Overview

This document addresses the use of Epkinly (epcoritamab-bysp), a T-cell-engaging bispecific antibody for the treatment of adults 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 (HGBL), after two or more lines of systemic therapies. Epkinly is administered by a subcutaneous injection once every 28 days after initial step-up dosing cycles. Two dosages are available for the step-up dosing 4 mg/0.8 mL vial and a maintenance dose vial of 48 mg/0.8 mL.

Epkinly has a boxed warning for serious or life-threatening cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).

Definitions and Measures

ECOG or Eastern Cooperative Oncology Group Performance Status:

A scale and criteria used by doctors and researchers to assess how an individual’s disease is progressing, assess how the disease affects the daily living abilities of the individual, and determine appropriate treatment and prognosis. This scale may also be referred to as the WHO (World Health Organization) or Zubrod score which is based on the following scale:

• 0 = Fully active, able to carry on all pre-disease performance without restriction
• 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, for example, light house work, office work
• 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours
• 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours
• 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair
• 5 = Dead

Line of Therapy:

• First-line therapy: The first or primary treatment for the diagnosis, which may include surgery, chemotherapy, radiation therapy or a combination of these therapies.
• Second-line therapy: Treatment given when initial treatment (first-line therapy) is not effective or there is disease progression.
• Third-line therapy: Treatment given when both initial (first-line therapy) and subsequent treatment (second-line therapy) are not effective or there is disease progression.

Refractory Disease: Illness or disease that does not respond to treatment.

Relapse or recurrence: After a period of improvement, during which time a disease (for example, cancer) could not be detected, the return of signs and symptoms of illness or disease. For cancer, it may come back to the same place as the original (primary) tumor or to another place in the body.

Clinical Criteria

When a drug is being reviewed for coverage under a member’s medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose. Epkinly (epcoritamab-bysp)

Requests for Epkinly (epcoritamab-bysp) may be approved if the following criteria are met:

1. I.
2. II.
3. III.
4. IV.

1. Individual has a diagnosis of CD20+ relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from indolent lymphoma and high-grade B-cell lymphoma (HGBL); AND
2. Individual has received two or more prior lines of therapy, including at least one anti-CD20 monoclonal antibody; AND
3. Individual is using Epkinly as a single agent; AND
4. Individual has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

Requests for Epkinly (epcoritamab-bysp) may not be approved for the following;

• Individual has central nervous system involvement of lymphoma; OR
• Individual has an ongoing active infection; OR
• Individual with known impaired T-cell immunity; OR
• I.
• II.
• III.
• IV.

When the above criteria are not met and for all other indications.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

HCPCS

J9321

ICD-10 Diagnosis

C83.30-C83.39

Document History

New: 06/12/2023