CurrentEmblemHealthPolicy MG.MM.PH.394

Elrexfio (elranatamab-bcmm) injection solution

Coverage and medical necessity criteria for Elrexfio (elranatamab-bcmm) for adult patients with relapsed or refractory multiple myeloma, including dosing, authorization periods, applicable codes, and renewal requirements for EmblemHealth members.

Policy Summary

PayerEmblemHealth

PolicyElrexfio (elranatamab-bcmm) injection solution

Policy CodePolicy MG.MM.PH.394

Change TypeAnnual Review — diagnosis/code updates

Effective Date

Next Review DateApr 3, 2025

Key ActionSubmit clinical evidence that the member meets the coverage criteria to obtain prior authorization.

SourceLink

POLICY UPDATE CHANGES

Annual Review: updated diagnosis codes.

Annual Review: removed C9399 and J9999, added C9165 and J1323, updated dosing limits, no criteria changes.

≥4Required prior therapies for eligibility

6 moInitial authorization

12 moRenewal authorization

J1323HCPCS

ListedNDCs

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Coverage and Medical Necessity Criteria

Initial Therapy (Multiple Myeloma)

Covered when ALL of the following are met

Age: Patient is 18 years of age or older>=18 years

Diagnosis and prior therapy: Patient has relapsed or refractory multiple myeloma and has tried and failed at least four prior therapies including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody>=4 prior lines

Continuation / Renewal Criteria

Renewal covered when ALL of the following are met

Response: Member has responded positively to the treatment as determined by the prescribing physicianclinical response per prescriber

Toxicity: Member has not experienced unacceptable toxicity from the drugno unacceptable toxicity

This policy applies only to adult patients (≥18 years). Patients under 18 years of age (pediatric patients) are excluded from coverage for this indication per the policy definition of eligible patients.

salvage

Line of therapy: Relapsed or refractory multiple myeloma after at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody>=4 prior lines

Dosing and Regimens

Regimen	Schedule
{"text":"Step-up dosing","status":""},{"text":"12 mg subcutaneous on Day 1; 32 mg subcutaneous on Day 4; 76 mg subcutaneous on Day 8 (first treatment dose)","status":""}
{"text":"Maintenance dosing","status":""},{"text":"76 mg subcutaneous weekly through Week 24; then 76 mg every 2 weeks thereafter","status":""}

Provider Requirements and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial approvals are for 6 months; continuation approvals may be granted for 12 months when criteria are met.

Initial Approval: 6 months
Continuation Approval: 12 months

Documentation Required

Clinical Evidence Submission

The treating physician must submit clinical evidence that the member meets the coverage criteria for review. Without submission of the required clinical documentation, EmblemHealth will be unable to properly review the request for preauthorization or for post-payment review. Clinical evidence should demonstrate the member meets the specific medical necessity criteria for the indication being requested.

Treating physician or primary care provider must submit clinical evidence to EmblemHealth.
Failure to submit documentation may prevent preauthorization or post-payment review.

Applicable Billing and Diagnosis Codes

Applicable HCPCS CodesHCPCSCovered

J1323

Injection, elranatamab-bcmm, 1 mg

Applicable NDCsNDCCovered

00069-2522-xx	Elrexfio 40mg/mL 1.1mL
00069-4494-xx	Elrexfio 40mg/mL 1.9mL

Applicable ICD-10 DiagnosesICD-10Covered

C90.00	Multiple myeloma not having achieved remission
C90.02	Multiple myeloma in relapse
C90.10	Plasma cell leukemia not having achieved remission
C90.11	Plasma cell leukemia in remission
C90.12	Plasma cell leukemia in relapse

inv-07: Prior therapies requirement

Required number of prior therapiesAt least four prior therapies (>=4 prior lines)

Required therapy classes (examples)Must include a proteasome inhibitor (PI)

Required therapy classes (examples)Must include an immunomodulatory drug (IMiD)

Required therapy classes (examples)Must include an anti‑CD38 monoclonal antibody

Age requirement tied to prior therapiesPatient must be 18 years of age or older

Clinical Background

Elranatamab-bcmm (ELREXFIO) is a bispecific BCMA-directed T‑cell engaging antibody that binds BCMA on plasma cells, plasmablasts, and multiple myeloma cells and CD3 on T cells, resulting in T‑cell activation, proinflammatory cytokine release, and cytolysis of BCMA‑expressing myeloma cells. It is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 monoclonal antibody.

Drug Definitions

inv-13: ELREXFIO (elranatamab-bcmm)

Drug name (generic / brand)Elranatamab‑bcmm (ELREXFIO)

Mechanism of actionBispecific BCMA‑directed T‑cell engaging antibody that binds BCMA on plasma cells and CD3 on T cells, activating T cells and leading to cytolysis of BCMA‑expressing cells

Pharmacologic effects notedActivation of T cells with proinflammatory cytokine release and resultant multiple myeloma cell lysis

Indication summaryFor adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy including a PI, an IMiD, and an anti‑CD38 antibody

Operational Notes

Documentation Required

Documentation required for review (operational reminder)

The treating physician or primary care provider must submit clinical evidence to EmblemHealth (or ConnectiCare, as applicable) demonstrating the member meets the policy criteria to enable preauthorization or post-payment review.

Failure to submit required clinical evidence may prevent proper preauthorization or post-payment review and lead to denial.