EPKINLY (epcoritamab-bysp)

EPKINLY (epcoritamab-bysp)

Office-Administration – subcutaneous (SC) injection

Diagnosis considered for coverage:

• Diffuse Large B-cell Lymphoma (DLBCL): Indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy.
  • This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Coverage Criteria:

For diagnosis of lymphoma:

• Diagnosis of one of the following:
  • Relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS)
  • Diffuse large B-cell lymphoma (DLBCL) arising from indolent lymphoma
  • High grade B-lymphoma; AND
• Patient has had two or more lines of systemic therapy (e.g., chemotherapy)

Reauthorization Criteria:

For diagnosis of lymphoma:

• Patient does not show evidence of progressive disease while on therapy.

Dosing:

• DLBCL; high-grade B-lymphoma:
  • EPKINLY dosing begins with a step-up dose schedule:
    • Cycle 1 –
      • Day 1 (Step-up dose 1): 0.16 mg
      • Day 8 (Step-up dose 2): 0.8 mg
      • Day 15, 22 (Full dose): 48 mg
    • Cycles 1, 3 – Day 1, 8, 15, 22: 48 mg
    • Cycles 4 to 9 – Day 1, 15: 48 mg
    • Cycle 10 and beyond – Day 1: 48 mg
  • Each treatment cycle is 28 days long.

Coverage Duration:

• 1 year

Authorization is not covered for the following:

• The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• Black Box Warnings:
  • Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving EPKINLY. Initiate treatment with the EPKINLY step-up dosing schedule to reduce the incidence and severity of CRS. Withhold EPKINLY until CRS resolves or permanently discontinue based on severity.
  • Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), including life-threatening and fatal reactions, can occur with EPKINLY. Monitor patients for neurological signs or symptoms of ICANS during treatment. Withhold EPKINLY until ICANS resolves or permanently discontinue based on severity.
• EPKINLY should only be administered by a qualified healthcare professional with appropriate medical support to manage severe reactions such as CRS and ICANS.
• Diffuse large B-cell lymphomas (DLBCLs) are the most common type of non-Hodgkin lymphoma cancer (in which cancer cells form in the lymph system) and are marked by rapidly growing tumors in the lymph nodes, spleen, liver, bone marrow, or other tissues and organs. Signs and symptoms may include swollen lymph nodes, fever, extreme night sweats, fatigue, and weight loss.
• High-grade B-cell lymphoma is an aggressive form of B-cell lymphoma.
• DLBCL not otherwise specified (NOS) is defined by large-cell morphology, mature B-cell phenotype, and lack of criteria defining a specific LBCL entity. Lymphomas that are classified as DLBCL NOS are morphologically and molecularly heterogeneous.

Policy Updates:

• 11/14/2023 – New policy approved by WHA P&T Committee. (P&T 11/14/2023)

References:

1. Epkinly Prescribing Information. Genmab US, Inc. Plainsboro, NJ. May 2023.
2. Food and Drug Administration. FDA press release: FDA approves treatment for relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma. May 19, 2023(a). FDA Web site. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-relapsed-or-refractory-diffuse-large-b-cell-lymphoma-and-high-grade-b-cell. Accessed July 18, 2023.
3. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology –B-Cell Lymphomas. V5.2023. NCCN Web site. https://www.nccn.org/professionals/physician_gls/pdf/b-cell.pdf. Accessed July 7, 2023.