Ofatumumab
DESCRIPTION
Ofatumumab is a monoclonal antibody which binds specifically to both small and large extracellular loops of the CD20 molecule. The CD20 molecule is highly expressed in most B-cell malignancies. While its exact mechanism of antineoplastic activity is not known, it is suggested that ofatumumab causes cell lysis through complement-dependant cytotoxicity and antibody-dependant, cell-mediated cytotoxicity.
An example of a preparation of ofatumumab is Arzerra™.
REFER TO DECISION SUPPORT TREE
POLICY
Ofatumumab for the treatment of chronic lymphocytic leukemia (CLL) is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Ofatumumab for the treatment of other conditions/diseases is considered investigational.
MEDICAL APPROPRIATENESS
Ofatumumab for the treatment of chronic lymphocytic leukemia (CLL) is considered medically appropriate if an individual is refractory to ALL of the following:
Fludarabine
Alemtuzumab
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.
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).
Well-designed, randomized, controlled trials with long-term follow-up are not available to determine the long-term benefits of ofatumumab for the treatment of other conditions/diseases.
SOURCES
Lexi-Comp Online. (2011, May). AHFS DI. Ofatumumab. Retrieved June 21, 2011 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2011, May). Ofatumumab. Retrieved June 17, 2011 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2011, April). NCCN Drugs & Biologics Compendium™. Ofatumumab. Retrieved June 17, 2011 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2009, October). Center for Drug Evaluation and Research. Arzerra® (ofatumumab). Retrieved June 17, 2011 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125326lbl.pdf.
ORIGINAL EFFECTIVE DATE: 6/12/2010
MOST RECENT REVIEW DATE: 8/2/2011
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
Ofatumumab (Arzerra™)
Does the individual have a diagnosis of chronic lymphocytic lymphoma (CLL)?
If yes, go to question #2
If no, this does not meet medical necessity and/or medical appropriateness criteria
Does the individual show evidence of disease that is refractory to treatment with fludarabine and alemtuzumab?
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.