CARVYKTI (ciltacabtagene autoleucel)

Office Administration - intravenous (IV) infusion\

Diagnosis considered for coverage:

Carvykti is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for:

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

For diagnosis of relapsed or refractory multiple myeloma:

  • Dose does not exceed 0.5 × 10^6 CAR-positive viable T cells per kg body weight, with a maximum of 1.0 × 10^8 CAR-positive viable T cells per single dose infusion; AND
  • Patient is 18 years of age or older; AND
  • Prescribed by or in consultation with an oncologist or hematologist; AND
  • Patient has received at least four prior lines of therapy; AND
  • Disease has refractory to all of the following:
    • Proteasome inhibitor (e.g., bortezomib, carfilzomib)
    • Immunomodulatory agent (e.g., lenalidomide, thalidomide)
    • Anti-CD38 monoclonal antibody (e.g., daratumumab)
Coverage Duration:
  • One-time infusion
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:
  • Administer Carvykti at a REMS-certified healthcare facility.
  • Repeat infusion of Carvykti has not been studied.  Coverage is limited to one infusion of Carvykti per lifetime.
References:
  1. Berdeja JG, Madduri D, Usmani SZ, et al. Ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy in patients with relapsed or refractory multiple myeloma (CARTITUDE-1: a phase 1b/2 open-label study. Lancet. 2021; 398(10297):314-324.
  2. Carvykti [package insert], Horsham, PA: Janssen Biotech, Inc.; February 2022.
  3. Food and Drug Administration. FDA News Release: FDA approves ciltacabtagene autoleucel for relapsed or refractory multiple myeloma. March 7, 2022. FDA approves ciltacabtagene autoleucel for relapsed or refractory multiple myeloma | FDA. Accessed April 12, 2022.
  4. Food and Drug Administration. FDA News Release: FDA approves first cell-based gene therapy for adult patients with multiple myeloma. March 27, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-first-cell-based-gene-therapy-adult-patients-multiple-myeloma. Accessed April 13, 2022.
  5. Mikhael J, Ismaila N, Cheung MC, et al. Treatment of multiple myeloma: ASCO and CCO joint clinical practice guideline. J Clin Oncol. 2019;37:1228-1263.
  6. National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology: Multiple myeloma. Version 5.2022 – March 9, 2022. NCCN Web site. https://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf. Accessed April 12, 2022.
  7. Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5(6):649-655.

Last review date: August 16, 2022

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