Initial Approval Criteria:
A.
B-cell Precursor Acute Lymphoblastic Leukemia (second
relapse or refractory)
1.
The member is age 25 years or younger.
2.
Medication is prescribed by an oncologist or in
consultation with an oncologist.
3.
The member has a diagnosis of B-cell acute
lymphoblastic leukemia with confirmed CD-19 tumor expression.
4.
The member does not have an active infection or
inflammatory disorder.
5.
The member does not have primary central nervous
system lymphoma.
6.
The Eastern Cooperative Oncology Group performance
status is 0 to 3.
7.
The member has not
received prior CAR-T therapy.
8.
The health-care facility
has enrolled in the Kymriah® Risk Evaluation and Mitigation Strategies and
training has been given to the provider on
the management of
cytokine release syndrome and neurological toxicities.
Approval duration: Only 1 dose per lifetime will be provided on this drug
regardless of Provider.
B.
Diffuse Large B-cell
Lymphoma (relapsed or refractory)
1.
The member is 18 years or older.
2.
Medication is prescribed by an oncologist or in consultation with an oncologist.
3.
The member has a diagnosis of diagnosis of relapsed or refractory large B-cell
lymphoma (such as diffuse large B-cell lymphoma, high grade B-cell lymphoma,
diffuse large B-cell lymphoma arising from follicular lymphoma).
4.
The member must have relapsed or refractory disease as progression after two or
more lines of systemic therapy (which may or may not include therapy supported
by autologous stem cell transplant). The member must have received adequate
prior therapy including, at a minimum, the following:
a.
An anthracycline-containing chemotherapy regimen
b.
For CD20+ disease, an anti-CD20 monoclonal antibody
c.
For members with transformed follicular lymphoma, prior chemotherapy refractory
disease after transformation to DLBCL
5.
The member has an Eastern Cooperative Oncology Group performance status of 0 or
1.
6.
The member does not have primary central nervous system lymphoma.
7.
The member does not have an active infection or inflammatory disorder.
8.
The member has not received prior CAR-T therapy.
9.
The health-care facility has enrolled in the Kymriah® Risk Evaluation and
Mitigation Strategies and training has been given to the provider on the
management of cytokine release syndrome and neurological toxicities.
Approval duration: Only 1 dose per lifetime will be provided on this drug
regardless of Provider.
Codes
Used In This BI:
1)
Q2042