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 patients 6 months of age and older 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: 6 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
• Patient is 6 months of age or older
AND
• Medication will be applied by a healthcare professional
AND
• Wound(s) being treated meet 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
• Prescribed by or in consultation with a 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 meet 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 a specialist with expertise in wound care

P & T Revisions

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. May 2023.
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

• 2025-07-14: 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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