Currentblue cross blue shield - tennesseePolicy N/A

Epcoritamab-bysp (Epkinly™)

Defines coverage and authorization criteria for Epkinly (epcoritamab-bysp) for treatment of various B-cell lymphomas including DLBCL, HGBL, follicular lymphoma, and related transformations, including combination and monotherapy scenarios and continuation/reauthorization limits.

Policy Summary

Payerblue cross blue shield - tennessee

PolicyEpcoritamab-bysp (Epkinly™)

Policy CodePolicy N/A

Change Typeclarified

Effective DateID_CHS_2025a

Next Review Date

Key ActionProviders must obtain authorization for Epkinly; approvals are granted for up to 12 months and for specified cycle limits (e.g., up to 12 cycles for combination with lenalidomide and rituximab in FL).

SourceLink

POLICY UPDATE CHANGES

Policy lists FDA-approved indications and compendial uses considered covered when approval criteria are met.

3FDA-Approved Indications Listed

12 monthsStandard Authorization Duration

12Max Cycles for FL combo

Coverage Summary & Indications

Epkinly (epcoritamab-bysp) is covered with criteria for specified B‑cell lymphoma indications per FDA approvals and recognized compendia. Coverage aligns to the FDA‑approved indications for relapsed or refractory diffuse large B‑cell lymphoma (DLBCL) and high‑grade B‑cell lymphoma after ≥ 2 prior lines of systemic therapy, and for follicular lymphoma (FL) as combination therapy with lenalidomide and rituximab or as monotherapy after ≥ 2 prior lines of systemic therapy; the policy references the Epkinly package insert (March 2026) and the NCCN Drugs & Biologics Compendium (2026) as aligned sources for covered uses and criteria.

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FDA-Approved Indications (covered when criteria met)

Epkinly is indicated for the following FDA-approved populations:

ANY of the following

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 (HGBL), after two or more lines of systemic therapy.>= 2 prior lines of systemic therapy
Treatment of adult patients with relapsed or refractory follicular lymphoma (FL) in combination with lenalidomide and rituximab.up to 12 cycles when authorized under combination regimen per policy
Treatment of adult patients with relapsed or refractory follicular lymphoma (FL) as monotherapy after two or more lines of systemic therapy.>= 2 prior lines of systemic therapy

Covered Indications / Authorization Criteria

Authorization of 12 months may be granted when one of the following criteria is met:

ANY of the following

Requested medication will be used as subsequent therapy for follicular lymphoma in combination with lenalidomide and rituximab for up to 12 cycles total for no response, relapsed, or progressive disease.up to 12 cycles total
Combination with GemOx
- Requested medication will be used as subsequent therapy in combination with GemOx (gemcitabine and oxaliplatin) for relapsed/refractory disease
- Disease subtype is one of: Diffuse large B-cell lymphoma (DLBCL); High grade B-cell lymphoma; HIV-related B-cell lymphoma including HIV-related DLBCL, primary effusion lymphoma, HHV8-positive DLBCL, not otherwise specified; Monomorphic post-transplant lymphoproliferative disorder (B-cell type).
Single agent after prior therapies
- Requested medication will be used as a single agent after at least 2 prior lines of systemic therapy>= 2 prior lines of systemic therapy
- Member has partial response, no response, progressive, relapsed or refractory disease
- Disease subtype is one of: Diffuse large B-cell lymphoma (DLBCL); High grade B-cell lymphoma; Histologic transformation of indolent lymphoma to DLBCL; HIV-related B-cell lymphoma including HIV-related DLBCL, primary effusion lymphoma, and HHV8-positive DLBCL, not otherwise specified; Monomorphic post-transplant lymphoproliferative disorder (B-cell type); Follicular lymphoma.
Histologic (Richter) transformation: Treatment of histologic (Richter) transformation to DLBCL.

Continuation / Reauthorization Criteria

Authorization of 12 months may be granted for continued treatment when:

ALL of the following

Member requests reauthorization for an indication listed in the coverage criteria section.
There is no evidence of unacceptable toxicity or disease progression while on the current regimen.
For follicular lymphoma in combination with lenalidomide and rituximab: total maximum of 12 cycles will be authorized.maximum 12 cycles

Key surface thresholds

Prior systemic lines required for DLBCL / FL monotherapy>= 2 prior lines of systemic therapy

Authorization duration12 months

Maximum cycles for FL combination (lenalidomide + rituximab)Up to 12 cycles total

Provider Actions & Authorization Requirements

Prior Authorization

Authorization required with 12-month limit

Authorization is required for Epkinly. Approvals may be granted for up to 12 months. For follicular lymphoma when used in combination with lenalidomide and rituximab, a maximum of 12 cycles total will be authorized.

Documentation Required

Documentation of prior therapies and disease status

Providers should document prior therapies, disease subtype, treatment response or progression, and absence of unacceptable toxicity when requesting authorization or reauthorization for Epkinly.

Lines of prior systemic therapy
Disease subtype (e.g., DLBCL, HGBL, FL, histologic transformation, HIV-related B‑cell lymphoma, monomorphic post‑transplant lymphoproliferative disorder)
Evidence of response, no response, progression, relapse, or partial response
Documentation of no unacceptable toxicity while on the current regimen

Background

Epkinly (epcoritamab-bysp) is indicated for relapsed/refractory B‑cell lymphomas per FDA labeling and recognized compendia. This policy aligns coverage to FDA approvals and standard oncology compendia for regimen details, dosing, and monitoring, and references the Epkinly package insert (March 2026) and the NCCN Drugs & Biologics Compendium (2026) for prescribing and safety information.

GemOx: Combination chemotherapy regimen of gemcitabine and oxaliplatin.

Revision History

ID_CHS_2025aclarifiedLatest

Document labeled as Draft Revision Policy: Do Not Implement; reference to March 2026 package insert and NCCN 2026. Policy lists FDA-approved indications and compendial uses considered covered when approval criteria are met; specifies covered FDA indications for Epkinly (DLBCL after ≥2 lines, FL with lenalidomide+rituximab, FL monotherapy after ≥2 lines), authorization limits (12 months; up to 12 cycles for FL combo), combination and single-agent use criteria (including GemOx combination and single-agent after ≥2 prior systemic therapies), histologic (Richter) transformation coverage, continuation/reauthorization criteria, and statement that all other indications are experimental/investigational and not medically necessary.