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Coverage Policies

Coverage for DAYVIGO™ 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.

Coverage for DAYVIGO 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 DAYVIGO. 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 DAYVIGO 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 step therapies for DAYVIGO.

When DAYVIGO is Not Covered by a Health Plan, Coverage May be Requested

Coverage of DAYVIGO is determined by the member's pharmacy benefit. Providers or patients should contact the health plan directly to determine whether DAYVIGO is included on the formulary. If DAYVIGO is not covered by the plan, an exception may be requested by the patient and 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.

“Prior Authorization Required” Categorization

Prior authorization (PA) is a requirement that the physician obtain approval from the health insurance plan prior to prescribing DAYVIGO.

“Step Therapy” Categorization

Your insurer may ask if the patient has tried and failed at another sleep therapy before trying DAYVIGO. In this case, it is important to include documentation of any previous treatments in the appeal letter.

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.

Medicare Part D

The Part D drug benefit provides beneficiaries with coverage for outpatient prescription drugs. 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 75% 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.

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 DAYVIGO 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.

Need Help With NDC Codes?

NDC codes identify specific product package sizes for DAYVIGO
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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

DAYVIGO (lemborexant) is an orexin receptor antagonist indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • DAYVIGO is contraindicated in patients with narcolepsy.

WARNINGS AND PRECAUTIONS

  • Central Nervous System (CNS) Depressant Effects and Daytime Impairment:

    DAYVIGO can impair daytime wakefulness. CNS depressant effects may persist in some patients up to several days after discontinuing DAYVIGO. Prescribers should advise patients about the potential for next-day somnolence.

    Driving ability was impaired in some subjects taking DAYVIGO 10 mg. Risk of daytime impairment is increased if DAYVIGO is taken with less than a full night of sleep remaining or at a higher than recommended dose. If taken in these circumstances, patients should not drive or engage in activities requiring mental alertness.

    Use with other classes of CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression, which can cause daytime impairment. Dosage adjustments of DAYVIGO and concomitant CNS depressants may be necessary when administered together. Use of DAYVIGO with other insomnia drugs is not recommended. Patients should be advised not to consume alcohol in combination with DAYVIGO.

    Because DAYVIGO can cause drowsiness, patients, particularly the elderly, are at a higher risk of falls.

  • Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and Cataplexy-Like Symptoms:

    Sleep paralysis, an inability to move or speak for up to several minutes during sleep-wake transitions, hypnagogic/hypnopompic hallucinations, including vivid and disturbing perceptions can occur with DAYVIGO. Prescribers should explain these events to patients.

    Symptoms similar to mild cataplexy can occur with DAYVIGO and can include periods of leg weakness lasting from seconds to a few minutes, can occur either at night or during the day, and may not be associated with identified triggering event (e.g., laughter or surprise).

  • Complex Sleep Behaviors:

    Complex sleep behaviors, including sleep-walking, sleep-driving, and engaging in other activities while not fully awake (e.g., preparing and eating food, making phone calls, having sex), have been reported to occur with the use of hypnotics such as DAYVIGO. Events can occur in hypnotic-naïve and hypnotic-experienced persons. Patients usually do not remember these events. Complex sleep behaviors may occur following the first or any subsequent use of DAYVIGO, with or without the concomitant use of alcohol and other CNS depressants. Discontinue DAYVIGO immediately if a patient experiences a complex sleep behavior.

  • Patients with Compromised Respiratory Function:

    The effect of DAYVIGO on respiratory function should be considered for patients with compromised respiratory function. DAYVIGO has not been studied in patients with moderate to severe obstructive sleep apnea (OSA) or chronic obstructive pulmonary disease (COPD).

  • Worsening of Depression/Suicidal Ideation:

    Incidence of suicidal ideation or suicidal behavior, as assessed by questionnaire, was higher in patients receiving DAYVIGO than placebo (0.3% for DAYVIGO 10 mg, 0.4% for DAYVIGO 5 mg, and 0.2% for placebo). In primarily depressed patients treated with hypnotics, worsening of depression and suicidal thoughts and actions (including completed suicides) have been reported. Suicidal tendencies may be present in such patients and protective measures may be required. Intentional overdose is more common in this group of patients; therefore, the lowest number of tablets that is feasible should be prescribed at any one time. The emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation.

  • Need to Evaluate for Comorbid Diagnoses:

    Treatment of insomnia should be initiated only after careful evaluation of the patient. Re-evaluate for comorbid conditions if insomnia persists or worsens after 7 to 10 days of treatment. Worsening of insomnia or the emergence of new cognitive or behavioral abnormalities may be the result of an unrecognized underlying psychiatric or medical disorder and can emerge during the course of treatment with sleeppromoting drugs such as DAYVIGO.

ADVERSE REACTIONS

  • The most common adverse reaction (reported in 5% of patients treated with DAYVIGO and at least twice the rate of placebo) with DAYVIGO was somnolence (10% for DAYVIGO 10 mg, 7% for DAYVIGO 5 mg, 1% for placebo).

DRUG INTERACTIONS

  • CYP3A Inhibitors: The maximum recommended dose of DAYVIGO is 5 mg no more than once per night when co-administered with weak CYP3A inhibitors. Avoid concomitant use of DAYVIGO with strong or moderate CYP3A inhibitors.

  • CYP3A Inducers: Avoid concomitant use of DAYVIGO with moderate or strong CYP3A inducers.

USE IN SPECIFIC POPULATIONS

  • Pregnancy and Lactation: There is a pregnancy exposure registry that monitors pregnancy outcomes in women who are exposed to DAYVIGO during pregnancy. Healthcare providers are encouraged to register patients in the DAYVIGO pregnancy registry by calling 1-888-274-2378. There are no available data on DAYVIGO use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

    There are no data on the presence of lemborexant in human milk, the effects on the breastfed infant, or the effects on milk production. Infants exposed to DAYVIGO through breastmilk should be monitored for excess sedation.

  • Geriatric Use: Exercise caution when using doses higher than 5 mg in patients ≥65 years old.

  • Renal Impairment: Patients with severe renal impairment may experience an increased risk of somnolence.

  • Hepatic Impairment: The maximum recommended dose of DAYVIGO is 5 mg in patients with moderate hepatic impairment. DAYVIGO is not recommended in patients with severe hepatic impairment. Patients with mild hepatic impairment may experience an increased risk of somnolence.

DRUG ABUSE AND DEPENDENCE

  • DAYVIGO is a Schedule IV-controlled substance.

  • Because individuals with a history of abuse or addiction to alcohol or other drugs may be at increased risk for abuse and addiction to DAYVIGO, follow such patients carefully.

For more information about DAYVIGO, see full Prescribing Information.

This information is intended for use by 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.

DAYVIGO™ is a trademark of Eisai R&D Management Co., Ltd. and is licensed to Eisai Inc.©2020 Eisai Inc.

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