CurrentCentenePolicy CP.PHAR.410

Bortezomib (Boruzu, Velcade)

Defines medical necessity criteria, indications (FDA-approved and NCCN-recommended off-label), dosing/administration guidance, contraindications, approval durations by line of business, required documentation, and coding implications for bortezomib formulations (Boruzu, Velcade, generics) for Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyBortezomib (Boruzu, Velcade)

Policy CodePolicy CP.PHAR.410

Change TypeAnnual review / formulary updates

Effective Date12.11.18

Next Review Date

Key ActionProvider must submit documentation (office notes, labs, other clinical information) supporting that member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

1Q 2026 annual review added KICS indication; added disease qualifiers for Castleman disease and Kaposi sarcoma; added monotherapy requirement for adult T-cell leukemia/lymphoma; removed requirement for use as subsequent therapy for pediatric ALL; revised Medicaid/HIM initial approval durations from 6 to 12 months.

RT4 added new formulation Boruzu and corrected Commercial continued approval duration to '6 months or to the member's renewal date'.

1Q 2025 annual review: for NCCN recommended uses initial criteria added mantle cell lymphoma and HIV-related B-cell lymphoma; updated 'AIDS-related Kaposi Sarcoma' to 'Kaposi Sarcoma'.

1Q 2024 annual review removed specification that 1 mg and 2.5 mg were specially indicated after 1 prior therapy; revised product availability.

1Q 2023 annual review updated HCPCS codes and applied template changes; added HCPCS J9051 and removed inactive J9044.

1Q 2022 annual review removed requirement for Velcade to be prescribed in combination with HIV therapy for Kaposi sarcoma; added T-ALL indication per NCCN.

2FDA-approved indications

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NCCN off-label indications listed

1.3 mg/m2Max dose (guideline)

≥30Min days to qualify for continuation

Coverage Summary

Background: Bortezomib is a proteasome inhibitor indicated for adult patients with multiple myeloma (MM) and mantle cell lymphoma (MCL). The policy addresses branded products Boruzu and Velcade as well as generic formulations and redirects branded requests to generic bortezomib when appropriate unless contraindicated or clinically significant adverse effects occur.

Scope summary / high-level coverage stance: Coverage is covered_with_criteria and aligned with FDA-approved indications and NCCN-recommended uses. The policy defines medical necessity criteria, required prescriber specialty (oncologist or hematologist), age requirements, dosing limits, approval durations by line of business, required documentation, and coding implications for bortezomib formulations (Boruzu, Velcade, generics).

Indications and dosing constraints: The FDA-approved indications are MM and MCL. Dosing guidance follows product labeling for first-line and relapse regimens; the referenced maximum dose is 1.3 mg/m2. For branded Boruzu and Velcade requests, members must use bortezomib (generic equivalent) unless contraindicated or clinically significant adverse effects are experienced. Prescribed regimens must be FDA-approved or recommended by NCCN, and off-label or >FDA dosing must be supported by practice guidelines or peer-reviewed literature submitted by the prescriber.

Initial Therapy Criteria

Initial Approval Criteria

Covered when ALL of the following are met:

ALL of the following

Diagnosis
- Multiple myeloma (MM)
- Mantle cell lymphoma (MCL) (B-cell lymphoma subtype)
Prescribed by or in consultation with an oncologist or hematologist
Age ≥ 18 years
For Boruzu and Velcade requests, member must use bortezomib, unless contraindicated or clinically significant adverse effects are experienced
Dose limits
- Dose does not exceed 1.3 mg/m2

NCCN-Recommended Off-Label Uses — Initial Approval

NCCN Recommended Uses (off-label) - Initial Approval

Covered when ALL of the following are met:

ALL of the following

Diagnosis (one of the following)
- Kaposi sarcoma: relapsed or refractory disease that is T1 extensive, T0 cutaneous, or nodal after ≥ 2 prior lines of systemic therapy
- Kaposi sarcoma: KICS (Kaposi-sarcoma associated herpesvirus-associated inflammatory cytokine syndrome) in combination with rituximab
- Mantle cell lymphoma (B-cell lymphoma)
- HIV-related B-cell lymphoma

Continuation (Renewal) Criteria

All indications in Section I (continued therapy) must meet all:

ALL of the following

Member is currently receiving medication via Centene benefit, or documentation supports that member has been receiving the requested agent for at least 30 days≥ 30 days
Member is responding positively to therapy
For Boruzu and Velcade requests, member must use bortezomib, unless contraindicated or clinically significant adverse effects are experienced
Dose increase

Other Diagnoses / Indications and Not Authorized Uses

Other Diagnoses/Indications and Diagnoses/Indications Not Authorized

If use is not listed in Sections I-II or label recently changed (within 6 months), follow the steps below:

ANY of the following

If drug had a recent label change not yet reflected in policy: refer to relevant no coverage or non-formulary policy depending on formulary status (CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16)
If requested use is not listed under section III (not-covered) and criterion above does not apply: refer to off-label use policy for relevant line of business (CP.CPA.09, HIM.PA.154, CP.PMN.53)

Diagnoses/Indications Not Authorized: Non-FDA approved indications that are not addressed in this policy are not authorized unless sufficient documentation of efficacy and safety per the off-label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or evidence of coverage documents is provided

Provider Actions & Billing Requirements

Prior Authorization

Prescriber specialty requirement

Prescriptions must be written by an oncologist or hematologist, or the request must document that the prescriber consulted with an oncologist or hematologist. This specialty requirement is mandatory for approval.

Documentation Required

Submit supporting documentation

Submit clinical documentation to demonstrate that the member meets all approval criteria. Acceptable supporting documentation includes office/chart notes, laboratory results, and other relevant clinical information.

Prior Authorization

Use branded product redirect

For requests for the branded products Boruzu or Velcade, member must use generic bortezomib unless the member has a contraindication or clinically significant adverse effects to the generic. If requesting an off‑label dose that exceeds FDA limits, the prescriber must submit evidence supporting that dosing.

Applicable Codes

HCPCS/J-codes for bortezomibHCPCSCovered

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

Clinical Evidence & Background

Evidence and primary sources: the policy references the Velcade and Boruzu Prescribing Information and the National Comprehensive Cancer Network (NCCN) Drug & Biologics Compendium and disease-specific NCCN guidelines as primary sources.

Mechanism and indications summary: Bortezomib is a proteasome inhibitor indicated for adult multiple myeloma and mantle cell lymphoma; NCCN also supports multiple off-label uses addressed in the policy (see policy for the full list).

Alignment with FDA and NCCN: Coverage criteria are aligned with FDA-approved labeling for Boruzu and Velcade and with NCCN recommendations—prescribed regimens must be FDA-approved or recommended by NCCN, and dosing follows labeled maximums (maximum dose 1.3 mg/m2) with allowance for off-label dosing only when supported by practice guidelines or peer-reviewed literature.

Surface definitions

KICSKaposi-sarcoma associated herpesvirus (KSHV)-associated inflammatory cytokine syndrome

MMMultiple myeloma

MCLMantle cell lymphoma

NCCN

Revision History

10.27.25annual_review

1Q 2026 annual review: added KICS indication; added disease qualifiers for Castleman disease and Kaposi sarcoma; added monotherapy requirement for adult T‑cell leukemia/lymphoma; removed requirement for use as subsequent therapy for pediatric ALL; revised Medicaid/HIM initial approval durations from 6 to 12 months; references reviewed and updated.

02.26P&T_approvalLatest

P&T approval for the 1Q 2026 annual review recorded (02.26).

09.24.25

Policy Summary

PayerCentene

PolicyBortezomib (Boruzu, Velcade)

Policy CodePolicy CP.PHAR.410

Change TypeAnnual review / formulary updates

Effective Date12.11.18

Next Review Date

Key ActionProvider must submit documentation (office notes, labs, other clinical information) supporting that member has met all approval criteria.

SourceLink

On This Page

Maximum dose per product labeling

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

Multicentric Castleman disease (B-cell lymphoma subtype) as subsequent therapy for relapsed, refractory, or progressive disease

Systemic light chain amyloidosis

Adult T-cell leukemia/lymphoma - as single-agent subsequent therapy

Monotherapy requirement per update

Waldenström macroglobulinemia/lymphoplasmacytic lymphoma

T-cell acute lymphoblastic leukemia (T-ALL) - for relapsed or refractory disease

Pediatric acute lymphoblastic leukemia (ALL)

Pediatric Hodgkin lymphoma (HL) - as subsequent therapy in combination with ifosfamide and vinorelbine

Prescribed by or in consultation with an oncologist or hematologist

Age requirement

Age ≥ 18 years

For Boruzu and Velcade requests, member must use bortezomib, unless contraindicated or clinically significant adverse effects are experienced

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

New dose does not exceed 1.3 mg/m21.3 mg/m2

New 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

Surface thresholds

Maximum dose1.3 mg/m2

Duration before considering member currently receiving for continuation≥ 30 days

Documentation Required

Dose justification for off-label or >FDA dosing

If the requested dose exceeds the FDA maximum or is for an off‑label dosing regimen, the prescriber must provide supporting evidence such as relevant practice guidelines or peer‑reviewed literature to justify the dose.

Billing Rule

Code use guidance

Use the appropriate HCPCS J-code for the product and strength when billing. Listed codes (informational only) include J9041, J9046, J9048, J9049, J9051, and J9054. Coding information is for reference and inclusion or exclusion of a code does not guarantee coverage.

National Comprehensive Cancer Network

RT4: added new formulation Boruzu; corrected Commercial continued approval duration to '6 months or to the member's renewal date'.

02.25annual_review

1Q 2025 annual review: for NCCN recommended uses (off-label) initial criteria added mantle cell lymphoma and HIV‑related B‑cell lymphoma; updated 'AIDS‑related Kaposi Sarcoma' to 'Kaposi Sarcoma'; references reviewed and updated.

02.24annual_review

1Q 2024 annual review: removed specification that 1 mg and 2.5 mg were specially indicated after 1 prior therapy; revised product availability for solutions; references reviewed and updated.

02.23annual_review

1Q 2023 annual review: no significant changes; references reviewed and updated; updated HCPCS codes (J9046, J9048, J9049).

02.22annual_review

1Q 2022 annual review: removed requirement for Velcade to be prescribed with HIV therapy for Kaposi sarcoma per NCCN; added T‑ALL indication per NCCN; references reviewed and updated.