BlueCross BlueShield of Tennessee Medical Policy Manual

Elotuzumab

NDC CODE(S)

00003-2291-11 - Empliciti 300 mg vial (BMS)

 

00003-4522-11 - Empliciti 400 mg vial (BMS)

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.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
Multiple myeloma

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 Empliciti is not given)

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).

No controlled studies were found in the published literature that validate the use of elotuzumab for the treatment of any other conditions or diseases.

SOURCES

Lexi-Comp Online. (2016, October). AHFS DI. Elotuzumab. Retrieved October 27, 2016 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2016, October). Elotuzumab. Retrieved October 27, 2016 from MICROMEDEX Healthcare Series.  

National Comprehensive Cancer Network. (2016). NCCN Drugs & Biologics Compendium® Elotuzumab. Retrieved October 27, 2016 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 October 27, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/761035s000lbl.pdf.

ORIGINAL EFFECTIVE DATE:  12/1/2015

MOST RECENT REVIEW DATE:  12/1/2016

ID_MRx

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.

Pharmaceutical Decision Support Tree

Elotuzumab (Empliciti ™)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #6

  1. Does the individual have a diagnosis of multiple myeloma?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Will treatment be in combination with lenalidomide and dexamethasone?

If yes, go to question #4

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is there documentation that the individual has received one to three prior therapies?

If yes, go to question #5

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for 1200 billable units weekly or less for the first two 28-day cycles (8 doses) , then every two weeks thereafter beginning day 1 of cycle 3, for dosage of 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 for an authorization period of 6 months?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual continue to meet initial approval criteria in questions 2 through 5?

If yes, go to question #7

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Has the disease reached stabilization and/or absence of progression?

If yes, go to question #8

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is there absence of unacceptable toxicity from the drug, e.g., fatigue, diarrhea, pyrexia, constipation, cough, peripheral neuropathy, nasopharyngitis, upper respiratory tract infection, decreased appetite, pneumonia, etc.?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.