Coverage Policy Manual
Policy #: 2017013
Category: Pharmacy
Initiated: April 2017
Last Review: April 2018
  Elotuzumab (Empliciti™)

Description:
Elotuzumab is a monoclonal antibody that targets the Signaling Lymphocytic Activation Molecule Family member 7 (SLAMF7) protein and directly activates natural killer cells and facilitates the killing of myeloma cells through antibody-dependent cellular cytotoxicity.   (Clinical Pharmacology, 2017).  
 
Regulatory Status
Empliciti™ was FDA-approved in 2015. (U.S. Food and Drug Administration 2015).
 

Policy/
Coverage:
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage
Criteria
 
Elotuzumab meets primary coverage criteria and is covered for the following listed indications:
 
FDA labeled
 
    1. For the treatment of multiple myeloma in patients who have received 1 to 3 prior lines of therapy, in combination with lenalidomide and dexamethasone.
 
 
Off-label (2017)
 
    1. For the treatment of multiple myeloma in patients who have received 1 to 3 prior lines of therapy, in combination with bortezomib and dexamethasone
 
 
 
Dosing:
The prescribed regimen must be in compliance with FDA-approved dosing, with a dosing regimen of less than 10mg/kg weekly for 2 weeks, then 10mg/kg every 2 weeks thereafter.
 
Elotuzumab is given as an IV infusion at a rate of 2ml/min.
 
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary
Coverage Criteria
The use of Elotuzumab for the treatment of any other indications or any other circumstances than those outlined above does not meet member benefit certificate primary coverage criteria.
 
For members with contracts without primary coverage criteria, the use of Elotuzumab for the treatment of any other indications or any other circumstances than those outlined above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 

Rationale:
Elotuzumab was evaluated in a proof-of-concept, open-label phase 2 study in which 150 patients were randomly assigned to receive either elotuzumab with bortezomib and dexamethasone (EBd) or bortezomib and dexamethasone (Bd).  Patients were aged 18 years or older with a confirmed diagnosis of multiple myeloma and had documented progression after 1 to 3 prior lines of therapy. The study met its primary endpoint of PFS with a 28% reduction in the risk of progression or death with EBd compared with Bd. Median PFS was 9.7 months with EBd vs 6.9 months with Bd. The 1 year PFS rate was 39% with EBd vs 33% with Bd. Overall response rate for the elotuzumab group was 66% for the EBd vs 63% for the Bd group. Adverse event reporting was similar in both arms of the study. For the EBd group, AEs were reported at 100% while the BD group reported 96% AEs. The most common grade 3 or higher AEs were infections and thrombocytopenia. Thrombocytopenia occurred less in the EBd group (9%) than the Bd group (17%). (Jakubowiak, 2016)
 
The safety and efficacy of elotuzumab in combination with lenalidomide and dexamethasone were evaluated in a randomized, open-label trial in patients with multiple myeloma who had received one to three prior therapies and had documented progression following their most recent therapy. A total of 646 patients were randomized in a 1:1 ratio to receive either elotuzumab in combination with lenalidomide and low-dose dexamethasone or lenalidomide and low-dose dexamethasone. The median PFS for the elotuzumab group was 19.4 months while the standard treatment group PFS was 14.9 months. ORR was 78.5% (14 complete responses, 91 very good partial responses, and 147 partial responses). Serious adverse reactions were reported in 65.4% of patients treated with elotuzumab vs 56.5% patients treated on the control arm. The most frequent serious adverse reactions in the elotuzumab arm compared to the control arm were: pneumonia (15.4% vs. 11%), pyrexia (6.9% vs. 4.7%), respiratory tract infection (3.1% vs. 1.3%), anemia (2.8% vs. 1.9%), pulmonary embolism (3.1% vs. 2.5%), and acute renal failure (2.5% vs. 1.9%). (Lonial, 2015)
 
2018 Update
A literature search conducted through April 2018 did not reveal any new information that would prompt a change in the coverage statement.  

CPT/HCPCS:
J9176Injection, elotuzumab, 1 mg

References: Bristol-Myers Squibb Company(2015) Empliciti® [package insert]. Princeton, NJ: Bristol-Myers Squibb Company.; 2015

Elsevier.(2017) Elotuzumab [Internet]. Tampa (FL): Elsevier. c2017- [cited 2017 March 23]. Available from: http://www.clinicalpharmacology.com

Jakubowiak A, Offidini M, Peqourie B, et al.(2016) Randomized phase 2 study: elotuzumab plus bortezomib/dexamethasone vs bortezomib/dexamethasone for relapsed/refractory MM. Blood 2016 June 9; 127(23): 2833–2840.

Lonial, et al.(2015) Elotuzumab Therapy for Relapsed or Refractory Multiple Myeloma. N Engl J Med 2015; 373:621-631

NCCN(2017) NCCN Compendia. https://www.nccn.org/professionals/drug_compendium/MatrixGenerator/Matrix.aspx?AID=5. Accessed March 23, 2017.


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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