Last Review Date: 07/05/2023

Date of Origin: 07/05/2023

Dates Reviewed: 07/2023

1. Length of Authorization ¹

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

2. Dosing Limits

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

• Epkinly 4 mg/0.8 mL single-dose vial: 1 vial on days 1 and 8 of cycle 1
• Epkinly 48 mg/0.8 mL single-dose vial: 1 vial on days 15 and 22 of cycle 1; days 1, 8, 15, 22 of cycles 2 and 3; days 1 and 15 of cycles 4 to 9; and day 1 of cycle 10 and beyond

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

Diffuse Large B-Cell Lymphoma (28-day cycles)

• Cycle 1: 1 billable unit (0.16 mg) on day 1, 5 billable units (0.8 mg) on day 8, 300 billable units (48 mg) on days 15 and 22
• Cycles 2 and 3: 300 billable units (48 mg) on days 1, 8, 15, 22
• Cycles 4 to 9: 300 billable units (48mg) on days 1 and 15
• Cycles 10 and beyond: 300 billable units (48 mg) on day 1

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND

Universal Criteria ¹

• Prophylaxis for infection will be followed according to local guidelines (e.g., Pneumocystis jirovecii pneumonia (PJP), Herpes virus, etc.); AND
• Patient does not have a clinically significant active systemic infection; AND
• Patient does not have primary central nervous system (CNS) lymphoma or CNS involvement of disease; AND
• Patient has not received prior allogeneic hematopoietic stem cell transplantation (HSCT); AND

Diffuse Large B-cell lymphoma (DLBCL) † ^1,2

• Patient has a diagnosis of DLBCL (Note: includes disease arising from indolent lymphoma, high-grade B-cell lymphoma and not otherwise specified disease); AND
• Patient has relapsed or refractory disease; AND
• Used after at least two prior lines of systemic therapy with at least one line containing anti-CD20 monoclonal antibody therapy (e.g., rituximab, etc.)

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

4. Renewal Criteria ¹

Coverage may be renewed based upon the following criteria:

• Patient continues to meet the universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: serious infections, serious or life-threatening cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS), severe cytopenias, etc.; AND
• Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS Code:

• J9999 – Not otherwise classified, antineoplastic drug (Discontinue use on 01/01/2024)
• J9321 – Injection, epcoritamab-bysp, 0.16 mg; 1 billable unit = 0.16 mg (Effective 01/01/2024)

• C9155 – Injection, epcoritamab-bysp, 0.16 mg; 1 billable unit = 0.16 mg (Discontinue use on 01/01/2024)

NDC(s):

• Epkinly 4 mg/0.8 mL single-dose vial: 82705-0002-xx
• Epkinly 48 mg/0.8 mL single-dose vial: 827005-0010-xx

7. References

1. Epkinly [package insert]. Plainsboro, NJ; Genmab, Inc.; May 2023. Accessed May 2023.
2. Hutchings M, Mous R, Clausen MR, et al. Dose escalation of subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: an open-label, phase 1/2 study. Lancet. 2021 Sep 25;398(10306):1157-1169. doi: 10.1016/S0140-6736(21)00889-8. Epub 2021 Sep 8.
3. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) epcoritamab. National Comprehensive Cancer Network, 2023. 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 May 2023.
4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas, Version 3.2023. National Comprehensive Cancer Network, 2023. 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 Guidelines, go online to NCCN.org. Accessed May 2023.

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