Last Review Date: 05/05/2025

Date of Origin: 02/23/2016

Dates Reviewed: 02/2016, 01/2017, 05/2017, 08/2017, 11/2017, 02/2018, 05/2018, 09/2018, 12/2018, 03/2019, 06/2019, 09/2019, 12/2019, 03/2020, 6/2020, 09/2020, 03/2021, 03/2022, 03/2023, 03/2024, 05/2025

1. Length of Authorization

Coverage will be provided for 6 months and may be renewed.

2. Dosing Limits

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

    Multiple Myeloma:

• 1200 billable units every 7 days for 8 doses, 1200 billable units on days 1 & 11 (21 day cycle) for 12 doses, then 2400 billable units every 28 days

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND

Multiple Myeloma † ‡ Ф ^1-6

• Patient has previously treated relapsed or progressive disease; AND
  • Used in combination with lenalidomide and dexamethasone; OR
  • Used in combination with pomalidomide and dexamethasone after at least two prior therapies including lenalidomide and a proteasome inhibitor (e.g., bortezomib, carfilzomib, ixazomib, etc.); OR
  • Used in combination with bortezomib and dexamethasone ‡

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ^1,2

Coverage may be renewed based upon the following criteria:

• Patient continues to meet the indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
• Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe infusion reactions, infections, second primary malignancies, hepatotoxicity, etc.

5. Dosage/Administration ^1,3

6. Billing Code/Availability Information

HCPCS Code:

• J9176 − Injection, elotuzumab, 1 mg; 1 billable unit = 1 mg

NDC(s):

• Empliciti 300 mg single-dose vial: 00003-2291-xx
• Empliciti 400 mg single-dose vial: 00003-4522-xx

7. References

1. Empliciti [package insert]. Princeton, NJ; Bristol-Myers Squibb Company; March 2022. Accessed April 2025.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for elotuzumab. National Comprehensive Cancer Network, 2025. 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 April 2025.
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. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma Version 2.2025. National Comprehensive Cancer Network, 2025. 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 Guidelines, go online to NCCN.org. Accessed April 2025.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A