Elotuzumab (Empliciti)

Policy ID: I-166-007

Section: Injections

Effective Date: October 01, 2019

Revised Date: May 12, 2022

Revision Effective Date: July 01, 2022

Last Reviewed: May 23, 2023

Applies To: Commercial and Medicaid Expansion

Description

Elotuzumab (Empliciti®) is a humanized IgG1 monoclonal antibody that specifically targets the Signaling Lymphocytic Activation Molecule Family member 7 (SLAMF7) protein, which is present on myeloma cells and natural killer cells.

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Elotuzumab (Empliciti) may be considered medically necessary for individuals 18 years of age and older for the treatment of multiple myeloma when the following criteria are met:

Individual has received one (1) to three (3) prior therapies; and
- Elotuzumab (Empliciti) is being used in combination with lenalidomide and dexamethasone; or
Individual has received at least two (2) prior therapies including lenalidomide and a proteasome inhibitor; and
- Elotuzumab (Empliciti) is being used in combination with pomalidomide and dexamethasone; or

Compendia Sources

Elotuzumab (Empliciti) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

The use of elotuzumab (Empliciti) not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

J9176

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

C90.00

C90.02

C90.10

C90.12

C90.20

C90.22

C90.30

C90.32

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-14-2019 Updated codes

Internal Medical Policy Committee 3-16-2020 Changed to a pre-certification policy

Internal Medical Policy Committee 11-19-2020 Annual review, no clinical content change

Internal Medical Policy Committee 11-23-2021 Annual review, no clinical content change

Internal Medical Policy Committee 5-24-2022

Removed NCCN recommendations and
Added this statement "Elotuzumab (Empliciti)) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.",
Removed dx Z85.79

Internal Medical Policy Committee 5-23-2023 Annual review, no clinical content change

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: I-166-005

Section: Injections

Effective Date: October 01, 2019

Revised Date: October 20, 2020

Revision Effective Date: January 04, 2021

Last Reviewed: November 23, 2021

Archived Date: June 30, 2022

Applies To: Commercial and Medicaid Expansion

Description

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

Food and Drug Administration (FDA) Indications

Elotuzumab (Empliciti) may be considered medically necessary for individuals 18 years of age and older when the following criteria are met:

Therapy for multiple myeloma; and
Individual has received one (1) to three (3) prior therapies; and
- Elotuzumab (Empliciti) is being used in combination with lenalidomide and dexamethasone; or
Individual has received at least two (2) prior therapies including lenalidomide and a proteasome inhibitor; and
- Elotuzumab (Empliciti) is being used in combination with pamalidomide and dexamethasone.

Procedure Codes

J9176

National Comprehensive Cancer Network (NCCN) Recommendations

Multiple Myeloma

Elotuzumab (Empliciti) may be considered medically necessary for individuals 18 years of age and older when the following criteria are met:

Therapy for previously treated myeloma for relapse or progressive disease in combination with:
- Lenalidomide and dexamethasone in individuals who have received one (1) to three (3) prior therapies (preferred regimen*); or
- Bortezomib and dexamethasone; or
- Pomalidomide and dexamethasone in individuals who have received at least two (2) prior therapies, including an immunomodulatory agent and a proteasome inhibitor.

Elotuzumab (Empliciti) is considered experimental/investigational for any other indication and therefore non-covered. Scientific evidence does not support its use for any other indications.

Procedure Codes

J9176

*Note: Language derived from National Comprehensive Cancer Network (NCCN) guidelines

Diagnosis Codes

C90.00

C90.02

C90.10

C90.12

C90.20

C90.22

C90.30

C90.32

Z85.79

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-14-2019 Updated codes

Internal Medical Policy Committee 3-16-2020 Changed to a pre-certification policy

Internal Medical Policy Committee 11-19-2020 Annual review, no clinical content change

Internal Medical Policy Committee 11-23-2021 Annual review, no clinical content change

Links

References (PDF)

Disclaimer

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