CurrentAnthemPolicy CC-0242

Epkinly (epcoritamab-bysp) coverage

Criteria and coding for prior authorization and medical necessity of Epkinly (epcoritamab-bysp) for treatment of specified relapsed/refractory B-cell lymphomas for Anthem members.

Policy Summary

PayerAnthem

PolicyEpkinly (epcoritamab-bysp) coverage

Policy CodePolicy CC-0242

Change TypeAdded FDA indication and NCCN clarifications (material changes)

Effective Date

Next Review Date

Key ActionObtain prior authorization and document diagnosis and evidence of at least two prior systemic therapy lines including an anti‑CD20 agent.

SourceLink

POLICY UPDATE CHANGES

Add FDA indication for use in relapsed or refractory follicular lymphoma.

Add NCCN recommendation for use in Richter's transformation in CLL/SLL.

Clarify existing NCCN recommendations for use in DLBCL, High-Grade B-cell lymphoma, HIV-related B-cell lymphoma, and PTLD B-cell lymphoma.

Added ICD-10-CM diagnosis codes including C83.00-C83.09 and C91.10/C91.12 and others; removed some previously listed HCPCS/CPT placeholders.

CRS/ICANSboxed warning

q28dadministration

2+prior lines

J9321drug code

Coverage / Approval Criteria

Approval Criteria

Requests for Epkinly may be approved when the following logical combinations are met:

Age or Diagnosis

Qualifying diagnoses: CD20+ relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from indolent lymphoma; High-grade B-cell lymphoma (HGBL); Post-transplant lymphoproliferative disorders (PTLD) (NCCN 2A); HIV-related B-cell lymphomas (NCCN 2A); Classic follicular lymphoma (label, NCCN 2A)
see policy list

Prior therapy requirement for single-agent use: Individual has received two or more prior lines of therapy, including at least one anti-CD20 monoclonal antibody>=2 prior lines; includes anti-CD20 requirement

see requirement for single-agent Epkinly

Policy Summary

PayerAnthem

PolicyEpkinly (epcoritamab-bysp) coverage

Policy CodePolicy CC-0242

Change TypeAdded FDA indication and NCCN clarifications (material changes)

Effective Date

Next Review Date

Key ActionObtain prior authorization and document diagnosis and evidence of at least two prior systemic therapy lines including an anti‑CD20 agent.

SourceLink

On This Page

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Permitted regimen contexts: (A) Epkinly used as single agent for any listed B-cell lymphoma; OR (B) Epkinly used as second-line or subsequent therapy in combination with gemcitabine + oxaliplatin for DLBCL, HGBL, HIV-related B-cell lymphoma, or PTLD (NCCN 2A); OR (C) Epkinly combined with lenalidomide + rituximab for relapsed/refractory follicular lymphoma (label); OR (D) Epkinly use for CLL/SLL with Richter's transformation (NCCN 2A)

combination and label-based contexts allowed

Requests for Epkinly (epcoritamab-bysp) may not be approved if any of the following exclusionary conditions are present: central nervous system involvement of lymphoma; ongoing active infection; known impaired T‑cell immunity. Additionally, requests will be denied when the stated coverage criteria are not met or for any other non‑specified indications.

Requests that do not meet the policy’s specified coverage criteria — including required diagnosis, prior therapy history, and permitted regimen contexts — are not approved. When the above criteria are not satisfied, or the requested use falls outside the listed indications and combinations, the request should be denied as not meeting medical necessity per this policy.

Regimens and Dosing

Regimen	Indication / Line of therapy	Dosing schedule (key details)
Epkinly (epcoritamab-bysp) — single‑agent (subcutaneous)	Relapsed/refractory CD20+ DLBCL (including DLBCL arising from indolent lymphoma), High‑grade B‑cell lymphoma (HGBL), post‑transplant lymphoproliferative disorder (PTLD), HIV‑related B‑cell lymphomas, and relapsed/refractory follicular lymphoma after two or more prior systemic therapy lines (including at least one anti‑CD20 monoclonal antibody)	Step‑up subcutaneous administration per label followed by maintenance dosing every 28 days (q28d)

Regimen	Indication / Line of therapy	Notes
Epkinly in combination with gemcitabine + oxaliplatin	Diffuse large B‑cell lymphoma (DLBCL), High‑grade B‑cell lymphoma (HGBL), HIV‑related B‑cell lymphoma, or PTLD — allowed as second‑line or subsequent therapy	Use supported by NCCN as a 2A recommendation for second‑line or subsequent therapy

Regimen	Indication / Line of therapy	Notes
Epkinly combined with lenalidomide + rituximab (or rituximab biosimilars)	Relapsed or refractory follicular lymphoma	Combination per FDA label for relapsed/refractory follicular lymphoma

Provider Requirements & Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approval is contingent on meeting the clinical criteria outlined in the policy.

Prior authorization required for Epkinly (epcoritamab-bysp).
Approval contingent on meeting documented clinical criteria.

Step Therapy

Step Therapy / Prior Treatments

For requests to be considered, the patient must have received prior systemic therapies as described below. Submit documentation of prior lines of systemic therapy, including agents and dates.

Requires prior exposure to two or more prior lines of systemic therapy for primary B‑cell lymphoma indications.
At least one prior therapy must include an anti‑CD20 monoclonal antibody (e.g., rituximab or biosimilar).
Step-therapy requirement applies to single-agent Epkinly use for relapsed/refractory DLBCL, HGBL, PTLD, HIV-related B‑cell lymphoma, and follicular lymphoma (where applicable).

Documentation Required

Required Documentation

Provide medical records that support the diagnosis and prior treatment history. Include relevant ICD-10-CM diagnosis codes and documentation of prior therapies, dates, and responses.

Submit diagnostic documentation using applicable ICD-10-CM codes (e.g., C83.30-C83.38 for DLBCL; C82.00-C82.99 for follicular lymphoma; C91.10/C91.12 for CLL/SLL; D47.Z1 for PTLD; B20 where HIV-related lymphoma applies).
Document prior lines of therapy (agents, start/stop dates, and clinical response).
If requesting combination regimens (gemcitabine + oxaliplatin; lenalidomide + rituximab), provide prior treatment rationale and supporting evidence.

Denial Risk

Denial Triggers / Contraindications

Requests will be denied when exclusion criteria or contraindications are present or when required clinical criteria are not met.

Do not approve if there is central nervous system involvement of lymphoma.
Do not approve if the patient has an ongoing active infection.
Do not approve if the patient has known impaired T‑cell immunity.
Do not approve when the step-therapy and prior‑treatment requirements or other policy criteria are not met.

Billing and Diagnosis Codes

Covered HCPCS / Drug CodeHCPCSCovered

J9321

Injection, epcoritamab-bysp, 0.16 mg [Epkinly]

Relevant ICD-10 Diagnosis CodesICD-10

B20	Human immunodeficiency virus [HIV] disease
C82.00-C82.99	Follicular lymphoma
C83.00-C83.09	Small cell B-cell lymphoma
C83.30-C83.38	Diffuse large B-cell lymphoma
C83.398	Diffuse large B-cell lymphoma of other extranodal and solid organ sites
C83.80-C83.89	Other non-follicular lymphoma
C85.10-C85.19	Unspecified B-cell lymphoma
C85.20-C85.29	Mediastinal (thymic) large B-cell lymphoma
C91.10	Chronic lymphocytic leukemia of B-cell type not having achieved remission
C91.12	Chronic lymphocytic leukemia of B-cell type in relapse

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Line of Therapy Criteria

third-line

Third-line requirement: For approval as third-line therapy: individual has received two or more prior lines of systemic therapy (including at least one anti-CD20 monoclonal antibody) and Epkinly is being used as a single agent for a listed B‑cell lymphoma indication>=2 prior lines; includes anti‑CD20 requirement

See single‑agent line requirement in policy

second-line | subsequent

Second-line or subsequent combination use: Epkinly may be used as second-line or subsequent therapy when given in combination with gemcitabine + oxaliplatin for DLBCL, High‑Grade B‑cell lymphoma, HIV‑related B‑cell lymphoma, or PTLD (NCCN 2A)second-line or later

NCCN 2A combination context per policy

Biomarkers and Test Requirements

CD20 — biomarker requirement

Required biomarkerCD20 positive (CD20+) status required for listed DLBCL indication

Applicable diagnosesCD20+ relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from indolent lymphoma

Other covered B‑cell lymphomasPolicy also lists High‑grade B‑cell lymphoma (HGBL), PTLD, HIV‑related B‑cell lymphomas, and classic follicular lymphoma (these diagnoses are specified separately) — CD20 requirement applies to the DLBCL criterion

Definitions and Clinical Terms

ECOG Performance Status (0–5)

ECOG 0Fully active, able to carry on all pre‑disease performance without restriction

ECOG 1Restricted in physically strenuous activity but ambulatory and able to carry out light or sedentary work

ECOG 2Ambulatory and capable of all self‑care but unable to carry out work activities; up and about >50% of waking hours

ECOG 3Capable of only limited self‑care; confined to bed or chair >50% of waking hours

ECOG 4Completely disabled; cannot carry on any self‑care; totally confined to bed or chair

ECOG 5Dead

Line of Therapy definitions

First‑line therapyThe first or primary treatment for the diagnosis (may include surgery, chemotherapy, radiation, or combinations)

Second‑line therapyTreatment given when initial (first‑line) therapy is not effective or there is disease progression; Epkinly may be used second‑line or subsequent in combination regimens per NCCN 2A

Third‑line therapyTreatment given when both initial and subsequent (second‑line) therapies are not effective or there is disease progression; single‑agent Epkinly approval requires two or more prior lines (i.e., third‑line or later) including at least one anti‑CD20 monoclonal antibody

Background

Epkinly (epcoritamab-bysp) is a T‑cell engaging bispecific antibody used for certain relapsed or refractory B‑cell lymphomas. The policy recognizes labeled and NCCN‑supported uses including single‑agent Epkinly and specific combination regimens (for example, with gemcitabine + oxaliplatin or with lenalidomide + rituximab) for the listed diagnoses. Note that the policy excludes patients with CNS lymphoma involvement, active infection, or known impaired T‑cell immunity from approval considerations.