DESCRIPTION
Belimumab is a monoclonal antibody. It is produced by recombinant DNA technology using a mammalian cell expression system. Belimumab prevents the survival of B lymphocytes by blocking the binding of soluble human B lymphocyte stimulator protein (BLyS) to receptors on B lymphocytes. This reduces the activity of B-cell mediated immunity and the autoimmune response.
An example of a preparation of belimumab is BenlystaŽ.
REFER TO DECISION SUPPORT TREE
POLICY
Belimumab for the treatment of lupus is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Belimumab for the treatment of other conditions/diseases, including, but not limited to, the following: severe active lupus nephritis and severe active central nervous system lupus is considered investigational.
MEDICAL APPROPRIATENESS
Belimumab for the treatment of lupus is considered medically appropriate if ALL of the following criteria are met:
The individual has a diagnosis of active systemic lupus erythematosus (SLE)
Is 18 years of age or older
The disease is autoantibody-positive
Is receiving standard therapy (e.g., corticosteroids, antimalarials, nonsteroidal anti-inflammatory (NSAID), immunosuppressive agents)
ABSENCE of combination therapy with other biologic agents or intravenous cyclophosphamide
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).
There is insufficient evidence supporting the use of belimumab for the treatment of other conditions/diseases, including, but not limited to, the following: severe active lupus nephritis and severe active central nervous system lupus.
SOURCES
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2011). Belimumab. Retrieved March 22, 2011 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. (2011, March). Center for Drug Evaluation and Research. Approval letter: BenlystaŽ (belimumab). Retrieved March 22, 2011from http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103948s5070lt.pdf.
U. S. Food and Drug Administration. (2011, March). Center for Drug Evaluation and Research. Label and Approval History. BenlystaŽ. Retrieved March 22, 2011 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125370s0000lbl.pdf.
U. S. Food and Drug Administration. (2011, March). Center for Drug Evaluation and Research. Medication Guide: BenlystaŽ (belimumab). Retrieved March 22, 2011 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125370s0000MedG.pdf.
ORIGINAL EFFECTIVE DATE: 8/13/2011
MOST RECENT REVIEW DATE: 8/13/2011
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
Belimumab (BenlystaŽ)
Is the requested medication being used to treat severe active lupus nephritis and severe active central nervous system lupus?
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 active systemic lupus erythematosus (SLE) and ALL of the following?
Is 18 years of age or older
The disease is autoantibody - positive
Is receiving standard therapy (e.g., corticosteroids, antimalarials, nonsteroidal anti-inflammatory (NSAID), immunosuppressive agents)
ABSENCE of combination therapy with other biologic agents or intravenous cyclophosphamide
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.