Last Review Date: 01/06/2025

Date of Origin: 01/06/2025

Dates Reviewed: 01/2025

1. Length of Authorization

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

2. Dosing Limits

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

• 1200 mg every 3 weeks

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND

Universal Criteria

• Patient has not received previous therapy with a programmed death (PD-1/PD-L1)-directed therapy (e.g., avelumab, nivolumab, pembrolizumab, dostarlimab, atezolizumab, durvalumab, cemiplimab, nivolumab/relatlimab, retifanlimab, tislelizumab, toripalimab, etc.), unless otherwise specified ^Δ; AND

Cutaneous Squamous Cell Carcinoma (cSCC) † ^1-7

• Patient has locally advanced or metastatic disease ^Δ; AND
• Patient is not a candidate for curative surgery or curative radiation; AND
• Used as a single agent

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

4. Renewal Criteria ^{Δ 1}

Coverage may be renewed based upon the following criteria:

• Patient continues to meet the universal and other indication-specific relevant criteria identified in section III; AND
• Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe or life-threatening infusion-related reactions, severe immune-mediated adverse reactions (e.g., pneumonitis, hepatotoxicity/hepatitis, colitis, endocrinopathies, nephritis with renal dysfunction, dermatitis/dermatologic adverse reactions, etc.), complications of allogeneic hematopoietic stem cell transplantation (HSCT), etc.

5. Dosage/Administration ^1,13,18

6. Billing Code/Availability Information

HCPCS Code:

• J9999 – Not otherwise classified, antineoplastic drugs

NDC:

• Unloxcyt 300 mg/5 mL single-dose vial: 83444-0301-xx

7. References

1. Unloxcyt [package insert]. Waltham, MA; Checkpoint Therapeutics, Inc; December 2024. Accessed December 2024.
2. Referenced with permission from the NCCN Drugs and Biologics Compendium (NCCN Compendium®) cosibelimab. National Comprehensive Cancer Network, 2024. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed December 2024.
3. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Squamous Cell Skin Cancer. Version 1.2024. National Comprehensive Cancer Network, 2024. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed December 2024.
4. Fahrenbruch R, Kintzel P, Bott AM, et al. Dose Rounding of Biologic and Cytotoxic Anticancer Agents: A Position Statement of the Hematology/Oncology Pharmacy Association. J Oncol Pract. 2018 Mar;14(3):e130-e136.
5. Hematology/Oncology Pharmacy Association (2022). Intravenous Cancer Drug Waste Issue Brief. Retrieved from: https://www.hoparx.org/documents/65/HOPA_Drug_Waste_Issue_Brief_-_Updated_01.19.22_FINAL.pdf
6. Bach PB, Conti RM, Muller RJ, et al. Overspending driven by oversized single dose vials of cancer drugs. BMJ. 2016 Feb 29;352:i788.

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