ABECMA (idecabtagene vicleucel) 

Office Administration

Indications for Prior Authorization:
  • Indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody
Coverage Criteria:

For diagnosis of relapsed or refractory multiple myeloma:

  • Dose does not exceed 1 single dose, AND
  • Patient is 18 years of age or older, AND
  • Patient has a diagnosis of relapsed or refractory multiple myeloma, AND
  • Prescribed by or in consultation with a hematologist/oncologist, AND
  • Disease is relapsed or refractory after four or more prior lines of therapy, including all of the following:
    • An immunomodulatory agent (e.g., Thalomid®, Revlimid®, Pomalyst®)
    • A proteasome inhibitor (e.g., Velcade®, Kyprolis®, Ninlaro®)
    • An anti-CD38 monoclonal antibody (e.g., Darzalex®, Darzalex Faspro™, Sarclisa®), AND
  • Patient has received lymphodepleting chemotherapy prior to infusion of Abecma, AND
  • Patient has not been previously treated with chimeric antigen receptor (CAR-T) therapy (e.g., Abecma, Breyanzi®, Kymriah®, Tecartus™, Yescarta®), AND
  • Approval already authorized for T cell collection, AND
  • Prophylactic systemic corticosteroids will not be used as they may interfere with Abecma’s activity
Coverage Duration:
  • 1 dose
Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:
  • Recommended dose: 300 to 460 × 106 CAR-positive T cells
    • Abecma is provided as a single dose for infusion containing a suspension of chimeric antigen receptor (CAR)-positive T cells in one or more infusion bags
  • Abecma is for autologous use only
  • Administer Abecma 2 days after completion of lymphodepleting chemotherapy. Administer acetaminophen and diphenhydramine approximately 30 to 60 minutes before Abecma.
  • Administer Abecma at a REMS-certified healthcare facility
  • Ensure that a minimum of 2 doses of tocilizumab and emergency equipment are available prior to infusion and during the recovery period
  • Black Box Warnings:
    • Cytokine Release Syndrome (CRS)
    • Neurologic toxicities
    • Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS)
    • Prolonged Cytopenia
  • Warnings: hypersensitivity reactions, active infections or inflammatory disorders, prolonged cytopenias, hypogammaglobulinemia, secondary malignancies, and effects on ability to drive and use machines
Policy Updates:
  • 8/17/2021 – New policy approved by P&T.
References:
  • Abecma Prescribing Information. Celgene Corporation. Summit, NJ. March 2021.
  • National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology: Multiple Myeloma. V7.2021. Available at: https://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf. Accessed April 29, 2021.
  • Munshi, Nikhil C., et al. Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma. New England Journal of Medicine, vol. 384, no. 8, 2021, pp. 705–716.

Last review date: August 17, 2021

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