Idecabtagene Vicleucel (BB2121) Form

Idecabtagene vicleucel (Abecma®) is an anti-B cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell immunotherapy. FDA Approved Indication(s) Abecma is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
All requests reviewed under this policy require medical director review. It is the policy of health plans affiliated with Centene Corporation® that Abecma is medically necessary when the following criteria are met:
I. 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 multiple myeloma;
2. Prescribed by or in consultation with an oncologist or hematologist;
3. Age ≥ 18 years;

4. One of the following (a or b): a. Member has measurable disease as evidenced by one of the following assessed within the last 30 days (i, ii, or iii): 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 (see Appendix D), assessed within 60 days following the last dose of the last 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. One immunomodulatory agent (e.g., Revlimid®, Pomalyst®, Thalomid®); b. One proteasome inhibitor (e.g., bortezomib, Kyprolis®, Ninlaro®); Page 1 of 8

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

5. 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) B. Other diagnoses/indications (must meet 1 or 2):

   1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
   2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
      II. Continued Therapy A. Multiple Myeloma
   3. Continued therapy will not be authorized as Abecma is indicated to be dosed one time only. Approval duration: Not applicable B. Other diagnoses/indications (must meet 1 or 2):
   4. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: Page 2 of 8

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   CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

   2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
      III. Diagnoses/Indications for which coverage is NOT authorized:
      A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid or evidence of coverage documents; B. Known 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). IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key BCMA: B-cell maturation antigen CAR: chimeric antigen receptor CNS: central nervous system FDA: Food and Drug Administration
      FLC: free light chain IMWG: International Myeloma Working Group Appendix B: Therapeutic Alternatives
      This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization. Drug Name Dosing Regimen Varies Varies Varies Dose Limit/ Maximum Dose Varies Varies Varies Varies Varies Varies Varies Varies Varies Varies Varies bortezomib/Revlimid® (lenalidomide) /dexamethasone bortezomib/cyclophosphamide/dexamethasone bortezomib/doxorubicin (or liposomal doxorubicin)/ dexamethasone Kyprolis® (carfilzomib)/Revlimid® (lenalidomide) /dexamethasone Kyprolis® (carfilzomib)/cyclophosphamide/ dexamethasone Kyprolis® (carfilzomib – weekly or twice weekly)/dexamethasone Ninlaro® (ixazomib)/Revlimid® (lenalidomide)/dexamethasone Page 3 of 8

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   Drug Name Dosing Regimen Varies Varies Varies Varies Varies Varies Varies Varies Varies Varies Varies Ninlaro® (ixazomib)/dexamethasone Ninlaro® (ixazomib)/pomalidomide/dexamethasone bortezomib/dexamethasone bortezomib/Thalomid® (thalidomide)/dexamethasone cyclophosphamide/Revlimid® (lenalidomide)/dexamethasone Revlimid® (lenalidomide)/dexamethasone VTD-PACE (dexamethasone/Thalomid® (thalidomide)/cisplatin/doxorubicin/ cyclophosphamide/etoposide/bortezomib) Revlimid® (lenalidomide)/low-dose dexamethasone Darzalex® (daratumumab) or Darzalex Faspro™ (daratumumab/hyaluronidase-fihj)/bortezomib/melphan/ prednisone Darzalex® (daratumumab) or Darzalex Faspro™ (daratumumab/hyaluronidase-fihj)/ bortezomib/dexamethasone Darzalex® (daratumumab) or Darzalex Faspro™ (daratumumab/hyaluronidase-fihj)/Revlimid® (lenalidomide)/ dexamethasone Darzalex® (daratumumab) or Darzalex Faspro™ (daratumumab/hyaluronidase-fihj) Darzalex® (daratumumab) or Darzalex Faspro™ (daratumumab/hyaluronidase-fihj)/pomalidomide/ dexamethasone Empliciti® (elotuzumab)/Revlimid® (lenalidomide)/ dexamethasone Empliciti® (elotuzumab)/bortezomib/dexamethasone Varies Empliciti® (elotuzumab)/pomalidomide/dexamethasone Varies bendamustine/bortezomib/dexamethasone Varies bendamustine/Revlimid® (lenalidomide)/ dexamethasone Varies Varies panobinostat/bortezomib/dexamethasone panobinostat/Kyprolis® (carfilzomib) Varies panobinostat/Revlimid® (lenalidomide)/ dexamethasone Varies Varies pomalidomide/cyclophosphamide/dexamethasone Varies pomalidomide/dexamethasone pomalidomide/bortezomib/dexamethasone Varies pomalidomide/ Kyprolis® (carfilzomib)/ dexamethasone Varies Sarclisa® (isatuximab-irfc)/pomalidomide/dexamethasone Varies Xpovio® (selinexor)/bortezomib/dexamethasone Varies Xpovio® (selinexor)/Darzalex® (daratumumab) or Varies Darzalex Faspro™ (daratumumab/hyaluronidase- fihj)/dexamethasone Varies Varies Varies Dose Limit/ Maximum Dose Varies Varies Varies Varies Varies Varies Varies Varies Varies Varies Varies Varies Varies Varies Varies Varies Varies Varies Varies Varies Varies Varies Varies Varies Varies Varies Varies Varies Page 4 of 8

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   Drug Name Xpovio® (selinexor)/pomalidomide/dexamethasone Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Dosing Regimen Varies Dose Limit/ Maximum Dose Varies Appendix C: Contraindications/Boxed Warnings
   • Contraindication(s): none reported • Boxed warning(s): cytokine release syndrome, neurologic toxicities, hemophagocytic lymphohistiocytosis/macrophage activation syndrome, and prolonged cytopenia Appendix D: General Information • Patients with CNS involvement with their multiple myeloma were excluded from the pivotal KarMMa trial.
   • The IMWG response criteria for multiple myeloma definition of progressive disease requires only one of the following: o Increase of 25% from lowest response value in any of the following:  Serum M-component (absolute increase must be ≥ 0.5 g/dL), and/or  Urine M-component (absolute increase must be ≥ 200 mg/24 h), and/or o Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels (absolute increase must be > 10 mg/dL) o Only in patients without measurable serum and urine M protein levels and without measurable disease by FLC levels, bone marrow plasma cell percentage irrespective of baseline status (absolute increase must be ≥ 10%) o Appearance of a new lesion(s), ≥ 50% increase from nadir in SPD (sum of the products of the maximal perpendicular diameters of measured lesions) of > 1 lesion, or ≥ 50% increase in the longest diameter of a previous lesion >1 cm in short axis; o ≥ 50% increase in circulating plasma cells (minimum of 200 cells per μL) if this is the only measure of disease V. Dosage and Administration Indication Multiple myeloma Single IV infusion; target dose: 300- Dosing Regimen 460 x 106 CAR-positive T cells Maximum Dose 460 x 106 CAR-positive T- cells VI. Product Availability Single-dose unit infusion bag: frozen suspension of genetically modified autologous T-cells labeled for the specific recipient VII.