Description
Epcoritamab-bysp (Epkinly
TM
) is a bispecific CD20-directed T-cell engaging antibody that binds to CD3 receptors. Epcoritamab-bysp activated T-cells, cause the release of proinflammatory cytokines and induce lysis of B-cells.
Policy Application
All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.
Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Epcoritamab-bysp (Epkinly) may be considered medically necessary in adult individuals for the following conditions:
-
For the treatment of 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;
or
Compendia Sources
- Epcoritamab-bysp (Epkinly) may be considered medically necessary for treatment of any of the current category 1, 2A, or 2B NCCN recommendations.
The use of epcoritamab-bysp (Epkinly)
for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
NOTE:
In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the
United States Food and Drug Administration (U.S. FDA)-approved
product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.
