DESCRIPTION
Lenalidomide, an analogue of thalidomide, is the lead compound in a new class of anti-cancer drugs called immunomodulating agents (IMiDs). It exhibits immunomodulatory, anti-neoplastic, antiangiogenic and anti-inflammatory properties. While lenalidomide’s exact mechanism of action is not fully understood, it effectively alters the tumor cell microenvironment, exhibiting both antiproliferative and proapoptotic effects on some types of tumor cells.
Lenalidomide has been shown to modulate the production of various cytokines key to tumor survival (e.g., tumor necrosis factor alpha [TNF-α], vascular endothelial growth factor [VEGF], Interleukin-6 [IL-6] and interleukin-8 [IL-8]) through downregulation. It has also been shown to promote the activation of T- and natural killer (NK) cell-mediated antitumor response. Additionally, lenalidomide appears to inhibit the expression of cyclooxygenase-2 (COX-2) but not COX-1.
An example of a preparation of lenalidomide is Revlimid®.
REFER TO DECISION SUPPORT TREE
POLICY
Lenalidomide is considered medically necessary for the following conditions if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Anemia
Multiple myeloma
Lenalidomide for the treatment of other conditions/diseases is considered investigational. (See Applicable Tennessee State Mandate Requirements below.)
MEDICAL APPROPRIATENESS
Lenalidomide is considered medically appropriate for the treatment of ANY ONE of the following:
Anemia with ALL the following:
The individual is transfusion-dependent
The individual is diagnosed with ANY ONE of the following:
Low-risk myelodysplastic syndrome (MDS)
Intermediate-1-risk MDS
MDS associated with a deletion 5q cytogenetic abnormality designated as del(5)(q31-33)
Multiple myeloma when used in combination with dexamethasone
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 the use of lenalidomide for additional uses 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):
NHL - Mantle Cell lymphoma
Low-risk myelodysplastic syndrome (MDS) not associated with a deletion 5q cytogenetic
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 lenalidomide for the treatment of other conditions/diseases.
SOURCES
Chanan-Khan, A. A. & Cheson, B. D. (2008). Lenalidomide for the treatment of B-cell malignancies. Journal of Clinical Oncology, 26 (9), 1544-1552.
Lenalidomide (Revlimid) for anemia of myelodysplastic syndrome. (2006, April). The Medical Letter On Drugs and Therapeutics, 48 (issue 1232), 31-32.
Lexi-Comp Online. (2009). AHFS DI. Lenalidomide. Retrieved August 10, 2009 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2009). Lenalidomide. Retrieved August 10, 2009 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2009). NCCN Drugs & Biologics Compendium™. Lenalidomide. Retrieved August 10, 2009 the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2009, February). Center for Drug Evaluation and Research. Revlimid® (lenalidomide). Retrieved August 10, 2009 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021880s006s016s017lbl.pdf.
ORIGINAL EFFECTIVE DATE: 7/8/2006
MOST RECENT REVIEW DATE: 3/11/2010
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
Lenalidomide (Revlimid®)
Does the individual have a diagnosis of anemia?
If yes, go to question #2
If no, go to question #4
Does the individual have a diagnosis of transfusion-dependent, low-risk or intermediate-1-risk myelodysplastic syndrome (MDS)?
If yes, go to question #3
If no, this does not meet medical necessity and/or medical appropriateness criteria
Is the MDS associated with a deletion 5q cytogenetic abnormality designated as del (5) (q31-33)?
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #4
Does the individual have a diagnosis of multiple myeloma and is the agent being used in combination with dexamethasone?
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.