CurrentAvMedPolicy Pub. 100-2

Zevaskyn (prademagene zamikeracel) prior authorization for DEB

Prior authorization and step-edit requirements for one-time medical use of Zevaskyn in members with Dystrophic Epidermolysis Bullosa (DEB); applies to AvMed members and prescribing providers requesting coverage of J3389.

Policy Summary

PayerAvMed

PolicyZevaskyn (prademagene zamikeracel) prior authorization for DEB

Policy CodePolicy Pub. 100-2

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain one-time prior authorization and submit required supporting documentation, including molecular genetic testing and wound assessments.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J3389billing code listed for Zevaskyn

≥6minimum member age

≥20 cm2minimum wound area

up to 12max sheets per patient

one-timeauthorization intent

Coverage Criteria

Policy Summary

PayerAvMed

PolicyZevaskyn (prademagene zamikeracel) prior authorization for DEB

Policy CodePolicy Pub. 100-2

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain one-time prior authorization and submit required supporting documentation, including molecular genetic testing and wound assessments.

SourceLink

On This Page

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Initial Authorization Criteria

Covered when ALL of the following are met

Initial Authorization: Member is ≥ 6 years of age; provider is a specialist in dermatology or has consulted with a specialist knowledgeable in DEB at a Qualified Treatment Center; diagnosis of Dystrophic Epidermolysis Bullosa (DEB) confirmed by detection of two recessive COL7A1 mutations on molecular genetic testing and positive NC1+ expression; indirect immunofluorescence (IIF) assay shows absence of an immune response to type VII collagen; wounds are partial-thickness RDEB wounds open chronically ≥ 6 months, stage 2, with wound area ≥ 20 cm2, clean with adequate granulation tissue and excellent vascularization and not infected; member does not have history of squamous cell carcinoma (SCC) in the treatment area; member does not have severe hypersensitivity (e.g., anaphylaxis) to vancomycin or amikacin; provider attests sheets will only be applied to partial-thickness RDEB wounds open ≥ 6 months; member has completed a proper trial of Vyjuvek (beremagene geperpavec) for at least 6 months (1 treatment cycle) unless an exception is approved case-by-case; Zevaskyn will NOT be used concurrently in the same wound with another disease-modifying therapeutic agent indicated for DEB.see node text

All criteria must be documented; prior Vyjuvek trial exceptions considered case-by-case. To support each checked item, submit required documentation (labs, diagnostics, chart notes).

Reauthorization Criteria

Reauthorization (one-time) covered when ALL of the following are met

Reauthorization: All initial authorization criteria were previously met; member demonstrates disease response to treatment as evidenced by improvement (healing) of treated wound sites and/or reduction in skin infections with supporting wound care documentation; continued treatment is required for new expansion of pre-existing or development of new (de novo) open wounds (Zevaskyn is intended as a one-time treatment per area; retreatment of previously grafted wounds is considered investigational and will not be renewed); member has not experienced unacceptable toxicity from the drug (e.g., severe hypersensitivity reactions, new malignancy, or serious infection).see node text

Wound care documentation required to demonstrate response and to justify treatment of new wounds.

Coverage for Zevaskyn (prademagene zamikeracel) is conditional. Zevaskyn will NOT be used concurrently, in the same wound, with another disease-modifying therapeutic agent indicated for DEB (this exclusion does not apply to routine wound care items such as topicals, dressings, or antibiotics). Documentation supporting that the proposed treated wound will not receive another disease-modifying DEB therapy must be provided with the prior authorization request. Additionally, Zevaskyn is intended as a one-time treatment per area; subsequent requests for retreatment of the same wound will be evaluated only under the reauthorization rules and are restricted as described below.

Re-treatment of wounds that were previously grafted is considered investigational and will not be renewed. For reauthorization, Zevaskyn may be approved only for new expansion of pre-existing or newly developed open wounds; requests to re-treat areas that have already undergone grafting are not eligible for renewal and must be supported by wound care documentation demonstrating a qualifying new wound site if considered at all.

Coding and Supply Limits

Affected HCPCSHCPCS

J3389

Zevaskyn (prademagene zamikeracel)

NDCNDC

NDC 84103-007-01

Zevaskyn single-dose containers (4 sheets per container)

inv-07: Maximum sheets manufactured per patient — up to 12 sheets

Maximum sheets manufactured per patientUp to 12 Zevaskyn cellular sheets may be manufactured from patient biopsies (one sheet = 41.25 cm2).

Sheet sizeEach sheet measures 41.25 cm2 (5.5 cm x 7.5 cm).

Usage noteSheets are intended for application to partial-thickness RDEB wounds meeting authorization criteria; all documentation must be submitted to support use.

inv-08: Maximum containers supplied — 3 containers (each container = 4 sheets)

Maximum containers supplied3 containers total per manufactured lot; each container holds 4 sheets (one container = four 5.5 cm x 7.5 cm sheets).

Container = sheets1 transport container contains 4 Zevaskyn sheets (covers 4 × 41.25 cm2).

NDCNDC 84103-007-01 corresponds to single-dose containers (4 sheets per container).

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

One-time prior authorization is required for Zevaskyn (J3389). The prescribing physician must sign and clearly print their name on the PA form (preprinted stamps not valid). Fax the completed request and all required documentation to 1-877-535-1391. Incomplete, incorrect, or illegible information may delay processing or result in denial.

Drug: Zevaskyn (prademagene zamikeracel) (J3389)
Fax: 1-877-535-1391
Prescribing physician signature required (no preprinted stamps)

Step Therapy

Prior Disease-Modifying Therapy Requirement

Member must have had a proper trial of therapy with Vyjuvek (beremagene geperpavec-svdt) for at least 6 months (one treatment cycle) prior to initiating Zevaskyn. Verification is required via chart notes and/or paid claims. Exceptions to this prior disease-modifying therapy requirement will be assessed on a case-by-case basis when clinical presentation, severity, and chronicity of the member's DEB are documented to demonstrate increased morbidity or medical necessity.

Required prior therapy: Vyjuvek (beremagene geperpavec-svdt) — minimum 6 months (1 treatment cycle)
Verification: chart notes and/or paid claims
Exceptions considered with appropriate clinical documentation

Documentation Required

Required Supporting Documentation

Submit complete supporting documentation with the PA request. All clinical criteria must be met and documented; include molecular genetic testing, protein expression, wound assessments, immunofluorescence results, and wound care records to support treatment response or need.

Genetic testing: documentation showing two COL7A1 mutations with recessive inheritance
Protein expression: positive NC1 expression in skin
IIF assay: indirect immunofluorescence showing absence of immune response to type VII collagen
Wound documentation: photos, wound size (≥ 20 cm2), duration (≥ 6 months), stage (partial-thickness/Stage 2), granulation/vascularization status, and evidence wounds are clean and not infected
Evidence of prior Vyjuvek therapy (chart notes and/or paid claims) when applicable

Denial Risk

Incomplete Documentation Risks Denial

Missing, incomplete, or illegible documentation may delay review or result in denial. Ensure all fields on the PA form are complete (including provider phone/fax) and that the prescribing physician signature is present. Provide clear wound-care documentation when claiming treatment response or need for reauthorization.

Incomplete forms or missing signatures can delay or deny authorization
Include provider contact info (phone and fax) on the request
Failure to supply required genetic, pathology, IIF, or wound documentation risks denial

Background

Dystrophic Epidermolysis Bullosa (DEB) is a genetic disorder caused by defects in type VII collagen resulting in fragile skin and chronic partial-thickness wounds. Zevaskyn is a patient‑derived cellular sheet therapy manufactured from biopsies intended as a localized, one-time treatment to promote healing of selected partial‑thickness RDEB wounds. Eligibility requires confirmation of DEB by molecular testing (two recessive COL7A1 mutations), positive NC1 protein expression, absence of an immune response to type VII collagen on IIF assay, and wound characteristics including being partial‑thickness, open ≥ 6 months, stage 2, clean, well‑granulated, well‑vascularized, and with a treated wound area of ≥ 20 cm2.

OpenPayer

Zevaskyn (prademagene zamikeracel) prior authorization for DEB

Coverage Criteria

Coding and Supply Limits

Provider Actions and Requirements

Background

Definitions