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Coverage Policies

Coverage for BANZEL® is primarily through a patient’s pharmacy benefit. Coverage and reimbursement may vary significantly by payor, plan, and patient. Payors can base coverage decisions on formal policies or make decisions on a case-by-case basis.

The Part D drug benefit provides beneficiaries with coverage for outpatient prescription drugs. BANZEL® is primarily covered under Part D. The Part D benefit is administered by private health plans: either stand-alone prescription drug plans (PDPs) or Medicare Advantage prescription drug (MA-PD) plans. Medicare established a standard benefit design for Part D, with an annual deductible and three tiers of co-insurance. Part D plan sponsors may construct their own benefits, as long as their plan provides equal or better coverage than the standard. There is a gap between the initial coverage period and the catastrophic coverage period. While in this gap, known as the "doughnut hole", the beneficiary is responsible for 100% of drug costs (but may receive a 50% discount on covered brand name drugs). Some plans provide drug coverage to beneficiaries during the coverage gap, although plans may only cover generic drugs during this period.

 

For current information, visit the CMS website to find the Medicare Part D Standard Benefit Design.

 

For assistance in understanding your patients' benefit for BANZEL® please contact the Eisai Assistance Program at 1-855-EISAI-4-U (1-855-347-2448). Hours of operation are Monday to Friday, 9 am to 5 pm ET.

Medicaid is a government insurance program that covers low-income parents and children, people who are elderly, and people with disabilities. State Medicaid programs and the federal government share the costs of covering most medical expenses for Medicaid beneficiaries.

Coverage and reimbursement for BANZEL® through Medicaid will vary from state to state, as each Medicaid program establishes its own eligibility standards and determines the type, amount, duration, and scope of services.

For more information on Medicaid reimbursement for BANZEL®, contact the Eisai Assistance Program at 1-855-EISAI-4-U (1-855-347-2448). Hours of operation are Monday to Friday, 9 am to 5 pm ET.

Coverage for BANZEL® is variable amongst plans offered by commercial payors. Most third-party payors, including Health Maintenance organization (HMO) plans, managed care organizations, indemnity plans and others may allow coverage for BANZEL®. However, specific coverage requirements and restrictions will vary based on plan type. The lack of a formal published policy from a particular payor does not mean that BANZEL® is not covered by that payor.

Many Commercial Prescription Plans Have Developed a Formulary, or List of Brand-Name Prescription Drugs that the Company Prefers

Payor formularies are often organized into tiers. If a plan's pharmacy benefit involves tiers, members typically pay the smallest copayments for drugs in the lowest tier and the highest copayments for drugs in the highest tier. Some commercial plans may apply coverage and utilization restrictions such as prior authorization or quantity limit edits to BANZEL®.

When BANZEL® is Not Covered by a Health Plan, Coverage May Be Requested

Coverage of BANZEL® is determined by the member's pharmacy benefit. Providers or patients should contact the health plan directly to determine whether BANZEL® is included on the formulary. If BANZEL® is not covered by the plan, an exception may be requested by the prescriber. Determinations are made on a case-by-case basis and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract including medical necessity requirements.

If you need additional assistance obtaining a payor's specific requirements for requesting coverage for BANZEL®, please call The BANZEL® Assistance Program at 1-855-EISAI-4-U (1-855-347-2448). Hours of operation are Monday to Friday, 9 am to 5 pm ET.

Appeal Request

An appeal is a request to change a previous negative decision made by health plan. A representative/prescriber or patient may appeal the negative decision related to coverage. The prescriber will need to provide a reason why he/she believes the coverage decision was incorrect and what the expected outcome should be. Along with the request form, supporting documentation may include previous medical necessity-related denials, the patient's medical records, and documentation from the healthcare professional or facility.

If you need additional assistance obtaining a payor's specific requirements for requesting coverage for BANZEL®, please call The Eisai Assistance Program at 1-855-EISAI-4-U (1-855-347-2448).

Need Help with NDC Codes?

NDC codes identify specific product package sizes for BANZEL®

Pivotal Trial Design

BANZEL® was studied as adjunctive treatment with a range of AEDs

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

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Indication

BANZEL® (rufinamide) 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:

  • 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.
  • 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.

Precautions:

  • 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.
  • Multi-organ hypersensitivity syndrome 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 Drug Reaction with Eosinophilia and Systemic Symptoms 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.
  • 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 4 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 (13% 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

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit
http://www.FDA.gov/medwatch or call 1-800-FDA-1088.

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.

BANZEL® is a registered trademark of Eisai R&D Management Co., Ltd., licensed to Eisai Inc.

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