Last Review Date: 02/01/2024

Date of Origin: 07/05/2023

Dates Reviewed: 07/2023, 02/2024

1. Length of Authorization

Coverage will be provided for 6 months and may be renewed.

2. Dosing Limits

A. Quantity Limit (max daily dose) [NDC Unit]:

• Vyjuvek single-dose vial containing 5×10⁹ PFU/mL: 1 vial every 7 days

B. Max Units (per dose and over time) [HCPCS Unit]:

• 25 billable units every 7 days

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 6 months of age; AND

Universal Criteria ¹

• Patient has not received a skin graft within the prior 3 months; AND

Dystrophic Epidermolysis Bullosa (DEB) † Ф ^1,2

• 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

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ¹

Coverage can be renewed based on the following criteria:

• Patient continues to meet the indication-specific relevant criteria identified in section III; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: any severe medication reactions warranting therapy discontinuation, etc.; 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

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS Code:

• J3401 – Beremagene geperpavec-svdt for topical administration, containing nominal 5 x 10⁹ pfu/ml vector genomes, per 0.1 ml; 1 billable unit = 0.1 mL

NDC:

• Vyjuvek 1.0 mL extractable volume in a single-use, single-dose vial containing 5×10⁹ PFU/mL: 82194-0510-xx (outer carton) and 82194-0501-xx (inner drug vial)

7. References

1. Vyjuvek™ [package insert]. Pittsburgh, PA; Krystal Biotech, Inc.; May 2023. Accessed January 2024.
2. Guide SV, Gonzalez ME, Bagci S, et al. Trial of Beremagene Geperpavec (B-VEC) for Dystrophic Epidermolysis Bullosa. N Engl J Med 2022; 387:2211-2219. DOI: 10.1056/NEJMoa2206663.
3. Pfender EG, Lucky AW. Dystrophic Epidermolysis Bullosa. GeneReviews. https://www.ncbi.nlm.nih.gov/books/NBK1304/ (Accessed on May 25, 2020).

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A