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 multiple myeloma is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Bortezomib for the treatment of mantle cell lymphoma is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Bortezomib, for the treatment of other conditions/diseases, including, but not limited to, solid tumor malignancy and hematological malignancies other than multiple myeloma or mantle cell lymphoma is considered investigational.
MEDICAL APPROPRIATENESS
Bortezomib for the treatment of multiple myeloma is considered medically appropriate if the individual is 18 years of age or older.
Bortezomib for the treatment of mantle cell lymphoma is considered medically appropriate if ALL of the following criteria are met:
The individual is 18 years of age or older
The individual 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.
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).
Insufficient evidence was found in the published literature to support the use of bortezomib for the treatment of other conditions/diseases.
SOURCES
Lexi-Comp Online. (2008). AHFS DI. Bortezomib. Retrieved July 8, 2008 from Lexi-Comp Online with AHFS.
Mateos, M. V., Hernández, J. M., Hernández, M. T., Gutiérrez, N. C., Palomera, L., Fuertes, M., et al. (2007). Bortezomib plus melphalan and prednisone in elderly untreated patients with multiple myeloma: updated time-to-events results and prognostic factors for time to progression. Haemotologica, 93(4), 560-565 (IIa, B).
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2008). Bortezomib. Retrieved July 8, 2008 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. (2008, June). Center for Drug Evaluation and Research. Approval letter for new indication of Velcade®. Retrieved July 8, 2008 from http://www.fda.gov/cder/foi/appletter/2008/021602se1-015ltr.pdf.
U. S. Food and Drug Administration. (2008, June). Center for Drug Evaluation and Research. Velcade® (bortezomib) for injection label information. Retrieved July 7, 2008 from http://www.fda.gov/cder/foi/label/2008/021602s015lbl.pdf.
ORIGINAL EFFECTIVE DATE: 7/9/2005
MOST RECENT REVIEW DATE: 12/19/2008
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 requested medication being used to treat a solid tumor malignancy or hematological malignancies other than multiple myeloma or mantle cell lymphoma?
If yes, this does not meet medical necessity and/or medical appropriateness criteria
If no, go to question #2
Does the individual have a diagnosis of multiple myeloma?
If yes, go to question #3
If no, go to question #4
Is the individual 18 years of age or older?
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, this does not meet medical necessity and/or medical appropriateness criteria
Does the individual have a diagnosis of mantle cell lymphoma?
If yes, go to question #5
If no, this does not meet medical necessity and/or medical appropriateness
Does the individual show evidence of ALL of the following?
The individual is 18 years of age or older
The individual 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.