Overview

This document addresses the use of Carvykti (ciltacabtagene autoleucel), 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. Ciltacabtagene autoleucel is prepared from the patient’s peripheral blood mononuclear cells (obtained via leukapheresis), which are enriched for T cells. When infused back into the patient, the anti-BCMA CAR T cells recognize and eliminate BCMA-expressing target cells. In addition to T cells, ciltacabtagene autoleucel may contain natural killer (NK) cells.

Carvykti has a black box warning for life-threatening or fatal cytokine release syndrome (CRS), neurologic toxicities, Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome HLH/MAS and prolonged and/or recurrent cytopenia. Due to these black box warnings, Carvykti is only available through a Risk Evaluation and Mitigation Strategy (REMS) program.

The National Comprehensive Cancer Network® (NCCN) provides additional recommendations with a category 2A level of evidence for the following uses:

• Multiple Myeloma

Definitions and Measures

Chemotherapy: Medical treatment of a disease, particularly cancer, with drugs or other chemicals.

Disease Progression: Cancer that continues to grow or spread.

Refractory Disease: Illness or disease that does not respond to treatment.

Relapse or recurrence: After a period of improvement, during which time a disease (for example, cancer) could not be detected, the return of signs and symptoms of illness or disease. For cancer, it may come back to the same place as the original (primary) tumor or to another place in the body.

Clinical Criteria

When a drug is being reviewed for coverage under a member’s medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose.

Carvykti (ciltacabtagene autoleucel)

1. Individual is 18 years of age or older; AND
2. Individual has a diagnosis of relapsed or refractory multiple myeloma; AND
3. If individual has a history of an allogeneic stem cell transplant, there are no current signs of active graft versus host disease (GVHD); AND
4. Individual has adequate bone marrow reserve defined by all of the following:
   • Absolute neutrophil count (ANC) ≥ 1000 cells/uL; AND
   • Platelet count ≥ 50,000 cells/uL;
5. Individual has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; AND
6. Individual has not received prior CAR T-cell or B-cell maturation antigen (BCMA) targeted therapy; AND
7. Individual is using as a one-time, single administration treatment.

Carvykti (ciltacabtagene autoleucel) may not be approved for the following (Berdeja 2021):

1. Not Applicable I.
2. Not Applicable II.
3. Not Applicable III.
4. Not Applicable IV.
5. Not Applicable V.
6. Not Applicable VI.
7. Not Applicable VII.
8. Not Applicable VIII.

Carvykti (ciltacabtagene autoleucel) may not be approved for the following (Berdeja 2021):

9. Repeat administration; OR
10. Active presence or history of central nervous system involvement with myeloma; OR
11. Using in combination with other chemotherapy agents (not including the use of lymphodepleting chemotherapy prior to infusion); OR
12. Presence of plasma cell leukemia, Waldenstrom’s macroglobulinemia, POEMS syndrome, or primary AL amyloidosis; OR
13. Individual has active GVHD; OR
14. History of autologous stem cell transplant less than or equal to 12 weeks before apheresis; OR
15. If prescribed in combination with other CAR T-cell immunotherapy (e.g. Abecma, Breyanzi, Kymriah, Tecartus, Yescarta); OR
16. History of cardiac conditions, such as New York Heart Association (NYHA) stage III or IV congestive heart failure, myocardial infarction or coronary artery bypass graft (CABG) within the past 6 months, history of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration, or history of severe nonischemic cardiomyopathy; OR
17. Left ventricular ejection fraction (LVEF) less than 45% (scan performed withing 8 weeks of apheresis); OR
18. Active hepatitis B, active hepatitis C, human immunodeficiency virus (HIV) positive, or other active, uncontrolled infection; OR
19. When the above criteria are not met, and for all other indications.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

HCPCS

• Q2056

ICD-10 Diagnosis

• C90.00
• C90.02

Ciltacabtagene autoleucel, up to 100 million autologous b-cell maturation antigen (BCMA) directed car-positive t cells, including leukapheresis and dose preparation procedures, per therapeutic dose [Carvykti]

• Multiple myeloma not having achieved remission
• Multiple myeloma in relapse

Document History

Revised: 11/19/2023