CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Um Onc_1281 Empliciti Elotuzumab_11292024

Defines accepted indications, continuation and exclusion criteria, and approval authority for Empliciti (elotuzumab) use for cancer (primarily relapsed/refractory multiple myeloma) including required supporting evidence sources. Applies to medication requests processed by Evolent for Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyUm Onc_1281 Empliciti Elotuzumab_11292024

Policy CodePolicy N/A

Change TypeClarified committee review and effective dates

Effective DateNov 29, 2024

Next Review Date

Key ActionAll medication requests for Empliciti must be processed and authorized by Evolent; medications not authorized may be deemed not approvable and not reimbursable

SourceLink

POLICY UPDATE CHANGES

Approval date recorded as November 13, 2024 and effective date November 29, 2024; committee review history updated through 11/13/24.

2Covered combination regimens

20 mg/kgMaximum allowable dose

1-3Prior therapies (lenalidomide combo)

>=2Prior regimens (pomalidomide combo)

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Coverage Summary

Empliciti (elotuzumab) is indicated for relapsed/refractory multiple myeloma in combination with lenalidomide or pomalidomide plus dexamethasone in specified prior-therapy settings. The policy aligns coverage with FDA labeling, CMS-recognized compendia, and NCCN/ASCO guidance and peer-reviewed literature per CMS requirements. Scope: defines accepted indications, continuation and exclusion criteria, and approval authority for Empliciti use in cancer. Payer/applicability: applies to medication requests processed by Evolent on behalf of Neighborhood Health Plan of Rhode Island.

Key thresholds and statistics

Maximum doseDo not exceed 20 mg/kg

Prior therapies required (lenalidomide combo)1-3 prior therapies for combination with lenalidomide (Revlimid), with or without dexamethasone

Prior regimens required (pomalidomide combo)At least 2 prior regimens including an immunomodulatory agent (specifically lenalidomide unless intolerance) and a proteasome inhibitor (specifically bortezomib/Velcade unless intolerance)

Clinically meaningful outcomes (ASCO guidance)Defined as Hazard Ratio < 0.80 and recommended OS/PFS benefit of at least 3 months

Initial Therapy Criteria

Approved use in Multiple Myeloma (Relapsed/Refractory)

Empliciti may be used in members with relapsed/refractory multiple myeloma in any one of the following combinations:

ONE of

In combination with Revlimid (lenalidomide), with or without dexamethasonePrior therapies: 1-3 prior therapies
lenalidomide required prior therapy count per policy unless intolerance/contraindication
In combination with Pomalyst (pomalidomide), with or without dexamethasonePrior regimens: at least 2 prior regimens including an immunomodulatory agent (specifically lenalidomide unless intolerance/contraindication) and a proteasome inhibitor (specifically bortezomib/Velcade unless intolerance/contraindication)
Specifies required prior exposure to an IMiD (lenalidomide) and a proteasome inhibitor (Velcade)

Continuation Therapy Criteria

Exclusions / Investigational Use

Requests that would exceed the policy maximum dose of 20 mg/kg or that document disease progression while receiving an elotuzumab-containing regimen are excluded and therefore not approvable under this policy.

Provider Actions

Prior Authorization

Medication requests processed by Evolent

All medication requests for Empliciti must be processed and authorized by Evolent. Medications that are not authorized by Evolent may be deemed not approvable and therefore not reimbursable.

Documentation Required

Support with recognized evidence

Use must be supported by FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets the CMS Medicare Benefit Policy Manual Chapter 15 requirements.

Denial Risk

Denial for disease progression

Applicable Codes

No specific billing codes listed in policymixed

No codes listed

Clinical Evidence

Evidence: ELOQUENT-3 (Dimopoulos et al.), NEJM 2018; ELOQUENT-2 extended follow-up (Dimopoulos MA et al.), Cancer 2018; Empliciti prescribing information (Bristol-Myers Squibb 2022). This policy aligns with these sources and with CMS requirements for supported evidence.

Background

Empliciti (elotuzumab) is indicated for relapsed/refractory multiple myeloma in combination with lenalidomide or pomalidomide plus dexamethasone in specified prior-therapy settings. Policy coverage is aligned with FDA labeling, CMS-recognized compendia, NCCN and ASCO guidelines, and peer-reviewed literature meeting CMS Medicare Benefit Manual Chapter 15 requirements. Scope summary: applies to medication requests processed by Evolent for Neighborhood Health Plan of Rhode Island.

Revision History

11/13/2024committee review/approval

Committee review and approval recorded; approval date November 13, 2024. No clinical policy statement changes stated.

11/29/2024effectiveLatest

Policy effective date November 29, 2024. No clinical policy statement changes stated.

03/23/2016 - 11/08/2023committee review history