Access & Affordability

Otsuka offers financial assistance and cost savings for eligible NUEDEXTA patients

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Copay card savings

Eligible patients may pay as little as $0* for a 90-day prescription with commercial insurance

Card must be activated before use. Visit NUEDEXTA.com/activate or call 1-855-468-3339.

Share this card with your patients to help them save on their NUEDEXTA prescription and refills.

Print savings card

*Restrictions apply. Eligible patients may pay as little as $0 for a 90-day supply of NUEDEXTA or $20 for a 30-day supply of NUEDEXTA with a maximum savings of $1335 per use and an annual maximum savings of $2670 per calendar year. Benefit cap applies regardless of copay amount.

AUTHORIZATION PROCESS

Additional support to help your patients throughout the authorization process

Access support with CoverMyMeds

CoverMyMeds provides prior authorization (PA) support for eligible patients, streamlines the PA process, and simplifies access for patients in one centralized location.

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Submit prior authorizations and request formulary exception and appeals support

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Track patient case status and gain visibility from prescription through approval

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Conduct benefits verification and investigation

Dedicated Field Reimbursement Managers (FRMs) are available to educate prescribers and pharmacists on the PA access and approval process for NUEDEXTA.

We’re here to help.

Call 1-855-4NUEDEX (468-3339)
Providers can create a free account or log into an existing account at CoverMyMeds.com.

Need help logging in? Case Managers are available via phone or live chat via the website.

Prior authorization

Some insurance providers and Medicare Part D plans may require prior authorization (PA) for the patients
or residents for whom you prescribe NUEDEXTA. Other plans may require reauthorization 3 to 6 months after the initial
PA is granted or on the anniversary of the initial PA. Each health plan will determine the PA criteria for its formulary.

There are 4 common pieces of documentation generally requested by plans as part of their
PA process to ensure that NUEDEXTA is being used safely and appropriately:
Primary diagnosis
Underlying neurologic conditions
That NUEDEXTA is not
contraindicated for the
patient (please refer to the
Prescribing Information)
Medical or clinical history
Code PBA diagnosis first (F48.2†), followed by the diagnosis code for the underlying neurologic condition
Common requirements/documentation for reauthorization
  • Patient continues to meet plan’s PA criteria
  • Demonstrated improvement of PBA symptoms may be required
  • Attestation of specialist consultation or prescribed by a specialist
  • Attestation that risks and contraindications have been
    considered and verified
†The ICD-10 diagnosis code is provided for informational purposes only and does not guarantee that the billing code will be appropriate or that coverage and reimbursement will result. Providers should consult with their payers for all relevant coverage, coding, and reimbursement requirements. It is the sole responsibility of the provider to select proper codes and ensure the accuracy of all claims used in seeking reimbursement. This resource is not intended as legal advice or as a substitute for a provider’s independent professional judgment.

IMPORTANT SAFETY INFORMATION and INDICATION for NUEDEXTA® (dextromethorphan HBr and quinidine sulfate)INDICATION and IMPORTANT SAFETY INFORMATION for NUEDEXTA® (dextromethorphan HBr and quinidine sulfate)

INDICATION

NUEDEXTA is indicated for the treatment of pseudobulbar affect (PBA).

PBA occurs secondary to a variety of otherwise unrelated neurologic conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the underlying emotional state. PBA is a specific condition, distinct from other types of emotional lability that may occur in patients with neurologic disease or injury.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:

  • Quinidine and Related Drugs: NUEDEXTA contains quinidine and should not be used concomitantly with other drugs containing quinidine, quinine, or mefloquine.
  • Hypersensitivity: NUEDEXTA is contraindicated in patients with a history of NUEDEXTA-, quinine-, mefloquine-, or quinidine-induced thrombocytopenia, hepatitis, bone-marrow depression, lupus-like syndrome, or known hypersensitivity to dextromethorphan (e.g., rash, hives).
  • MAOIs: NUEDEXTA is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs), or in patients who have taken MAOIs within the preceding 14 days, due to the risk of serious and possibly fatal drug interactions, including serotonin syndrome. Allow at least 14 days after stopping NUEDEXTA before starting an MAOI.
  • Cardiovascular: NUEDEXTA is contraindicated in patients with a prolonged QT interval, congenital long QT syndrome, history suggestive of torsades de pointes, heart failure, patients receiving drugs that both prolong QT interval and are metabolized by CYP2D6 (e.g., thioridazine and pimozide), patients with complete atrioventricular (AV) block without implanted pacemaker, or at high risk of complete AV block.

Thrombocytopenia and Other Hypersensitivity Reactions: Quinidine can cause immune-mediated thrombocytopenia that can be severe or fatal. Non-specific symptoms, such as lightheadedness, chills, fever, nausea, and vomiting, can precede or occur with thrombocytopenia. NUEDEXTA should be discontinued immediately if thrombocytopenia occurs.

Hepatotoxicity: Hepatitis, including granulomatous hepatitis, has been reported in patients receiving quinidine, generally during the first few weeks of therapy. Discontinue immediately if this occurs.

Cardiac Effects: NUEDEXTA causes dose-dependent QTc prolongation. QT prolongation can cause torsades de pointes–type ventricular tachycardia, with the risk increasing as the degree of prolongation increases. When initiating NUEDEXTA in patients at risk for QT prolongation and torsades de pointes, electrocardiographic (ECG) evaluation of QT interval should be conducted at baseline and 3 to 4 hours after the first dose. Some risk factors include use with CYP3A4 inhibitors or drugs that prolong QT interval, electrolyte abnormalities, bradycardia, or left ventricular hypertrophy or dysfunction. If patients taking NUEDEXTA experience symptoms that could indicate the occurrence of cardiac arrhythmias (e.g., syncope or palpitations), NUEDEXTA should be discontinued, and the patient further evaluated.

Concomitant Use of CYP2D6 Substrates: NUEDEXTA inhibits CYP2D6 and may interact with other drugs metabolized by CYP2D6. Adjust dose of CYP2D6 substrates as needed.

Dizziness: NUEDEXTA may cause dizziness. Take precautions to reduce the risk of falls.

Serotonin Syndrome: Use of NUEDEXTA with selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants increases the risk of “serotonin syndrome.”

Anticholinergic Effects of Quinidine: Monitor for worsening in myasthenia gravis.

Adverse Reactions: The most common adverse reactions (incidence of ≥3% and two-fold greater than placebo) in patients taking NUEDEXTA are diarrhea, dizziness, cough, vomiting, asthenia, peripheral edema, urinary tract infection, influenza, increased gamma-glutamyltransferase, and flatulence.

These are not all the risks for use of NUEDEXTA.

To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).

INDICATION

NUEDEXTA is indicated for the treatment of pseudobulbar affect (PBA).

PBA occurs secondary to a variety of otherwise unrelated neurologic conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the underlying emotional state. PBA is a specific condition, distinct from other types of emotional lability that may occur in patients with neurologic disease or injury.

Please see FULL PRESCRIBING INFORMATION.