Zevaskyn (prademagene zamikeracel)

POLICY NUMBER

L.5.01.628

Zevaskyn (prademagene zamikeracel)

Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.

DESCRIPTION

Zevaskyn (prademagene zamikeracel) is an autologous cell sheet-based gene therapy indicated for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). In patients with RDEB, both copies of the COL7A1 gene are mutated, resulting in the absence or low levels of biologically active C7 protein and lack of anchoring fibrils (AFs). This causes skin fragility and other signs and symptoms of RDEB. Zevaskyn (prademagene zamikeracel) consists of a patient's own cells that have been gene-modified to express the COL7A1 gene to produce the C7 protein. These cells are formed into cellular sheets for topical application onto wounds.

POLICY

Zevaskyn (prademagene zamikeracel) is considered not medically necessary as there are other options covered by the Plan for the treatment of recessive dystrophic epidermolysis bullosa.

Services related to delivery and/or administration of a medication which has not been approved through the BCBSMS PA review process will be considered not medically necessary.

POLICY EXCEPTIONS

State Health Plan (State and School Employees) Participants

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B. appropriate with regard to standards of good medical practice; and

C. not solely for the convenience of the Member, his or her Provider; and

D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

BCBSMS may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.

POLICY HISTORY

11/01/2025: New policy added.

01/01/2026: Code Reference section updated to add new HCPCS code J3389. Removed unclassified biologics code J3590.

SOURCE(S)

Zevaskyn prescribing information. Abeona Therapeutics Inc. April 2025. Last accessed October 2025.

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Not Medically Necessary Codes

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