63323-0721-XX Bortezomib 3.5 MG SOLR (FRESENIUS KABI USA)
Bortezomib is the first antineoplastic agent to target the proteasome, a large intracellular cytoplasmic organelle responsible for the majority of protein degradation in mammalian cells. Proteins are tagged for destruction when conjugated to ubiquitin. They then enter the proteasome and are degraded via the ubiquitin-proteasome pathway. This pathway is central to cellular homeostasis, playing an essential role in the cell cycle, cellular proliferation and apoptosis.
Bortezomib, a boron-containing molecule, reversibly inhibits the ubiquitin-proteasome pathway resulting in cell-cycle arrest and apoptosis. It has been shown in vitro to be cytotoxic to a variety of cancer cells and in vivo causes a delay in tumor growth.
Bortezomib for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met: (See Medical Appropriateness below.)
Adult T-Cell Leukemia/Lymphoma
Mantle cell lymphoma
Multicentric Castleman’s Disease
Primary cutaneous CD30+ T-Cell Lymphoproliferative Disorders
Systemic Light Chain Amyloidosis
Waldenström’s macroglobulinemia/lymphoplasmacytic lymphoma
Bortezomib for the treatment of other conditions/diseases is considered investigational.
Bortezomib is considered medically appropriate if ALL of the following criteria are met:
Individual is 18 years of age or older
Diagnosis of ANY ONE of the following:
Adult T-Cell Leukemia/Lymphoma used as a single agent for non-responders to first-line therapy for acute disease or lymphoma and ANY ONE of the following:
Used second-line if intent is to proceed to high-dose therapy with allogeneic stem cell rescue (HDT/ASCR)
Subsequent therapy after (HDT/ASCR)
Mantle cell lymphoma if ANY ONE of the following:
Used as initial therapy in transplant ineligible patients as a component of VR-CAP (bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone)
Used as second-line therapy for extended response to prior chemoimmunotherapy as a single agent or in combination with rituximab
Multicentric Castleman disease (CD) if ALL of the following
Used as subsequent therapy Individual has progressed following treatment for relapsed/refractory or progressive disease
Used as a single agent or in combination with rituximab
Multiple myeloma If ANY ONE of the following:
Used as primary therapy for active (symptomatic) disease or for relapse after 6 months following primary induction therapy
Used as maintenance therapy as a single agent
Used as therapy for relapse or progressive disease
Primary cutaneous CD30+ T-Cell Lymphoproliferative Disorders used as single agent for relapsed or refractory disease and ANY ONE of the following:
Individual has primary cutaneous anaplastic large cell lymphoma (pcALCL) with multifocal lesions
Individual has cutaneous ALCL with regional nodes (excludes systemic ALCL)
Systemic light chain amyloidosis if ANY ONE of the following:
Individual is newly diagnosed and ANY ONE of the following:
Used in combination with cyclophosphamide and dexamethasone
Used as a single agent
Used in combination with dexamethasone with or without melphalan
Individual has relapsed or refractory disease* and ANY ONE of the following:
Used as a single agent
Used in combination with dexamethasone with or without melphalan *Consider repeating initial therapy if relapse-free for several years
Waldenström’s macroglobulinemia (WM) / lymphoplasmacytic lymphoma (LPL) used as ANY ONE of the following:
Used in combination with dexamethasone and rituximab
Used as a single agent or in combination with rituximab
Used in combination with dexamethasone
Bortezomib is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet the initial approval criteria
Tumor response as shown by stabilization of disease or decrease in size of tumor or tumor spread
Absence of unacceptable toxicity from the agent, e.g., peripheral neuropathy, hypotension, cardiac toxicity, pulmonary toxicity, posterior reversible encephalopathy syndrome, gastrointestinal toxicity, thrombocytopenia, neutropenia, tumor lysis syndrome, hepatic toxicity, etc.
|INDICATION(S)||DOSAGE & ADMINISTRATION|
|Multiple myeloma - previously untreated||1.3 mg/m² IV in combination with oral melphalan and oral prednisone for nine 6-week treatment cycles. In cycles 1-4, Velcade is given twice weekly (days 1, 4, 8, 11, 22, 25, 29, and 32). In cycles 5-9, Velcade is given once weekly (days 1, 8, 22, and 29).|
|Multiple myeloma & Mantle Cell Lymphoma- relapsed||
1.3mg/m² IV twice weekly x 4 doses (days 1, 4, 8, and 11) followed by a 10- day rest period (days 12-21).For extended therapy of more than 8 cycles, bortezomib may be administered on the standard schedule or, for relapsed multiple myeloma, on a maintenance schedule of once weekly for 4 weeks (days 1, 8, 15, and 22), followed by a 13-day rest period (days 23 to 35)
1.3 mg/m2 IV twice weekly for 2 weeks (days 1, 4, 8, and 11) in a 21 day cycle
ORIn combination with rituximab alone:
|All Other Indications||1.3mg/m² IV twice weekly (days 1, 4, 8, and 11) for 2 weeks of a 21 day cycle|
|Bortezomib for Injection, for intravenous use Only and thus should NOT be considered therapeutically interchangeable (i.e. not suitable for substitution) for other non-approved indications|
LENGTH OF AUTHORIZATION
Coverage will be provided for 6 months and may be renewed.
Refer to DOSAGE LIMITS below
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.
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, the express terms of the health plan will govern.
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).
Lexi-Comp Online. (2018). AHFS DI. Bortezomib. Retrieved September 17, 2018 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2018, August). Bortezomib. Retrieved September 17, 2018 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium®. Bortezomib. Retrieved September 18, 2018 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2018,July). Center for Drug Evaluation and Research. Bortezomib for injection. Retrieved September 13, 2018 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205004s002lbl.pdf.
ORIGINAL EFFECTIVE DATE: 7/9/2005
MOST RECENT REVIEW DATE: 1/31/2019
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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Maximum billable units per dose and over time by indication as a Medical Benefit