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Blue Cross NC prademagene zamikeracel Coverage Update | OpenPayer

CurrentBlue Cross Blue Shield - North CarolinaPolicy N/A

Prademagene zamikeracel (Zevaskyn) gene‑modified cellular sheets — coverage criteria

Policy governs coverage and medical necessity criteria for prademagene zamikeracel (Zevaskyn) topical, gene‑modified cellular sheets for treatment of wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB) and applies to Blue Cross NC members and their providers.

Policy Summary

PayerBlue Cross Blue Shield - North Carolina

PolicyPrademagene zamikeracel (Zevaskyn) gene‑modified cellular sheets — coverage criteria

Policy CodePolicy N/A

Change TypeCoding and revenue code additions

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization with documentation confirming age ≥6 years, RDEB diagnosis with biallelic COL7A1 confirmation, wound characteristics (stage 2, ≥20 cm2, ≥6 months), absence of SCC/infection, specialist prescriber or consultation, and requested dose within FDA‑labeled dosing.

SourceLink

POLICY UPDATE CHANGES

Added applicable revenue codes 0891 and 0892 associated with the HCPCS code(s).

Added HCPCS code J3389 (1 unit per treatment) to dosing reference table and removed C9399, J3490, and J3590 (termed 12/31/2025).

>=6Minimum patient age for coverage

>=20 cm2Minimum wound surface area

6 monthsDuration of approval

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Coverage and Medical Necessity Criteria

Medical Necessity Criteria

Covered when ALL of the following are met:

Main eligibility: 1. The patient is 6 years of age or older;

medical record documentation required

Main eligibility: 2. Diagnosis of recessive dystrophic epidermolysis bullosa (RDEB).

medical record documentation required

Genetic confirmation: 3. Diagnosis confirmed by molecular genetic testing detecting biallelic COL7A1 mutations with recessive inheritance; OR

medical record documentation required

3a OR 3b

3a: Molecular genetic testing detecting presence of biallelic mutation(s) in COL7A1 with recessive inheritance (documented)
medical record documentation required
3b: Confirmation that BOTH parents do NOT have any evidence of dominant disease (as alternative confirmation of recessive inheritance)
medical record documentation required

Wound characteristics: 4. Cutaneous wound(s) associated with RDEB that are stage 2 (partial-thickness) with surface area ≥ 20 cm2 and present for at least 6 months;

medical record documentation required

Safety exclusions: 5. No current evidence or history of squamous cell carcinoma in the area undergoing treatment;

medical record documentation required

Infection status: 6. No evidence of systemic infection or active infection in the area undergoing treatment;

medical record documentation required

Concomitant therapy: 7. Will NOT be used in combination on the same treatment area with Filsuvez (birch triterpenes), Vyjuvek (beremagene geperpavec-svdt), or another gene therapy for this indication;

medical record documentation required

Prescriber qualifications: 8. Prescriber is a specialist in the area of the patient's diagnosis (e.g., dermatologist, geneticist) or has consulted with such a specialist;

medical record documentation required

Prior treatment of area: 9. The requested agent will be applied to an area that has NOT been previously treated with the requested agent;

medical record documentation required

Treatment setting: 10. The requested agent will be administered at a qualified treatment center (QTC);

medical record documentation required

Dosing and quantity limits: 11. The requested dose is within FDA-labeled dosing for the indication and the requested quantity does not exceed maximum units allowed for the duration of approval (one application per affected area; up to 12 sheets per surgical session).

medical record documentation required; duration of approval 180 days (one-time application per treatment area)

This therapy must not be used concurrently on the same treatment area with other topical or gene therapies specified in the policy. Specifically, use in combination on the same treatment area with Filsuvez (birch triterpenes), Vyjuvek (beremagene geperpavec‑svdt), or another gene therapy for the requested indication is excluded and medical record documentation confirming non‑concurrent use is required.

Treatment is considered not medically necessary when the policy criteria are not met. Examples include patients younger than 6 years, diagnoses other than RDEB, absence of molecular genetic confirmation of biallelic COL7A1 mutations (or lack of parental confirmation of recessive inheritance), wounds that do not meet the required stage (stage 2), surface area < 20 cm2, or duration < 6 months, presence or history of squamous cell carcinoma in the treatment area, active or systemic infection in the area, prior treatment of the area with the same agent, prescription without specialist involvement or consultation, or administration outside a qualified treatment center.

Billing Codes, Thresholds, and Dosing

Applicable HCPCS / Billing CodesHCPCS

J3389

HCPCS code for prademagene zamikeracel (1 unit per treatment) (per policy dosing reference)

Applicable Revenue CodesRevenue

0891	Revenue code: Special Processed Drugs - FDA Approved Cell Therapy
0892	Revenue code: Special Processed Drugs - FDA Approved Gene Therapy

inv-06: Minimum wound surface area — per treated wound threshold

Minimum wound surface area (per treated wound)At least 20 cm2 (stage 2 partial-thickness wounds) per treated wound

Wound stage requiredStage 2 (partial-thickness) wounds

Documentation requiredMedical record showing wound stage and measured surface area ≥20 cm2

inv-07: Minimum wound duration — required duration prior to treatment

Minimum wound durationWound(s) present for at least 6 months prior to treatment

Documentation requiredMedical record documentation confirming wound duration ≥6 months

Provider Requirements, Authorization, and Denial Triggers

Prior Authorization

Prior Authorization and Dosing Limits

Prior authorization is required. Dosing must be within FDA-labeled dosing for the requested indication, and the requested quantity must not exceed the maximum units allowed per surgical session or duration of approval. Duration of approval: 180 days (6 months); one-time application per treatment area(s). Maximum units per surgical session: up to 12 cellular sheets (HCPCS J3389).

Prior authorization required before therapy initiation
Dose must follow FDA-labeled dosing and not exceed maximum units per surgical session (up to 12 cellular sheets)
Duration of approval: 180 days (6 months); one-time application per treatment area(s)
HCPCS: J3389

Step Therapy

Step Therapy

No step therapy requirements are specified for this policy.

Clinical Background

Recessive dystrophic epidermolysis bullosa (RDEB) is an inherited blistering disorder caused by mutations in the COL7A1 gene that result in defective type VII collagen and fragile skin with chronic, non‑healing wounds. Prademagene zamikeracel (Zevaskyn) are autologous, gene‑corrected keratinocyte sheets — patient‑derived cells engineered to provide functional COL7A1 — that are applied topically as cellular sheets to treat RDEB‑associated cutaneous wounds.

Product Definitions and Supply Limits

inv-14: Product dosing and supply — sheet dimensions and maximum sheets manufactured/provided per patient per session

Sheet dimensions and areaEach sheet measures 5.5 cm x 7.5 cm and covers 41.25 cm2

Maximum sheets manufactured/provided per patient per sessionUp to 12 sheets may be manufactured from patient biopsies and supplied per surgical session

Supply formulationSupplied as single-dose of up to 12 cellular sheets consisting of patient's gene-modified cells

Dosing basisRecommended dose is based on wound surface area; one application per affected area