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