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