BlueCross BlueShield of Tennessee Medical Policy Manual

Elotuzumab  (Empliciti®)

NDC CODE(S)

00003-2291-XX EMPLICITI 300MG Solution Reconstituted (B-M SQUIBB U.S.[PRIMARY CARE])

00003-4522-XX EMPLICITI 400MG Solution Reconstituted (B-M SQUIBB U.S.[PRIMARY CARE])

DESCRIPTION

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.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL CRITERIA

Multiple Myeloma

RENEWAL CRITERIA

DOSAGE/ADMINISTRATION

INDICATION

DOSE

Multiple myeloma in combination with lenalidomide and dexamethasone

10 mg/kg intravenously every week (Days 1, 8, 15, & 22) for the first two 28-day cycles (8 doses); then every 2 weeks thereafter (Days 1 & 15) beginning with cycle 3.

Continue treatment until disease progression or unacceptable toxicity.

Multiple myeloma in combination with

pomalidomide and dexamethasone

10 mg/kg intravenously every week (Days 1, 8, 15, & 22) for the first two 28-day cycles (8 doses); then 20 mg/kg every 4 weeks thereafter (Day 1) beginning with cycle 3.

Continue treatment until disease progression or unacceptable toxicity.

Multiple myeloma in combination with

bortezomib and dexamethasone

10 mg/kg intravenously every week (Days 1, 8 & 15) for the first two 21-day cycles (6 doses); then on Days 1 & 11 for the next six 21-day cycles (cycles 3 to 8 [12 doses]); then every 2 weeks per 28-day cycle thereafter (Days 1 & 15) beginning with cycle 9.

Continue treatment until disease progression or unacceptable toxicity.

LENGTH OF AUTHORIZATION

Coverage will be provided for 6 months and may be renewed

DOSING LIMITS

Max Units (per dose and over time) [HCPCS Unit]:

Multiple Myeloma – Given in combination with Lenalidomide/Dexamethasone:

Multiple Myeloma – Given in combination with Pomalidomide/Dexamethasone:

Multiple Myeloma – Given in combination with Bortezomib/Dexamethasone:

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.

IMPORTANT REMINDER

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.

ADDITIONAL INFORMATION 

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).

SOURCES

1.     Empliciti [package insert]. Princeton, NJ; Bristol-Myers Squibb Company; October 2019. Accessed August January 2021.

2.     Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for elotuzumab. National Comprehensive Cancer Network, 20210. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed January 2021.

3.     Jakubowiak A, Offidani M, Pégourie B, et al. Randomized phase 2 study: elotuzumab plus  bortezomib/dexamethasone vs bortezomib/dexamethasone for relapsed/refractory MM. Blood. 2016 Jun 9;127(23):2833-40.

4.     Lonial S, Dimopoulos M, Palumbo A, et al. Elotuzumab Therapy for Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2015 Aug 13;373(7):621-31. doi: 10.1056/NEJMoa1505654. Epub 2015 Jun 2.

5.     Dimopoulos MA, Dytfeld D, Grosicki S, et al. Elotuzumab plus Pomalidomide and Dexamethasone for Multiple Myeloma. N Engl J Med. 2018 Nov 8;379(19):1811-1822. doi: 10.1056/NEJMoa1805762.

6.     Lexi-Comp Online. (February, 2021). AHFS DI. Elotuzumab. Retrieved March 12, 2021 from Lexi-Comp Online with AHFS.

7.     MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2020, August). Elotuzumab. Retrieved March 12, 2021 from MICROMEDEX Healthcare Series.  

ORIGINAL EFFECTIVE DATE:  12/1/2015

MOST RECENT REVIEW DATE:    7/31/2021

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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.

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