Last Review Date: 11/05/2024

Date of Origin: 05/03/2021

Dates Reviewed: 05/2021, 10/2021, 11/2021, 08/2022, 11/2023, 06/2024, 11/2024

1. Length of Authorization

Coverage will be provided for one treatment course (1 dose of Abecma) and may not be renewed.

2. Dosing Limits

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

• 1 dose of up to 510 million autologous CAR-positive viable T-cells (supplied as one or more infusion bags in metal cassettes)

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

• 1 billable unit (1 dose of up to 510 million autologous CAR-positive viable T-cells)

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND
• Healthcare facility must enroll in and comply with the requirements of the ABECMA REMS Program; AND
• Patient has not received prior CAR-T cell therapy; AND
• Patient does not have an active infection or inflammatory disorder; AND
• Patient has not received live vaccines within 6 weeks prior to the start of lymphodepleting chemotherapy, and will not receive live vaccines during idecabtagene vicleucel treatment, and until immune recovery following treatment; AND
• Patient has been screened for cytomegalovirus (CMV), hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) in accordance with clinical guidelines prior to collection of cells (leukapheresis); AND
• Prophylaxis for infection will be followed according to standard institutional guidelines; AND
• Used as single agent therapy (not applicable to lymphodepleting or additional chemotherapy while awaiting manufacture); AND
• Patient does not have known central nervous system (CNS) involvement with myeloma or a history or presence of clinically relevant CNS pathology; AND
• Patient does not have active or a history of plasma cell leukemia; AND
• Patient has an ECOG performance status of 0-1; AND

Multiple Myeloma † ‡ Ф ^1-3,7

• Patient has relapsed or refractory disease; AND
  • Patient has received at least two (2) prior lines of therapy, including a proteasome inhibitor (e.g., bortezomib, carfilzomib, ixazomib, etc.), an immunomodulatory agent (e.g., lenalidomide, thalidomide, pomalidomide, etc.), and an anti-CD38 monoclonal antibody (e.g., daratumumab, isatuximab, etc.); OR
  • Patient has received at least three (3) prior lines of therapy

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

4. Renewal Criteria

Coverage cannot be renewed.

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS Code:

• Q2055 – Idecabtagene vicleucel, up to 510 million autologous b-cell maturation antigen (bcma) directed car-positive t cells, including leukapheresis and dose preparation procedures, per therapeutic dose

NDC:

• Abecma suspension for intravenous infusion [A single dose of ABECMA contains a cell suspension of 300 to 510 x 10⁶ CAR-positive T cells in one or more infusion bags]:
  • 50 mL, 250 mL, and 500 mL infusion bags and metal cassettes: 59572-0515-xx

7. References

1. Abecma [package insert]. Summit, NJ; Celgene., Inc., July 2024. Accessed September 2024.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) idecabtagene vicleucel. 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 September 2024.
3. Munshi NC, Anderson LD Jr, Shah N, et al. Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma. N Engl J Med. 2021 Feb 25;384(8):705-716. Doi: 10.1056/NEJMoa2024850.
4. Majzner RG, Mackall CL. Tumor Antigen Escape from CAR T-cell Therapy. Cancer Discov 2018;8:1219-1226.
5. Lee DW, Gardner R, Porter DL, et al. Current concepts in the diagnosis and management of cytokine release syndrome. Blood 2014; 124(2): 188-95. Errata in Blood: 2015;126(8):1048. And 2016;128(11):1533.
6. Kumar S, Paiva B, Anderson KC, et al. International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma. Lancet Oncol 2016; 17(8): e328-46.
7. Rodríguez-Otero P, Ailawadhi S, Arnulf B, et al. B08 IDECABTAGENE VICLEUCEL VERSUS STANDARD REGIMENS IN PATIENTS WITH TRIPLE-CLASS–EXPOSED RELAPSED AND REFRACTORY MULTIPLE MYELOMA: KARMMA-3 A PHASE 3 RANDOMIZED CONTROLLED TRIAL. Hemasphere. 2023 May 9;7(Suppl ):7-8. Doi: 10.1097/01.HS9.0000936124.56965.24. PMCID: PMC10171743.

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/LCA/LCD):  N/A