

Policy CodePolicy IP0747

Change TypeMaterial revision

Effective DateSep 1, 2026

Last ReviewJul 23, 2026

Next Review DateN/A

Key ActionObtain prior authorization and submit documentation confirming that each target wound meets the coverage criteria.

SourceLink

On This Page

Specialist Prescribing or Consultation

Zevaskyn must be prescribed by, or administered in consultation with, a physician who specializes in the condition being treated.

Documentation Required

Patient-Specific Supporting Documentation

Submit patient-specific documentation supporting the applicable criteria. Documentation may include chart notes, prescription claims records, prescription receipts, or other relevant information, and must include patient-specific identifying information.

Genetic testing results confirming the diagnosis
Clinical features and target-wound documentation
Prescriber attestations and specialist involvement

Documentation Required

Genetic Confirmation of RDEB

Document a confirmed diagnosis of recessive dystrophic epidermolysis bullosa (RDEB) by genetic testing showing a pathogenic variant in both alleles of the COL7A1 gene.

Documentation Required

Clinical RDEB Features

Document at least one clinical feature of RDEB. Examples include blistering, wounds, and scarring.

Documentation Required

Target Wound Assessment and Attestations

Document one or more open target wounds to be treated and attest that each target wound meets the policy requirements.

The target wound is clean in appearance and does not appear infected.
The target wound has adequate granulation tissue and vascularization.
The target wound is chronic and has been present for at least 6 months.
There is no evidence or clinical suspicion of squamous cell carcinoma at the target wound.
Zevaskyn has not previously been applied to the target wound.

Denial Risk

Diagnosis or Indication Not Established

Coverage may be denied when the RDEB diagnosis is not confirmed as required or when Zevaskyn is requested for an indication other than RDEB. Use for any other indication is considered not medically necessary.

Genetic confirmation of pathogenic variants in both COL7A1 alleles is required.
The requested use must be for the covered RDEB indication.

Denial Risk

Target Wound Requirements Not Met

Coverage may be denied when the target wound does not meet the required clinical conditions or when required prescriber attestations are absent.

Wound is not clean in appearance or appears infected.
Inadequate granulation tissue or vascularization.
Wound has been present for less than 6 months.
Evidence or clinical suspicion of squamous cell carcinoma at the target wound.
Medication was previously applied to the target wound.

Denial Risk

Specialist Involvement Missing

Coverage requires Zevaskyn to be prescribed by, or administered in consultation with, a dermatologist or wound care specialist. Missing required specialist involvement may result in denial.

Denial Risk

Use Outside Covered Indication

Zevaskyn for any use other than the covered RDEB indication is considered not medically necessary.

Requests outside the FDA-approved RDEB indication are not covered under this policy.

Billing Rule

Dose or Application Exceeds Policy Limits

The standard authorization is for one application of up to 12 gene-modified cellular sheets. Requests outside the established dosing may be reviewed case by case by a clinician, such as a Medical Director or Pharmacist.

Limit: one application.
Limit: up to 12 sheets.
Extended approvals may be allowed when the patient continues to meet the criteria and dosing.

Diagnosis is confirmed by genetic testing

Target Wound

DefinitionAn open wound selected for treatment with Zevaskyn

Appearance and tissue statusClean in appearance, apparently uninfected, with adequate granulation tissue and vascularization

Additional requirementsPresent for at least 6 months, with no evidence or clinical suspicion of squamous cell carcinoma, and not previously treated with Zevaskyn