Alemtuzumab
DESCRIPTION
Alemtuzumab is a recombinant DNA derived humanized anti-CD52 monoclonal antibody. CD52 is a glycoprotein that is expressed on the surface of normal and malignant B and T lymphocytes, NK cells, monocytes, macrophages and tissues of the male reproductive system. Alemtuzumab, an antineoplastic agent, binds to CD52 causing a sequence of events that leads to the lysis of leukemic cells.
An example of a preparation of alemtuzumab is Campath®.
REFER TO DECISION SUPPORT TREE
POLICY
Alemtuzumab for the treatment of chronic lymphocytic leukemia is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Alemtuzumab for the treatment of other conditions/diseases, including, but not limited to, multiple sclerosis is considered investigational. (See Applicable Tennessee State Mandate Requirements below.)
MEDICAL APPROPRIATENESS
Alemtuzumab for the treatment of chronic lymphocytic leukemia is considered medically appropriate if ALL of the following criteria are met:
Disease is B-cell positive (B-CLL)
Used as a single agent
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 alemtuzumab 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 - Chronic lymphocytic leukemia / small lymphocytic
NHL - Mycosis fungoides and Sézary syndrome
NHL - Peripheral T-cell lymphoma
Waldenström's macroglobulinemia / Lymphoplasmacytic 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).
There is insufficient evidence supporting the use of alemtuzumab for the treatment of other conditions/diseases, including, but not limited to, multiple sclerosis.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (5:2010). Uses of monoclonal antibodies for the treatment of Non-Hodgkin lymphoma and acute myeloid Leukemia in the non-stem-cell transplant setting. (2.03.05). Retrieved February 9, 2011 from BlueWeb.
Lexi-Comp Online. (2011). AHFS DI. Alemtuzumab. Retrieved February 9, 2011 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2010, December). Alemtuzumab. Retrieved February 9, 2011from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2011). NCCN Drugs & Biologics Compendium™. Alemtuzumab. Retrieved February 9, 2011 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2007, September). Center for Drug Evaluation and Research. FDA Approval Letter. BL 103948/5070. Retrieved February 9, 2011from http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103948s5070lt.pdf.
U. S. Food and Drug Administration. (2007, September). Center for Drug Evaluation and Research. Label and Approval History. Campath® (alemtuzumab). Retrieved February 9, 2011 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103948s5070lbl.pdf.
ORIGINAL EFFECTIVE DATE: 12/8/2007
MOST RECENT REVIEW DATE: 7/9/2011
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
Alemtuzumab (Campath®)
Is the requested medication being used to treat multiple sclerosis?
If yes, this does not meet medical necessity and/or medical appropriateness criteria
If no, go to question #2
Is alemtuzumab being used for the treatment of chronic lymphocytic leukemia with ALL of the following?
Disease is B-cell positive (B-CLL)
Used as a single agent
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.