CurrentNeighborhood Health Plan of Rhode IslandPolicy UM ONC_1479

Epkinly (epcoritamab-bysp) — Coverage Criteria and Authorization Rules

Criteria and authorization rules for use of Epkinly (epcoritamab-bysp) for cancer treatment for Neighborhood Health Plan of Rhode Island members; covers FDA-approved and some off-label uses supported by recognized compendia or literature and applies to providers submitting medication requests processed by Evolent.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEpkinly (epcoritamab-bysp) — Coverage Criteria and Authorization Rules

Policy CodePolicy UM ONC_1479

Change TypeNo material changes

Effective DateJuly 26,2024

Next Review Date

Key ActionProviders must submit medication requests to Evolent for authorization; continuation requests are allowed only if member has not experienced disease progression, prior use within the last year without >30-day lapse, and no additional medications are being added.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3committee review dates listed

48 mgsingle dose maximum listed

2prior therapies for follicular lymphoma

Phase 1/2key clinical evidence cited

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COVERAGE CRITERIA

Covered when criteria below are met

Epcoritamab (Epkinly) is covered for one of the following adult indications:

DLBCL (relapsed/refractory): Monotherapy for relapsed or refractory diffuse large B-cell lymphoma (including DLBCL arising from indolent lymphoma and high-grade B‑cell).
Follicular lymphoma (relapsed/refractory): Monotherapy for relapsed or refractory follicular lymphoma in adults who have failed at least two systemic therapies.

Continuation authorization: Continuation requests allowed if the member has not experienced disease progression on Epkinly; the medication was used within the last year without a lapse of more than 30 days of having an active authorization; and no additional medications are being added to the continuation request.

Requests will be excluded or denied when there is documented disease progression while taking Epkinly (epcoritamab-bysp). Concurrent administration of Epkinly with other anticancer therapies is not allowed. Additionally, dosing that exceeds a single dose of 48 mg is an exclusion and will not be approved.

Use of Epkinly for investigational or off‑label indications that lack sufficient evidence is considered not approvable. The policy defines sufficient evidence as support from FDA labeling, CMS‑recognized compendia, or acceptable peer‑reviewed literature that adequately represents the patient and cancer characteristics, the treatment regimen, and reports clinically meaningful outcomes (generally benefits in overall survival or progression‑free survival of at least 3 months). Nonrandomized trials with substantial subject numbers may provide supportive evidence, whereas case reports, meeting abstracts without a full peer‑reviewed article, or other anecdotal reports are insufficient.

Provider Actions and Authorization

Prior Authorization

Prior Authorization and Continuation Rules

Prior authorization is required. Providers must submit medication requests for Epkinly (epcoritamab-bysp) to Evolent for review and authorization before dispensing. Continuation requests are exempt from this policy only when the member has not experienced disease progression on the requested medication, the medication was used within the last year without a lapse of more than 30 days of having an active authorization, and no additional medications are being added to the continuation request.

Submit all medication requests to Evolent for prior authorization
Continuation exemption conditions:
• No disease progression on Epkinly
• Used within last 12 months with ≤30-day lapse from an active authorization
• No additional medications added to the continuation request

Step Therapy

Step Requirement for Follicular Lymphoma

For follicular lymphoma, Epkinly (epcoritamab-bysp) may be used as monotherapy in adult members with relapsed or refractory disease only after failure of at least two prior systemic therapies.

Indication: Relapsed or refractory follicular lymphoma
Requirement: Member must have failed ≥ 2 systemic therapies

Documentation Required

Supporting Evidence Required

The use of Epkinly must be supported by one of the following sources: FDA-approved product labeling; CMS-recognized compendia; NCCN or ASCO clinical guidelines; or peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 standards.

Acceptable supporting evidence: FDA labeling, CMS compendia, NCCN/ASCO guidelines, or CMS-standard peer-reviewed literature

Denial Risk

Denial Triggers and Exclusion Criteria

Requests may be denied when any exclusion criteria are met, including disease progression on Epkinly, concurrent use with other anticancer therapies, dosing above the single-dose limit (48 mg), investigational or insufficiently evidenced off-label use, or when supporting evidence does not meet CMS standards (e.g., reliance on case reports or abstracts without full peer-reviewed articles).

Denial triggers:
• Disease progression while on Epkinly
• Concurrent use with other anticancer therapies
• Single dose exceeds 48 mg
• Investigational use or off-label indications lacking sufficient evidence
• Evidence limited to case reports or abstracts without full peer-reviewed publication

Background

Epkinly (epcoritamab‑bysp) is an anti‑B‑cell bispecific antibody indicated as monotherapy for certain relapsed or refractory B‑cell lymphomas. The policy covers Epkinly for relapsed or refractory diffuse large B‑cell lymphoma (including DLBCL arising from indolent lymphoma) and for relapsed or refractory follicular lymphoma in adults who have failed at least two systemic therapies. Authorization and continuation rules require support from FDA labeling, recognized compendia, or acceptable peer‑reviewed literature; continuation is allowed only if the member has not experienced disease progression on Epkinly and other continuation conditions are met.

Step	Required prior therapies	Coverage
1
Failure of at least two systemic therapies for relapsed or refractory follicular lymphoma (Epkinly to be used as monotherapy)
Covered with criteria

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEpkinly (epcoritamab-bysp) — Coverage Criteria and Authorization Rules

Policy CodePolicy UM ONC_1479

Change TypeNo material changes

Effective DateJuly 26,2024

Next Review Date

SourceLink

On This Page

OpenPayer

Epkinly (epcoritamab-bysp) — Coverage Criteria and Authorization Rules

Coverage Criteria

Coding and Limits

Provider Actions and Authorization

Background

Definitions

Initial Therapy Criteria

Continuation Therapy Criteria

Step Therapy Requirements

Quantity Limits