Rufinamide
DESCRIPTION
Rufinamide, a triazole derivative, is structurally unrelated to current antiepileptic drugs. It is thought to exert its effect by regulating the activity of sodium channels in the brain which carry excessive electrical charges that may cause seizures.
An example of a preparation of rufinamide is Banzel™.
REFER TO DECISION SUPPORT TREE
POLICY
Rufinamide for the treatment of seizures is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Rufinamide for the treatment of other conditions/diseases is considered investigational.
MEDICAL APPROPRIATENESS
Rufinamide for the treatment of seizures is considered medically appropriate if ALL of the following criteria are met:
The individual is 4 years of age or older
The agent is being used as an adjunctive treatment for seizures associated with Lennox-Gastaut syndrome (i.e., a severe form of epilepsy with an onset of seizures usually before 4 years of age)
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 rufinamide for the treatment of other conditions/diseases.
SOURCES
Lexi-Comp Online. (2010). AHFS DI. Rufinamide. Retrieved July 20, 2010 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2010). Rufinamide. Retrieved July 20, 2010 from MICROMEDEX Healthcare Series.
Rufinamide (Banzel) for epilepsy. (2009, March). The Medical Letter On Drugs and Therapeutics, 51 (Issue 1307), 18-19.
U. S. Food and Drug Administration. (2009, October). Center for Drug Evaluation and Research. FDA Approval Letter. NDA 21-911/S-004. Retrieved July 20, 2010 from http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021911s004ltr.pdf.
U. S. Food and Drug Administration. (2008, November). Center for Drug Evaluation and Research. FDA Label Information. Banzel™ (rufinamide) tablets. Retrieved July 20, 2010 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021911lbl.pdf.
ORIGINAL EFFECTIVE DATE: 6/13/2009
MOST RECENT REVIEW DATE: 10/6/2010
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
Rufinamide (Banzel™)
Is the agent being used for the treatment of seizures and does the individual show evidence of ALL the following criteria?
The individual is 4 years of age or older
The agent is being used as an adjunctive treatment for seizures associated with Lennox-Gastaut syndrome (i.e., a severe form of epilepsy with an onset of seizures usually before 4 years of age)
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.