ModifiedmhnPolicy CP.PHAR.308

Elotuzumab (Empliciti)

Defines medical necessity criteria, dosing, and authorization requirements for Empliciti (elotuzumab) use in multiple myeloma across commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyElotuzumab (Empliciti)

Policy CodePolicy CP.PHAR.308

Change TypeMaterial coverage updates

Effective DateFeb 1, 2017

Next Review Date

Key ActionSubmit prior authorization with supporting clinical documentation showing diagnosis, prescriber specialty, measurable or progressive disease, and prior therapies.

SourceLink

POLICY UPDATE CHANGES

Initial approval duration changed from 6 to 12 months for Medicaid/HIM.

Added hematologist as prescriber option and clarified disease must be relapsed or refractory per NCCN.

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

≥1Required prior therapies for initial approval

≥18Minimum patient age

6 moApproval duration (Commercial)

12 moApproval duration (Medicaid/HIM)

10 mg/kg

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Standard Empliciti dose (cycles 1–2)

Coverage Criteria for Empliciti (elotuzumab)

Not Authorized Indications

Not authorized uses: Non-FDA approved indications not addressed in this policy are not authorized unless sufficient documentation of efficacy and safety is provided consistent with applicable off-label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or other evidence of coverage documents.

Initial coverage criteria

Covered when ALL of the following are met

Prescriber: Prescribed by an appropriate specialist; hematologist explicitly added as an allowed prescriber option.

Disease status: Member has relapsed or refractory multiple myeloma per NCCN criteria and progressive disease per IMWG definition (as incorporated into policy).

Authorization duration: Initial approval duration appropriate to the member's line of business: Commercial — 6 months or to the member's renewal date, whichever is longer; Medicaid/HIM — 12 months.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the request includes sufficient documentation of efficacy and safety in accordance with the referenced off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid), or an applicable evidence of coverage document.

Coding references and related content in this policy are provided for informational purposes only and do not by themselves establish coverage. Providers must follow applicable coding and claims submission guidance when requesting reimbursement.

Uses for non‑FDA approved indications without adequate supporting documentation of efficacy and safety per the off‑label use policies noted in this document are not authorized under this policy and may be denied.

There are no explicit statements within these policy sections that label any use as 'not medically necessary' using that exact phrasing; however, coverage remains subject to the clinical criteria and documentation requirements described elsewhere in the policy.

Covered Regimens and Dosing

Regimen component	Cycles 1–2 dosing	Cycles ≥3 dosing / maximum dose
Empliciti: 10 mg/kg IV once weekly (days 1, 8, 15, 22); Dexamethasone: 28 mg PO 3–24 hours before Empliciti plus 8 mg IV 45–90 minutes before Empliciti; Lenalidomide: 25 mg PO daily on days 1–21 of a 28‑day cycle.
Empliciti: 10 mg/kg IV once weekly (days 1, 8, 15, 22); Dexamethasone: 28 mg PO 3–24 hours before Empliciti plus 8 mg IV 45–90 minutes before Empliciti; Pomalidomide: 4 mg PO daily on days 1–21 of a 28‑day cycle.
Empliciti: 10 mg/kg IV every 2 weeks (days 1 and 15). Dexamethasone: continue as for cycles 1–2 and on Empliciti off‑weeks give 40 mg PO daily if ≤75 years or 20 mg PO daily if >75 years.
Empliciti: 20 mg/kg IV every 4 weeks. Dexamethasone: continue as for cycles 1–2 and on non‑Empliciti days give 40 mg PO daily if ≤75 years or 20 mg PO daily if >75 years.

Appendix B item	Description / purpose
Appendix B was updated with examples of previously treated (relapsed or refractory) multiple myeloma regimens per current NCCN Multiple Myeloma guidelines.
Appendix B now includes examples of previously treated regimens consistent with NCCN guidance to support regimen selection for relapsed/refractory disease.

Coding and Measurement Thresholds

HCPCS CodesHCPCS

J9176

Injection, elotuzumab, 1 mg

HCPCS CodesHCPCS

J9176

Injection, elotuzumab, 1 mg

Measurable disease thresholds — serum/urine M‑protein and involved FLC thresholds

Serum M‑protein thresholdSerum M‑protein ≥ 0.5 g/dL (assessed within the last 30 days)

Urine M‑protein thresholdUrine M‑protein ≥ 200 mg/24 h (assessed within the last 30 days)

Involved free light chain (FLC) thresholdInvolved FLC ≥ 10 mg/dL (100 mg/L) with abnormal serum FLC ratio (assessed within the last 30 days)

Unit definition — mapping J9176 to 1 mg

HCPCS unit mappingHCPCS J9176 represents elotuzumab, 1 mg per unit

Billing descriptionJ9176 — Injection, elotuzumab, 1 mg

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization is required for Empliciti (elotuzumab). Requests must include clinical documentation demonstrating that the member meets all approval criteria and any dosing/regimen limits. Approval durations: Commercial — 6 months or to the member's renewal date, whichever is longer; Medicaid/HIM — 12 months.

HCPCS J9176 (Injection, elotuzumab, 1 mg) — include on claims as applicable
Dosing limits: with lenalidomide — 10 mg/kg/week for cycles 1–2 (4 doses per 28-day cycle) then 10 mg/kg every 2 weeks thereafter; with pomalidomide — 10 mg/kg weekly for cycles 1–2 then 20 mg/kg every 4 weeks thereafter

Documentation Required

Submit Supporting Clinical Documentation

Providers must submit supporting documentation such as office chart notes, relevant laboratory results, and any other clinical information that verifies diagnosis, prior therapies, response, and rationale for selected regimen (including citations if off-label). Lack of adequate documentation may lead to denial or delay.

Line of Therapy Definitions and Uses

second-line

Second-line (lenalidomide+dexamethasone): Empliciti in combination with lenalidomide and dexamethasone for patients who have received one to three prior therapies (indication per FDA).

salvage

Salvage (pomalidomide+dexamethasone): Empliciti in combination with pomalidomide and dexamethasone for adult patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (indication per FDA).

second-line

Line of therapy - policy reference: Policy references use in previously treated (relapsed or refractory) multiple myeloma per NCCN; Appendix B updated with examples of previously treated regimens per current NCCN Multiple Myeloma guidelines.

Definitions and Clinical Criteria

Elotuzumab (Empliciti) — SLAMF7‑directed immunostimulatory monoclonal antibody

Agent classElotuzumab (Empliciti) is a SLAMF7‑directed immunostimulatory monoclonal antibody

Indication contextUsed in combination regimens for relapsed or refractory multiple myeloma per policy and prescribing information

Regimen examples referencedPolicy references combinations with lenalidomide+dexamethasone and pomalidomide+dexamethasone (see covered regimens)

IMWG progressive disease — IMWG criteria summary (>=25% M‑protein increase etc.)

Percent increase criterion≥ 25% increase from nadir in serum M‑component (with absolute increase ≥ 0.5 g/dL) qualifies as progressive disease per IMWG

Urine M‑component criterion≥ 25% increase from nadir in urine M‑component (with absolute increase ≥ 200 mg/24 h)

Background

Empliciti (elotuzumab) is a SLAMF7‑directed immunostimulatory monoclonal antibody indicated for use in combination regimens for relapsed or refractory multiple myeloma. The FDA‑approved combinations include Empliciti with lenalidomide and dexamethasone for patients with one to three prior therapies, and Empliciti with pomalidomide and dexamethasone for patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

Revision History

2025-07-09approval_duration_changeLatest

Initial approval duration changed from 6 to 12 months for Medicaid/HIM (applies to Medicaid/HIM line of business).

2024-07-15criteria_and_prescriber_update

Added hematologist as an explicit prescriber option and added requirement that disease be relapsed or refractory per NCCN; IMWG progressive disease criterion added for alignment.

2021-08-11

Policy Summary

Payermhn

PolicyElotuzumab (Empliciti)

Policy CodePolicy CP.PHAR.308

Change TypeMaterial coverage updates

Effective DateFeb 1, 2017

Next Review Date

Key ActionSubmit prior authorization with supporting clinical documentation showing diagnosis, prescriber specialty, measurable or progressive disease, and prior therapies.

SourceLink

On This Page

Coding noteCodes are informational; inclusion does not guarantee coverage — verify coding guidance prior to claim submission

Documented relapsed or refractory disease per NCCN/IMWG when applicable
Prescriber specialty and rationale (hematologist permitted per recent updates)
Copies of prior therapy records and response assessments

Denial Risk

Insufficient Documentation / Non‑Covered Indications

Coverage is not authorized for non‑FDA approved indications that are not addressed in this policy unless sufficient evidence of efficacy and safety is provided per off‑label use policies (CP.CPA.09 for Commercial, HIM.PA.154 for Marketplace, CP.PMN.53 for Medicaid). Insufficient or missing documentation for off‑label uses or for required criteria may result in denial.

Reference off‑label policies: CP.CPA.09, HIM.PA.154, CP.PMN.53
Denial risk if documentation does not support requested indication or dosing

Billing Rule

Coding and Claims Risk

Coding and claims submission are subject to current professional coding guidance. Inclusion of codes in this policy is informational only and does not guarantee payment. Providers should verify HCPCS/CPT and other billing requirements prior to claim submission.

HCPCS: J9176 — Injection, elotuzumab, 1 mg (informational)
Accurate coding and claim documentation required to support medical necessity

FLC criterion for nonmeasurable patientsIn patients without measurable serum/urine M‑protein, an absolute increase in involved–uninvolved FLC > 10 mg/dL indicates progression

Other IMWG PD findingsProgression may also be shown by new lesions, ≥50% increase in lesion SPD or longest diameter, ≥50% increase in circulating plasma cells, or ≥10% absolute increase in bone marrow plasma cells

Relapsed or refractory multiple myeloma — definition per NCCN and IMWG (policy-added IMWG criterion)

Clinical definitionRelapsed or refractory multiple myeloma: disease characterized as relapsed or refractory per NCCN and IMWG response criteria; the policy explicitly requires disease be relapsed or refractory

IMWG progressive disease inclusionPolicy adds IMWG progressive disease criterion (e.g., ≥25% M‑protein increase with absolute thresholds, new lesions, FLC or marrow changes) as evidence of progression

Prescriber and age requirementsPrescribed by or in consultation with an oncologist or hematologist; patient age ≥ 18 years

Prior therapy requirementMember must have received ≥ 1 prior therapy for initial approval

Updated Appendix B Therapeutic Alternatives and modified reference from HIM.PHAR.21 to HIM.PA.154; references reviewed and updated.

2022-07-28appendix_update

Updated Appendix B per NCCN Multiple Myeloma guidelines for primary therapy and previously treated MM; references reviewed and updated (no significant clinical changes).

2023-08-05appendix_update

Updated Appendix B with examples of previously treated regimens per current NCCN Multiple Myeloma guidelines; references reviewed and updated (no significant clinical changes).