CurrentEmblemHealthPolicy MG.MM.PH.322

Blenrep (belantamab mafodotin-blmf) Intravenous

Medical coverage policy governing intravenous belantamab mafodotin (Blenrep) for treatment of relapsed or refractory multiple myeloma for EmblemHealth members; applies to provider preauthorization and renewal requests.

Policy Summary

PayerEmblemHealth

PolicyBlenrep (belantamab mafodotin-blmf) Intravenous

Policy CodePolicy MG.MM.PH.322

Change TypeAnnual review

Effective DateNov 11, 2020

Next Review DateFeb 27, 2025

Key ActionSubmit clinical evidence that the member meets policy criteria to support prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial authorization period

2.5 mg/kgDose per infusion

574Max units/21 days

≥4Prior therapy required

Coverage Criteria for Blenrep (belantamab mafodotin)

inv-01: Initial Therapy

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Initial coverage criteria: A. Patient is 18 years of age or older; AND B. Blenrep is prescribed by, or in consultation with, an oncologist; AND C. The patient has a diagnosis of multiple myeloma; AND D. The patient has relapsed or refractory disease; AND E. The patient has previously received at least four systemic lines of therapy for the treatment of multiple myeloma, including one drug from each of the following classes: i. Anti‑CD38 monoclonal antibody; ii. Proteasome inhibitor; iii. Immunomodulatory agent; AND F. Blenrep will be prescribed and dispensed in accordance with the BLENREP REMS program.

inv-02: Renewal Criteria

Coverage can be renewed in 6-month intervals when ALL of the following are met:

Renewal criteria: 1. Stabilization of disease or absence of disease progression; AND 2. Absence of unacceptable toxicity from the drug (examples include ocular toxicity, infusion-related and hypersensitivity reactions, myelosuppression).

This policy governs medical coverage of intravenous belantamab mafodotin (Blenrep) for EmblemHealth members. The document notes that BLENREP was withdrawn from the US market in 2/2023 (recorded in the revision history), though the policy text does not otherwise add an explicit exclusion based solely on market withdrawal. The policy remains a coverage with criteria document that establishes clinical and administrative requirements for prior authorization, dosing limits, and renewal when used for relapsed or refractory multiple myeloma.

Continuation of treatment with belantamab mafodotin is not supported when there is documented disease progression or when the patient experiences unacceptable toxicity. Examples of unacceptable toxicity listed in the renewal criteria include ocular toxicity, infusion-related and hypersensitivity reactions, and myelosuppression. When treatment is discontinued for progression or toxicity, follow-up actions should include documenting the reason for stopping therapy in the medical record and submitting that information with any subsequent authorization or appeals to support clinical decision-making and reimbursement review.

Regimen	Indication	Dosing	Maximum units per 21 days
Belantamab mafodotin (Blenrep) intravenous regimen
Relapsed or refractory multiple myeloma after ≥4 prior systemic lines of therapy including an anti‑CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent
2.5 mg/kg IV infusion over approximately 30 minutes once every 3 weeks
574 billable units (287 mg) every 21 days

Coding — Procedure, NDC, and Diagnosis Codes

Applicable Procedure CodesHCPCSCovered

J9037

Injection, belantamab mafodotin-blmf, 0.5 mg; 1 billable unit = 0.5 mg

Applicable NDCsNDC

00173-0896-01

Blenrep 100-mg single-dose vial

Applicable ICD-10 DiagnosesICD-10Covered

C90.0	Multiple myeloma
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
D47.2	Monoclonal gammopathy
Z85.79	Personal history of other malignant neoplasms of lymphoid, hematopoietic and related tissues

Max HCPCS units per dosing interval

Maximum HCPCS units per dosing interval574 billable units (287 mg) every 21 days

HCPCS unit definition1 billable unit = 0.5 mg (per J9037 description in coding)

Dosing intervalEvery 21 days (once every 3 weeks)

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required — submit documentation that the member meets age, diagnosis, prior lines of therapy, oncologist involvement, and BLENREP REMS enrollment.

Patient age (>= 18 years).
Diagnosis of multiple myeloma and documentation of relapsed or refractory disease.
Evidence that BLENREP is prescribed by or in consultation with an oncologist.
Documentation of enrollment and compliance with the BLENREP REMS program.

Documentation Required

Clinical Evidence Submission Required

The treating physician or primary care provider must submit clinical evidence that the member meets all policy criteria for multiple myeloma treatment with BLENREP. Without this documentation, EmblemHealth will not be able to properly review the prior authorization request or perform post-payment review.

Clinical notes and treatment history supporting relapsed/refractory status.
Confirmation that the patient has received at least four prior systemic lines of therapy.
Specific agents/classes used in prior lines, showing inclusion of: anti‑CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.
Oncologist consultation notes when therapy is prescribed by a non-oncologist.

Denial Risk

Documentation Required for Review

Documentation required for review — missing or incomplete evidence may prevent proper review and result in denial or delay of authorization.

Complete prior therapy history (dates, agents, responses).
Diagnostic and staging information supporting current disease status.
REMS enrollment documentation and dispensing plan.
Provider contact information and treating oncologist name/signature, if applicable.

Covered Regimens and Administration

Regimen	Indication / Prior therapy requirement	Dosing regimen	Max HCPCS units (per 21 days)
Belantamab mafodotin (Blenrep)
Relapsed/refractory multiple myeloma in patients who have received ≥4 prior systemic lines of therapy, including an anti‑CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent
2.5 mg/kg IV infusion over ~30 minutes every 3 weeks
574 billable units (287 mg) every 21 days

Line of Therapy Definition

inv-15: salvage

Line of therapy requirement: Patient must have relapsed or refractory disease and previously received at least four systemic lines of therapy including an anti‑CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.>=4 prior systemic lines

Salvage therapy context: intended for patients at salvage line of therapy who have exhausted prior systemic options.

Drug Definitions

Blenrep (belantamab mafodotin-blmf) — ADC description and mechanism

Agent class and targetBlenrep (belantamab mafodotin-blmf) is an antibody–drug conjugate (ADC); the antibody is an afucosylated IgG1 directed against BCMA

Cytotoxic payloadThe small-molecule payload is monomethyl auristatin F (MMAF), a microtubule inhibitor that disrupts the microtubule network leading to cell-cycle arrest and apoptosis

Mechanism of tumor cell killAfter BCMA binding and internalization, proteolytic cleavage releases MMAF intracellularly; tumor killing occurs via MMAF-induced apoptosis and antibody-mediated cytotoxicity/phagocytosis (ADCC/ADCP)

Administration noteAdministered intravenously per dosing regimen; policy revision history notes withdrawal from the US market in 2/2023

Background

Belantamab mafodotin (Blenrep) is an antibody–drug conjugate targeting B-cell maturation antigen (BCMA) on plasma cells. The ADC consists of an afucosylated IgG1 antibody linked to the microtubule inhibitor monomethyl auristatin F (MMAF); after BCMA binding and internalization, the MMAF payload is released intracellularly to disrupt microtubules, cause cell-cycle arrest and apoptosis, and the antibody component may mediate antibody-dependent cellular cytotoxicity/phagocytosis.

Revision History

2025-02-27annual reviewLatest

Annual review noted withdrawal of Blenrep (belantamab mafodotin) from the US market in February 2023.

2024-04-01annual review

Updated dosing limits; no changes to clinical coverage criteria.

2023-07-25annual review

Added ICD-10 diagnosis codes to the policy (multiple myeloma and related plasma cell neoplasms).