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Prior Authorization Criteria for Prademagene Zamikeracel (Zevaskyn) Effective May 1, 2026

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Effective for dates of service on or after May 1, 2026, providers must receive prior authorization for prademagene zamikeracel (Zevaskyn) (procedure code J3389).

Prademagene zamikeracel (Zevaskyn) is an autologous cell sheet-based gene therapy that is indicated to treat wounds in adult and pediatric clients with recessive dystrophic epidermolysis bullosa (RDEB).

Prior Authorization Criteria

Providers must submit prior authorization requests for prademagene zamikeracel (Zevaskyn) using the Special Medical Prior Authorization (SMPA) Request Form.

Requests for Initial Therapy

The Texas Medicaid & Healthcare Partnership (TMHP) may approve initial therapy with prademagene zamikeracel (Zevaskyn) for 12 months if all the following criteria are met:

  • The client is 6 years of age or older.
  • The client has a diagnosis of RDEB (diagnosis code Q812) that has been confirmed by biopsy and genetic testing that detected biallelic mutation in the COL7A1 gene.
  • The client has at least one chronic cutaneous stage 2 wound that is adequate for treatment and:
    • Has been open or present for at least six months.
    • Has an area of ≥ 20 cm2.
    • Has not previously been treated with prademagene zamikeracel (Zevaskyn).
  • The client’s target wound is not infected.
  • The client’s wound area shows no current evidence or history of squamous cell carcinoma.
  • The client does not have severe hypersensitivity (such as anaphylaxis) to vancomycin or amikacin.

Requests for Renewal or Continuation of Therapy

For renewal or continuation of therapy with prademagene zamikeracel (Zevaskyn), the client must meet the following requirements:

  • The client must meet the initial approval criteria if the request is for previously untreated or newly developed wounds. Reauthorization for the same wound is not permitted.
  • The client must not have unacceptable toxicity from prademagene zamikeracel (Zevaskyn) (such as severe hypersensitivity reactions and development of new malignancies).
  • The client shows a positive response to treatment, defined as improvement (healing) of treated wound sites and reduction of skin infections.

For more information, call the TMHP Contact Center at 800-925-9126.

Note: Texas Medicaid managed care organizations (MCOs) must provide all medically necessary, Medicaid-covered services to Medicaid members who are enrolled in their MCO. Administrative procedures, such as prior authorization, precertification, referrals, and claims and encounter data filing, may differ from traditional Medicaid (fee-for-service) and from MCO to MCO. Providers should contact the member’s specific MCO for details.