ABECMA (idecabtagene vicleucel)

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.