CurrentUnitedHealthcarePolicy 2025 P 2213-6

Clinical Pharmacy Programs - Nuedexta

Defines UnitedHealthcare prior authorization/medical necessity criteria for initiation and reauthorization of Nuedexta for treatment of pseudobulbar affect (PBA), including required diagnoses, qualifying neurologic conditions, prescriber requirements, cardiac safety, and authorization duration.

Policy Summary

PayerUnitedHealthcare

PolicyClinical Pharmacy Programs - Nuedexta

Policy CodePolicy 2025 P 2213-6

Change TypeAnnual review; authorization duration clarified

Effective DateOct 1, 2025

Next Review Date

Key ActionPrior authorization required; approval contingent on meeting initial or reauthorization criteria and documenting cardiac safety and prescriber specialty (neurologist).

POLICY UPDATE CHANGES

Updated initial authorization to 12 months (7/2024).

Annual review completed 7/2025 with updated references.

12 moInitial Authorization Duration

12 moReauthorization Duration

6Qualifying neurologic conditions

1Required prescriber specialty

Coverage Summary

This policy establishes UnitedHealthcare prior authorization/medical necessity criteria for Nuedexta (dextromethorphan/quinidine) for the treatment of pseudobulbar affect (PBA). It requires a diagnosis of PBA, documentation of one of the listed qualifying neurologic conditions (ALS, Alzheimer’s disease, multiple sclerosis, Parkinson’s disease, stroke, or traumatic brain injury), documented absence of cardiac rhythm disorders, and that the medication be prescribed by or in consultation with a neurologist. Initial and reauthorization approvals are issued for 12 months. Coverage stance: covered_with_criteria. Policy number: 2025 P 2213-6.

Key Policy Facts

Initial Authorization Duration12 months

Reauthorization Duration12 months

Listed qualifying neurologic conditions6 (ALS; Alzheimer's disease; MS; Parkinson's disease; Stroke; Traumatic brain injury)

Required prescriber specialtyNeurologist (prescribed by or in consultation with)

Effective date2025-10-01

Last review2025-07-01

Initial Therapy Criteria

Initial Authorization

Nuedexta will be approved based on all of the following criteria:

ALL of the following

Diagnosis of pseudobulbar affect
One of the following underlying neurologic conditions
- Amyotrophic lateral sclerosis (ALS)
- Alzheimer's disease
- Multiple sclerosis (MS)
- Parkinson's disease
- Stroke
- Traumatic brain injury
Documented absence of cardiac rhythm disorders
Requires documentation that no cardiac rhythm disorders are present
Prescribed by or in consultation with a neurologist

Continuation / Reauthorization Criteria

Reauthorization

Nuedexta will be approved for reauthorization when the following is met:

ALL of the following

Documentation of positive clinical response to therapy

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization/medical necessity program applies. Approval is contingent on meeting the program's initial authorization or reauthorization criteria (see criteria for diagnosis, qualifying neurologic condition, cardiac safety, and prescriber specialty). Automated approvals and reauthorizations based solely on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic may be used by the program.

Documentation Required

Document cardiac safety and prescriber specialty

For initial authorization, provide documentation that no cardiac rhythm disorders are present and that the drug is prescribed by or in consultation with a neurologist.

Documentation Required

Document clinical response for reauthorization

For reauthorization, providers must document a positive clinical response to therapy to support continued coverage.

Applicable Codes

Referenced diagnosis codesICD-10

G12.21	Amyotrophic lateral sclerosis (ALS)
G30.9	Alzheimer's disease, unspecified
G35	Multiple sclerosis
G20	Parkinson disease
I63.9	Cerebral infarction (stroke), unspecified
S06.5X9A	Traumatic brain injury, unspecified, initial encounter
R47.89	Other disturbances of speech and voice (used when PBA coded clinically)

DrugNDCCovered

00078-0700-01

Nuedexta (dextromethorphan hydrobromide and quinidine sulfate) 20 mg/10 mg, example package NDC

Referenced diagnosis codes (policy text)ICD-10

No codes listed

Background & Clinical Evidence

Nuedexta (combination dextromethorphan hydrobromide and quinidine sulfate) is indicated for the treatment of pseudobulbar affect (PBA), a condition that occurs secondary to various neurologic disorders and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA is distinct from other types of emotional lability seen with neurologic disease or injury.

Reference: Nuedexta [package insert]. Otsuka America Pharmaceutical, Inc.; December 2022.

Revision History

2024-07material_change