ModifiedHealth NetPolicy N/A

Elotuzumab (Empliciti) — coverage criteria for multiple myeloma

Medical necessity criteria, dosing, and coverage guidance for elotuzumab (Empliciti) when used to treat adults with multiple myeloma in Health Net lines of business (Commercial, HIM, Medicaid). Applies to providers requesting prior authorization.

Policy Summary

PayerHealth Net

PolicyElotuzumab (Empliciti) — coverage criteria for multiple myeloma

Policy CodePolicy N/A

Change TypeMaterial updates — added prescriber option and disease definitions (4Q 2024)

Effective DateFeb 1, 2017

Next Review DateN/A

Key ActionSubmit prior authorization with documentation showing diagnosis, prescriber type (including hematologist), and IMWG/NCCN evidence of relapsed or refractory disease.

SourceLink

POLICY UPDATE CHANGES

Added hematologist as prescriber option.

Added criterion disease is relapsed or refractory per NCCN.

Added IMWG criterion defining progressive multiple myeloma disease.

For Commercial line of business, revised approval duration to standard language of '6 months or to the member's renewal date, whichever is longer.'

1-3FDA indication (lenalidomide combo)

>=2FDA indication (pomalidomide combo)

6 moCommercial initial approval

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6 moMedicaid/HIM initial approval

4Q2024Recent material update

Coverage Criteria

inv-01: Initial Therapy

Covered when ALL of the following are met

Initial Approval: Member has a diagnosis of multiple myeloma

Prescriber: Prescribed by or in consultation with an oncologist or hematologist

Added hematologist as prescriber option in 4Q2024 review

Disease status: Disease is relapsed or refractory

Per NCCN (added in 4Q2024 review)

Combination regimen: Empliciti is prescribed in combination with dexamethasone and either pomalidomide, lenalidomide, or bortezomib (regimen must be FDA-approved or recommended by NCCN)

Off-label combinations require supporting evidence

inv-02: Continued Therapy

Covered when ALL of the following are met for continuation

Current therapy: Member is currently receiving Empliciti via Centene benefit or documentation supports current use for a covered indication and member has received medication for at least 30 days

Response: Member is responding positively to therapy

Dose limits: New dose does not exceed specified dosing schedules per combination (same dosing rules as initial therapy) or is supported by practice guidelines/peer-reviewed literature for off-label use

If request is for dose increase, must meet the dosing criteria for lenalidomide or pomalidomide combos or provide supporting literature

inv-03: Initial/continued therapy coverage conditions

Covered when criteria per NCCN and IMWG for relapsed/refractory multiple myeloma are met and prescriber is authorized (hematologist added):

Coverage prerequisites: Prescriber is appropriate (hematologist or oncologist); disease is relapsed or refractory per NCCN; IMWG progressive disease criterion met

Detailed element-level criteria (e.g., IMWG thresholds) are in Appendix D and policy appendices

Requests for use of elotuzumab (Empliciti) for non‑FDA approved indications that are not specifically addressed in this clinical policy are not authorized unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid), or unless the member’s evidence of coverage document otherwise provides coverage.

When caring for Medicaid members, state Medicaid coverage provisions take precedence if they conflict with the provisions of this clinical policy; providers should consult the applicable state Medicaid manual for any Medicaid‑specific coverage rules or exclusions.

This policy is guidance to help determine medical necessity and does not override contract language, Evidence of Coverage, or state/federal requirements; coverage is subject to plan terms, limitations, exclusions, and applicable administrative policies.

Use of elotuzumab for indications that are not FDA‑approved and not addressed in this policy is considered not authorized unless there is adequate supporting evidence per the referenced off‑label use policies. Requests lacking such documentation may be treated as not medically necessary and may be denied.

This policy has been subject to regular annual review. The 4Q 2022 and 4Q 2023 reviews noted no significant changes, while the 4Q 2024 annual review included operational updates (for example, adding hematologist as an authorized prescriber and aligning disease definitions to NCCN/IMWG). These reviews inform how the criteria are operationalized for prior authorization but do not, by themselves, change the requirement that documentation must meet the stated clinical criteria.

Coding and Definitions

HCPCS CodesHCPCS

J9176

Injection, elotuzumab; 1 mg

HCPCS Codes referencedHCPCS

J9176

Injection, elotuzumab; 1 mg

IMWG thresholds for progressive disease (numeric values)

Serum M-componentAbsolute increase ≥ 0.5 g/dL

Urine M-componentAbsolute increase ≥ 200 mg per 24 hours

Involved free light chain (FLC)Absolute increase > 10 mg/dL (only in patients without measurable serum and urine M-protein)

Bone marrow plasma cellsAbsolute increase ≥ 10% (only in patients without measurable serum/urine M-protein and without measurable disease by FLC)

Circulating plasma cells250% increase (minimum of 200 cells/µL) if this is the only measure of disease

Radiologic/lesional progressionAppearance of new lesion(s), or ≥50% increase from nadir in SPD of >1 lesion, or ≥50% increase in longest diameter of a previous lesion >1 cm in short axis

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must include clinical documentation demonstrating that the member meets all approval criteria (diagnosis of multiple myeloma, relapsed or refractory disease per NCCN, prescriber is an oncologist or hematologist, evidence of measurable or IMWG-defined progressive disease, prior therapy history, and prescribed regimen is FDA‑approved or NCCN‑recommended). Approval is granted when criteria are met.

Submit office/chart notes, labs (serum M‑protein, urine M‑protein, serum free light chain), IMWG/NCCN assessments, and prior therapy documentation.
Prescriber must be an oncologist or hematologist (or consultation documented).
Regimen must be FDA‑approved or recommended by NCCN; relevant off‑label requests require supporting evidence.

Note

Approval Duration

Commercial approvals are typically granted for 6 months or through the member's renewal date, whichever is longer. Medicaid/HIM duration: 6 months.

Background

Elotuzumab (Empliciti) is a monoclonal antibody targeting SLAMF7 and is indicated in combination with immunomodulatory agents and dexamethasone for treatment of relapsed or refractory multiple myeloma. Dosing regimens in the policy reference the product prescribing information (empliciti dosing: 10 mg/kg IV weekly for cycles 1–2 then every 2–4 weeks thereafter depending on combination) and the policy relies on IMWG and NCCN definitions to define measurable and progressive disease when determining coverage.

Definitions

Progressive disease — IMWG definitions

Criterion trigger (any one)Increase of 25% from lowest response value in any IMWG measure qualifies as progression

Serum M-componentAbsolute increase ≥ 0.5 g/dL

Urine M-componentAbsolute increase ≥ 200 mg/24 h

Involved FLC (only if serum/urine not measurable)Absolute increase > 10 mg/dL

Bone marrow plasma cells (only if other measures not available)Absolute increase ≥ 10%

New lesions or lesion growthAppearance of new lesion(s) or ≥50% increase in lesion size (SPD or longest diameter criteria)

Line of Therapy Guidance

inv-23: second-line

FDA indication lenalidomide combo: Empliciti with lenalidomide + dexamethasone for patients who have received 1 to 3 prior therapies

FDA indication pomalidomide combo: Empliciti with pomalidomide + dexamethasone for patients who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor

inv-24: mixed

Line of therapy: Policy references primary therapy and therapy for previously treated multiple myeloma per NCCN; relapsed or refractory disease criteria (IMWG/NCCN) guide use across lines of therapy

Specific first-line vs subsequent-line decision logic is in Appendix B/NCCN guidance

Covered Regimens

Regimen	Coverage status	Notes
Empliciti + lenalidomide + dexamethasone
Empliciti + pomalidomide + dexamethasone
Empliciti + bortezomib + dexamethasone

Examples of previously treated regimens (Appendix B)	Coverage status	Notes
Bortezomib/dexamethasone; Bortezomib/lenalidomide/dexamethasone; Bortezomib/cyclophosphamide/dexamethasone; Carfilzomib/lenalidomide/dexamethasone; Cyclophosphamide/lenalidomide/dexamethasone
Daratumumab/lenalidomide/dexamethasone; Daratumumab/pomalidomide/dexamethasone; Daratumumab/bortezomib/dexamethasone; Elotuzumab/lenalidomide/dexamethasone; Elotuzumab/pomalidomide/dexamethasone; Elotuzumab/bortezomib/dexamethasone
Bendamustine-based regimens; Carfilzomib/cyclophosphamide/dexamethasone; Bortezomib/liposomal doxorubicin/dexamethasone; Other NCCN-recommended combinations for previously treated MM (see Appendix B for full list)

Policy Summary

PayerHealth Net

PolicyElotuzumab (Empliciti) — coverage criteria for multiple myeloma

Policy CodePolicy N/A

Change TypeMaterial updates — added prescriber option and disease definitions (4Q 2024)

Effective DateFeb 1, 2017

Next Review DateN/A

Key ActionSubmit prior authorization with documentation showing diagnosis, prescriber type (including hematologist), and IMWG/NCCN evidence of relapsed or refractory disease.

SourceLink

On This Page

Approval duration

Commercial approval duration6 months or to the member's renewal date, whichever is longer

Medicaid/HIM initial duration (historical)6 months (initial)

NotesDuration language was standardized for Commercial line during the 4Q 2024 annual review

Commercial: 6 months or to member renewal date, whichever is longer.

Medicaid/HIM: 6 months.

Documentation Required

Required Clinical Documentation

Provider must submit supporting documentation (office notes, labs, imaging, pathology, and other clinical information) that substantiate the diagnosis, disease status (relapsed/refractory and/or IMWG‑defined progression), prior therapies, and rationale for the selected combination regimen.

Documentation should include evidence of measurable disease within specified timeframes (e.g., serum M‑protein, urine M‑protein, or involved free light chain) or IMWG evidence of progressive disease assessed within policy time windows.
Include documentation of prescriber specialty (oncologist or hematologist) or documented consultation.

Note

Therapeutic Alternatives / PA May Apply

Therapeutic alternatives exist and some combination agents (pomalidomide, lenalidomide, bortezomib and others listed in appendices) may also require prior authorization. Ensure the prescribed Empliciti regimen and dosing align with FDA or NCCN recommendations; off‑label uses must include supporting evidence per off‑label policies.

Appendix B lists therapeutic alternatives and example regimens per NCCN.
Pomalyst, lenalidomide, bortezomib and other listed agents may require PA.
Off‑label uses not addressed in this policy require sufficient efficacy/safety documentation per applicable off‑label policies.

Denial Risk

Denial Risk / Triggers

Missing or insufficient documentation, failure to meet prescriber/type requirements, lack of evidence of relapsed/refractory disease per NCCN or IMWG progressive disease criteria, or requests for non‑FDA indications without supportive evidence may result in denial.

Denial triggers include: incomplete clinical records, unsupported off‑label use, prescriber not oncology/hematology or no documented consultation, and failure to demonstrate relapsed/refractory status or IMWG progression.

Relapsed/refractory MM and IMWG progressive disease (policy references)

Relapsed or refractory per NCCNPolicy requires disease be relapsed or refractory per NCCN Multiple Myeloma guidance (NCCN MM v4.2024 referenced)

IMWG progressive disease referenceProgression determination uses IMWG criteria (serum M-component ≥0.5 g/dL; urine ≥200 mg/24 h; involved FLC >10 mg/dL; bone marrow ≥10%; new lesions, etc.)

Prescriber requirementRequests must document appropriate prescriber (oncologist or hematologist) and disease status per NCCN/IMWG