CARVYKTI (ciltacabtagene autoleucel)

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.