CurrentMass General Brigham Health PlanPolicy 101

Medical Policy Zevaskyn (prademagene zamikeracel)

This policy governs medical necessity, prior authorization, and coverage variations for Zevaskyn (prademagene zamikeracel), an autologous gene-corrected skin-sheet therapy for treating wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB), across Mass General Brigham Health Plan lines of business.

Policy Summary

PayerMass General Brigham Health Plan

PolicyZevaskyn (prademagene zamikeracel) medical policy

Policy CodePolicy 101

Change TypeNo material change

Effective DateMar 1, 2026

Next Review Date

Key ActionObtain prior authorization and submit documentation including genetic test confirming biallelic COL7A1 mutations, evidence of at least one wound to be treated, and patient age for Medicare Advantage, ACO, One Care and SCO members.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

FDA-approvedindication

Age ≥ 6min age

Up to 12max sheets

Not coveredCommercial/QHP stance

J3389authorized code

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Coverage Criteria

Medical necessity criteria

Covered when ALL of the following are met for applicable lines of business:

Eligibility requirements: 1. The member is at least six years of age; and 2. The member has a confirmed diagnosis of recessive dystrophic epidermolysis bullosa (RDEB) with genetic testing showing biallelic mutations of the COL7A1 gene; and 3. The member has at least one wound to be treated.

Applies to Medicare Advantage, Mass General Brigham ACO (per MassHealth Table 72 submission to the MassHealth DUR Program), One Care and Senior Care Options members as described in plan-specific variations.

Zevaskyn (prademagene zamikeracel) is considered Experimental and Investigational and is not covered for members enrolled in Commercial and Qualified Health Plans.

Coding

Authorized CodeHCPCS

J3389

Topical administration, prademagene zamikeracel, per treatment

Provider Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for Medicare Advantage members. Mass General Brigham Health Plan follows CMS guidance (NCDs, LCDs, LCAs, Medicare manuals) for medical necessity determinations; when CMS guidance is absent, the Plan's medical policies apply.

Medicare Benefit Policy Manual Chapter 15 - Covered Medical and Other Health Services

Prior Authorization

Prior Authorization Required (ACO)

Prior authorization is required for Mass General Brigham ACO members. Requests for Zevaskyn for ACO members must be submitted to the MassHealth Drug Utilization Review Program; criteria are in Table 72: Agents Not Otherwise Classified.

Submit prior authorization requests to the MassHealth Drug Utilization Review Program
See Table 72: Agents Not Otherwise Classified for criteria

Prior Authorization

Prior Authorization Required (One Care / SCO)

Prior authorization is required for One Care and Senior Care Options members. The Plan uses CMS guidance for medical necessity determinations; if Medicare Advantage criteria are not met or absent, MassHealth medical necessity guidelines apply.

If Medicare Advantage criteria are not met, apply MassHealth criteria
One Care/SCO follow Medicare Advantage variation then MassHealth fallback

Documentation Required

Required documentation for Medicare/One Care/SCO

Provider impact: for Medicare, One Care, and SCO members, document CMS-based medical necessity and, when applicable, MassHealth criteria. Ensure genetic testing confirming biallelic COL7A1 mutations and evidence of at least one wound are included when applicable to meet criteria.

Required documentation for Medicare/One Care/SCO: confirmed diagnosis of RDEB with genetic test showing biallelic COL7A1 mutations
Documentation of at least one wound to be treated
Include relevant CMS or MassHealth medical necessity references when applicable

Denial Risk

Coverage Denial Risk for Commercial Members

Commercial and Qualified Health Plan members: Zevaskyn is considered Experimental and Investigational and is not covered. Requests for coverage for Commercial and QHP members may be denied based on this determination.

Zevaskyn = Experimental and Investigational — not covered for Commercial and Qualified Health Plan members

Background

Recessive dystrophic epidermolysis bullosa (RDEB) is an inherited blistering disorder characterized by fragile skin, chronic nonhealing wounds, scarring, pain, nutritional compromise, and an elevated risk of squamous cell carcinoma. Zevaskyn is a cutaneous gene therapy composed of autologous skin sheets transduced with a retroviral vector carrying normal copies of the COL7A1 gene, intended to treat chronic open wounds in patients with RDEB.

Definitions

Zevaskyn (prademagene zamikeracel)

Therapy descriptionCutaneous gene therapy of autologous skin sheets transduced with a retroviral vector carrying normal copies of the COL7A1 gene to treat chronic open wounds in RDEB.

Generic nameprademagene zamikeracel

Proprietary nameZevaskyn

IndicationTreatment of chronic open wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB).

Confirmed RDEB

Minimum ageAt least 6 years of age

Diagnostic confirmation