CurrentCareSourcePolicy N/A

UTILIZATION MANAGEMENT MEDICAL POLICY

Utilization management policy for medical-benefit coverage of Epkinly (epcoritamab-bysp) for adult patients with relapsed or refractory diffuse large B-cell lymphoma and other B-cell lymphomas after two or more lines of systemic therapy, including dosing and prior authorization guidance.

Policy Summary

PayerCareSource

PolicyUTILIZATION MANAGEMENT MEDICAL POLICY

Policy CodePolicy N/A

Change TypeAnnual Revision (added Classic Follicular Lymphoma)

Effective Date

Next Review Date

Key ActionPrior authorization is recommended for medical benefit coverage of Epkinly; approvals provided for the durations noted (typically 1 year) and extended approvals allowed if patient continues to meet criteria and dosing.

SourceLink

POLICY UPDATE CHANGES

Annual Revision added 'Classic Follicular Lymphoma' as a new condition of approval.

New policy created with initial review date 06/05/2023.

1FDA-Approved Indications listed (DLBCL)

3Other supported indications listed (Follicular, HIV-related, Post-transplant)

2Required prior lines of therapy

1 yearTypical approval duration

Scope: Utilization management policy for medical-benefit coverage of Epkinly (epcoritamab-bysp) for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and other supported B-cell lymphomas after ≥ 2 lines of systemic therapy, including dosing and prior authorization guidance. Coverage stance: covered_with_criteria (approvals when recommended authorization criteria and dosing are met).

Boxed warnings: Epkinly carries boxed warnings for cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome.

Typical approval duration: approvals are generally provided for 1 year per policy (last reviewed 06/12/2024).

Policy Thresholds and Approval Duration

Lines of prior systemic therapy≥ 2 lines

Age≥ 18 years

Typical approval duration1 year

Initial Therapy Criteria — FDA-Approved Indication (DLBCL)

FDA-Approved Indication - Diffuse Large B-Cell Lymphoma (DLBCL)

Approve for 1 year if the patient meets ALL of the following:

ALL of the following

Patient is ≥ 18 years of age
Patient has received two or more lines of systemic therapy≥ 2 lines
Examples of systemic therapy include R-CHOP, D(H)A + platinum regimens, rituximab-containing combinations
Medication is given as a single agent
Medication is prescribed by or in consultation with an oncologist
Dosing regimen
- Dosing schedule
  - Cycle 1 Day 1: 0.16 mg
  - Cycle 1 Day 8: 0.8 mg
  - Cycle 1 Day 15: 48 mg
  - Cycle 1 Day 22: 48 mg
  - Cycles 2 and 3 Days 1, 8, 15, 22: 48 mg
    Maximum of 4 injections in cycles 2 and 3
  - Cycles 4 to 9 Days 1 and 15: 48 mg

Initial Therapy Criteria — Other Supported Indications

Other Uses with Supportive Evidence

Approve for 1 year if the patient meets ALL of the following for each listed indication:

Indications

Classic Follicular Lymphoma
- Patient is ≥ 18 years of age
- Patient has received two or more lines of systemic therapy≥ 2 lines
  Examples include CHOP + rituximab or obinutuzumab (Gazyva), CVP + rituximab or Gazyva
- Medication is given as a single agent
- Medication is prescribed by or in consultation with an oncologist
- Dosing regimen up to 48 mg subcutaneous in 28-day cycles per policy scheduleup to 48 mg per dose
  Cycles 2 and 3: maximum of 4 injections; Cycles 4 to 9: maximum of 2 injections; Cycles 10 and beyond: maximum of 1 injection
HIV-Related B-Cell Lymphomas
- Patient is ≥ 18 years of age
- Patient has received two or more lines of systemic therapy≥ 2 lines
  Examples include R-CHOP, R-EPOCH
- Medication is given as a single agent
- Medication is prescribed by or in consultation with an oncologist
- Dosing regimen up to 48 mg subcutaneous in 28-day cycles per policy scheduleup to 48 mg per dose
  Cycles 2 and 3: maximum of 4 injections; Cycles 4 to 9: maximum of 2 injections; Cycles 10 and beyond: maximum of 1 injection
Post-Transplant Lymphoproliferative Disorders
- Patient is ≥ 18 years of age
- Patient has received two or more lines of systemic therapy≥ 2 lines
  Examples include R-CHOP and R-CEPP
- Medication is given as a single agent
- Medication is prescribed by or in consultation with an oncologist
- Dosing regimen up to 48 mg subcutaneous in 28-day cycles per policy scheduleup to 48 mg per dose
  Cycles 2 and 3: maximum of 4 injections; Cycles 4 to 9: maximum of 2 injections; Cycles 10 and beyond: maximum of 1 injection

Continuation Therapy Criteria

Continuation/renewal: Authorizations are issued for 1 year and extended approvals are allowed if the patient continues to meet the policy criteria and dosing requirements.

Requests for dosing that deviate from the established policy schedule (including doses outside the documented subcutaneous dosing regimen up to 48 mg) will be considered on a case-by-case basis by a clinician (Medical Director or Pharmacist).

Unproven / Not Recommended

Not Recommended for Approval

Coverage is not recommended when the situation is not listed in the Recommended Authorization Criteria.

Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria

Criteria will be updated as new published data are available

Provider Actions / Prior Authorization

Prior Authorization

Prior authorization required

Prior authorization is recommended for medical benefit coverage of Epkinly; approvals are provided for the durations noted (typically 1 year) and extended approvals are allowed if the patient continues to meet criteria and dosing.

Documentation Required

Prescriber qualification

Epkinly must be prescribed by or in consultation with a physician who specializes in the condition treated (oncologist).

Billing Rule

Dosing outside policy

Requests for doses outside the established dosing documented in this policy will be considered on a case-by-case basis by a clinician (Medical Director or Pharmacist).

Clinical Evidence & Guidelines

Evidence and guidance: NCCN B-Cell Lymphomas Clinical Practice Guidelines v2.2024 (April 30, 2024) and Epkinly prescribing information (Genmab; 2023) support use.

Background evidence summary: Epkinly is a bispecific CD20xCD3 T-cell engager indicated for relapsed/refractory DLBCL and has NCCN guideline support for multiple B-cell lymphomas (including follicular lymphoma, DLBCL, transformed disease, high-grade B-cell lymphomas, HIV-related B-cell lymphomas, and post-transplant lymphoproliferative disorders).

Background & Definitions

Background: Epkinly is a bispecific CD20-directed CD3 T-cell engager administered by subcutaneous injection and indicated for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in adults after two or more lines of systemic therapy.

Boxed warnings: Epkinly has boxed warnings for cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome.

Dosing summary: The policy dosing schedule includes step-up dosing in Cycle 1 (Day 1: 0.16 mg; Day 8: 0.8 mg; Days 15 and 22: 48 mg) followed by 48 mg per the described cycle schedule (28-day cycles with specified injections in cycles 2–3, 4–9, and cycle 10+).

Term	Definition
DLBCL	Diffuse large B-cell lymphoma, includes DLBCL not otherwise specified, DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma.