Last Review Date: 03/05/2024

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

1. Length of Authorization

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

2. Dosing Limits

1. Quantity Limit (max daily dose) [NDC Unit]:

• Empliciti 300 mg single-dose vial: 16 vials per 28 days for 2 cycles; subsequent cycles are 8 vials per 28 days
• Empliciti 400 mg single-dose vial: 12 vials per 28 days for 2 cycles; subsequent cycles are 6 vials per 28 days

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

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 day 1 of cycle 3

Multiple Myeloma – 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 day 1 of cycle 3

Multiple Myeloma – Given in combination with Bortezomib/Dexamethasone:

• 1200 billable units weekly for the first two 21-day cycles (6 doses), then every 10 days for the next six 21-day cycles (cycles 3 to 8 [12 doses]), then every 2 weeks per 28-day cycle thereafter beginning day 1 of cycle 9

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND

Multiple Myeloma † ‡ Ф ^1-5

• Patient has previously treated relapsed or progressive disease; AND
  • Used in combination with lenalidomide and dexamethasone; OR
  • Used in combination with pomalidomide and dexamethasone in patients with lenalidomide-refractory disease; 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 February 2024.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for elotuzumab. National Comprehensive Cancer Network, 2024. 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 February 2024.
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.

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