Bortezomib (Velcade®; Bortezomib, Boruzu™)
MPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
POLICY
INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
FDA-Approved Indications
Compendial Uses
All other indications are considered experimental/investigational and not medically necessary.
COVERAGE CRITERIA
Multiple Myeloma
Authorization of 12 months may be granted for the treatment of multiple myeloma.
Mantle Cell Lymphoma
Authorization of 12 months may be granted for the treatment of mantle cell lymphoma.
Multicentric Castleman disease
Authorization of 12 months may be granted for the treatment of multicentric Castleman disease as subsequent therapy.
Systemic Light Chain Amyloidosis
Authorization of 12 months may be granted for the treatment of systemic light chain amyloidosis.
Waldenström Macroglobulinemia/Lymphoplasmacytic Lymphoma
Authorization of 12 months may be granted for the treatment of Waldenström macroglobulinemia/lymphoplasmacytic lymphoma.
Adult T-cell Leukemia/Lymphoma
Authorization of 12 months may be granted for the treatment of adult T-cell leukemia/lymphoma when the requested medication will be used as a single agent for subsequent therapy.
Antibody Mediated Rejection of Solid Organ
Authorization of 12 months may be granted for the treatment of antibody mediated rejection of solid organ.
Acute Lymphoblastic Leukemia
Authorization of 12 months may be granted for the treatment of acute lymphoblastic leukemia.
Follicular Lymphoma
Authorization of 12 months may be granted for the treatment of relapsed or refractory follicular lymphoma.
Kaposi Sarcoma
Authorization of 12 months may be granted for the treatment of Kaposi sarcoma as subsequent therapy.
Pediatric Classic Hodgkin Lymphoma
Authorization of 12 months may be granted for the treatment of relapsed or refractory Pediatric Classic Hodgkin Lymphoma.
POEMS (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal Protein, Skin Changes) Syndrome
Authorization of 12 months may be granted for treatment of POEMS syndrome in combination with dexamethasone.
DOSAGE AND ADMINISTRATION
Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or evidence-based practice guidelines.
For all indications, dosing does not exceed 1.6 mg/m2 per dose and does not require more than 7 doses per 30-day period.
CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in the coverage criteria section II when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
ADDITIONAL INFORMATION
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
REFERENCES
ORIGINAL EFFECTIVE DATE: 7/9/2005
MOST RECENT REVIEW DATE: 6/10/2025
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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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