BlueCross BlueShield of Tennessee Medical Policy Manual

Bortezomib

NDC CODE(S)

63020-0049-XX Velcade 3.5 MG SOLR (MILLENNIUM PHARMACEUTICALS)

 

63323-0721-XX Bortezomib 3.5 MG SOLR (FRESENIUS KABI USA)

DESCRIPTION

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.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

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).
Mantle Cell Lymphoma - previously untreated 1.3 mg/m² IV in combination with rituximab, cyclophosphamide, doxorubicin, and oral prednisone for six 3-week cycles. Velcade is given twice weekly for two weeks (Days 1, 4, 8, and 11) followed by a 10-day rest period on Days 12-21. For patients with a response first documented at cycle 6, two addition cycles are recommended.
Multiple myeloma & Mantle Cell Lymphoma- relapsed

1.3mg/m² IV/SC 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)
Waldenström’s macroglobulinemia

1.3 mg/m2  IV/ SC twice weekly for 2 weeks (days 1, 4, 8, and 11) in a 21 day cycle 

OR

 In combination with rituximab alone:: 1.6mg/m² days 1, 8, and 15 of a 28 day cycle
All Other Indications

1.3mg/m²  IV/SC twice weekly (days 1, 4, 8, and 11) for 2 weeks of a 21 day cycle

LENGTH OF AUTHORIZATION

Coverage will be provided for 6 months and may be renewed.

Click here to view DOSAGE LIMITS

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.

IMPORTANT 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, the express terms of the health plan will govern.

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).

No controlled studies were found in the published literature that validate the use of bortezomib for the treatment or prevention of other conditions or diseases.

SOURCES

Lexi-Comp Online. (2017). AHFS DI. Bortezomib. Retrieved January 02, 2018 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2017, December). Bortezomib. Retrieved January 02, 2018 from MICROMEDEX Healthcare Series.  

National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium®. Bortezomib. Retrieved January 02, 2018 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2017, June). Center for Drug Evaluation and Research. Velcade® (bortezomib) for injection. Retrieved January 02, 2018 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021602s042lbl.pdf.

ORIGINAL EFFECTIVE DATE:  7/9/2005

MOST RECENT REVIEW DATE:  1/22/2018

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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.

This document has been classified as public information.

 

 


DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit

Diagnosis

MAXIMUM UNITS/DOSE

All Indications

140 billable units every 21 days