Pharmacy Prior Authorization Criteria

Vyjuvek (beremagene geperpavec-svdt)

Indications for Prior Authorization

Vyjuvek (beremagene geperpavec-svdt)

• For diagnosis of Wound care in dystrophic epidermolysis bullosa
  Indicated for the treatment of wounds in adults and pediatric patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.

Criteria

Vyjuvek

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of dystrophic epidermolysis bullosa (DEB)
AND
• Presence of collagen type VII alpha 1 chain (COL7A1) gene mutation as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• Medication is being used for the treatment of wounds that require healing
AND
• Wound(s) being treated meets all of the following criteria [2]:
• Adequate granulation tissue
• Excellent vascularization
• No evidence of active wound infection in the wound being treated
• No evidence or history of squamous cell carcinoma in the wound being treated
AND
• Medication is not being used concurrently with other FDA approved therapies (e.g., Filsuvez) on the same target wound for the treatment of epidermolysis bullosa
AND
• Standard wound care management not adequate in healing wounds (e.g., daily wound dressings, pain management, controlling infections)
AND
• One of the following:
• Medication will be applied by a healthcare professional
OR
• Patient or caregiver has received training for the application of Vyjuvek
AND
• Prescribed by or in consultation with one of the following:
• dermatologist
• specialist with expertise in wound care

Vyjuvek

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy as evidenced by wound healing (e.g., reduction in number or size of wounds)
AND
• Wound(s) being treated meets all of the following criteria [2]:
• Adequate granulation tissue
• Excellent vascularization
• No evidence of active wound infection in the wound being treated
• No evidence or history of squamous cell carcinoma in the wound being treated
AND
• Medication is not being used concurrently with other FDA approved therapies (e.g., Filsuvez) on the same target wound for the treatment of epidermolysis bullosa
AND
• Prescribed by or in consultation with one of the following:
• dermatologist
• specialist with expertise in wound care

P & T Revisions

2025-12-03, 2025-11-21, 2025-07-14, 2024-07-03, 2024-05-20, 2024-03-13, 2023-07-28, 2023-08-17

References

1. Vyjuvek Prescribing Information. Krystal Biotech, Inc. Pittsburgh, PA. September 2025.
2. Guide SV, Gonzalez ME, Bağcı IS, et al. Trial of beremagene geperpavec (B-VEC) for dystrophic epidermolysis bullosa. N Engl J Med. 2022;387:2211-9.

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Revision History

• 2025-12-03: Add EHB formulary to guideline
• 2025-11-21: Update Guideline
• 2025-07-14: 2025 Annual Review - Program update with no change to clinical intent. Revised criteria to align with standard UM verbiage.
• 2024-07-03: 2024 UM Annual Review. No criteria changes
• 2024-05-20: update guideline
• 2024-03-13: Changed specialist prescriber from dermatologist to specialist with expertise in wound care
• 2023-07-28: New program for Vyjuvek
• 2023-08-17: New program for Vyjuvek

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