CurrentCignaPolicy IP0747

Zevaskyn

Defines prior authorization, clinical criteria, dosing, and coding for coverage of Zevaskyn (autologous gene-modified cell sheets) for treatment of wounds in recessive dystrophic epidermolysis bullosa (RDEB) for Cigna-administered plans.

Policy Summary

PayerCigna

PolicyZevaskyn

Policy CodePolicy IP0747

Change TypeNew policy

Effective DateAug 15, 2025

Next Review Date

Key ActionPrior Authorization is required; approve only for patients meeting the policy criteria and dosing, with documentation (genetic testing, clinical features, target wound characteristics) and specialist prescribing.

POLICY UPDATE CHANGES

New policy created for Zevaskyn effective 08/15/2025.

1Indication covered (RDEB wounds)

12Max sheets per application

>=6 moChronic wound duration req

Coverage Summary

Coverage stance: covered_with_criteria. Scope: prior authorization policy defining clinical criteria, dosing, and coding for Zevaskyn (autologous gene‑modified cell sheets) for treatment of wounds in recessive dystrophic epidermolysis bullosa (RDEB) in Cigna‑administered plans. Indication: Zevaskyn (prademagene zamikeracel) is indicated for treatment of wounds in patients with RDEB. Effective date: 08/15/2025.

Headline thresholds and supportive stats: the policy requires target wounds to be chronic (present ≥ 6 months) and approves a single application of up to 12 sheets (each ~41.23/41.25 cm2). Pivotal VIITAL Phase III results cited: 35/43 wounds (81%) healed with Zevaskyn vs 7/43 (16%) with standard of care at Month 6; P < 0.0001, with co‑primary pain reduction also significant.

FDA-Approved Indication — Initial approval

Approve a single application (up to 12 sheets) if the patient meets ALL of the following (A, B, and C):

Initial approval criteria

A) Genetic confirmation: Diagnosis confirmed by genetic testing showing a pathogenic variant in both alleles in the collagen type VII alpha 1 chain (COL7A1) gene
documentation required
B) Clinical features and wounds
- i) Clinical feature(s): Patient has at least one clinical feature of recessive dystrophic epidermolysis bullosa
  documentation required; examples include but are not limited to blistering, wounds, and scarring
- ii) Target wound(s) present: Patient has one or more open wound(s) that will be treated (i.e., 'target wound[s])
  documentation required
- iii) Target wound(s) characteristics (per prescriber)
  - a) Clean and non-infected: Target wound(s) is clean in appearance and does not appear to be infected
  - b) Granulation and vascularization: Target wound(s) has adequate granulation tissue and vascularization
  - c) Chronic duration: Target wound(s) is chronic wound(s) (present ≥ 6 months)>= 6 months
  - d) Squamous cell carcinoma consideration: Squamous cell carcinoma has been considered for the target wound(s)
C) Prescriber requirement: Medication is prescribed by or in consultation with a dermatologist or wound care specialist

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Unproven / Exclusions

Operational exclusions/limits: only a single application is approved (one application of up to 12 gene‑modified cellular sheets). Receipt of sample product does not satisfy coverage criteria. Per dosing instructions, all sheets must be applied in one sterile surgical procedure.

Provider Actions

Prior Authorization

Prior authorization required

Prior Authorization is required for benefit coverage of Zevaskyn. Approval is recommended only for patients who meet the policy criteria and dosing; extended approvals are allowed if criteria continue to be met.

J3590

Documentation Required

Documentation of diagnosis and wound characteristics required

Required documentation includes: genetic testing confirming pathogenic COL7A1 variants in both alleles; documentation of clinical features of RDEB (examples include blistering, wounds, and scarring); documentation of one or more open target wound(s) to be treated; and documentation that target wound(s) meet required characteristics (clean appearance without infection, adequate granulation tissue and vascularization, chronic duration ≥ 6 months) and that squamous cell carcinoma has been considered.

Documentation Required

Specialist prescribing requirement

Zevaskyn must be prescribed by or in consultation with a dermatologist or wound care specialist due to the specialized evaluation and monitoring required.

Billing Rule

Single application dosing and sheet limits

Approve one application of up to 12 gene-modified cellular sheets; all sheets must be applied in one sterile surgical procedure per dosing instructions.

J3590

Documentation Required

Receipt of sample product not sufficient

Receipt of sample product does not satisfy any criteria requirements for coverage.

Clinical Evidence

35/43 (81%) vs 7/43 (16%)VIITAL Phase III wound healing at 6 months; P < 0.0001

Zevaskyn: 35/43Healed wounds (Zevaskyn) in VIITAL Phase III

SOC: 7/43Healed wounds (Standard of Care) in VIITAL Phase III

VIITAL Phase III pivotal study context: VIITAL was a randomized, intrapatient‑controlled, multicenter Phase III trial in patients with RDEB treating matched large wounds; eligible wounds were ≥ 20 cm2 and chronic (≥ 6 months). Up to twelve ~41.23 cm2 autologous gene‑modified cell sheets were manufactured from patient biopsies and surgically applied to wounds. The trial showed significantly higher wound healing at Month 6 for Zevaskyn versus standard of care (81% vs 16%; P < 0.0001) and greater pain reduction (co‑primary).

Background and Definitions

Background: Zevaskyn is an autologous cell sheet‑based gene therapy (prademagene zamikeracel) for RDEB wounds composed of patient cells transduced ex vivo with a replication‑incompetent retroviral vector containing full‑length COL7A1 to express functional collagen VII. Up to twelve ~41.23–41.25 cm2 sheets may be manufactured from patient skin punch biopsies and are intended to be surgically applied to prepared wound beds with resorbable sutures; application requires debridement and all sheets are applied in one sterile surgical procedure.

Definitions:

Zevaskyn — Autologous cell sheet‑based gene therapy (prademagene zamikeracel) composed of autologous cells transduced with a retroviral vector containing full‑length COL7A1, producing functional collagen VII protein.

Target wound(s) — Open wound(s)

Maximum sheets per application12

Chronic wound duration requirement>= 6 months

Policy Summary

PayerCigna

PolicyZevaskyn

Policy CodePolicy IP0747

Change TypeNew policy

Effective DateAug 15, 2025

Next Review Date

On This Page

OpenPayer

Zevaskyn

Coverage Summary

Unproven / Exclusions

Applicable Codes

Provider Actions

Clinical Evidence

Background and Definitions

Revision History