CurrentCareSourcePolicy N/A

UTILIZATION MANAGEMENT MEDICAL POLICY

Defines prior authorization recommendation, coverage criteria, dosing regimens, prescriber requirements, approval duration, and non-covered circumstances for Empliciti (elotuzumab) when used for multiple myeloma under the medical benefit.

Policy Summary

PayerCareSource

PolicyUTILIZATION MANAGEMENT MEDICAL POLICY

Policy CodePolicy N/A

Change TypeAnnual revision (no criteria changes)

Effective Date

Next Review Date

Key ActionPrior Authorization is recommended; approve for 1 year when listed criteria and dosing are met and Empliciti is prescribed by or in consultation with an oncologist or hematologist.

SourceLink

POLICY UPDATE CHANGES

Annual revision 04/09/2025 with no criteria changes.

1Covered Indication (Multiple Myeloma)

1 yearTypical Approval Duration

≥18Minimum Age

Coverage Summary

Coverage stance: Covered with criteria for the FDA‑approved indication of multiple myeloma. Approval is for 1 year when the listed criteria are met. Minimum age for approval is ≥18, and Empliciti must be prescribed by or in consultation with an oncologist or hematologist.

FDA-Approved Indication - Multiple Myeloma (Authorize for 1 year)

Approve for 1 year if the patient meets ALL of the following (A, B, C, and D):

ALL of the following

A: Patient is ≥ 18 years of age
B: Patient has tried at least one therapy/regimen for multiple myeloma
Examples of agents used in other regimens include bortezomib, lenalidomide, cyclophosphamide, daratumumab (Darzalex)
C: Empliciti is used in combination with at least one other agent
Examples of agents that may be used in combination with Empliciti include lenalidomide, bortezomib, and pomalidomide (Pomalyst)
D
- Approve ONE of the following regimens
  - Regimen A: Dose is 10 mg/kg IV once weekly for up to nine infusions followed by subsequent 10 mg/kg infusions with doses separated by at least 2 weeks
  - Regimen B: Dose is 10 mg/kg IV once weekly for up to eight doses followed by subsequent 20 mg/kg infusions with doses separated by at least 4 weeks

ref": "b0_1"

title": "FDA-Approved Indication - Multiple Myeloma (Authorize for 1 year)"

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization is recommended for medical benefit coverage of Empliciti. Approval is recommended for patients who meet the listed criteria and dosing; approvals are provided for a duration of 1 year. Requests for doses outside the established dosing documented in this policy will be considered on a case-by-case basis by a clinician.

Documentation Required

Specialist prescribing requirement

Empliciti must be prescribed by or in consultation with an oncologist or a hematologist. Because specialized skills are required for evaluation, diagnosis, monitoring for adverse events, and assessing long-term efficacy, approval requires involvement of the prescribing or consulting specialist.

Billing Rule

Approval duration

Approvals are granted for 1 year when the policy criteria are met. Requests for dosing outside the dosing regimens documented in this policy (e.g., doses or schedules not listed) will be reviewed on a case-by-case basis by a clinician.

Clinical Evidence & References

Evidence: NCCN Multiple Myeloma Clinical Practice Guidelines in Oncology (version 1.2025, Sept 17, 2024) recommend Empliciti‑containing regimens for relapsed/refractory multiple myeloma after 1–3 prior therapies, with specific recommendations for combinations such as Empliciti/lenalidomide/dexamethasone (category 1), Empliciti/bortezomib/dexamethasone (category 2A), and Empliciti/pomalidomide/dexamethasone (preferred in certain post‑proteasome/lenalidomide–exposed patients).

Evidence: Empliciti prescribing information, Bristol‑Myers Squibb; March 2022 (Prescribing information).

Background & Definitions

Background and mechanism: Empliciti (elotuzumab) is a SLAMF7‑directed immunostimulatory antibody indicated in multiple myeloma in combination with other agents. NCCN recommends Empliciti‑containing regimens for relapsed/refractory disease after 1–3 prior therapies, commonly combined with lenalidomide, pomalidomide, or bortezomib depending on prior exposures and line of therapy.

Definition: Empliciti is the brand name for elotuzumab, a SLAMF7‑directed immunostimulatory antibody used in multiple myeloma.

Quick Facts

Covered IndicationMultiple myeloma

Typical Approval Duration1 year

Minimum Age≥18 years

Revision History

2023-04-12annual_revision

Annual revision with no criteria changes

2024-04-24annual_revision

Annual revision with no criteria changes

2025-04-09annual_revisionLatest

Annual revision with no criteria changes

Policy Summary

PayerCareSource

PolicyUTILIZATION MANAGEMENT MEDICAL POLICY

Policy CodePolicy N/A

Change TypeAnnual revision (no criteria changes)

Effective Date

Next Review Date

Key ActionPrior Authorization is recommended; approve for 1 year when listed criteria and dosing are met and Empliciti is prescribed by or in consultation with an oncologist or hematologist.

SourceLink

On This Page

OpenPayer

UTILIZATION MANAGEMENT MEDICAL POLICY

Coverage Summary

Applicable Codes

Provider Actions

Clinical Evidence & References

Background & Definitions

Revision History