CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Empliciti (elotuzumab) — coverage criteria for relapsed/refractory multiple myeloma

Defines accepted indications, coverage criteria, and coding for Empliciti (elotuzumab) use in adults with relapsed/refractory multiple myeloma for Neighborhood Health Plan of Rhode Island members; applies to providers requesting authorization for the medication.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEmpliciti (elotuzumab) — coverage criteria for relapsed/refractory multiple myeloma

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document prior therapies and the requested Empliciti combination per FDA labeling or accepted compendia/guidelines.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

20 mg/kgmaximum allowed dose

J9176HCPCS code

1-3lenalidomide combo prior therapies

≥2pomalidomide combo prior regimens

Commercial/Exchange/Medicaidlines of business

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Coverage Criteria for Empliciti (elotuzumab)

Initial and Continuation Coverage Criteria

Covered when ALL of the following are met for adult members with relapsed/refractory multiple myeloma:

Indication: Member is an adult with relapsed/refractory multiple myeloma and the request is for Empliciti (elotuzumab) in an approved combination.

Supported by FDA labeling or accepted compendia/guidelines.

Permitted combination regimens: Empliciti (elotuzumab) in combination with lenalidomide (with or without dexamethasone) OR Empliciti (elotuzumab) in combination with pomalidomide (with or without dexamethasone).

Prior therapy requirement for lenalidomide combination: For Empliciti combined with lenalidomide, member has received 1-3 prior therapies.1-3 prior therapies

Prior therapy requirement for pomalidomide combination: For Empliciti combined with pomalidomide, member has received at least two prior regimens including an immunomodulatory agent (lenalidomide) and a proteasome inhibitor (bortezomib) unless intolerance or contraindication.>=2 prior regimens

Continuation criteria: For continuation of therapy, member must not have experienced disease progression on Empliciti; prior authorization must have been active within the last year without a lapse greater than 30 days; and no additional medications are being added to the continuation request.

Dose limit: Requested dose does not exceed the maximum allowed dose of 20 mg/kg.<=20 mg/kg

Requests will be denied when the use of Empliciti (elotuzumab) is investigational or for an off-label indication lacking sufficient evidence as defined by CMS-recognized compendia or acceptable peer-reviewed literature. Coverage is also excluded for members who experience disease progression while receiving an Empliciti-containing regimen, and for requests that exceed the maximum dose of 20 mg/kg.

Empliciti use for indications not supported by CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature is not covered. Insufficient evidence includes reliance on case reports, abstracts without full peer-reviewed publication, or studies that do not adequately represent the patient or regimen characteristics or clinically meaningful outcomes as defined by guideline standards.

Permitted Combination Regimens

Regimen	Prior therapy requirement	Coverage status
Elotuzumab + lenalidomide (with or without dexamethasone)
Members who have received 1-3 prior therapies
Covered when criteria met
Elotuzumab + pomalidomide (with or without dexamethasone)
Members who have received at least two prior regimens including lenalidomide (unless intolerance/contraindication) and bortezomib (unless intolerance/contraindication)
Covered when criteria met

Billing and Coding

Drug HCPCS CodesHCPCSCovered

J9176

Injection, elotuzumab, 1 mg

Maximum dose — elotuzumab

Maximum allowed dose20 mg/kg

Dose applicabilityApplies to all Empliciti (elotuzumab) requests; requests exceeding this dose are a denial trigger

Unit of measuremilligrams per kilogram (mg/kg)

Policy referenceListed under Exclusion Criteria: 'The maximum dose should not exceed 20 mg/kg.'

Provider Requirements and Authorization Rules

Prior Authorization

Prior Authorization Required and Supporting Evidence

Prior authorization is required. Medication use must be supported by FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets CMS standards.

Prior authorization required for Empliciti (elotuzumab).
Supporting evidence must be one of: FDA labeling; CMS-recognized compendia; NCCN or ASCO guidelines; acceptable peer-reviewed literature per CMS Medicare Benefit Policy Manual Chapter 15.

Documentation Required

Continuation Request Conditions

Continuation requests may be approved without a new authorization when all of the following are true: 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.

Approved Lines of Therapy

second-line | later

Line of therapy mapping: Use with lenalidomide: members who have received 1-3 prior therapies (interpreted as second-line through later). Use with pomalidomide: members who have received at least two prior regimens including lenalidomide and bortezomib unless intolerance/contraindication (second-line or later).

Relapsed/Refractory Multiple Myeloma — permitted use context

DefinitionRelapsed/refractory multiple myeloma: the disease context in which Empliciti (elotuzumab) is permitted as part of specified combination regimens.

Permitted combinationsEmpliciti in combination with lenalidomide (with or without dexamethasone) OR Empliciti in combination with pomalidomide (with or without dexamethasone).

Prior therapy requirement — lenalidomide comboMember has received 1-3 prior therapies when Empliciti is combined with lenalidomide.

Background and Indication

Empliciti (elotuzumab) is a monoclonal antibody indicated for use in adults with relapsed/refractory multiple myeloma as part of combination regimens. Coverage is defined for Empliciti when used in approved combinations (for example with lenalidomide or pomalidomide plus dexamethasone) in the relapsed/refractory setting; continuity of authorization requires absence of disease progression and other continuation conditions. Requests must adhere to documented prior therapies and dosing limits, including a maximum dose of 20 mg/kg.

Policy Revision History

November 2025template_and_replacementLatest

Converted to new Evolent guideline template and replaced prior policy UM ONC_1281; updated indication section and references.

November 2024administrative_update

Updated NCH verbiage to Evolent.