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)    Abecma requires prior authorization.

2)    Abecma is used to treat multiple myeloma and is billed under the medical benefit.

3)    Abecma requests must be reviewed by the Precision Drug Action Committee (PDAC).

Abecma is considered medically necessary for members meeting the following criteria:

I.             Initial Approval Criteria

a.    Multiple Myeloma (must meet all)

                                          i.    Diagnosis of relapsed or refractory multiple myeloma;

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

                                       iii.    Age ≥ 18 years;

                                       iv.    One of the following”

1.    Member has measurable disease as evidenced by one of the following assessed within the last 30 days

a.    Serum M-protein ≥ 1 g/dL;

b.    Urine M-protein ≥ 200 mg/24 h;

c.    Serum free light chain (FLC) assay: involved FLC level ≥ 10 mg/dL (100 mg/L) provided serum FLC ratio is abnormal;

2.    Member has progressive disease, as defined by the IMWG response criteria (see Appendix D), assessed within 60 days following the last dose of the last antimyeloma drug regimen received;

                                        v.    Member has received ≥ 4 prior lines of therapy that include all of the following:

1.    One immunomodulatory agent (e.g., Revlimid®, Pomalyst®, Thalomid®);

2.    One proteasome inhibitor (e.g., bortezomib, Kyprolis®, Ninlaro®);

3.    One anti-CD38 antibody (e.g., Darzalex®/Darzalex Faspro™, Sarclisa®);

                                       vi.    Member does not have known central nervous system (CNS) involvement with myeloma, or history or presence of clinically relevant CNS pathology (e.g., epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson`s disease, cerebellar disease, organic brain syndrome, or psychosis);

                                      vii.    Member has not previously received treatment with anti-BCMA targeted therapy (e.g., Blenrep™, Tecvayli™);

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

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

                                        x.    Dose does not exceed 460 x 106 CAR-positive T-cells

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

No reauthorization is allowed.

Codes Used In This BI:

1)    Q2055 – idecabtagene vicleucel, up to 460 million autologous b-cell maturation antigen directed car-positive t cells

1)    Abecma Prescribing Information. Summit, NJ: Celgene Corporation; March 2021. Available at: https://www.abecma.com. Accessed January 18, 2023.

2)    Efficacy and safety study of bb2121 in subjects with relapsed and refractory multiple myeloma (KarMMa). Available at: https://clinicaltrials.gov/ct2/show/NCT03361748. Accessed January 18, 2023.

3)    Munshi NC, Anderson LD, Shah N, et al. Idecabtagene vicleucel in relapsed and refractory multiple myeloma. N Engl J Med. 2021; 348(8): 705-716.

4)    Raje N, Berdeja J, Lin Y, et al. Anti-BCMA CAR T-cell therapy bb2121 in relapsed or refractory multiple myeloma. N Engl J Med. 2019; 380(18): 1726-1737

5)    National Comprehensive Cancer Network. Multiple Myeloma Version 3.2023. Available at: https://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf. Accessed January 18, 2023.

6)    National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at: http://www.nccn.org/professionals/drug_compendium. Accessed January 18, 2023.