Asset Publisher
Abecma® (idecabtagene vicleucel) (Intravenous)
Policy Number: VP-0598
Intravenous
Last Review Date: 06/04/2024
Date of Origin: 05/03/2021
Dates Reviewed: 05/2021, 10/2021, 11/2021, 08/2022, 11/2023, 06/2024
FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill. |
- Length of Authorization
Coverage will be provided for one treatment course (1 dose of Abecma) and may not be renewed.
- Dosing Limits
- 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)
- 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)
- Initial Approval Criteria 1
Submission of medical records (chart notes) related to the medical necessity criteria is REQUIRED on all requests for authorizations. Records will be reviewed at the time of submission. Please provide documentation related to diagnosis, step therapy, and clinical markers (i.e., genetic and mutational testing) supporting initiation when applicable. Please provide documentation via direct upload through the PA web portal or by fax. |
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.)
† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug
- Renewal Criteria
Coverage cannot be renewed.
- Dosage/Administration 1
Indication |
Dose |
Multiple Myeloma |
Lymphodepleting chemotherapy:
Abecma infusion:
|
For autologous use only. For intravenous use only.
|
|
Premedication:
Monitoring after infusion:
|
|
|
- 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
- References
- Abecma [package insert]. Summit, NJ; Celgene., Inc., April 2024. Accessed April 2024.
- Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) idecabtagene vicleucel. National Comprehensive Cancer Network, 2023. 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 2023.
- 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.
- Majzner RG, Mackall CL. Tumor Antigen Escape from CAR T-cell Therapy. Cancer Discov 2018;8:1219-1226.
- 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.
- 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.
- 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
ICD-10 |
ICD-10 Description |
C90.00 |
Multiple myeloma not having achieved remission |
C90.02 |
Multiple myeloma, in relapse |
C90.10 |
Plasma cell leukemia not having achieved remission |
C90.12 |
Plasma cell leukemia in relapse |
C90.20 |
Extramedullary plasmacytoma not having achieved remission |
C90.22 |
Extramedullary plasmacytoma in relapse |
C90.30 |
Solitary plasmacytoma not having achieved remission |
C90.32 |
Solitary plasmacytoma in relapse |
Z85.79 |
Personal history of other malignant neoplasms of lymphoid, hematopoietic and related tissues |
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
Medicare Part B Administrative Contractor (MAC) Jurisdictions |
||
Jurisdiction |
Applicable State/US Territory |
Contractor |
E (1) |
CA, HI, NV, AS, GU, CNMI |
Noridian Healthcare Solutions, LLC |
F (2 & 3) |
AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ |
Noridian Healthcare Solutions, LLC |
5 |
KS, NE, IA, MO |
Wisconsin Physicians Service Insurance Corp (WPS) |
6 |
MN, WI, IL |
National Government Services, Inc. (NGS) |
H (4 & 7) |
LA, AR, MS, TX, OK, CO, NM |
Novitas Solutions, Inc. |
8 |
MI, IN |
Wisconsin Physicians Service Insurance Corp (WPS) |
N (9) |
FL, PR, VI |
First Coast Service Options, Inc. |
J (10) |
TN, GA, AL |
Palmetto GBA |
M (11) |
NC, SC, WV, VA (excluding below) |
Palmetto GBA |
L (12) |
DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA) |
Novitas Solutions, Inc. |
K (13 & 14) |
NY, CT, MA, RI, VT, ME, NH |
National Government Services, Inc. (NGS) |
15 |
KY, OH |
CGS Administrators, LLC |
ABECMA® (idecabtagene vicleucel) Prior Auth Criteria |
|