In the absence of coverage criteria from applicable Medicare statutes, regulations, NCDs, LCDs, CMS manuals, or other Medicare coverage documents, this policy uses internal coverage criteria developed by the Company in consideration of peer-reviewed medical literature, clinical practice guidelines, and/or regulatory status.
The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.
MEDICALLY NECESSARY
INITIAL THERAPY: B-CELL LYMPHOMAS
Epcoritamab-bysp (Epkinly) is considered medically necessary and, therefore, covered in adult individuals with partial response, no response, progressive, relapsed or refractory (including disease progression posttransplant or chimeric antigen receptor [CAR] T-cell therapy) when the criteria presented below are met:
Diffuse Large B-Cell Lymphoma (DLBCL) and High-Grade B-cell Lymphomas
- Second-line and subsequent therapy in combination with GemOx (gemcitabine and oxaliplatin) regimen in one of the following conditions:
- for relapsed disease <12 months after completion of first-line therapy or primary refractory disease in noncandidates for CAR T-cell therapy
- for relapsed disease >12 months after completion of first-line therapy if no intention to proceed to transplant
- as alternative systemic therapy for relapsed or refractory disease
- Third-line and subsequent therapy as a single agent (National Comprehensive Cancer Network [NCCN]-preferred):
Histologic Transformation of Indolent Lymphomas to Diffuse Large B-Cell Lymphoma
- Third-line therapy as a single agent
Human Immunodeficiency Virus (HIV)--Related B-Cell Lymphomas (HIV-related diffuse large B-cell lymphoma, primary effusion lymphoma, and HHV8-positive diffuse large B-cell lymphoma, not otherwise specified, or for HIV-related plasmablastic lymphoma)
- Second-line and subsequent therapy in combination with GemOx (gemcitabine and oxaliplatin) regimen for one of the following conditions:
- for relapsed disease <12 months after completion of first-line therapy or primary refractory disease in noncandidates for CAR T-cell therapy
- for relapsed disease >12 months after completion of first-line therapy if no intention to proceed to transplant
- as alternative systemic therapy for relapsed or refractory disease
- Third-line and subsequent therapy as a single agent
Post-Transplant Lymphoproliferative Disorders (PTLD)
- Second-line and subsequent therapy in combination with GemOx (gemcitabine and oxaliplatin) regimen for one of the following monomorphic PTLD (B-cell type) conditions:
- for relapsed disease <12 months after completion of first-line therapy or primary refractory disease in noncandidates for CAR T-cell therapy
- for relapsed disease >12 months after completion of first-line therapy if no intention to proceed to transplant
- as alternative systemic therapy for relapsed or refractory disease
- Third-line and subsequent therapy as single agent in individuals with monomorphic PTLD (B-cell type)
Classic Follicular Lymphoma
- Third-line and subsequent therapy as single agent in individuals with classic follicular lymphoma
Epcoritamab-bysp (Epkinly) is considered medically necessary and, therefore, covered in combination with lenalidomide and rituximab (R2) as second-line therapy in individuals with relapsed or refractory (R/R) follicular lymphoma (FL).
CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)/SMALL LYMPHOCYTIC LYMPHOMA (SLL)
Epcoritamab-bysp (Epkinly) is considered medically necessary and, therefore, covered as a single agent for histologic (Richter) transformation to diffuse large B-cell lymphoma in individuals with the following clonal status:
- Untreated CLL or clonally unrelated disease at initial diagnosis
- Additional therapy for partial response, refractory disease, or progression while on treatment with chemoimmunotherapy regimens
- Previously treated CLL and clonally related or clonal relation unknown in either of the following circumstances:
- First-line treatment
- Continuation therapy for complete response until progression or as additional therapy not previously used for partial response, refractory disease, or progression while on treatment with CIT (chemoimmunotherapy) or non-CIT regimens
CONTINUATION THERAPY
Epcoritamab-bysp (Epkinly) is considered medically necessary and, therefore, covered for continuation therapy when there is documentation of no evidence of unacceptable toxicity or disease progression while on the current regimen.
MANDATES
PENNSYLVANIA MEMBERS
In accordance with the Commonwealth of Pennsylvania's Act 6 of 2020 or Fair Access to Cancer Treatment Act, for members who are enrolled in Pennsylvania commercial products who have stage 4, advanced metastatic cancer, refer to the Medical Policy titled "Coverage of Anticancer Prescription Oral and Injectable Drugs and Biologics and Supportive Agents" (08.01.08) for additional information regarding the applicable coverage of drugs and biologics.
EXPERIMENTAL/INVESTIGATIONAL
All other uses for epcoritamab-bysp (Epkinly) are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.
REQUIRED DOCUMENTATION
The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.
The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
