vp-0598
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Abecma® (idecabtagene vicleucel) (Intravenous)

Policy Number: VP-0598

Last Review Date: 05/03/2021

Date of Origin: 05/03/2021

Date Reviewed: 05/20201

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.

 

I. Length of Authorization

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

II. Dosing Limits

  1. Quantity Limit (max daily dose) [NDC Unit]:
  • 1 dose of up to 460 million autologous car -positive viable t-cells (supplied as one or more infusion bags in metal cassettes)
  1. Max Units (per dose and over time) [HCPCS Unit]:
  • 1 dose of up to 460 million autologous car -positive viable t-cells (supplied as one or more infusion bags in metal cassettes)

III. Initial Approval Criteria 1-7

Submission of medical records 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 via direct upload through the PA web portal or by fax.

Coverage is provided in the following conditions:

  • Patient is 18 years or older; AND
  • Healthcare facility has enrolled in the ABECMA REMS Program and training has been given to providers on the management of cytokine release syndrome (CRS) and neurological toxicities; AND
  • Patient has not received prior CAR-T or B-cell maturation antigen (BCMA) targeted therapy; AND
  • Patient has not received prior allogeneic hematopoietic stem cell transplant; AND
  • Patient does not have a clinically significant active systemic infection or inflammatory disorder; AND
  • Patient has not received live vaccines within 6 weeks prior to the start of lymphodepleting chemotherapy, during idecabtagene vicleucel treatment, and will not receive live vaccines 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 has been followed according to local institutional guidelines or clinical practice; 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 involvement, including a history or presence of clinically relevant pathology, with myeloma; AND
  • Patient does not have active or a history of plasma cell leukemia; AND

Multiple Myeloma † Ф 1-3

  • Patient has measurable disease, defined as one or more of the following:
    • Serum M-protein ≥ 1.0 g/dL
    • Urine M-protein ≥ 200 mg/24 h
    • Serum free light chain (FLC) assay: involved FLC ratio level ≥ 10 mg/dL (provided serum FLC ratio is abnormal); AND
  • Patient has relapsed or refractory disease; AND
  • Patient has received at least 4 prior therapies, including a proteasome inhibitor (e.g., bortezomib, etc.), an immunomodulatory agent (e.g., lenalidomide, thalidomide, etc.) and an anti-CD38 monoclonal antibody (e.g., daratumumab, isatuximab, etc.)

FDA Approved Indication(s); Compendium Recommended Indication(s); Ф Orphan Drug

IV. Renewal Criteria

Coverage cannot be renewed.

V. Dosage/Administration

Indication

Dose

Multiple Myeloma

Lymphodepleting chemotherapy:

  • Administer cyclophosphamide 300 mg/m2 and fludarabine 30 mg/m2 intravenously daily for three days infused 2-7 days before infusion of Abecma.

Abecma Infusion:

  • Premedicate with 650 mg acetaminophen and 25-50 mg diphenhydramine (or 12.5 mg IV or another H1-antihistamine) 30-60 minutes prior to infusion. Avoid prophylactic system corticosteroids which may interfere with Abecma activity.
  • Once Abecma has been drawn into syringes, proceed with administration as soon as possible. The total time from removal from frozen storage to patient administration should not exceed 2 hours as indicated by the time entered on the syringe label.
  • A single dose of Abecma contains a cell suspension of 300 to 460 x 106 chimeric antigen receptor (CAR)-positive T cells in one or more infusion bags.

Monitoring:

  • Monitor patients daily at a certified healthcare facility during the first week following infusion for signs and symptoms of CRS and neurologic toxicities.
  • Instruct patients to remain within proximity of the certified healthcare facility for at least 4 weeks following infusion.
  • Refrain from driving or hazardous activities for 8 weeks.

For autologous use only. For intravenous use only.

  • Abecma is prepared from the patient’s peripheral blood mononuclear cells, which are obtained via a standard leukapheresis procedure
  • One treatment course consists of lymphodepleting chemotherapy followed by an infusion of one or more bags of Abecma.
  • Confirm Abecma availability prior to starting the lymphodepleting regimen.
  • Confirm the patient’s identity with the patient identifiers on the shipper and the respective Certificate of Release for Infusion (RFI Certificate) prior to infusion.
  • Store infusion bag in the vapor phase of liquid nitrogen (less than or equal to minus 130°C). Thaw prior to infusion.
  • Ensure that 2 doses of tocilizumab and emergency equipment are available prior to infusion and during the recovery period.
  • Abecma contains human blood cells that are genetically modified with replication incompetent self-inactivating lentiviral vector. Follow universal precautions and local biosafety guidelines for handling and disposal.

VI. Billing Code/Availability Information

HCPCS code:

  • J9999 - Not otherwise classified, antineoplastic drug
  • C9399 – Unclassified drugs or biologicals (Hospital outpatient use only)

NDC:

  • Abecma suspension for intravenous infusion [A single dose of ABECMA contains a cell suspension of 300 to 460 x 106 CAR-positive T cells in one or more infusion bags]:
    • 50 mL, 250 mL and 500 mL infusion bags and metal cassettes: 59572-515-xx)

VII. References

  1. Abecma [package insert]. Summit, NJ; Celgene., Inc., March 2021. Accessed April 2021.
  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) idecabtagene vicleucel. National Comprehensive Cancer Network, 2021. 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 2021.
  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.

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

D47.2

Monoclonal gammopathy

Z85.79

Personal history of other malignant neoplasms of lymphoid, hematopoietic and related tissues

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

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 Determination (NCD), Local Coverage Article and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-search.aspx. Additional indications may be covered 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 Government Benefit Administrators, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

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