Elotuzumab (Empliciti)

Section: Injections
Effective Date: April 01, 2020
Last Reviewed: March 16, 2020

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.

U.S. 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 to three 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.

 

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 to three prior therapies (preferred regimen*); or
    • Bortezomib and dexamethasone; or
    • Pomalidomide and dexamethasone in individuals who have received at least two 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: 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. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

*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

NA