Vyjuvek™
Drug - Vyjuvek™ (beremagene geperpavec-svdt) [Krystal Biotech, Inc.]
March 2025
Therapeutic Area - Dystrophic epidermolysis bullosa (DEB)
Initial approval criteria
- Patient is at least 6 months of age; AND
- Vyjuvek must be prescribed by or in consultation with a dermatologist; AND
Universal Criteria
- Patient has not received a skin graft within the prior 3 months; AND
Dystrophic Epidermolysis Bullosa (DEB)
- Patient has a diagnosis of dystrophic epidermolysis bullosa as established by detection of mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene on molecular genetic testing; AND
- Patient has cutaneous wound(s) which are clean with adequate granulation tissue, excellent vascularization, and do not appear infected.
- Initial approval is for 6 months
Renewal criteria
- Patient continues to meet the indication-specific relevant criteria identified in the initial approval criteria; AND
- Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include any severe medication reactions warranting therapy discontinuation; AND
- Disease response with treatment as defined by improvement (healing) of treated wound sites, reduction in skin infections, etc.; AND
- Patient requires continued treatment due to new or existing open wounds
- Renewal approval is for 6 months
Quantity limits
- 6 months to 3 years of age: 0.8 mL once a week
- 3 years of age and older: 1.6 mL once a week
- Estimated maximum weekly dose and the corresponding requested number of cartons and days supplied and number of refills must be clearly stated on the prior authorization request form
- Early renewal requests must include documented prioritized wound treatment plan
Questions
Provider Call Center (844) 575-7887
