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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: 07/01/2021 Title: Breyanzi (Lisocabtagene maraleucel)
Revision Date: 08/01/2023 Document: BI686:00
CPT Code(s):
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)    Breyanzi (Lisocabtagene maraleucel) requires prior authorization.

2)    Breyanzi is indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.

3)    Breyanzi is a specialty medication.


Medical Statement

Breyanzi (Lisocabtagene maraleucel) is considered medically necessary for members age 18 or older who meet the following criteria:

 

A.        Large B-Cell Lymphoma* (must meet all):

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

1.    Diagnosis of one of the following LBCL (a–h );

a.    DLBCL;

b.    DLBCL transformed from one of the following:

                              i.    Follicular lymphoma

                            ii.    Nodal marginal zone lymphoma;

                           iii.    Gastric mucosa=associated lymphoid tissue (MALT) lymphoma;

                           iv.    Nongastric MALT Lymphoma (noncutaneous);

                            v.    Splenic marginal zone lymphoma

c.    Primary Mediastinal Large B Cell Lymphoma (PMBCL);

d.    Transformed Follicular Lymphoma (TFL) to DLBCL;

e.    Transformed Nodal Marginal Zone lymphoma (MZL) to DLBCL;

f.     High-grade B-cell lymphomas with translocations of MYC and BCL2 and/or BCL6 (double/triple hit lymphoma) or high-grade B-cell lymphomas, not otherwise specified;

g.    Monomorphic post-transplant lymphoproliferative disorders (B-cell type);

h.    HIV-related DLBCL, primary effusion lymphoma, and HHV8-positive DLBCL

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

3.    Age ≥ 18 years;

4.    Request is for one of the following:

a.    Disease is refractory or member has relapsed after ≥ 2 lines of systemic therapy that includes an anti-CD20 therapy (e.g., rituximab) and one anthracycline containing regimen (e.g., doxorubicin);*

b.    Disease that is refractory (defined as no complete remission) to or has relapsed (defined as complete remission followed by biopsy-proven disease relapse) no more than 12 months after first-line chemoimmunotherapy that included an antiCD20 monoclonal antibody (e.g., rituximab*) and anthracycline-containing regimen (e.g., doxorubicin);

c.    Member is not eligible for HSCT due to comorbidities or age (see Appendix D for examples) and disease is refractory (defined as no complete remission) to or has relapsed (defined as complete remission followed by biopsy-proven disease relapse) after first-line chemoimmunotherapy that included an anti-CD20 monoclonal antibody (e.g., rituximab*) and anthracycline-containing regimen (e.g., doxorubicin);

*Prior authorization may be required for rituximab

5.    Member does not have primary CNS disease;

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

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

8.    Dose does not exceed 110 x 106 chimeric antigen receptor (CAR)-positive viable T cells.

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

 

 

 

Reauthorization Criteria

A.   Large B-Cell Lymphoma

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

Approval duration: Not applicable

 

 

Appendix A: Abbreviation/Acronym Key

 

ALC: absolute lymphocyte count

CAR: chimeric antigen receptor

CNS: central nervous system

CRS: cytokine release syndrome

DLBCL: diffuse large B-cell lymphoma

FDA: Food and Drug Administration

LBCL: large B-cell lymphoma

 

Appendix B: Contraindications/Boxed Warnings

 

•           Contraindication(s): none reported

•           Boxed warning(s): cytokine release syndrome and neurologic toxicities

 

Appendix C: General Information

 

•           Patients with primary CNS disease were excluded from the TRANSCEND NHL 001 trial. For primary CNS lymphoma, NCCN treatment guidelines for CNS cancers recommend a high-dose methotrexate induction-based regimen or whole brain radiation therapy, and consolidation therapy with high-dose chemotherapy with stem cell rescue, high-dose cytarabine with or without etoposide, low dose whole brain radiation therapy, or continuation with monthly high-dose methotrexate-based regimen.

•           In the TRANSCEND NHL 001 trial, three of six patients in the efficacy-evaluable set with secondary CNS lymphoma achieved a complete response.

•           No prespecified threshold for blood counts, including absolute lymphocyte count, was required for enrollment in the TRANSCEND NHL 001 trial.

 

Dosage and Administration

Indication

Dosing Regimen

Maximum Dose

LBCL

Target dose: 50 to 110 x 106 CAR-positive viable T cells

110 x 106 CAR-positive viable T cells

 

Product Availability

Single-dose 5 mL vial: frozen suspension of genetically modified autologous T-cells labeled for the specific recipient


Reference

1.    Breyanzi Prescribing Information. Bothell, WA: Juno Therapeutics, Inc.; June 2022. Available at: https://packageinserts.bms.com/pi/pi_breyanzi.pdf. Accessed January 30, 2023.

2.    ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). Identifier NCT02631044, Study Evaluating the Safety and Pharmacokinetics of JCAR017 in B-cell Non-Hodgkin Lymphoma (TRANSCEND-NHL-001); 21 June 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT02631044?term=lisocabtagene&draw=2&rank=4. Accessed January 30, 2023

3.    Abramson JS, Palomba ML, Gordon LI, et al. Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study. Lancet. 2020 September 19; 396: 839-852.

4.    National Comprehensive Cancer Network. B-cell Lymphomas Version 1.2023. Available at: https://www.nccn.org/professionals/physician_gls/pdf/b-cell.pdf. Accessed January 30, 2023.

5.    National Comprehensive Cancer Network Drug and Biologics Compendium. Available at http://www.nccn.org/professionals/drug_compendium. Accessed January 30, 2023.

6.    ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). Identifier NCT03575351, A Study to Compare the Efficacy and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas (TRANSFORM); 10, June 2021. Available at: https://www.clinicaltrials.gov/ct2/show/NCT03575351. Accessed January 30, 2023.

7.    Kamdar M, Solomon SR, Arnason JE, et al. Lisocabtagene Maraleucel Versus Standard of Care with Salvage Chemotherapy Followed By Autologous Stem Cell Transplantation As Second-Line Treatment in Patients with Relapsed or Refractory Large B-Cell Lymphoma (TRANSFORM): Results from an interim analysis of an open-label, randomized, phase 3 trial. Lancet 2022; 399: 2294-308.

8.    ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). Identifier NCT03483103, Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-PILOT-017006); 25, April 2022. Available at: https://clinicaltrials.gov/ct2/show/NCT03483103. Accessed January 30, 2023.

9.    Sehgal AR, Hildebrandt G, Ghosh N, et al. 2020 ASCO Annual Meeting I, Meeting Abstract: Lisocabtagene maraleucel (liso-cel) for treatment of second-line (2L) transplant noneligible (TNE) relapsed/refractory (R/R) aggressive large B-cell non-Hodgkin lymphoma (NHL): Updated results from the PILOT study. Journal of Clinical Oncology. 20, May 2020; 38 (15): 8040.

10. Sehgal A, Hoda D, Riedell PA, et al. Lisocabtagene maraleucel as second-line therapy in adults with relapsed or refractory large B-cell lymphoma who were not intended for haematopoietic stem cell transplantation (PILOT): an open-label, phase 2 study. Lancet Oncol. 2022 Aug; 23 (8): 1066-1077.

Addendum:

1)    Effective 08/01/2023: Updated DLBCL criteria per NCCN Compendium.


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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