BlueCross BlueShield of Tennessee Medical Policy Manual

Elotuzumab

NDC CODE(S)

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))

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

RENEWAL CRITERIA

INDICATION
Multiple Myeloma
DOSAGE & ADMINISTRATION

In combination with lenalidomide and dexamethasone

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

Lenalidomide 25 mg orally daily Days 1-21

Oral dexamethasone 28 mg given weekly when elotuzumab is also given & 40 mg on weeks elotuzumab is not given

Intravenous dexamethasone 8 mg given weekly when elotuzumab is given

In combination with pomalidomide and dexamethasone

10 mg/kg intravenously every week (D1, D8, D15, & D22) for the first two 28-day cycles (8 doses); then 20 mg/kg every 4 weeks thereafter (D1) beginning with cycle 3

Individuals ≤ 75 years old:

o Pomalidomide 4 mg orally daily Days 1-21

o Oral dexamethasone 28 mg given weekly when elotuzumab is also given & 40 mg on weeks elotuzumab is not given)

o Intravenous dexamethasone 8 mg given weekly when elotuzumab is given

Individuals ≥ 75 years old:

o Pomalidomide 4 mg orally daily Days 1-21

o Oral dexamethasone 8 mg given weekly when elotuzumab is also given & 20 mg on weeks elotuzumab is not given

  o Intravenous dexamethasone 8 mg given weekly when elotuzumab is given

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

Refer to DOSAGE LIMITS below

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

Lexi-Comp Online. (2019,February). AHFS DI. Elotuzumab. Retrieved April 29, 2019 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2018, November). Elotuzumab. Retrieved April 29, 2019 from MICROMEDEX Healthcare Series.  

National Comprehensive Cancer Network. (2019). NCCN Drugs & Biologics Compendium® Elotuzumab. Retrieved January 22, 2019 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2018, November). Center for Drug Evaluation and Research. Empliciti® (elotuzumab) for injection, for intravenous use, Retrieved April 29, 2019 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761035s008lbl.pdf.

ORIGINAL EFFECTIVE DATE: 12/1/2015

MOST RECENT REVIEW DATE:  6/11/2019

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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.

This document has been classified as public information.

 

DOSAGE LIMITS

aximum billable units per dose and over time by indication as a Medical Benefit; 1 billable unit = 1 mg

DIAGNOSIS

 

MAXIMUM UNITS

 

Multiple Myeloma

Given in combination with Lenalidomide/Dexamethasone

1200 billable units weekly for the first two 28-day cycles (8 doses), then every two weeks thereafter beginning D1 of cycle 3

Given in combination with Pomalidomide/Dexamethasone

1200 billable units weekly for the first two 28-day cycles (8 doses), then 2300 billable units every four weeks thereafter beginning D1 of cycle 3