VYJUVEK (beremagene geperpavec-svdt)

VYJUVEK (beremagene geperpavec-svdt)

Medical Administration – Office Administered

Diagnosis considered for coverage:

• 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.
   

Coverage Criteria:

For diagnosis of wound care in dystrophic epidermolysis bullosa:

• Diagnosis of dystrophic epidermolysis bullosa AND
• Patient has mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene AND
• Medication is being used for the treatment of wounds AND
• Patient is 6 months of age or older AND
• Medication will be applied by a healthcare professional AND
• Prescribed by or in consultation with a dermatologist AND
• Wound(s) being treated meet all of the following criteria:
  • Adequate granulation tissue AND
  • Excellent vascularization AND
  • No evidence of active wound infection in the wound being treated AND
  • No evidence or history of squamous cell carcinoma in the wound being treated

Reauthorization Criteria:

For diagnosis of wound care in dystrophic epidermolysis bullosa:

• Documentation of positive clinical response (e.g., decrease in wound size, increase in granulation tissue, complete wound closure AND
• Wound(s) being treated meet all of the following criteria
  • Adequate granulation tissue AND
  • Excellent vascularization AND
  • No evidence of active wound infection in the wound being treated AND
  • No evidence or history of squamous cell carcinoma in the wound being treated

Coverage Duration: 

Initial: 6 months
Reauthorization: 6 months

Dosing: 

For diagnosis of wound care in dystrophic epidermolysis bullosa:

• B-VEC is applied once weekly by a healthcare professional in a healthcare facility or in the home setting. 
• Maximum dosing is determined by age. 
  • For patients aged 6 months to < 3 years, the maximum weekly volume of B-VEC is 0.8 mL; for patients ≥ 3 years, the maximum weekly volume of B-VEC is 1.6 mL.
• The dose per wound is determined by the surface area of the wound and ranges from 0.2 mL to 0.6 mL
   

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.
 

Additional Information: 

• Orphan Drug, Rare Pediatric Disease, and Fast Track designations and underwent Priority Review
• Manufacturer was granted a rare pediatric disease priority review voucher which entitles the manufacturer to priority review of another product or to sell the voucher to another sponsor
• B-VEC gel is prepared by the pharmacy by mixing Vyjuvek biological suspension into the excipient gel for use within 8 hours of application if stored at room temperature (20° to 25°C [68° to 77°F]) or within 48 hours if stored in the refrigerator (2º to 8ºC [35.6º to 46.4ºF]).
• B-VEC gel should be applied in droplets spaced evenly within the wound, approximately 1 cm by 1 cm apart. The droplet pattern should loosely resemble a grid. Wounds should have non-adherent hydrophobic dressing placed atop the B-VEC gel droplets then covered by a standard dressing. Wound dressing should not be changed within 24 hours after B-VEC application
   

Policy Updates:

• 3/1/2024 (policy effective date)- New Vyjuvek Criteria (P&T 2/20/2024) (P&T meeting February) 

References:

• Vyjuvek Prescribing Information. Krystal Biotech, Inc. Pittsburgh, PA. May 2023. 
• Guide SV, Gonzalez ME, Ba?c? IS, et al. Trial of beremagene geperpavec (B-VEC) for dystrophic epidermolysis bullosa. N Engl J Med 2022;387:2211-9. DOI: 10.1056/NEJMoa2206663 
• Vyjuvek. IBM Micromedex Solutions. Truven Health Analytics, Inc. Ann Arbor, MI. Accessed Nov. 28, 2023. http://www.micromedexsolutions.com.