Medicare Advantage

Medical Policy

Title:

Elranatamab-bcmm (Elrexfio™)

Policy #:

MA08.168

Policy

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.

MEDICALLY NECESSARY

Elranatamab-bcmm (Elrexfio) injection is considered medically necessary and, therefore, covered as a single agent in adult individuals with refractory or relapsed multiple myeloma (RRMM) who have received at least four prior therapies, including a proteasome inhibitor (e.g., bortezomib, carfilzomib, ixazomib), an immunomodulatory agent (e.g., thalidomide, lenalidomide, pomalidomide), and an anti-CD38 monoclonal antibody (isatuximab-irfc, daratumumab) as National Comprehensive Cancer Network (NCCN)-preferred therapy.

HOSPITAL ADMISSION FOR ADMINISTRATION

When the medical necessity criteria has been met, the hospital admission for first cycle administration of elranatamab-bcmm (Elrexfio), as recommended by the US Food and Drug Administration (FDA), is covered in accordance with the following timeframes*:

First Cycle: Individuals should be hospitalized for 48 hours after administration of the first step-up dose, and for 24 hours after administration of the second step-up dose due to the risk of cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome (ICANS).

*Hospital stays that are longer than the preceding timeframes must be re-evaluated for medical necessity.

EXPERIMENTAL/INVESTIGATIONAL

All other uses for elranatamab-bcmm (Elrexfio) not identified in this policy are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug.

Guidelines

There is no Medicare coverage determination addressing elranatamab-bcmm (Elrexfio); therefore, the Company policy is applicable.

BLACK BOX WARNINGS

Refer to the specific manufacturer's prescribing information for any applicable Black Box Warnings.

BENEFIT APPLICATION

Subject to the applicable Evidence of Coverage, elranatamab-bcmm (Elrexfio) is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in the medical policy are met.

For Medicare Advantage members, certain drugs are available through either the member's medical benefit (Part B benefit) or pharmacy benefit (Part D benefit), depending on how the drug is prescribed, dispensed, or administered. This medical policy only addresses instances when elranatamab-bcmm (Elrexfio) is covered under a member's medical benefit (Part B benefit). It does not address instances when elranatamab-bcmm (Elrexfio) is covered under a member's pharmacy benefit (Part D benefit).

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Elranatamab-bcmm (Elrexfio) was approved by the FDA on August 14, 2023, for the treatment of adult individuals with relapsed or refractory multiple myeloma, who previously received four or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug, and anti-CD38 monoclonal antibody.

PEDIATRIC USE

The safety and effectiveness of elranatamab-bcmm (Elrexfio) have not been established in pediatric individuals less than 18 years of age.

Description

Multiple myeloma (MM) is a cancer of plasma cells. Healthy plasma cells grow and divide to make new cells; once cells grow old or get damaged, they die. Because of the genetic variations in MM, the myeloma cells replicate uncontrollably throughout the bone marrow, do not die when they get old or damaged, outnumber normal blood cells in the bone marrow, and destroy the bone tissue. The antibodies synthesized by myeloma cells do not fight infections in the same way as normal antibodies do. MM symptoms are low blood counts that cause anemia, bone pain, kidney damage due to elevated creatinine or serum protein, infection, fatigue, and hypercalcemia.

Nearly all individuals with myeloma who receive standard therapies have relapse. Those with triple-class–refractory MM (i.e., disease that is refractory to a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody) or relapsed MM who receive standard treatment have a poor prognosis. Therefore, there is a high demand for agents that treat MM in individuals who do not respond or who progress after first- or subsequent-line therapy.

Elranatamab-bcmm (Elrexfio)is a bispecific T-cell engager (BiTE) that binds on T cells and to B-cell maturation antigen (BCMA)-directed CD3 expressed on the surface of MM cells and some healthy B-lineage cells.

PEER-REVIEW LITERATURE

SUMMARY

The safety and efficacy was evaluated in a phase II, MagnetisMM-3 trial, patients with relapsed/refractory MM received subcutaneous elranatamab once weekly. The primary population in whom the efficacy was seen were patients (n=123) without prior BCMA-directed therapy. The findings indicated an objective response rate (ORR) of 61.0% (75/123) and 35.0% greater than or equal to complete response (CR). Fifty responders switched to biweekly dosing, and 40 of those (80.0%) improved or maintained their response for 6 months or more. Common adverse events reported were infections, cytokine release syndrome, anemia, and neutropenia. With biweekly dosing, grade 3–4 adverse events decreased from 58.6% to 46.6%.

OFF-LABEL INDICATIONS

There may be additional indications contained in the Policy section of this document due to the evaluation of criteria highlighted in the Company's off-label policy, and/or review of clinical guidelines issues by leading professional organizations and government entities.

References

American Cancer Society [website]. Multiple Myeloma. Revised 02/2/2018. Available at: https://www.cancer.org/cancer/types/multiple-myeloma/about/what-is-multiple-myeloma.html. Accessed February 28, 2024.

American Hospital Formulary Service (AHFS). Drug Information. 2024. Elranatamab-bcmm. [LexiDrugs website]. 12/12/2023. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed February 28, 2024.

Centers for Medicare & Medicaid Services' (CMS). Guidance for Prior Authorization and Step Therapy for Part B Drugs in Medicare Advantage. 08/07/2018. Available at: https://www.cms.gov/Medicare/Health-Plans/HealthPlansGenInfo/Downloads/MA_Step_Therapy_HPMS_Memo_8_7_2018.pdf.

Elsevier's Clinical Pharmacology Compendium. Elranatamab-bcmm (Elrexfio).[Clinical Key Web site]. 08/24/23. Available at: https://www.clinicalkey.com/#!/ [via subscription only]. Accessed February 28, 2024.

Lexi-Drugs Compendium. Elranatamab-bcmm. [Lexicomp Online Web site]. 02/24/2024. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed February 28, 2024.

Micromedex® Healthcare Series [Internet database]. Elranatamab-bcmm. Greenwood Village, CO: Thomson Micromedex. 01/22/2024. Available at: http://www.micromedexsolutions.com/micromedex2/librarian. Accessed February 28, 2024.

Lesokhin AM, Tomasson MH, Arnulf B, et al. Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results. Nat Med 2023;29:2259-2267.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology – Multiple Myeloma. V2.2024. [NCCN Web site]. 10/01/2023. Available at: https://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf [via subscription only]. Accessed February 28, 2024.

National Comprehensive Cancer Network (NCCN). NCCN Drugs and Biologics Compendium. Elranatamab-bcmm. [NCCN Web site]. 2024. Available at: https://www.nccn.org/professionals/drug_compendium/content/Reports/Report.aspx?DrugCompendiumIds=359025 [via subscription only]. Accessed February 28, 2024.

US Food and Drug Administration (FDA). Elranatamab-bcmm (Elrexfio) prescribing information & approval letter. [FDA Web site]. 08/2023. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761345Orig1s000lbl.pdf. Accessed February 20, 2024.

Coding

CPT Procedure Code Number(s)

N/A

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

C90.00 Multiple myeloma not having achieved remission

C90.02 Multiple myeloma in relapse

C90.20 Extramedullary plasmacytoma not having achieved remission

C90.22 Extramedullary plasmacytoma in relapse

HCPCS Level II Code Number(s)

J1323 Injection, elranatamab-bcmm, 1 mg

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Version Effective Date:

4/22/2024

Version Issued Date: