Documents & Resources
Downloadable resources to assist you with reimbursement processes for BANZEL®.
FORMS
BANZEL® Eisai Assistance Program Benefit Investigation Form
The BANZEL® Eisai Assistance Program Benefit Investigation Form initiates a benefits investigation to provide information on patient insurance coverage and coverage restrictions. This may include any Prior Authorization requirements set by their insurance company. The completed benefit investigation form, insurance information, financial documentation, signature of the prescribing healthcare professional, and patient's signature are required for the form to be considered complete.
BANZEL® Sample Letter of Appeal
The sample appeal letter is a template of letter that could be used to appeal for coverage of BANZEL® with a payor.
BANZEL® Sample Letter of Medical Necessity
The Sample Letter of Medical Necessity is a template of a letter that could be used to provide a payor additional information about the need for a patient to use BANZEL®.
Rx Outreach Enrollment Form
This application is used to determine whether patients may be eligible for the BANZEL® Rx Outreach Medication Program. This form has been annotated to include specific information as it relates to BANZEL®.
PATIENT RESOURCES
These foundations offer financial and other assistance (education, counseling, support groups, etc.) to patients.
AEDpregnancyregistry.org >
If you are pregnant, call 1-888-233-2334 to enroll in the North American Antiepileptic Drug Pregnancy Registry.
LGS Foundation >
The LGS Foundation's mission is to improve the lives of individuals affected by Lennox-Gastaut Syndrome through research, programs, and education.
Identifying Lennox-Gastaut Syndrome (LGS)
Eisai cannot guarantee payment of any claim. Coding, coverage, and reimbursement may vary significantly by payor, plan, patient, and setting of care. Actual coverage and reimbursement decisions are made by individual payors following the receipt of claims. For additional information, customers should consult with their payors for all relevant coding, reimbursement, and coverage requirements. It is the sole responsibility of the provider to select the proper code and ensure the accuracy of all claims used in seeking reimbursement. All services must be medically appropriate and properly supported in the patient medical record.
Indication
BANZEL is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients 1 year of age and older, and in adults.
Important Safety Information
Contraindication:
- BANZEL is contraindicated in patients with Familial Short QT syndrome.
Warnings and Precautions:
- Suicidal behavior and ideation: AEDs increase the risk of suicidal thoughts or behavior in patients. Patients, their caregivers, and families should be informed of the risk and advised to monitor and report any emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior, or thoughts of self-harm. If these symptoms occur, consider if it may be related to the AED or illness because epilepsy itself can increase these risks.
- Central nervous system reactions: Use of BANZEL has been associated with central nervous system–related adverse reactions, such as somnolence or fatigue, coordination abnormalities, dizziness, gait disturbances, and ataxia.
- QT shortening: Formal cardiac ECG studies demonstrated shortening of the QT interval (mean = 20 msec, for doses ≥ 2400 mg twice daily) with BANZEL. Caution should be used when administering BANZEL with other drugs that shorten the QT interval.
- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Multi-organ hypersensitivity syndrome, also known as DRESS, has been reported in association with BANZEL therapy. In clinical trials, hypersensitivity reactions occurred in children less than 12 years of age and within 4 weeks of starting BANZEL therapy. In addition, rare cases of DRESS and Stevens-Johnson syndrome have been reported in association with rufinamide therapy post marketing. If any of these reactions are suspected, BANZEL should be discontinued and alternative treatment started. All patients who develop a rash while taking BANZEL must be closely supervised.
- Withdrawal of AEDs: As with all AEDs, BANZEL should be gradually withdrawn to minimize the risk of increased seizure frequency.
Adverse reactions:
- In the pooled, double-blind, adjunctive therapy studies in adults and pediatric patients ages 3 and older, the most commonly observed (≥10%) adverse reactions with BANZEL vs placebo, respectively, were headache (25% vs 20%), dizziness (17% vs 10%), fatigue (15% vs 9%), somnolence (12% vs 9%), and nausea (11% vs 7%).
- In a multicenter, parallel group, open-label study in pediatric patients (1 year to less than 4 years of age) the most commonly observed (≥10%) adverse reactions and with a higher frequency with BANZEL vs any other AED, respectively, were vomiting (24% vs 9%), somnolence (16% vs 0%), constipation (12% vs 9%), cough (12% vs 9%), bronchitis (12% vs 0%), rash (12% vs 9%), and decreased appetite (12% vs 9%).
For more information about BANZEL® please see Prescribing Information.
BANZEL® is available by prescription only.
BANZEL® Contact Information
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Phone number - 1-855-EISAI-4-U (1-855-347-2448)
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Monday - Friday, 9 am to 5 pm ET
This information is intended for use by our healthcare professionals in the United States only. Eisai Inc. recognizes the Internet is a global communications medium; however, laws, regulatory requirements and medical practices for pharmaceutical products vary from country to country. The Prescribing Information included here is not appropriate for use outside the United States.
This site contains information about products that may have different product labeling in different countries. This site is published by Eisai Inc.
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