Zevaskyn (prademagene zamikeracel) coverage for RDEB wounds
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This pharmacy policy governs prior-authorization medical coverage of Zevaskyn (autologous gene-modified cell-sheet therapy) for treatment of wounds in adult and pediatric members with recessive dystrophic epidermolysis bullosa (RDEB) in the payer's Arkansas PASSE program.
New policy for Zevaskyn created.
Added 'Zevaskyn will NOT be used concurrently with any other disease-modifying drug for EB applied to the same wound'.
Coverage Criteria for Zevaskyn
inv-01: Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met:
If met, approve for 6 months.
Zevaskyn (prademagene zamikeracel) is not authorized for indications other than those specifically listed in this policy. For any request to use Zevaskyn for a diagnosis or clinical circumstance not described here, refer to the payer's Off‑Label policy for review and coverage determination.
CareSource considers Zevaskyn (prademagene zamikeracel) not medically necessary for the treatment of conditions that are not listed in this document.
Initial Authorization Criteria (one-time application)
inv-13: Initial Therapy — Initial authorization criteria (one-time application)
Initial authorization criteria (one-time application):
Approval duration: 6 months (one-time application).
Reauthorization / Continuation Criteria
inv-14: Reauthorization — continuation / reauthorization rules
Reauthorization / continuation rules:
No continuation approvals will be granted.
Provider Actions, Documentation, and Denial Risks
Prior Authorization Required
Prior authorization required. Zevaskyn (prademagene zamikeracel) is a medical benefit and will be approved for 6 months when all initial criteria are met.
- Medical benefit — prior authorization required
- Approval duration: 6 months when all initial criteria are met
Concurrent Therapy Restriction
Zevaskyn must not be used concurrently with any other disease‑modifying drug for epidermolysis bullosa (EB) applied to the same wound.
- Concurrent therapy restriction: No other disease‑modifying EB therapies applied to the same wound during Zevaskyn treatment
Required Documentation
Documentation must include genetic testing and protein expression evidence plus wound and prescriber details. Required items:
- Genetic test report documenting two pathogenic COL7A1 mutations with recessive inheritance confirming RDEB
- Skin test/report confirming positive expression of the NC1 region of type VII collagen (NC1+)
- Wound documentation showing target wound(s) ≥ 20 cm² present ≥ 6 months
- Prescriber is a dermatologist or documentation of consultation with a dermatologist
- Dose/quantity documentation: wound surface area, number of sheets requested (one sheet = 41.25 cm²; up to 12 sheets may be manufactured), and plan for single surgical application
Denial Triggers for Initial Authorization
Denial may occur if any initial authorization criteria are not met.
- Age < 6 years at time of request
- Prescriber is not a dermatologist and no documented consultation with a dermatologist
- No genetic report confirming two COL7A1 mutations with recessive inheritance
- No documentation of NC1+ expression in skin
- Target wound(s) are < 20 cm² or present for < 6 months
- Concurrent use with another disease‑modifying EB therapy applied to the same wound
- Incomplete dosing/quantity or wound surface area documentation
Coding and Wound Criteria
| No codes listed |
Step Therapy / Operational Constraints
| Step | Requirement |
|---|---|
| 1 | Zevaskyn must NOT be used concurrently with any other disease-modifying drug for epidermolysis bullosa (EB) applied to the same wound. |
Quantity Limits and Dosing Units
Place of Service
Applied in a single hospital outpatient surgical session
Zevaskyn is applied topically to wounds in a single surgical session in the hospital outpatient setting.
- Dose based on wound surface area; one sheet covers 41.25 cm2
- Up to 12 sheets may be manufactured and supplied for potential use; apply in a single surgical session
Definitions
Background
Recessive dystrophic epidermolysis bullosa (RDEB) is a rare, inherited disorder of skin fragility caused by biallelic COL7A1 mutations that result in deficient type VII collagen and impaired anchoring fibrils. Zevaskyn is an autologous gene‑modified cell‑sheet therapy developed to express COL7A1 and produce type VII collagen when applied topically to chronic wounds in patients with RDEB; it is intended as a one‑time surgical application.
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