EmblemHealth bortezomib Prior Auth & Coverage

Recommended Authorization Criteria

Mantle Cell Lymphoma

Covered when ALL of the following are met for Mantle Cell Lymphoma

Mantle Cell Lymphoma Approval

B options
- i: Previously tried >=1 other therapy (examples: regimens containing a rituximab product, cytarabine, cisplatin, cyclophosphamide, doxorubicin, vincristine, or bendamustine).
- ii: Used in combination with at least one other agent (examples: a rituximab product, bendamustine, cyclophosphamide, doxorubicin).

Mantle Cell Lymphoma Dosing: Each individual dose must not exceed 1.3 mg/m2 administered intravenously or subcutaneously; AND the patient receives a maximum of six infusions over a 28-day period.

Multiple Myeloma

Covered when ALL of the following are met for Multiple Myeloma

Multiple Myeloma Approval

B options
- i: Combination examples include dexamethasone, cyclophosphamide, doxorubicin, Doxil (doxorubicin liposomal), lenalidomide, thalidomide, cisplatin, etoposide, daratumumab, pomalidomide, bendamustine, elotuzumab, panobinostat.
- ii: Used for maintenance therapy.

Multiple Myeloma Dosing: Each individual dose must not exceed 1.6 mg/m2 administered intravenously or subcutaneously; AND the patient receives a maximum of six infusions over a 28-day period.

Acute Lymphoblastic Leukemia

Covered when ALL of the following are met for Acute Lymphoblastic Leukemia

ALL Approval: Approve for 1 year if the patient has relapsed or refractory disease.

ALL Dosing: Each individual dose must not exceed 1.6 mg/m2 administered intravenously or subcutaneously; AND the patient receives a maximum of six infusions over a 28-day period.

Kaposi Sarcoma

Covered when ALL of the following are met for Kaposi Sarcoma

Kaposi Approval: Approve for 1 year if A) patient is >=18 years of age; AND B) patient has tried at least one systemic chemotherapy (examples include doxorubicin and paclitaxel).

Kaposi Dosing: Each individual dose must not exceed 1.6 mg/m2 administered intravenously or subcutaneously; AND the patient receives a maximum of three infusions over a 28-day period.

Castleman's Disease (multicentric)

Covered when ALL of the following are met for Castleman's Disease (multicentric)

Castleman's Approval: Approve for 1 year if A) patient is >=18 years of age; AND B) patient has multicentric Castleman's disease; AND C) patient has relapsed, refractory, or progressive disease.

Castleman's Dosing: Each individual dose must not exceed 1.6 mg/m2 administered intravenously or subcutaneously; AND the patient receives a maximum of six infusions over a 28-day period.

Classic Hodgkin Lymphoma

Covered when ALL of the following are met for Classic Hodgkin Lymphoma

Hodgkin Approval: Approve for 1 year if the patient has tried at least one systemic chemotherapy regimen (examples include doxorubicin, bleomycin, vincristine, etoposide, dacarbazine).

Hodgkin Dosing: Each individual dose must not exceed 1.6 mg/m2 administered intravenously or subcutaneously; AND the patient receives a maximum of six infusions over a 28-day period.

Systemic Light Chain Amyloidosis

Covered when ALL of the following are met for Systemic Light Chain Amyloidosis

Amyloidosis Approval: Approve for 1 year if the patient is >=18 years of age.

Amyloidosis Dosing: Each individual dose must not exceed 1.6 mg/m2 administered intravenously or subcutaneously; AND the patient receives a maximum of six infusions over a 28-day period.

T-Cell Lymphoma

Covered when ALL of the following are met for T-Cell Lymphoma

T-Cell Lymphoma Approval: Approve for 1 year if A) patient is >=18 years of age; AND B) patient has tried at least one systemic therapy (examples: EPOCH; brentuximab vedotin + CHP; zidovudine + interferon; CHOEP; HyperCVAD alternating with high-dose methotrexate and cytarabine).

T-Cell Lymphoma Dosing: Each individual dose must not exceed 1.6 mg/m2 administered intravenously or subcutaneously; AND the patient receives a maximum of six infusions over a 28-day period.

Waldenstrom's Macroglobulinemia / Lymphoplasmacytic Lymphoma

Covered when ALL of the following are met for Waldenstrom's Macroglobulinemia / Lymphoplasmacytic Lymphoma

Waldenstrom Approval: Approve for 1 year if A) patient is >=18 years of age; AND B) the medication will be used in combination with rituximab and dexamethasone.

Waldenstrom Dosing: Each individual dose must not exceed 1.6 mg/m2 administered intravenously or subcutaneously; AND the patient receives a maximum of six infusions over a 28-day period.

Coverage is not recommended for uses of bortezomib that are not listed in the Recommended Authorization Criteria. The policy will be updated as new published data become available, and requests for indications outside the listed criteria are not supported by this document.

This policy includes age requirements of ≥ 18 years for several indications. Specifically, an age minimum of ≥ 18 years was added for Mantle Cell Lymphoma, Multiple Myeloma, Castleman's Disease (multicentric), Kaposi Sarcoma, Systemic Light Chain Amyloidosis, and Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma as reflected in the policy history and revisions.

Bortezomib-containing Regimens Referenced

Regimen / Combination	Notes / Examples from policy	Coverage status
VR-CAP (bortezomib/rituximab/cyclophosphamide/doxorubicin/prednisone)	Listed by NCCN as a preferred induction option for newly diagnosed mantle cell lymphoma; referenced as an example regimen in policy guidance.	Covered
Bortezomib ± rituximab	Included for mantle cell lymphoma and multicentric Castleman's disease as listed treatment options; may be used as second-line or subsequent therapy.	Covered
Bortezomib + dexamethasone + rituximab	Example combination cited for Waldenstrom's macroglobulinemia/lymphoplasmacytic lymphoma and other B-cell malignancies in NCCN guidance and policy notes.	Covered
Bortezomib-containing regimens for multiple myeloma (examples: bortezomib + lenalidomide ± dexamethasone, bortezomib + cyclophosphamide, bortezomib + doxorubicin/Doxil)	Policy and NCCN list bortezomib-containing regimens as preferred for primary therapy and previously treated multiple myeloma; maintenance options include bortezomib ± lenalidomide (± dexamethasone for transplant candidates).	Covered
Bortezomib + ifosfamide + vinorelbine (example for Hodgkin lymphoma)	Mentioned in NCCN pediatric Hodgkin lymphoma guidance among subsequent therapy options for relapsed/refractory disease and referenced in policy guideline summary.	Covered
Bortezomib alone or in combination for systemic light chain amyloidosis	Listed by NCCN for primary therapy and previously treated disease; policy cites bortezomib combinations as treatment options.	Covered
Bortezomib for acute lymphoblastic leukemia in combination with chemotherapy	Included in NCCN guidance for relapsed/refractory ALL as a recommended regimen; policy references bortezomib + chemotherapy among recommended regimens.	Covered
Bortezomib ± rituximab for multicentric Castleman's disease	NCCN lists bortezomib ± rituximab among treatment options for relapsed/refractory multicentric Castleman's disease; policy notes similar examples.	Covered

Dosing Limits, Frequency, and Coding References

References to LCD/Articlesmixed

LCD L33394 (A52371)

Local Coverage Article: Billing and Coding: Bortezomib - Related to LCD L33394

Per-dose maximums

Per-dose maximum for mantle cell lymphomaEach individual dose must not exceed 1.3 mg/m2 administered intravenously or subcutaneously.

Per-dose maximum for other listed indicationsEach individual dose must not exceed 1.6 mg/m2 administered intravenously or subcutaneously.

Scope of dosing limitsLimits apply to listed indications including multiple myeloma, acute lymphoblastic leukemia, Kaposi sarcoma, Castleman's disease, classic Hodgkin lymphoma, systemic light chain amyloidosis, T-cell lymphoma, and Waldenstrom's macroglobulinemia/lymphoplasmacytic lymphoma.

Infusions per 28 days

Standard maximum infusions (most indications)Maximum six infusions over a 28-day period for most indications.

Kaposi sarcoma maximum infusions

Prior Authorization & Provider Next Steps

Prior Authorization

Prior Authorization Recommended

Prior Authorization is recommended for medical benefit coverage of bortezomib. Approval is recommended for patients who meet the Recommended Authorization Criteria and Dosing for the listed indications. Extended approvals may be granted if the patient continues to meet the Criteria and Dosing. All approvals are provided for the duration noted in the Criteria.

Prior Authorization recommended — approvals provided when Criteria and Dosing are met; extensions allowed if criteria continue to be met.
Policy incorporates Medicare NCDs/LCDs and companion articles; these may include specific HCPCS and ICD-10 code lists for billing and coding guidance.
Presence or absence of a specific HCPCS or ICD-10 code in an LCD or companion article is for reference only and is not solely determinative of coverage.

Billing Rule

Drug Background and Clinical Context

Bortezomib is a proteasome inhibitor used in hematologic malignancies; this policy aligns approvals and dosing limits with guideline recommendations and the product labeling. The document history shows additions and refinements to indications and criteria (for example, specifying multicentric Castleman's disease and adding age and prior-therapy requirements) to reflect guideline-concordant use. Where noted, the policy requires prior systemic therapy or other specified prior treatments before approval and limits dosing and frequency per indication.

Administration & Dose Modification Notes

Bortezomib administration

Preparation prior to administrationBortezomib must be reconstituted prior to intravenous or subcutaneous administration.

Routes of administrationMay be administered intravenously (IV) or subcutaneously (SC) as specified in dosing sections.

Dose modifications for toxicityDose modifications are recommended for management of hematologic toxicity (e.g., neutropenia, thrombocytopenia), non‑hematologic toxicity (Grade 3 or higher), peripheral neuropathy, and hepatic impairment; may include dose reduction or withholding until toxicity resolves.

First-line, Second-line, and Salvage Use

Line-of-therapy grouping — first-line | second-line | salvage (top-level node).

Line of therapy notes: Policy specifies prior therapy requirements for mantle cell lymphoma (prior therapy or combination), multiple myeloma (use with other agents or maintenance), Castleman's (relapsed/refractory), T-cell lymphoma (tried >=1 systemic therapy), Kaposi sarcoma (tried >=1 systemic chemotherapy).

Policy Revision Timeline

2018-07-11policy_created

Policy created as a new Medicare Advantage Medical Policy for bortezomib (Velcade).

2019-08-28policy_revision

Reviewed and revised original policy per Local Coverage Article A52371 and Oncology - Velcade Utilization Review Policy (completion of 2019 monitoring).

2020-01-30policy_revision

Non-clinical update added policy language about incorporation of Medicare coverage guidance and companion articles for billing/coding reference; references updated.

OpenPayer

Bortezomib (Velcade) Utilization Management — Medicare Advantage