CurrentViva HealthPolicy IC-0724

Elrexfio (elranatamab-bcmm) subcutaneous — coverage criteria

Defines prior authorization, dosing, renewal, and coverage criteria for Elrexfio (elranatamab-bcmm) subcutaneous in adults with relapsed or refractory multiple myeloma for Viva Health members.

Policy Summary

PayerViva Health

PolicyElrexfio (elranatamab-bcmm) subcutaneous — coverage criteria

Policy CodePolicy IC-0724

Change TypeNo material changes

Effective Date

Next Review DateMay 5, 2026

Key ActionObtain prior authorization; initial PA valid 6 months after inpatient step-up dosing and is renewable every 6 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial prior authorization validity

76 mgstandard treatment dose

≥18minimum member age for coverage

J1323HCPCS billing code (1 mg/unit)

≥4prior lines of therapy required

Coverage Criteria for Elrexfio (elranatamab-bcmm)

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Initial Approval Criteria

Covered when ALL of the following are met

Age and administration: Member is at least 18 years of age AND used as continuation therapy following inpatient administration of step-up dose 1 and step-up dose 2 AND member had an absence of unacceptable toxicity while on inpatient administration of step-up doses

Supports initial prior authorization validity

Universal criteria: Member does not have an active infection, including clinically important localized infections AND member will be administered prophylaxis for infection according to local guidelines AND member has not had an allogenic or an autologous stem cell transplant within the previous 12 weeks AND used as single agent treatment

Universal safety and administration conditions

Disease and prior therapy: Member has relapsed or refractory disease AND member has received at least 4 prior lines of therapy including a proteasome inhibitor (e.g., bortezomib, carfilzomib, ixazomib), an immunomodulatory agent (e.g., lenalidomide, thalidomide, pomalidomide), and an anti-CD38 monoclonal antibody (e.g., daratumumab, isatuximab)>=4 prior lines including PI, IMiD, anti-CD38

Line-of-therapy prerequisite

Renewal Criteria

Renewal is allowed when ALL of the following are met

Ongoing eligibility: Member continues to meet the universal and other indication-specific relevant criteria identified for initial approval (e.g., concomitant therapy requirements excluding prerequisite therapy, performance status) AND disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread AND absence of unacceptable toxicity from the drug

Examples of unacceptable toxicity include severe infections, neutropenia/febrile neutropenia, severe hepatotoxicity, neurologic toxicity including ICANS, and cytokine release syndrome (CRS)

Coverage is excluded when the member has an active infection (including clinically important localized infections), has had an allogenic or autologous stem cell transplant within the prior 12 weeks, or when Elrexfio is intended to be used in combination with other antineoplastic agents rather than as single‑agent therapy. Members must also receive appropriate infection prophylaxis per local guidelines; failure to meet these universal safety and administration conditions may render treatment ineligible under these criteria.

For Medicare Part B beneficiaries, coverage determinations for outpatient drugs are governed by the Medicare Benefit Policy Manual (Pub. 100‑2), Chapter 15, §50, and by any applicable National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), or Local Coverage Articles (LCAs). Where such CMS documents exist, compliance with those policies is required and may alter or supersede the non‑Medicare coverage rules in this policy; use the CMS coverage database (https://www.cms.gov/medicare-coverage-database/search.aspx) to identify relevant NCDs/LCDs/LCAs.

Coverage is limited to members who meet the disease and prior therapy prerequisites: the member must have relapsed or refractory disease and must have received at least 4 prior lines of therapy, which must include a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 monoclonal antibody. Use is not medically necessary for members who have not completed these required prior lines or who do not meet the universal safety/administration criteria (for example, active infection, recent transplant, or combination‑use).

Phase	Dose and timing	Administration notes
{"text":"Step-up (Day 1)","status":""}\|{"text":"12 mg subcutaneous on Day 1","status":""}\|{"text":"Hospitalize for 48 hours after first step-up dose; administer pre-treatment medications prior to dose","status":""}
{"text":"Step-up (Day 4)","status":""}\|{"text":"32 mg subcutaneous on Day 4","status":""}\|{"text":"Hospitalize for 24 hours after second step-up dose; maintain minimum 2 days between Day 1 and Day 4 doses; give pre-treatment medications","status":""}
{"text":"First treatment dose (Day 8)","status":""}\|{"text":"76 mg subcutaneous on Day 8","status":""}\|{"text":"Minimum 3 days between step-up dose 2 and first treatment dose; administer pre-treatment medications","status":""}
{"text":"Maintenance (Weeks 2–24)","status":""}\|{"text":"76 mg subcutaneous once weekly through Week 24","status":""}\|{"text":"Maintain minimum 6 days between treatment doses; outpatient administration after inpatient step-up period","status":""}
{"text":"Responder maintenance (Week ≥25)","status":""}\|{"text":"Transition to 76 mg every 2 weeks for members with ≥PR maintained ≥2 months after ≥24 weeks of treatment","status":""}\|{"text":"May transition to every 4 weeks (76 mg) for members who have been on the biweekly schedule and have maintained response","status":""}

Billing and Coding

Covered HCPCS CodesHCPCSCovered

J1323

Injection, elranatamab-bcmm, 1 mg; 1 billable unit = 1 mg

NDCsNDC

00069-4494-xx	Elrexfio 76 mg/1.9 mL solution for injection in a single-dose vial
00069-2522-xx	Elrexfio 44 mg/1.1 mL solution for injection in a single-dose vial

Covered ICD-10 Diagnosis CodesICD-10Covered

C90.00	Multiple myeloma not having achieved remission
C90.02	Multiple myeloma in relapse
C90.10	Plasma cell leukemia not having achieved remission
C90.12	Plasma cell leukemia in relapse
C90.20	Extramedullary plasmacytoma not having achieved remission
C90.22	Extramedullary plasmacytoma in relapse
C90.30	Solitary plasmacytoma not having achieved remission
C90.32	Solitary plasmacytoma in relapse
Z85.79	Personal history of other malignant neoplasms of lymphoid, hematopoietic and related tissues

Medicare Part B Covered Diagnosis CodesICD-10

No codes listed

HCPCS units and dosing frequency

Billing unit and equivalenceHCPCS J1323 = 1 mg per billable unit (use when billing); standard treatment dose equals 76 mg (76 billable units)

Initial dosing frequency76 billable units weekly through week 24

Maintenance dosing frequency (responders)After ≥24 weeks and response maintained ≥2 months, transition to 76 billable units every two weeks

Extended maintenance optionFor members who maintain response on every-two-week schedule after additional treatment, consider transition to 76 billable units every four weeks

Minimum interval between treatment dosesA minimum of 6 days should be maintained between treatment doses

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Initial prior authorization is valid for 6 months (180 days) following inpatient administration of the two step‑up doses (step‑up dose 1 and step‑up dose 2). Authorizations may be renewed every 6 months (180 days).

Initial PA: 6 months (180 days) after inpatient receipt of step‑up dose 1 and step‑up dose 2
Renewal: renewable every 6 months (180 days)

Note

Medicare Part B Coverage Reference

Medicare Part B coverage may apply. Follow the Medicare Benefit Policy Manual (Pub. 100-02), Chapter 15, §50 — Drugs and Biologicals, and comply with any applicable National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs). Non‑Medicare information in this section is intended for non‑Medicare coverage determinations; if Medicare rules apply, denials may occur when NCDs/LCDs are not met.

See: Medicare Benefit Policy Manual (Pub. 100-02), Chapter 15, §50
Search NCD/LCD/LCA: https://www.cms.gov/medicare-coverage-database/search.aspx
Medicare Part B Covered Diagnosis Codes: N/A (per appendix)

Step Therapy

Prerequisite Therapy

Prerequisite Therapy Requirement: Prior authorization is contingent on documented prior therapy history showing relapsed or refractory multiple myeloma with exposure to at least four prior lines of therapy that include a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 monoclonal antibody.

Must have relapsed or refractory disease
At least 4 prior lines of therapy, including: a proteasome inhibitor (e.g., bortezomib, carfilzomib, ixazomib), an immunomodulatory agent (e.g., lenalidomide, thalidomide, pomalidomide), and an anti‑CD38 monoclonal antibody (e.g., daratumumab, isatuximab)

Documentation Required

Required Documentation and Potential Denial Triggers

Documentation Required: Include patient age, confirmation of inpatient administration and tolerability of both step‑up doses, detailed prior therapy history demonstrating ≥4 prior lines including PI/IMiD/anti‑CD38, absence of unacceptable toxicity to step‑up dosing, and infection prophylaxis plan. Missing or incomplete documentation (including failure to show inpatient step‑up dosing or intolerable toxicity) may result in denial.

Age ≥ 18 years
Evidence of inpatient administration of step‑up dose 1 and step‑up dose 2 and documentation of tolerability
Prior therapy history with at least 4 prior lines including proteasome inhibitor, immunomodulatory agent, and anti‑CD38 antibody
Documentation of infection status and prophylaxis plan
No allogeneic or autologous stem cell transplant within prior 12 weeks
Used as single‑agent treatment

Denial Risk

Triggers for Denial

Denial Risk: Prior authorization will be denied for patients under 18 years of age, lack of documented inpatient step‑up dosing or intolerable toxicity from step‑up doses, failure to meet prerequisite prior therapies, active/uncontrolled infections without prophylaxis, recent transplant within 12 weeks, or non‑compliance with required documentation. For Medicare members, denials may also occur if applicable NCDs/LCDs/LCAs are not met.

Age < 18 years — not eligible
Missing inpatient step‑up dose administration or evidence of unacceptable toxicity — denial risk
Failure to document ≥4 prior lines including required drug classes — denial risk
Active clinically important infection or no prophylaxis — denial risk
Allogeneic/autologous SCT within 12 weeks — denial risk
Medicare: non‑compliance with NCDs/LCDs/LCAs may result in denial

Definitions and Key Terms

Step-up dosing definition

Step-up dose 112 mg on Day 1 (administered inpatient)

Step-up dose 232 mg on Day 4 (administered inpatient)

Purpose of step-up dosingAdministered inpatient to reduce incidence and severity of cytokine release syndrome (CRS) prior to first full treatment dose

First full treatment dose timingFirst treatment dose of 76 mg on Day 8 after step-up sequence

Unacceptable toxicity definition

Severe infectionsIncludes significant or life-threatening infections occurring while on therapy

Neutropenia / Febrile neutropeniaSevere decreases in neutrophil counts and associated febrile episodes

Severe hepatotoxicitySignificant liver injury attributed to the drug

Neurologic toxicity including ICANSImmune Effector Cell-Associated Neurotoxicity Syndrome and other severe neurologic events

Cytokine release syndrome (CRS)Severe CRS events prompting discontinuation or withholding of therapy

CMS coverage documents (Medicare Part B)

NCDNational Coverage Determination (NCD) — CMS-level policy for Medicare coverage of items and services

LCDLocal Coverage Determination (LCD) — Jurisdiction-specific contractor policy that may govern Medicare Part B coverage

LCALocal Coverage Article (LCA) — Article accompanying an LCD to clarify payment or benefit eligibility for Part B drugs

Covered Regimens and Dosing

Schedule element	Details	Switching / maintenance criteria
{"text":"Step-up dosing sequence","status":""}\|{"text":"12 mg on Day 1 then 32 mg on Day 4 (both subcutaneous)","status":""}\|{"text":"Step-up doses given inpatient to mitigate CRS risk; hospital observation 48 hrs after Day 1 and 24 hrs after Day 4","status":""}
{"text":"Initiation of full-dose therapy","status":""}\|{"text":"First full treatment dose 76 mg on Day 8 (subcutaneous)","status":""}\|{"text":"Minimum intervals: ≥2 days between step-up 1 and 2; ≥3 days between step-up 2 and Day 8","status":""}
{"text":"Weekly maintenance","status":""}\|{"text":"76 mg once weekly through Week 24","status":""}\|{"text":"Continue weekly dosing with minimum 6 days between treatment doses until Week 24","status":""}
{"text":"Biweekly maintenance (responders)","status":""}\|{"text":"For members who have received ≥24 weeks of treatment and achieved ≥partial response (PR) maintained for ≥2 months, switch to 76 mg every 2 weeks","status":""}\|{"text":"Eligibility requires ≥24 weeks of treatment and sustained PR or better for ≥2 months","status":""}
{"text":"Every-4-week maintenance (responders on biweekly)","status":""}\|{"text":"For members who have been on the every-2-week schedule after ≥24 weeks and have maintained response, switch to 76 mg every 4 weeks","status":""}\|{"text":"Requires maintained response while on biweekly schedule before transition to every 4 weeks","status":""}

Phase	Dose and timing	Administration notes
{"text":"Step-up (Day 1)","status":""}\|{"text":"12 mg subcutaneous on Day 1","status":""}\|{"text":"Hospitalize for 48 hours after first step-up dose; administer pre-treatment medications prior to dose","status":""}
{"text":"Step-up (Day 4)","status":""}\|{"text":"32 mg subcutaneous on Day 4","status":""}\|{"text":"Hospitalize for 24 hours after second step-up dose; maintain minimum 2 days between Day 1 and Day 4 doses; give pre-treatment medications","status":""}
{"text":"First treatment dose (Day 8)","status":""}\|{"text":"76 mg subcutaneous on Day 8","status":""}\|{"text":"Minimum 3 days between step-up dose 2 and first treatment dose; administer pre-treatment medications","status":""}
{"text":"Maintenance (Weeks 2–24)","status":""}\|{"text":"76 mg subcutaneous once weekly through Week 24","status":""}\|{"text":"Maintain minimum 6 days between treatment doses; outpatient administration after inpatient step-up period","status":""}
{"text":"Responder maintenance (Week ≥25)","status":""}\|{"text":"Transition to 76 mg every 2 weeks for members with ≥PR maintained ≥2 months after ≥24 weeks of treatment","status":""}\|{"text":"May transition to every 4 weeks (76 mg) for members who have been on the biweekly schedule and have maintained response","status":""}

Schedule element	Details	Switching / maintenance criteria
{"text":"Step-up dosing sequence","status":""}\|{"text":"12 mg on Day 1 then 32 mg on Day 4 (both subcutaneous)","status":""}\|{"text":"Step-up doses given inpatient to mitigate CRS risk; hospital observation 48 hrs after Day 1 and 24 hrs after Day 4","status":""}
{"text":"Initiation of full-dose therapy","status":""}\|{"text":"First full treatment dose 76 mg on Day 8 (subcutaneous)","status":""}\|{"text":"Minimum intervals: ≥2 days between step-up 1 and 2; ≥3 days between step-up 2 and Day 8","status":""}
{"text":"Weekly maintenance","status":""}\|{"text":"76 mg once weekly through Week 24","status":""}\|{"text":"Continue weekly dosing with minimum 6 days between treatment doses until Week 24","status":""}
{"text":"Biweekly maintenance (responders)","status":""}\|{"text":"For members who have received ≥24 weeks of treatment and achieved ≥partial response (PR) maintained for ≥2 months, switch to 76 mg every 2 weeks","status":""}\|{"text":"Eligibility requires ≥24 weeks of treatment and sustained PR or better for ≥2 months","status":""}
{"text":"Every-4-week maintenance (responders on biweekly)","status":""}\|{"text":"For members who have been on the every-2-week schedule after ≥24 weeks and have maintained response, switch to 76 mg every 4 weeks","status":""}\|{"text":"Requires maintained response while on biweekly schedule before transition to every 4 weeks","status":""}

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