Last Review Date: 06/05/2025

Date of Origin: 06/05/2025

Dates Reviewed: 06/2025

1. Length of Authorization

• Initial: Prior authorization validity will be provided initially for 6 months.
• Renewal: Prior authorization validity may be renewed every 6 months thereafter.

2. Dosing Limits

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

• Up to twelve (12) C7-expressing cellular sheets for each surgical session (supplied as 3 containers containing up to 4 sheets each)

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 6 years of age; AND

Universal Criteria ¹

• Patient does not have severe hypersensitivity (i.e., anaphylaxis) to vancomycin or amikacin; AND
• Will not be used concurrently, in the same wound, with another disease-modifying therapeutic agent indicated for DEB (e.g., birch triterpenes, beremagene geperpavecetc.) (NOTE: this does not include disease/wound management incidentals like topicals, dressings, antibiotics, etc.); AND
• Patient does not show current evidence or have a history of squamous cell carcinoma (SCC) in the area to be treated; AND

Recessive Dystrophic Epidermolysis Bullosa (RDEB) † Ф ^1,2

• Patient has a diagnosis of recessive dystrophic epidermolysis bullosa as established by detection of biallelic mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene on molecular genetic testing; AND

(Note: If unable to confirm a biallelic mutation, confirmation that BOTH parents do not have any evidence of dominant disease is also acceptable.)

• Patient has cutaneous wound(s) which are adequate for treatment (e.g., stage 2 wounds that have an area ≥20 cm²) and have been present for at least 6 months

† 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: severe hypersensitivity reactions, development of new malignancies, contracting a serious infectious disease or agent, etc.; AND
• Patient shows disease response to treatment as defined by improvement (healing) of treated wound sites, and/or reduction in skin infections, etc., as attested by his/her physician; AND
• Patient requires continued* treatment due to new expansion of pre-existing, or development of new (de novo), open wounds

(Note: Zevaskyn is intended as a one-time treatment per area. Re-treatment of wounds that were previously grafted would be considered investigational, at this time, and may not be renewed.)

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS Code:

• J3590 – Unclassified biologics

NDC:

• Zevaskyn sheets of 41.25 cm² (5.5 cm × 7.5 cm) with up to four sheets provided in a single transport container, and with up to three containers per manufactured lot, for a total of up to twelve sheets. All available sheets per manufactured lot are supplied under the same NDC: 84103-0007-xx

7. References

1. Zevaskyn™ [package insert]. Cleveland, OH; Abeona Therapeutics, Inc.; October 2024. Accessed April 2025.
2. Tang, J.Y. et al.  806 Results from VIITAL: A phase 3, randomized, intrapatient-controlled trial of an investigational collagen type VII gene–corrected autologous cell therapy, EB-101, for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). Journal of Investigative Dermatology, Volume 143, Issue 5, S138.
3. Lucky AW, Pope E, Crawford S. Dystrophic Epidermolysis Bullosa. GeneReviews. https://www.ncbi.nlm.nih.gov/books/NBK1304/. Initial Posting: August 21, 2006; Last Update: March 27, 2025. Accessed on April 29, 2025.
4. Has, C., Liu, L., Bolling, M.C., et al. (2020), Clinical practice guidelines for laboratory diagnosis of epidermolysis bullosa†. Br J Dermatol, 182: 574-592. https://doi-org.ezproxy.med.nyu.edu/10.1111/bjd.18128
5. Has, C., Bauer, J.W., Bodemer, C., Bolling, M.C., Bruckner-Tuderman, L., Diem, A., Fine, J.-.-D., Heagerty, A., Hovnanian, A., Marinkovich, M.P., Martinez, A.E., McGrath, J.A., Moss, C., Murrell, D.F., Palisson, F., Schwieger-Briel, A., Sprecher, E., Tamai, K., Uitto, J., Woodley, D.T., Zambruno, G. and Mellerio, J.E. (2020), Consensus reclassification of inherited epidermolysis bullosa and other disorders with skin fragility†. Br. J. Dermatol., 183: 614-627. https://doi-org.ezproxy.med.nyu.edu/10.1111/bjd.18921
6. Fine JD, Bruckner-Tuderman L, Eady RA, et al. Inherited epidermolysis bullosa: updated recommendations on diagnosis and classification. J Am Acad Dermatol 2014; 70:1103.
7. So JY, Nazaroff J, Iwummadu CV, et al. Long-term safety and efficacy of gene-corrected autologous keratinocyte grafts for recessive dystrophic epidermolysis bullosa. Orphanet J Rare Dis. 2022 Oct 17;17(1):377. doi: 10.1186/s13023-022-02546-9. PMID: 36253825; PMCID: PMC9574807.

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