CurrentCareSourcePolicy N/A

Oncology (Injectable) Bortezomib Products

Defines prior authorization and medical necessity criteria for injectable bortezomib products (intravenous or subcutaneous) for oncology indications and related hematologic disorders for CareSource members.

Policy Summary

PayerCareSource

PolicyOncology (Injectable) Bortezomib Products

Policy CodePolicy N/A

Change TypeName changeage requirements and formulation added

Effective DateN/A

Next Review DateNov 20, 2024

Key ActionObtain prior authorization and document oncology/hematology prescriber involvement and that patient meets the indication-specific criteria and dosing limits.

SourceLink

POLICY UPDATE CHANGES

An age requirement of ≥ 18 years was added for multiple listed indications (mantle cell lymphoma, multiple myeloma, Castleman's disease, Kaposi sarcoma, systemic light chain amyloidosis, Waldenstrom's macroglobulinemia/lymphoplasmacytic lymphoma).

Policy name was changed to 'Oncology (Injectable) Bortezomib Products' and the Boruzu ready-to-use injectable formulation was added to the policy.

Acute lymphoblastic leukemia approval condition was changed (previously listed as acute lymphoblastic lymphoma).

11indications with explicit criteria described

1 yeartypical authorization duration

≤ 1.6 mg/m2per-dose limit (most)

≤ 6

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Recommended Authorization Criteria

Mantle Cell Lymphoma (FDA-approved)

Coverage of bortezomib is recommended when ALL required condition-specific criteria and dosing limits are met.

Mantle Cell Lymphoma: Approve for 1 year if ALL of the following: (A) patient is ≥ 18 years of age; AND (B) patient meets ONE of the following: (i) has previously tried at least one other therapy for mantle cell lymphoma (examples include regimens containing vincristine or bendamustine); OR (ii) medication is used in combination with at least one other agent (examples include rituximab, bendamustine, cyclophosphamide, doxorubicin); AND (C) medication is prescribed by or in consultation with an oncologist or a hematologist.Dosing: each individual dose ≤ 1.3 mg/m2 IV or SC; maximum of six infusions per 28-day period

Examples of other therapies and combination agents provided in policy.

Multiple Myeloma (FDA-approved)

Multiple Myeloma: Approve for 1 year if ALL of the following: (A) patient is ≥ 18 years of age; AND (B) patient meets ONE of the following: (i) standard therapy conditions as per policy; OR (ii) medication is used for maintenance therapy; AND (C) medication will be used in combination with at least one other agent; AND (D) medication is prescribed by or in consultation with an oncologist or a hematologist.Dosing: each individual dose ≤ 1.6 mg/m2 IV or SC; maximum of six infusions per 28-day period

Policy lists multiple acceptable combination agents (e.g., dexamethasone, lenalidomide, daratumumab, pomalidomide, bendamustine, others).

Other uses with supportive evidence (ALL, Castleman’s, Hodgkin lymphoma)

Acute Lymphoblastic Leukemia: Approve for 1 year if BOTH: (A) patient has relapsed or refractory disease; AND (B) medication is prescribed by or in consultation with an oncologist.Dosing: each individual dose ≤ 1.6 mg/m2 IV or SC; maximum of six infusions per 28-day period

Listed under 'Other Uses with Supportive Evidence' and supported by guideline recommendations for relapsed/refractory disease.

Multicentric Castleman’s Disease: Approve for 1 year if ALL of the following: (A) patient is ≥ 18 years of age; AND (B) patient has multicentric Castleman’s disease with relapsed, refractory, or progressive disease; AND (C) medication is prescribed by or in consultation with an oncologist.Dosing: each individual dose ≤ 1.6 mg/m2 IV or SC; maximum of six infusions per 28-day period

Listed as other use with supportive evidence.

Classic Hodgkin Lymphoma: Approve for 1 year if BOTH: (A) patient has tried at least one systemic chemotherapy regimen; AND (B) medication is prescribed by or in consultation with an oncologist.

Additional other uses with supportive evidence

Kaposi Sarcoma: Approve for 1 year if ALL of the following: (A) patient is ≥ 18 years of age; AND (B) patient has tried at least one systemic chemotherapy; AND (C) medication is prescribed by or in consultation with an oncologist.Dosing: each individual dose ≤ 1.6 mg/m2 IV or SC; maximum of three infusions per 28-day period

Kaposi sarcoma dosing limit differs from other indications (maximum three infusions per 28 days).

Systemic Light Chain Amyloidosis: Approve for 1 year if BOTH: (A) patient is ≥ 18 years of age; AND (B) medication is prescribed by or in consultation with an oncologist or a hematologist.Dosing: each individual dose ≤ 1.6 mg/m2 IV or SC; maximum of six infusions per 28-day period

Listed in other uses with supportive evidence and referenced to NCCN guidance.

T-Cell Lymphoma: Approve for 1 year if ALL of the following: (A) patient is ≥ 18 years of age; AND (B) patient has tried at least one systemic therapy (examples include EPOCH, CHOEP, HyperCVAD, brentuximab vedotin + CHP); AND (C) medication is prescribed by or in consultation with an oncologist.

Coverage of bortezomib is not recommended for circumstances not listed in the Recommended Authorization Criteria. The policy criteria will be updated as new published data are available.

Any use that does not meet the listed Recommended Authorization Criteria is not recommended for approval and is considered not medically necessary under this policy.

Regimen / Example combination	Indication(s) where permitted	Notes / Dosing limits
Bortezomib + rituximab + dexamethasone (or other combinations including daratumumab, pomalidomide, elotuzumab)
Waldenstrom’s macroglobulinemia / lymphoplasmacytic lymphoma; systemic light-chain amyloidosis; T-cell lymphomas; Kaposi sarcoma (when listed as an option)
Per-policy: each individual dose must not exceed 1.6 mg/m2 IV/SC for most indications (1.3 mg/m2 for mantle cell lymphoma per its criteria); typical maximum of six infusions per 28-day period (Kaposi sarcoma may have a three-infusion limit).

Product Identifiers & Dosing Limits

Neutral: product identifiersNDC

NDCs not listed

Policy lists brand and generic products (Velcade; Boruzu/Amneal) but no explicit billing codes or NDCs presented in text.

inv-08: Per-dose maximum

Per-dose maximum range1.3–1.6 mg/m2 per individual dose (dose cap varies by indication)

Mantle cell lymphoma limitEach individual dose must not exceed 1.3 mg/m2 IV or SC

Most other indications limitEach individual dose must not exceed 1.6 mg/m2 IV or SC (multiple myeloma and listed supportive-evidence indications)

Route of administrationIntravenous (IV) or subcutaneous (SC) — same per-dose limits apply

inv-09: Maximum infusions per 28 days

Typical maximum infusions per 28 daysTypically up to 6 infusions per 28-day period for most indications

What the Prescriber Must Do

Prior Authorization

Prior authorization required

Prior Authorization is required for medical benefit coverage of bortezomib. Approval is recommended only when requests meet the Recommended Authorization Criteria and documented dosing limits. All approvals are provided for the duration noted in the criteria (typically up to 1 year). Requests for doses outside the dosing limits in this policy will be reviewed on a case-by-case basis by a clinician (Medical Director or Pharmacist).

Documentation Required

Prescriber and authorization documentation

The prescriber must be an oncologist or hematologist, or the prescription must be made in consultation with an oncologist or hematologist. Authorization requests must include documentation supporting the diagnosis, prior therapy history (when applicable), and the planned bortezomib dosing regimen (dose per administration, route, and schedule). For combination regimens, document the other agents to be used. Requests lacking this documentation may be denied.

Document prescriber specialty or consultation note with oncologist/hematologist
Provide diagnosis and indication-specific clinical information (e.g., relapsed/refractory status)

Clinical Background

Bortezomib is a proteasome inhibitor used in adults for multiple hematologic malignancies, most prominently multiple myeloma and mantle cell lymphoma. It appears in guideline-referenced regimens for a variety of lymphomas and related disorders and may be administered intravenously or subcutaneously with indication-specific dosing schedules and toxicity considerations.

Key Terms

inv-15: bortezomib — short definition/identifier

Drug class and identifierBortezomib — a proteasome inhibitor used for multiple hematologic malignancies

Formulations referencedInjectable preparations for IV or SC administration (Velcade/generics; Boruzu ready-to-use solution noted)

Typical indicationsUsed in adults for multiple myeloma and various lymphomas and related disorders as specified in policy

Line of Therapy Specifications

first-line | maintenance | previously treated

Line of therapy notes: Policy includes use across primary (first-line), maintenance, and previously treated disease; some indications require prior systemic therapy or prior therapy trials as noted per-indication.

Document Revision History

2024-12-11selected revisionLatest

Policy name changed to 'Oncology (Injectable) Bortezomib Products' and the Boruzu ready-to-use injectable formulation of bortezomib was added to the policy.

2024-11-20annual revision

Age requirement (≥ 18 years) was added for multiple indications including mantle cell lymphoma, multiple myeloma, Castleman’s disease, Kaposi sarcoma, systemic light-chain amyloidosis, and Waldenstrom’s macroglobulinemia/lymphoplasmacytic lymphoma.

2024-11-20