CurrentViva HealthPolicy IC-0561

Blenrep (belantamab mafodotin) — Coverage Criteria for Relapsed/Refractory Multiple Myeloma

Prior authorization policy for outpatient intravenous Blenrep for adults with relapsed or refractory multiple myeloma, including dosing, clinical criteria for initiation and renewal, and required monitoring.

Policy Summary

PayerViva Health

PolicyBlenrep (belantamab mafodotin) for multiple myeloma

Policy CodePolicy IC-0561

Change TypeNo material clinical or coverage changes

Effective DateSep 1, 2020

Next Review DateDec 2, 2025

Key ActionObtain prior authorization (initially valid 6 months, renewable every 6 months) and document baseline and ongoing ophthalmic exams including slit lamp and BCVA.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2.5 mg/kg q3wdose

280 mg q21dmax unit

6 monthsauth initial

every 6 morenewal

>=18min age

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Initial Therapy

Covered when ALL of the following are met:

Age: Patient is at least 18 years of age

Ophthalmic monitoring and ocular status: Baseline ophthalmic exam (including slit lamp exam and best corrected visual acuity) prior to first dose, ophthalmic exam prior to each dose and for new or worsening symptoms; therapy to be used with preservative-free artificial tears; patient does not have existing corneal epithelial disease (excludes mild punctate keratopathy)

Indication and prior therapy — combination or single agent: Either: (A) relapsed or refractory multiple myeloma used in combination with bortezomib and dexamethasone AND patient has received at least two prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent; OR (B) relapsed or refractory multiple myeloma used as a single agent AND patient has received at least three prior lines of therapy

Combination use is an FDA‑approved indication; single‑agent use is compendia‑approved

Transplant history: Patient has not had a prior allogeneic stem cell transplant

Renewal Criteria

Renewal is provided when ALL of the following are met:

Ongoing indication and performance: Patient continues to meet the indication‑specific relevant criteria such as concomitant therapy requirements and performance status identified in the Initial Therapy criteria

Clinical benefit: Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread

Tolerability: Absence of unacceptable toxicity from the drug (examples include ocular toxicity, severe infusion‑related reactions, thrombocytopenia)

The policy excludes patients with active corneal epithelial disease from initiation of belantamab mafodotin. Specifically, patients must not have existing corneal epithelial disease (note: this exclusion does not apply to mild punctate keratopathy). In addition, a history of prior allogeneic stem cell transplant is an exclusionary condition and such patients are not eligible for coverage under these criteria.

Coverage is limited to patients who meet the policy’s required prior lines of therapy. For use in combination with bortezomib and dexamethasone, the patient must have received at least two (2) prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent. For single‑agent use, the patient must have received at least three (3) prior lines of therapy. Use in patients who have received fewer than the specified prior lines of therapy is not supported.

Regimen	Dose / Schedule	Use
Belantamab mafodotin plus bortezomib and dexamethasone
Belantamab mafodotin 2.5 mg/kg IV every 3 weeks until disease progression or unacceptable toxicity
For relapsed or refractory multiple myeloma in patients who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent (FDA‑approved combination use)

Billing and Coding

HCPCS CodesHCPCS

C9399	Unclassified drugs or biologicals
J9999	Not otherwise classified, antineoplastic drugs

NDC(s)NDC

00173-0913-xx

Blenrep 70 mg lyophilized powder in single-dose vial for injection

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

inv-08: Per-dose HCPCS unit — maximum units per dose (HCPCS unit) and dosing frequency

Per-dose maximum (HCPCS unit)280 mg per dose

Dosing frequencyEvery 21 days (q3w)

Units reportingReport as HCPCS units consistent with 280 mg per dose

Provider Requirements, Documentation, and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial authorization will be provided for 6 months and may be renewed every 6 months thereafter. Patient must be at least 18 years of age at time of request.

Initial authorization: 6 months
Renewal: every 6 months
Minimum age: 18 years

Step Therapy

Required Prior Lines of Therapy

Required prior lines of therapy depend on how the therapy is used. When used in combination with bortezomib and dexamethasone, the patient must have received at least two prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent. When used as a single agent, the patient must have received at least three prior lines of therapy. The policy applies to relapsed or refractory multiple myeloma.

Combination therapy (with bortezomib + dexamethasone): ≥ 2 prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent
Single-agent use: ≥ 3 prior lines of therapy
Indication: relapsed or refractory multiple myeloma

Documentation Required

Required Clinical Documentation

Document baseline and ongoing ophthalmic assessments and treatment history. Lack of required documentation is a basis for denial.

Baseline ophthalmic exam including slit lamp exam and best corrected visual acuity (BCVA)
Ophthalmic assessment prior to each dose, for new or worsening ocular symptoms, and as clinically indicated
Documentation that therapy will be used with preservative-free artificial tears
Complete prior therapy history showing number and types of prior lines (agents/classes) to support step-therapy requirements

Denial Risk

Ophthalmic and Transplant Exclusions / Prior Therapy Failure

Exclusions that will result in non-coverage or denial if present at time of review.

Missing required ophthalmic examinations (baseline slit lamp and BCVA, ongoing assessments) — prior authorization will be denied if documentation is not provided
Existing corneal epithelial disease beyond mild punctate keratopathy — patients with more than mild corneal epithelial disease are excluded
Prior allogeneic stem cell transplant — patients with history of prior allogeneic transplant are excluded
Failure to meet required prior therapy requirements (see 'Required Prior Lines of Therapy') will result in non-coverage

Definitions

inv-15: Relapsed or refractory multiple myeloma — definition and linkage to ICD-10 codes

DefinitionMultiple myeloma that has relapsed after prior therapy or is refractory to treatment (relapsed or refractory disease)

Combination therapy requirementWhen used in combination with bortezomib and dexamethasone: patient must have received at least two prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent

Single-agent requirementWhen used as a single agent: patient must have received at least three prior lines of therapy

Ophthalmic and transplant linkageEligibility requires baseline and ongoing ophthalmic exams and absence of existing corneal epithelial disease (excluding mild punctate keratopathy); patient must not have had a prior allogeneic stem cell transplant

Related ICD-10 linkageSee covered diagnosis group for ICD-10 codes representing multiple myeloma, plasma cell leukemia, plasmacytoma and related history codes

Background

Belantamab mafodotin (Blenrep) is an antibody‑drug conjugate indicated for relapsed or refractory multiple myeloma. The policy addresses both combination and single‑agent use: when given with bortezomib and dexamethasone it is for patients who have received at least two (2) prior lines of therapy (including a proteasome inhibitor and an immunomodulatory agent); as a single agent it is for patients who have received at least three (3) prior lines of therapy. Because ocular toxicity is a known risk, the policy requires baseline and ongoing ophthalmic monitoring (including slit lamp exam and BCVA) and mandates use of preservative‑free artificial tears.

OpenPayer

Blenrep (belantamab mafodotin) — Coverage Criteria for Relapsed/Refractory Multiple Myeloma

Coverage Criteria for Blenrep (belantamab mafodotin)

Billing and Coding

Provider Requirements, Documentation, and Authorization

Line-of-Therapy Specifications

Definitions

Background

Revision History