Coverage Policies

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INDEX:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Effective Date: 07/01/2022 Title: Carvykti
Revision Date: 08/01/2023 Document: BI699:00
CPT Code(s): C9098
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Carvykti (ciltacabtagene autoleucel) requires prior authorization.

2)      Carvykti is indicated for the treatment of adults with relapsed and/or refractory multiple myeloma (MM) after four or more prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody.


Medical Statement

Initial Approval Criteria A. Multiple Myeloma* (must meet all):

 

*Only for initial treatment dose; subsequent doses will not be covered.

1. Diagnosis of relapsed or refractory MM;

2. Prescribed by or in consultation with an oncologist or hematologist;

3. Age ≥ 18 years;

4. One of the following:

a. Member has measurable disease as evidenced by one of the following assessed within the last 30 days (a, b, or c):

i. Serum M-protein ≥ 1 g/dL;

ii. Urine M-protein ≥ 200 mg/24 h;

iii. Serum free light chain (FLC) assay: involved FLC level ≥ 10 mg/dL (100 mg/L) provided serum FLC ratio is abnormal;

b. Member has progressive disease, as defined by the IMWG response criteria, assessed within 60 days following the last dose of anti-myeloma drug regimen received.

5. Member has received ≥ 4 prior lines of therapy (see Appendix B for examples) that include all of the following (a, b, and c):

a. A PI (e.g., bortezomib, Kyprolis®, Ninlaro®);

b. An IMiD (e.g., Revlimid®, Pomalyst®, Thalomid®);

c. An anti-CD38 antibody (e.g., Darzalex®/Darzalex Faspro™, Sarclisa®);

*Prior authorization may be required. Induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single regimen.

 6. Member does not have active or prior history of central nervous system (CNS) involvement (e.g., seizure, cerebrovascular ischemia) or exhibit clinical signs of meningeal involvement of MM;

7. Member has not previously received treatment with anti-BCMA targeted therapy (e.g., Blenrep™, Tecvayli);

8. Member has not previously received treatment with CAR T-cell immunotherapy (e.g., Abecma®, Breyanzi®, Kymriah™, Tecartus™, Yescarta™);

9. Carvykti is not prescribed concurrently with other CAR T-cell immunotherapy (e.g., Abecma, Breyanzi, Kymriah, Tecartus, Yescarta);

10. Dose does not exceed 1 x 108 CAR-positive viable T cells.

Approval duration: 3 months (1 dose only, with 4 doses of tocilizumab (Actemra) if requested at up to 800 mg per dose)

 

Continued Therapy

A. Multiple Myeloma:

1. Continued therapy will not be authorized as Carvykti is indicated to be dosed one time only.

Approval duration: Not applicable


Reference

1. Available at: https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/CARVYKTI-pi.pdf . Accessed March 2, 2022.

2. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). Identifier NCT03548207, A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-Cell Maturation Antigen (BCMA) in Participants With Relapsed or Refractory Multiple Myeloma (CARTITUDE-1); 28 January 2022. Available at: https://clinicaltrials.gov/ct2/show/NCT03548207?term=NCT03548207. Accessed February 1, 2022.

3. Madduri D, Berdeja JG, Usmani SZ, et al. CARTITUDE-1: Phase 1b/2 Study of

Ciltacabtagene Autoleucel, a B-Cell Maturation Antigen–Directed Chimeric Antigen

Receptor T Cell Therapy, in Relapsed/Refractory Multiple Myeloma; ASH 2020. Oral

Presentation 177; December 5-8, 2020. Available at:

https://ash.confex.com/ash/2020/webprogram/Paper136307.html. Accessed March 9, 2021.

4. 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.

5. National Comprehensive Cancer Network. Multiple Myeloma Version 5.2022. Available at:

https://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf. Accessed March 21, 2022.

6. National Comprehensive Cancer Network. Central Nervous System Cancers Version 2.2021. Available at: https://www.nccn.org/professionals/physician_gls/pdf/cns.pdf. Accessed April 5, 2022.

7. Chen CI, Masih-Khan E, Jiang H, et al. Central nervous system involvement with multiple myeloma: long term survival can be achieved with radiation, intrathecal chemotherapy, and immunomodulatory agents. British Journal of Hematology. August 2013; 162 (4): 483-488.

 

Addendum:

1)    Effective 08-01-2023: Added additional option to currently required measurable disease requirement to allow for progressive disease defined by IMWG,; clarified requirement for diagnosis of relapsed or refractory multiple myeloma.


Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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