ModifiedCentenePolicy N/A

Bortezomib (Velcade) coverage

Defines medical necessity, initial and continued therapy criteria, dosing constraints, authorized indications (FDA and selected NCCN off‑label uses), and coding implications for bortezomib for Centene lines of business.

Policy Summary

PayerCentene

PolicyBortezomib (Velcade) coverage

Policy CodePolicy N/A

Change TypeMaterial clinical and coding updates (NCCN additionsHCPCS code changes)

Effective DateDec 11, 2018

Next Review DateN/A

Key ActionSubmit prior authorization with supporting clinical documentation and use the updated HCPCS codes when requesting bortezomib.

SourceLink

POLICY UPDATE CHANGES

Updated HCPCS codes for bortezomib (added J9046, J9048, J9049, J9051; removed inactive J9044) and applied code updates to the policy.

Expanded NCCN-recommended (off-label) initial criteria to add mantle cell lymphoma and HIV-related B-cell lymphoma; updated Kaposi sarcoma nomenclature.

Removed requirement that Velcade be prescribed in combination with HIV therapy for Kaposi sarcoma.

Added new generic bortezomib strengths and single-dose solution formulations (2.5 mg and 3.5 mg) and redirected brand Velcade requests to generic bortezomib where applicable.

2FDA indications listed

6 moInitial authorization length

1.3 mg/m2Dose limit

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J9041,J9046,J9048,J9049

HCPCS codes referenced

≥4HCPCS codes (total listed)

noticeState Medicaid precedence

Coverage Criteria for Bortezomib

NCCN‑Recommended (off‑label) Initial Therapy

B. NCCN‑Recommended Uses (off‑label) — covered when ALL of the following are met:

ALL of the following

Diagnosis of one of the following: Kaposi sarcoma (advanced cutaneous, oral, visceral, or nodal disease); Mantle cell lymphoma (B‑cell lymphoma); Multicentric Castleman’s disease (B‑cell lymphoma subtype) as subsequent therapy; HIV‑related B‑cell lymphoma; Systemic light chain amyloidosis; Waldenström macroglobulinemia/lymphoplasmacytic lymphoma; Adult T‑cell leukemia/lymphoma as subsequent therapy; T‑cell acute lymphoblastic leukemia (T‑ALL) for relapsed or refractory disease; Pediatric Hodgkin lymphoma (HL) as subsequent therapy in combination with ifosfamide and vinorelbine; Pediatric acute lymphoblastic leukemia (ALL) as subsequent therapy.
Prescribed by or in consultation with an oncologist or hematologist.
For Velcade requests, member must use bortezomib (generic), if available, unless contraindicated or clinically significant adverse effects are experienced.
Age: ≥ 18 years for all indications except pediatric ALL and pediatric HL (pediatric indications apply as listed).
Dose does not exceed the FDA maximum limit for any FDA‑approved indication OR the dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence).

Coding and Dosing Constraints

Referenced HCPCS CodesHCPCS

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

Referenced HCPCS CodesHCPCS

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

New HCPCS Codes AddedHCPCS

J9051

Injection, bortezomib (new HCPCS added)

inv-12: Maximum single dose

Maximum single dose1.3 mg/m2

inv-13: Formulation strengths

Available single‑dose solution formulations2.5 mg and 3.5 mg single‑dose solution formulations (generic)

Sterile lyophilized powder strengths1 mg, 2.5 mg, 3.5 mg (Velcade branded product available as 3.5 mg lyophilized powder)

Single‑dose vial presentation notedSolution: 3.5 mg/3.5 mL and 3.5 mg/1.4 mL; solution formulations revised in 1Q2024

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for bortezomib (including branded Velcade requests). Providers must demonstrate the member meets the applicable diagnosis and clinical criteria, include the treating specialist involvement (prescribed by or in consultation with an oncologist or hematologist), confirm age criteria, and document dosing does not exceed FDA limits or is supported by guidelines or peer‑reviewed literature. Submit supporting clinical documentation (office notes, lab results, treatment history) with the prior authorization request.

Prior authorization required for all bortezomib requests.
Provide office notes, lab results, and documentation of prior therapies or response.
Specialist involvement: prescribed by or in consultation with an oncologist or hematologist.
Age criteria: adult indications generally require age ≥ 18 years; pediatric exceptions noted in policy.
Dosing: must not exceed 1.3 mg/m2 (or FDA maximum for the indication) unless supported by guidelines/peer‑reviewed literature.

Authorized Regimens and Line-of-Therapy Notes

first-line

First‑line line‑of‑therapy designation (top‑level):

First‑line MM: Bortezomib 1.3 mg/m2 IV or SC in combination regimens as specified (e.g., in combination with melphalan and prednisone for multiple myeloma first‑line) per dosing and administration guidance

second-line

Second‑line line‑of‑therapy designation (top‑level):

Relapse/Second‑line: Bortezomib 1.3 mg/m2 IV or SC as a single agent or in combination for relapse up to defined cycles (e.g., up to eight 3‑week cycles for MM relapse); therapy beyond specified cycles follows PI or clinical justification

first-line

First‑line (alternate) — additional top‑level node from updated sections:

Definitions and Abbreviations

inv-23: MCL definition

AbbreviationMCL = mantle cell lymphoma

ContextListed in Appendix A: Abbreviation/Acronym Key

Related indicationsIncluded as an FDA‑approved indication and as an NCCN‑recommended off‑label use in updated criteria

inv-24: MM definition

AbbreviationMM = multiple myeloma

Dosing contextMM dosing regimens reference 1.3 mg/m2 IV or SC for first‑line and relapse settings

Appendix locationDefined in Appendix A: Abbreviation/Acronym Key

Background

Bortezomib (Velcade and generic formulations) is a proteasome inhibitor primarily indicated for the treatment of multiple myeloma (MM) and mantle cell lymphoma (MCL). This policy incorporates those FDA‑approved indications and also addresses selected NCCN‑recommended off‑label uses, with requirements for specialist prescribing, dosing limits (including a maximum single dose of 1.3 mg/m2), and submission of supporting clinical documentation for off‑label requests.

Policy Summary

PayerCentene

PolicyBortezomib (Velcade) coverage

Policy CodePolicy N/A

Change TypeMaterial clinical and coding updates (NCCN additionsHCPCS code changes)

Effective DateDec 11, 2018

Next Review DateN/A

Key ActionSubmit prior authorization with supporting clinical documentation and use the updated HCPCS codes when requesting bortezomib.

SourceLink

On This Page

Billing Rule

Prior Authorization and Coding — use updated HCPCS

Use current HCPCS codes when requesting prior authorization and submitting claims. The policy was updated to add J9046, J9048, J9049, and J9051 and to remove inactive codes (e.g., J9044). Providers should reference the most up‑to‑date professional coding guidance and include the HCPCS codes on requests.

Updated HCPCS codes to reference in PA requests: J9041, J9046, J9048, J9049, J9051.
Removed inactive code: J9044 (do not use).
Include applicable HCPCS on PA submissions and claims.

Billing Rule

Brand-to-Generic Redirection (Velcade → bortezomib)

Requests for branded Velcade should be redirected to generic bortezomib when a generic is available unless the prescriber documents a medical contraindication or clinically significant adverse reaction to the generic product.

Velcade requests will be converted to generic bortezomib when available unless contraindicated.
Prescriber must document clinical rationale for brand‑only use.

Denial Risk

Coding-related Denials — verify codes and supply documentation

Claims may be denied if inactive or incorrect HCPCS codes are used, or if required supporting documentation is not submitted. Verify code validity prior to submission and supply clinical documentation to support the requested indication and dosing.

Coding-related denials possible for incorrect or inactive codes (e.g., previously used J9044).
Ensure PA and claim submissions use current codes: J9041, J9046, J9048, J9049, J9051.
Provide treatment notes, labs, and guideline citations when requesting off-label uses supported by NCCN.

Documentation Required

Required Coding and Documentation

Providers must include applicable HCPCS codes on requests and attach supporting clinical documentation: office notes, lab results, evidence of prior therapies/response, and citations when dosing or indications rely on guideline or peer‑reviewed support. Off‑label requests not addressed in the policy may be denied without sufficient off‑label documentation per applicable off‑label use policies.

Reference and use updated HCPCS codes: J9041, J9046, J9048, J9049, J9051 on PA requests.
Attach supporting documentation: office notes, labs, prior therapy history, pathology reports, and guideline or literature references for non‑FDA uses.
Off‑label uses not covered in this policy require evidence per CP.CPA.09, HIM.PA.154, or CP.PMN.53 (as applicable).

First‑line MCL: Bortezomib 1.3 mg/m2 IV or SC in combination regimens for mantle cell lymphoma first‑line (e.g., with rituximab, cyclophosphamide, doxorubicin and prednisone [VR‑CAP] for up to six 3‑week cycles)

Regimen	Indication	Coverage
Bortezomib 1.3 mg/m2 IV or SC in combination with melphalan and prednisone (nine 6‑week treatment cycles)	Multiple myeloma — first‑line	Covered when policy criteria are met

Regimen	Indication	Coverage
Bortezomib 1.3 mg/m2 IV or SC in combination with rituximab, cyclophosphamide, doxorubicin and prednisone (VR‑CAP) for up to six 3‑week cycles (plus two additional cycles if positive response)	Mantle cell lymphoma — first‑line	Covered when policy criteria are met

Regimen/Agent	Scope of NCCN‑recommended Uses	Coverage
Bortezomib (Velcade or generic formulations)	As indicated in the NCCN Drugs & Biologics Compendium, including mantle cell lymphoma, HIV‑related B‑cell lymphoma, Kaposi sarcoma, and other NCCN‑listed indications per updated compendium guidance	Covered when NCCN‑recommended criteria and policy requirements are met (documentation, prescriber specialty, dose limits)

inv-25: NCCN-recommended uses (off-label)

ScopeNCCN‑recommended off‑label uses addressed in policy include mantle cell lymphoma and HIV‑related B‑cell lymphoma (added 1Q2025)

Other NCCN‑listed indicationsKaposi sarcoma (updated nomenclature from AIDS‑related Kaposi sarcoma), systemic light‑chain amyloidosis, Waldenstrom macroglobulinemia, adult T‑cell leukemia/lymphoma, T‑ALL relapsed/refractory, pediatric HL and ALL subsequent therapy

Requirement for off‑label usePrescriber must provide supporting evidence and meet age/prescriber/dose criteria per NCCN‑recommended off‑label section