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.
An example of a preparation of bortezomib is Velcade®.
REFER TO DECISION SUPPORT TREE
POLICY
Bortezomib for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met: (See Medical Appropriateness below.)
Multiple myeloma
Mantle cell lymphoma
Bortezomib for the treatment of other conditions/diseases is considered investigational. (See Applicable Tennessee State Mandate Requirements below.)
MEDICAL APPROPRIATENESS
Bortezomib for the treatment of ANY ONE of the following is considered medically appropriate if the following criteria are met:
Multiple myeloma if the individual is 18 years of age or older
Mantle cell lymphoma if the individual meets ALL of the following:
Is 18 years of age or older
Has received at least one prior therapy
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
Tennessee State law requires coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is relative to life-threatening illnesses, such as cancer, AIDS, and coronary heart disease and recognized in one of the standard reference compendia (As defined in the statute: The United States Pharmacopoeia Drug Information, The American Medical Association Drug Evaluations, & The American Hospital Formulary Service Drug Information) or in the medical literature. This law is applicable to all fully insured members. The law is not applicable to self-funded accounts, but coverage for off-label uses may be provided based on the contractual agreement.
The NCCN Drugs & Biologics Compendium recognizes additional uses for bortezomib beyond the FDA-approved labeling in the treatment of the following conditions (Refer to the NCCN Drugs & Biologics Compendium or NCCN Clinical Practice Guidelines for detailed recommendations):
Solitary plasmocytoma
Smoldering multiple myeloma
Systemic light chain amyloidosis
Waldenström’s macroglobulinemia
Mycosis fungoides
Sézary syndrome
Peripheral T-cell lymphoma
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 dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., The American Hospital Formulary Service Drug Information).
No controlled studies were found in the published literature that validate the use of bortezomib in the treatment/prevention of any other conditions/diseases.
SOURCES
Lexi-Comp Online. (2010). AHFS DI. Bortezomib. Retrieved March 24, 2010 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2010). Bortezomib. Retrieved March 24, 2010 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2010). NCCN Drugs & Biologics Compendium™. Bortezomib. Retrieved March 24, 2010 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2009, December). Center for Drug Evaluation and Research. Velcade® (bortezomib) for injection. Retrieved March 24, 2010 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021602s019s020lbl.pdf.
ORIGINAL EFFECTIVE DATE: 7/9/2005
MOST RECENT REVIEW DATE: 9/15/2010
ID_BT
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.
Pharmaceutical Decision Support Tree
Bortezomib (Velcade®)
Is the individual 18 years of age or older?
If yes, go to question #2
If no, this does not meet medical necessity and/or medical appropriateness criteria
Does the individual have a diagnosis of active multiple myeloma?
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #3
Does the individual have a diagnosis of mantle cell lymphoma and has received at least one prior therapy?
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, this does not meet medical necessity and/or medical appropriateness criteria
This document has been classified as public information.