Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the
www.fepblue.org
website.
Idecabtagene vicleucel or
ciltacabtagene autoleucel
may be considered
medically necessary
for individuals with multiple myeloma if they meet all of the following criteria:
-
Are adults (age greater than or equal to 18) at the time of infusion;
and
-
Have a documented diagnosis of multiple myeloma;
and
-
Have relapsed or refractory disease after four (4) or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody (see Policy Guidelines);
and
-
Have adequate organ and bone marrow function as determined by the treating oncologist/hematologist;
and
-
Does not have active infection(s) or inflammatory disorders;
and
- Have not received prior chimeric antigen receptor T therapy or any other gene therapy and are not being considered for treatment with any other gene therapy.
Idecabtagene vicleucel and
ciltacabtagene autoleucel
are considered experimental/investigational for all other indications.
Policy Guidelines
Black Box Warning and Associated Restricted Program under a Risk Evaluation and Mitigation Strategy (REMS)
Idecabtagene vicleucel (Abecma) and
ciltacabtagene autoleucel
(Carvykti) have a black box warning because of the risks of cytokine release syndrome, neurologic toxicity, hemophagocytic lymphohistiocytosis/macrophage activation syndrome, and prolonged cytopenia. Idecabtagene vicleucel and
ciltacabtagene autoleucel
should not be administered to individuals with an active infection or inflammatory disorders. It is recommended that severe or life-threatening cytokine release syndrome be treated with tocilizumab or tocilizumab and corticosteroids. Individuals should be monitored for neurologic events after treatment.
T cell malignancies have occurred following treatment with B-cell maturation antigen (BCMA)- and CD19-directed genetically modified autologous T cell immunotherapies, including idecabtagene vicleuclel. Mature T cell malignancies, including chimeric antigen receptor (CAR)-positive tumors, may be present as soon as weeks following infusion, and may include fatal outcomes.
Parkinsonism and Guillain-Barré syndrome and their associated complications resulting in fatal or life-threatening reactions have occurred following treatment with ciltacabtagene autoleucel (Carvykti).
Idecabtagene vicleucel (Abecma) and
ciltacabtagene autoleucel
(Carvykti) are available only through a restricted program under a risk evaluation and mitigation strategy (REMS) called the Abecma REMS and Carvykti REMS, respectively. The requirement for the REMS components are as follows:
- Health care facilities that dispense and administer this chimeric antigen receptor T therapy must be enrolled and comply with the REMS requirements.
- Certified health care facilities must have onsite, immediate access to tocilizumab, and ensure that a minimum of two (2) doses of tocilizumab are available for each individual for administration within two (2) hours after infusion of this chimeric antigen receptor T therapy, if needed for treatment of cytokine release syndrome.
- Certified health care facilities must ensure that health care providers who prescribe, dispense, or administer these chimeric antigen receptor T therapies are trained to manage cytokine release syndrome and neurologic toxicities.
Guidance for Definitions for Relapsed and Refractory Multiple Myeloma
Relapsed Multiple Myeloma
As per the 2016 International Myeloma Working Group Uniform Response Criteria for Multiple Myeloma, relapse requires one (1) or more of the following direct indicators of increasing disease and/or end organ dysfunction that are considered related to the underlying plasma cell proliferative disorder.
- Development of new soft tissue plasmacytomas or bone lesions
- Definite increase in the size of existing plasmacytomas or bone lesions. A definite increase is defined as a 50% (and at least 1 cm) increase as measured serially by the sum of the products of the cross-diameters of the measurable lesion
- Hypercalcemia (greater than 11.5 mg/dL) [2.875 mmol/L]
- Decrease in hemoglobin of greater than 2 g/dL [1.25 mmol/L] or to less than 10 g/dL
- Rise in serum creatinine by 2 mg/dL or more [177 μmol/L or more]
- Hyperviscosity
Refractory Multiple Myeloma
In the protocol of the pivotal KarMMa study, refractory multiple myeloma was defined as documented progressive disease during or within 60 days (measured from the last dose) of completing treatment with the last anti-myeloma drug regimen. As per the 2016 International Myeloma Working Group Uniform Response Criteria for Multiple Myeloma, progression is defined as an increase of greater than or equal to 25% from the lowest response value in any one (1) or more of the following:
- Serum M-component (the absolute increase must be greater than or equal to 0.5 g/dL) and/or
- Urine M-component (the absolute increase must be greater than or equal to 200 mg/24 hour) and/or
- Only in subjects without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chains levels (the absolute increase must be greater than 10 mg/dL)
- Only in subjects without measurable serum and urine M-protein levels and without measurable disease by free light chains levels: bone marrow plasma cell percentage (the absolute percentage must be greater than or equal to 10%)
- Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas
- Development of hypercalcemia (corrected serum calcium greater than 11.5 mg/dL) that can be attributed solely to the plasma cell proliferative disorder
Prior Lines of Therapies for Multiple Myeloma
Three common classes of antimyeloma medications include anti-CD38 monoclonal antibodies (such as daratumumab or isatuximab), immunomodulatory drugs (such as thalidomide, lenalidomide, or pomalidomide) and proteasome inhibitors (such as bortezomib, carfilzomib, or ixazomib).
Procedure Codes
| 0537T | 0538T | 0539T | 0540T | Q2055 | Q2056 |
