ModifiedmhnPolicy CP.PHAR.410

Bortezomib (Boruzu, Velcade) coverage

Defines medical necessity, approval criteria, dosing, and coverage durations for bortezomib (Boruzu, Velcade) for adults with multiple myeloma, mantle cell lymphoma, and selected NCCN-recommended off-label uses for members of Centene-affiliated health plans.

Policy Summary

Payermhn

PolicyBortezomib (Boruzu, Velcade) coverage

Policy CodePolicy CP.PHAR.410

Change TypeCoding, formulation, and approval duration updates

Effective DateDec 11, 2018

Next Review Date

Key ActionSubmit prior authorization with documentation showing diagnosis, prescriber specialty, age, dosing within limits (≤1.3 mg/m2) or supporting literature for off-label dosing, and evidence of response for continuation requests.

SourceLink

POLICY UPDATE CHANGES

Added new formulation Boruzu to the policy and HCPCS coding.

Corrected commercial continued approval duration to '6 months or to the member's renewal date, whichever is longer.'

Updated HCPCS codes: added J9046, J9048, J9049 and later added J9051; removed inactive J9044.

Removed specification that 1 mg and 2.5 mg strengths were specially indicated after one prior therapy per PI update and revised product solution availability.

1.3 mg/m2max dose

6 monthsinitial approval

12 monthscontinuation (Medicaid/HIM)

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Coverage Criteria

Initial Approval — Multiple Myeloma and Mantle Cell Lymphoma

Covered when ALL of the following are met

Initial Approval MM/MCL: 1) Diagnosis of one of the following: a) Multiple myeloma (MM); or b) Mantle cell lymphoma (MCL, B‑cell lymphoma subtype).; 2) Prescribed by or in consultation with an oncologist or hematologist.; 3) Age ≥ 18 years.; 4) For Boruzu and Velcade requests, member must use bortezomib unless contraindicated or clinically significant adverse effects are experienced.; 5) Request meets one of the following: a) Dose does not exceed 1.3 mg/m2; OR b) Dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence).

Prescribed regimen must be FDA‑approved or recommended by NCCN.

Initial Approval — NCCN Recommended Uses (off-label)

Covered when ALL of the following are met

NCCN‑recommended off‑label uses: 1) Diagnosis of one of the following NCCN‑recommended uses: a) Kaposi sarcoma (advanced cutaneous, oral, visceral, or nodal disease) after ≥2 prior lines of systemic therapy; b) Mantle cell lymphoma (B‑cell lymphoma); c) HIV‑related B‑cell lymphoma; d) Multicentric Castleman’s disease (B‑cell subtype) as subsequent therapy; e) Systemic light chain amyloidosis; f) Adult T‑cell leukemia/lymphoma as subsequent therapy; g) Waldenström macroglobulinemia/lymphoplasmacytic lymphoma; h) T‑cell acute lymphoblastic leukemia (T‑ALL) for relapsed or refractory disease; i) Pediatric acute lymphoblastic leukemia (ALL) as subsequent therapy; j) Pediatric Hodgkin lymphoma (HL) as subsequent therapy in combination with ifosfamide and vinorelbine.; 2) Prescribed by or in consultation with an oncologist or hematologist.; 3) Age ≥ 18 years for adult indications (pediatric exceptions noted for ALL and HL).; 4) For Boruzu and Velcade requests, member must use bortezomib unless contraindicated or clinically significant adverse effects are experienced.; 5) Dose is within FDA maximum limit for any FDA‑approved indication or is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence).

Prescribed regimen must be FDA‑approved or recommended by NCCN; prescriber must supply supporting evidence for off‑label dosing/uses.

Continuation Therapy (All Indications in Section I)

Covered when ALL of the following are met

Continuation criteria: 1) Member is currently receiving the medication via the Centene benefit, or documentation supports current receipt of the requested agent for a covered indication and has received the medication for at least 30 days.; 2) Member is responding positively to therapy.; 3) For Boruzu and Velcade requests, member must use bortezomib unless contraindicated or clinically significant adverse effects are experienced.; 4) If request is for a dose increase, the new dose must either: a) not exceed 1.3 mg/m2; OR b) be supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence).

Prescribed regimen must be FDA‑approved or recommended by NCCN.

Coverage is not authorized for non‑FDA approved indications that are not specifically addressed in this policy unless the provider supplies sufficient documentation of efficacy and safety consistent with the referenced off‑label use policies or the member’s evidence of coverage. Providers seeking authorization for an off‑label use must follow the plan’s off‑label review processes (see CP.CPA.09 for commercial, HIM.PA.154 for marketplace, and CP.PMN.53 for Medicaid) and submit supporting clinical evidence when requested.

The listing of procedure or HCPCS/CPT codes in this policy is for informational and billing reference only. Inclusion or exclusion of any codes does not guarantee coverage. Providers must confirm coverage and follow the most up‑to‑date professional coding guidance and the member’s benefit documents when submitting claims.

Coding

Covered CPT Codesmixed

No codes listed

HCPCS codes for bortezomib productsHCPCS

J9041	Injection, bortezomib (Velcade), 0.1 mg
J9046	Injection, bortezomib (Dr. Reddy's), not therapeutically equivalent to J9041, 0.1 mg
J9048	Injection, bortezomib (Fresenius Kabi), not therapeutically equivalent to J9041, 0.1 mg
J9049	Injection, bortezomib (Hospira), not therapeutically equivalent to J9041, 0.1 mg
J9051	Injection, bortezomib (Maia), not therapeutically equivalent to J9041, 0.1 mg
J9054	Injection, bortezomib (Boruzu), 0.1 mg

inv-08: Maximum dose

Maximum dose1.3 mg/m2

Route/formulation detailsIV bolus (3–5 seconds) or subcutaneous injection

Typical dosing contextsUsed as 1.3 mg/m2 for first-line and relapse regimens per dosing guidance

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Bortezomib products (including Velcade, Boruzu, and other branded/generic formulations) require prior authorization. Requests must demonstrate the member meets the applicable medical necessity criteria in this policy (initial or continuation therapy) and include all required supporting documentation.

Applicable HCPCS: J9041, J9046, J9048, J9049, J9051, J9054 — prior authorization required for these codes
Prescriber requirement: Prescribed by or in consultation with an oncologist or hematologist
Age requirement: Age ≥ 18 years for adult indications (see policy for pediatric exceptions)

Billing Rule

HCPCS Codes and Prior Authorization

HCPCS coding is provided for informational purposes and links to PA requirements. Inclusion of a code here does not guarantee coverage — PA must be obtained and documentation submitted to support the coded indication and dose.

Covered Regimens

Regimen	Indication	Dose / Schedule	Coverage Status
Bortezomib + melphalan + prednisone	First-line multiple myeloma	Bortezomib 1.3 mg/m2 IV (3–5 second bolus) or SC in combination with oral melphalan and oral prednisone for nine 6-week treatment cycles

Regimen	Indication	Dose / Schedule	Coverage Status
Bortezomib as single agent or with dexamethasone	Relapsed multiple myeloma	Bortezomib 1.3 mg/m2 IV (3–5 second bolus) or SC as a single agent or in combination with dexamethasone for up to eight 3‑week cycles; therapy beyond eight cycles per PI; if relapse ≥6 months after prior response, may restart at last tolerated dose

Regimen	Indication	Dose / Schedule	Coverage Status
Bortezomib + rituximab + cyclophosphamide + doxorubicin + prednisone	First-line mantle cell lymphoma	Bortezomib 1.3 mg/m2 IV (3–5 second bolus) or SC in combination with IV rituximab, cyclophosphamide, doxorubicin, and oral prednisone for up to six 3‑week treatment cycles, plus two additional cycles if a positive response

Regimen	Indication / Source	Notes	Coverage Status
Bortezomib-containing regimens per NCCN compendium	NCCN-recommended uses (examples include Kaposi sarcoma, HIV-related B-cell lymphoma, multicentric Castleman's disease as subsequent therapy, systemic light chain amyloidosis, Waldenström macroglobulinemia, relapsed/refractory T‑ALL, selected pediatric ALL/HL subsequent therapy)	Regimens and dosing per NCCN Drugs & Biologics Compendium and disease‑specific NCCN guidelines; off‑label uses covered when NCCN recommends and policy initial criteria are met

Definitions

inv-18: MCL — Mantle cell lymphoma definition

DefinitionMantle cell lymphoma (MCL) — a B-cell lymphoma subtype

Relevant approvalsBortezomib is indicated for MCL in combination regimens per dosing guidance

Typical first-line regimenBortezomib 1.3 mg/m2 IV or SC with rituximab, cyclophosphamide, doxorubicin, and prednisone for up to six 3-week cycles (plus two cycles if response)

inv-19: MM — Multiple myeloma definition

DefinitionMultiple myeloma (MM)

Relevant approvalsBortezomib is indicated for MM; first-line regimen includes bortezomib 1.3 mg/m2 IV or SC with melphalan and prednisone for nine 6-week cycles

Line of Therapy

first-line

First‑line MM regimen: First‑line multiple myeloma: bortezomib 1.3 mg/m2 IV bolus (3–5 seconds) or subcutaneous injection in combination with oral melphalan and oral prednisone for nine 6‑week treatment cycles.

Maximum dose = 1.3 mg/m2 per dosing guidance.

first-line

First‑line MCL regimen: First‑line mantle cell lymphoma: bortezomib 1.3 mg/m2 IV bolus (3–5 seconds) or subcutaneous injection in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone for up to six 3‑week treatment cycles, plus two additional cycles if a positive response is achieved.

Maximum dose = 1.3 mg/m2 per dosing guidance.

salvage

Background

Bortezomib is a reversible proteasome inhibitor used in the treatment of hematologic malignancies and is FDA‑approved for multiple myeloma (MM) and mantle cell lymphoma (MCL). This policy defines medical necessity, dosing limits (including a maximum dose of 1.3 mg/m2 for typical regimens), and approved regimens for those indications and also incorporates selected NCCN‑recommended off‑label hematologic uses where supported by compendia or the referenced off‑label policies. Requests for non‑FDA indications must include sufficient clinical evidence per the plan’s off‑label policies and may be reviewed against NCCN guidance and the member’s benefit documents.