00003-2291-XX Empliciti 300 MG SOLR (B-M SQUIBB U.S. (PRIMARY CARE))
00003-4522-XX Empliciti 400 MG SOLR (B-M SQUIBB U.S. (PRIMARY CARE))
Elotuzumab is a recombinant monoclonal antibody which specifically targets the Signaling Lymphocytic Activation Molecule Family member 7 or SLAMF7 cell surface glycoprotein. It is referred to as a SLAMF7-directed immunostimulatory antibody. SLAMF7 is expressed on myeloma cells, Natural Killer cells, plasma cells as well as on other specific immune cell subsets within the hematopoietic cell lineage.Elotuzumab directly activates Natural Killer cells through both the SLAMF7 pathway as well as through Fc receptors. It also targets The SLAMF7 on myeloma cells through antibody-dependent cellular cytotoxicity (ADCC). It has been shown that in combination with lenalidomide, the activity of the Natural Killer cells and the antitumor activity was greater than the activity of that of either agent alone.
Elotuzumab for the treatment of multiple myeloma is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Elotuzumab for the treatment of other conditions/diseases is considered investigational.
Elotuzumab is considered medically appropriate if ALL of the following criteria are met:
Diagnosis of multiple myeloma with ALL of the following:
Individual is 18 years of age or older
Individual has diagnosis of relapsed or progressive disease
Treatment is ANY ONE of the following:
Used in combination with lenalidomide and dexamethasone after failure of one to three prior regimens
Used in combination with bortezomib and dexamethasone
Elotuzumab is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Disease has reached stabilization and/or absence of progression
Absence of unacceptable toxicity from the drug, e.g., severe infusion reactions, infections, second primary malignancies, hepatotoxicity, etc.
|INDICATION(S)||DOSAGE & ADMINISTRATION|
|Multiple myeloma in combination with lenalidomide||
10 mg/kg IV every week (D1, D8, D15, & D22) for the first two 28-day cycles (8 doses); then every 2 weeks thereafter (D1 & D15) beginning with cycle 3
Give in conjunction with lenalidomide (25 mg daily Days 1-21) and low-dose dexamethasone (given weekly: 28 mg when Empliciti is also given & 40 mg on weeks elotuzumab is not given)
Multiple myeloma in combination with bortezomib
10 mg/kg IV weekly for cycles 1 and 2, on days 1 and 11 for cycles 3 to 8, and then on days 1 and 15 thereafter
Bortezomib (1.3 mg/m2 IV or subcutaneously) administered on days 1, 4, 8, and 11 for cycles 1 to 8 and then on days 1, 8, and 15 thereafter
Dexamethasone 20 mg administered orally on non-elotuzumab dosing days, and as 8 mg orally plus 8 mg IV on elotuzumab dosing days
LENGTH OF AUTHORIZATION
Coverage will be provided for 6 months and may be renewed
Click here to view DOSAGE LIMITS
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
No controlled studies were found in the published literature that validate the use of elotuzumab for the treatment or prevention of other conditions or diseases.
Lexi-Comp Online. (2018). AHFS DI. Elotuzumab. Retrieved January 23, 2018 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2017, September). Elotuzumab. Retrieved January 23, 2018 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium® Elotuzumab. Retrieved January 23, 2018 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2015, November). Center for Drug Evaluation and Research. Empliciti™(elotuzumab) for injection, for intravenous use, Retrieved January 23, 2018 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761035s005lbl.pdf.
ORIGINAL EFFECTIVE DATE: 12/1/2015
MOST RECENT REVIEW DATE: 4/10/2018
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.
Maximum billable units per dose and over time by indication as a Medical Benefit