Coverage Policies
Coverage for FYCOMPA® 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.
Medicare Part D
The Part D drug benefit provides beneficiaries with coverage for outpatient prescription drugs. FYCOMPA® 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 either a copay or co-insurance. Part D plan sponsors may construct their own benefits, so 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 patient's benefit for FYCOMPA® please contact the Eisai Assistance Program at 1-855-EISAI-4-U (1-855-347-2448). Hours of operation are Monday to Friday 8 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 FYCOMPA® 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 FYCOMPA®, contact. the Eisai Assistance Program at 1-855-EISAI-4-U (1-855-347-2448). Hours of operation are Monday to Friday 8 am to 5 pm ET.
Coverage for FYCOMPA® 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 FYCOMPA®. 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 FYCOMPA® 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 FYCOMPA®.
When FYCOMPA® is Not Covered by a Health Plan, Coverage May Be Requested
Coverage of FYCOMPA® is determined by the member's pharmacy benefit. Providers or patients should contact the health plan directly to determine whether FYCOMPA® is included on the formulary. If FYCOMPA® 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 FYCOMPA®, please call The FYCOMPA® Assistance Program at 1-855-EISAI-4-U (1-855-347-2448). Hours of operation are Monday to Friday 8 am to 5 pm ET.
Appeal Request
An appeal is a request to change a previous negative decision made by a 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.
For more information on commercial payor-specific coverage of FYCOMPA®, contact the Eisai Assistance Program at 1-855-EISAI-4-U (1-855-347-2448). Hours of operation are Monday to Friday 8 am to 5 pm ET.
Need Help with NDC Codes?
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.
IMPORTANT SAFETY INFORMATION AND INDICATION
WARNING: SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS
- Serious or life-threatening psychiatric and behavioral adverse reactions including aggression, hostility, irritability, anger, and homicidal ideation and threats have been reported in patients taking FYCOMPA
- These reactions occurred in patients with and without prior psychiatric history, prior aggressive behavior, or concomitant use of medications associated with hostility and aggression
- Advise patients and caregivers to contact a healthcare provider immediately if any of these reactions or changes in mood, behavior, or personality that are not typical for the patient are observed while taking FYCOMPA or after discontinuing FYCOMPA
- Closely monitor patients particularly during the titration period and at higher doses
- FYCOMPA should be reduced if these symptoms occur and should be discontinued immediately if symptoms are severe or are worsening
SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS
In the partial-onset seizures clinical trials, hostility- and aggression-related adverse reactions occurred in 12% and 20% of patients randomized to receive FYCOMPA at doses of 8 mg and 12 mg per day, respectively, compared to 6% of patients in the placebo group. These effects were dose-related and generally appeared within the first 6 weeks of treatment, although new events continued to be observed through more than 37 weeks. These effects in FYCOMPA-treated patients led to dose reduction, interruption, and discontinuation more frequently than placebo-treated patients. Homicidal ideation and/or threat have also been reported postmarketing in patients treated with FYCOMPA. The combination of alcohol and FYCOMPA significantly worsened mood and increased anger. Patients taking FYCOMPA should avoid the use of alcohol. Patients, their caregivers, and families should be informed that FYCOMPA may increase the risk of psychiatric events. Patients should be monitored during treatment and for at least one month after the last dose of FYCOMPA, and especially when taking higher doses and during the initial few weeks of drug therapy (titration period) or at other times of dose increases. Similar serious psychiatric and behavioral events were observed in the primary generalized tonic-clonic (PGTC) seizure clinical trial.
SUICIDAL BEHAVIOR AND IDEATION
Antiepileptic drugs (AEDs), including FYCOMPA, increase the risk of suicidal thoughts or behavior in patients. Anyone considering prescribing FYCOMPA or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Patients, their caregivers, and families should be informed of the risk and advised to monitor and immediately report the emergence or worsening of depression, suicidal thoughts or behavior, thoughts about self-harm and/or any unusual changes in mood or behavior. Should suicidal thoughts and behavior emerge during treatment, consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.
DIZZINESS AND GAIT DISTURBANCE
FYCOMPA caused dose-related increases in events related to dizziness and disturbance in gait or coordination. Dizziness and vertigo were reported in 35% and 47% of patients in the partial-onset seizure trials randomized to receive FYCOMPA at doses of 8 mg and 12 mg per day, respectively, compared to 10% of placebo-treated patients. Gait disturbance related events were reported in 12% and 16% of patients in the partial-onset seizure clinical trials randomized to receive FYCOMPA at doses of 8 mg and 12 mg per day, respectively, compared to 2% of placebo-treated patients. These adverse reactions occurred mostly during the titration phase. These adverse reactions were also observed in the PGTC seizure clinical trial.
SOMNOLENCE AND FATIGUE
FYCOMPA caused dose-dependent increases in somnolence and fatigue-related events. Somnolence was reported in 16% and 18% of patients in the partial-onset seizure trials randomized to receive FYCOMPA at doses of 8 mg and 12 mg per day, respectively, compared to 7% of placebo-treated patients. Fatigue-related events were reported in 12% and 15% of patients in the partial-onset seizure trials randomized to receive FYCOMPA at doses of 8 mg and 12 mg per day, respectively, compared to 5% of placebo-treated patients. These adverse reactions occurred mostly during the titration phase. These adverse reactions were also observed in the PGTC seizure clinical trial. Patients should be advised against engaging in hazardous activities requiring mental alertness, such as operating motor vehicles or dangerous machinery, until the effect of FYCOMPA is known. Patients should be carefully observed for signs of central nervous system (CNS) depression when FYCOMPA is used with other drugs with sedative properties because of potential additive effects.
FALLS
Falls were reported in 5% and 10% of patients in the partial-onset seizure clinical trials randomized to receive FYCOMPA at doses of 8 mg and 12 mg per day, respectively, compared to 3% of placebo-treated patients.
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS)
DRESS, also known as multiorgan hypersensitivity, has been reported in patients taking AEDs, including FYCOMPA. DRESS may be fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling, in association with other organ system involvement. If signs or symptoms are present, immediately evaluate the patient and discontinue FYCOMPA if an alternative etiology for signs or symptoms cannot be established.
WITHDRAWAL OF AEDs
A gradual withdrawal is generally recommended with AEDs to minimize the potential of increased seizure frequency, but if withdrawal is a response to adverse events, prompt withdrawal can be considered.
MOST COMMON ADVERSE REACTIONS
The most common adverse reactions in patients aged 12 years and older receiving FYCOMPA (≥5% and ≥1% higher than placebo) include dizziness, somnolence, fatigue, irritability, falls, nausea, weight gain, vertigo, ataxia, headache, vomiting, contusion, abdominal pain, and anxiety. Adverse reactions in patients aged 4 to <12 years were generally similar to patients aged 12 years and older.
DRUG INTERACTIONS
FYCOMPA may decrease the efficacy of contraceptives containing levonorgestrel. Plasma levels of perampanel were decreased when administered with known moderate and strong CYP3A4 inducers, including, carbamazepine, phenytoin, or oxcarbazepine. Multiple dosing of FYCOMPA 12 mg per day enhanced the effects of alcohol on vigilance and alertness, and increased levels of anger, confusion, and depression. These effects may also be seen when FYCOMPA is used in combination with other CNS depressants.
PREGNANCY AND LACTATION
Physicians are advised to recommend that pregnant patients taking FYCOMPA enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. Caution should be exercised when FYCOMPA is administered to pregnant or nursing women as there are no adequate data on the developmental risk associated with use in pregnant women, and no data on the presence of perampanel in human milk, the effects on the breastfed child, or the effects of the drug on milk production.
HEPATIC AND RENAL IMPAIRMENT
Use in patients with severe hepatic or severe renal impairment is not recommended. Dosage adjustments are recommended in patients with mild or moderate hepatic impairment. Use with caution in patients with moderate renal impairment.
DRUG ABUSE AND DEPENDENCE
FYCOMPA is a Schedule III controlled substance and has the potential to be abused and lead to drug dependence and withdrawal symptoms including anxiety, nervousness, irritability, fatigue, asthenia, mood swings, and insomnia.
INDICATION
FYCOMPA® (perampanel) is indicated in patients with epilepsy aged 4 years and older for partial-onset seizures (POS) with or without secondarily generalized seizures and adjunctive therapy for patients aged 12 years and older for primary generalized tonic-clonic (PGTC) seizures.
View the Prescribing Information.
FYCOMPA® is a trademark of Eisai R&D Management Co., Ltd., licensed to Eisai Inc. Manufactured and Marketed by Eisai, Inc., Woodcliff Lake, NJ 07677.
FYCO-US3326 October 2019