Last Review Date: 07/05/2023

Date of Origin: 07/05/2023

Dates Reviewed: 07/2023

1. Length of Authorization

Coverage will be provided for six 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]:

• 1 vial 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

• 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 approved 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

6. Billing Code/Availability Information

HCPCS Code:

• J3590 – Unclassified biologics (Discontinue use on 01/01/2024)
• 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 (Effective 01/01/2024)

NDC:

• Vyjuvek 1.0 mL extractable volume in a single-use, single-dose vial containing 5×10⁹ PFU/mL: 82194-0510-xx

7. References

1. Vyjuvek™ [package insert]. Pittsburgh, PA; Krystal Biotech, Inc.; May 2023. Accessed May 2023.
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)

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 Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.

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