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Prior Authorization Criteria for Beremagene Geperpavec-svdt (Vyjuvek) Effective February 1, 2024

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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.

Effective for dates of service on or after February 1, 2024, prior authorization will be required for beremagene geperpavec-svdt (Vyjuvek), procedure code J3401.

Beremagene geperpavec-svdt (Vyjuvek) is a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy indicated to treat wounds in patients 6 months of age or older with dystrophic epidermolysis bullosa (DEB) and mutation in the collagen type VII alpha 1 chain (COL7A1) gene.

Prior Authorization Requirements for Beremagene Geperpavec-svdt (Vyjuvek)

Prior authorization requests for beremagene geperpavec-svdt (Vyjuvek) must be submitted with a Special Medical Prior Authorization (SMPA) Request Form.

Requests for Initial Therapy

Initial therapy for beremagene geperpavec-svdt (Vyjuvek) may be approved for a 6-month duration if all the following criteria are met:

  • The client is 6 months of age or older.
  • The client has a confirmed diagnosis of DEB (diagnosis code Q812).
  • Genetic testing must confirm that the client has a mutation in the COL7A1 gene.
  • The client does not have current evidence or history of squamous cell carcinoma or active infection in the area requiring beremagene geperpavec-svdt (Vyjuvek) application.
  • Female clients who are of childbearing age must have a confirmed negative pregnancy status, as treatment with beremagene geperpavec-svdt (Vyjuvek) may be potentially hazardous to a fetus.

Requests for Renewal or Continuation of Therapy

For renewal or continuation of therapy of beremagene geperpavec-svdt (Vyjuvek), the client must meet the following requirements:

  • The client continues to meet all the initial authorization approval criteria and is currently treated with beremagene geperpavec-svdt (Vyjuvek) with no severe adverse reactions.
  • The client has experienced positive clinical response to therapy as documented by either of the following:
    • The client has experienced a reduction in the number of wounds, decrease in wound size, increase in granulation tissue, or complete wound closure.
    • The client has not experienced any complications during beremagene geperpavec-svdt (Vyjuvek) treatment.

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