Last Review Date: 07/01/2022

Date of Origin: 04/04/2022

Dates Reviewed: 04/2022, 07/2022

1. Length of Authorization

Coverage will be provided for one treatment course (1 dose of Carvykti) and may not be renewed.

2. Dosing Limits

A. Quantity Limit (max daily dose) [NDC Unit]:

• 1 dose of up to 100 million autologous CAR-positive viable T-cells (supplied as an infusion bag in a metal cassette)

B. Max Units (per dose and over time) [HCPCS Unit]:

• 1 billable unit (1 dose of up to 100 million autologous CAR-positive viable T-cells)

3. Initial Approval Criteria ^1,3

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND
• Healthcare facility has enrolled in the CARVYKTI REMS Program and training has been given to providers on the management of cytokine release syndrome (CRS) and neurological toxicities; AND
• Patient has not received prior CAR-T or B-cell maturation antigen (BCMA) targeted therapy; AND
• Patient has not received prior allogeneic hematopoietic stem cell transplant within 6 months prior to therapy; AND
• Patient does not have an active infection or inflammatory disorder; AND
• Patient has not received live vaccines within 6 weeks prior to the start of lymphodepleting chemotherapy, and will not receive live vaccines during ciltacabtagene autoleucel treatment, and until immune recovery following treatment; AND
• Patient has been screened for cytomegalovirus (CMV), hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) in accordance with clinical guidelines prior to collection of cells (leukapheresis); AND
• Prophylaxis for infection will be followed according to standard institutional guidelines; AND
• Used as single agent therapy (not applicable to lymphodepleting or additional chemotherapy while awaiting manufacture); AND
• Patient does not have known central nervous system (CNS) involvement with myeloma or a history or presence of clinically relevant, active, CNS pathology; AND
• Patient does not have active or a history of plasma cell leukemia; AND
• Patient has an ECOG performance status of 0-1; AND

Multiple Myeloma † Ф ^1-3

• Patient has relapsed or refractory disease; AND
• Patient has received at least four (4) prior therapies, including a proteasome inhibitor (e.g., bortezomib, etc.), an immunomodulatory agent (e.g., lenalidomide, thalidomide, etc.) and an anti-CD38 monoclonal antibody (e.g., daratumumab, isatuximab, etc.)

† FDA Approved Indication(s); ‡ Compendium Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria

Coverage cannot be renewed.

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS Code:

• J9999 – Not otherwise classified, antineoplastic drug (Discontinue use on 10/01/2022)
• C9098 – 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 (Discontinue use on 10/01/2022)
• Q2056 – 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 (Effective 10/01/2022)

NDC:

• Carvykti suspension for intravenous infusion [A single dose of Carvykti contains a cell suspension of up to 1 x 10⁸ CAR-positive T cells in one or more infusion bags]:
  • 30 mL and 70 mL infusion bags and metal cassettes: 57894-0111-xx

7. References

1. Carvykti [package insert]. Horsham, PA; Janssen Biotech, Inc., March 2022. Accessed March 2022.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) ciltacabtagene autoleucel. National Comprehensive Cancer Network, 2022. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed March 2022.
3. 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 Jul 24;398(10297):314-324. doi: 10.1016/S0140-6736(21)00933-8. Epub 2021 Jun 24. Erratum in: Lancet. 2021 Oct 2;398(10307):1216.
4. Lee DW, Santomasso BD, Locke FL, et al. ASTCT consensus grading for cytokine release syndrome and neurologic toxicity associated with immune effector cells. Biol Blood Marrow Transplant 2019; 25: 625-638
5. Majzner RG, Mackall CL. Tumor Antigen Escape from CAR T-cell Therapy. Cancer Discov 2018;8:1219-1226.
6. Lee DW, Gardner R, Porter DL, et al. Current concepts in the diagnosis and management of cytokine release syndrome. Blood 2014; 124(2): 188-95. Errata in Blood: 2015;126(8):1048. and 2016;128(11):1533.
7. Kumar S, Paiva B, Anderson KC, et al. International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma. Lancet Oncol 2016; 17(8): e328-46.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Article and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCA/LCD):  N/A