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Pseudobulbar Affect (PBA) Prior Authorization with Quantity Limit Program Summary

Policy Number: PH-91097

This program applies to Blue Partner, Commercial, GenPlus, SourceRx and Health Insurance Marketplace formularies.      

POLICY REVIEW CYCLE                                                                                                                                            

Effective Date

Date of Origin   

04-01-2025           

04-01-2019

FDA LABELED INDICATIONS AND DOSAGE

Agent(s)

FDA Indication(s)

Notes

Ref#

Nuedexta®

(dextromethorphan hydrobromide and quinidine sulfate)

Capsule

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 neurological disease or injury.

1

See package insert for FDA prescribing information:  https://dailymed.nlm.nih.gov/dailymed/index.cfm

CLINICAL RATIONALE

Pseudobulbar Affect

Pseudobulbar affect (PBA) is a condition associated with common neurological diseases or brain injury that manifests as uncontrollable and inappropriate outbursts of laughter or crying that are independent of mood. PBA exacts a severe burden on the patient and caregivers in terms of reduced social functioning and often results in the patient’s isolation and inability to maintain employment. Studies have shown that quality of life is seriously decreased in patients with this condition. The pathophysiology of PBA is incompletely understood, but symptoms are thought to result from damage to neural pathways associated with motor functioning and emotional processing.(2) PBA is associated with underlying central nervous system disorders including amyotrophic lateral sclerosis (ALS), Parkinson’s disease (PD), multiple sclerosis (MS), Alzheimer’s disease (AD), stroke, dementia, and traumatic brain injury (TBI).(2,3)

Detection and diagnosis of PBA can be challenging. Evaluation and treatment are likely to be focused on the underlying neurological condition and the symptoms of PBA may be unreported or overlooked. PBA can be confused with psychotic disorders such as schizophrenia or mood disorders such as bipolar disorder, depression, or even epilepsy. Depression is the principal differential diagnostic challenge and can be differentiated from PBA by the uncontrollable, stereotypical and excessive nature of the PBA episodes. The presence of PBA can usually be detected by simply asking the patient or caregiver if they have a tendency to laugh or cry for no reason or have an exaggerated response to emotional situations.(2) PBA may be more objectively measured by published scales. The Center for Neurologic Study – Lability Scale (CNS-LS) is a seven-item self-administered questionnaire that asks about the control of laughter and crying, and has been validated in patients with ALS and MS.(2,3)

PBA can impact quality of life and disease burden in patients with common neurological disorders. The goal of treatment for PBA is to diminish the severity and frequency of episodes. By managing PBA with an appropriate pharmacological approach, clinicians can have a meaningful impact on symptoms that are socially embarrassing and functionally limiting for these patients.(3)

Efficacy

The efficacy of NUEDEXTA was demonstrated in one trial over 12 weeks in patients with pseudobulbar affect (PBA) with underlying amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS). Other trials at higher doses (dextromethorphan 30 mg/quinidine 30 mg) provided supportive evidence.(1)

PRISM II was an open-label, multicenter trial evaluating twice-daily Nuedexta over 90 days in adults with PBA secondary to dementia, stroke, or TBI (n=367). Nuedexta was shown to be well tolerated and it significantly reduced PBA episodes in patients with dementia, stroke, or TBI, showing similar improvement to phase 3 trials in patients with PBA with underlying ALS or MS.(4-6) 

Safety

Nuedexta is contraindicated in the following:(1)

  • Concomitant use with other drugs containing quinidine, quinine, or mefloquine.
  • In patients with a history of Nuedexta, quinine, mefloquine or quinidine-induced thrombocytopenia, hepatitis, bone marrow depression or lupus-like syndrome. Nuedexta is also contraindicated in patients with a known hypersensitivity to dextromethorphan (e.g. rash, hives).
  • 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.
  • In patients with a prolonged QT interval, congenital long QT syndrome or a history suggestive of torsades de pointes, and in patients with heart failure.
  • In patients receiving drugs that both prolong QT interval and are metabolized by CYP2D6 (e.g., thioridazine and pimozide), as effects on QT interval may be increased.
  • In patients with complete atrioventricular (AV) block without implanted pacemakers, or in patients who are at high risk of complete AV block.

REFERENCES                                                                                                                                                                           

Number

Reference

1

Nuedexta prescribing information. Avanir Pharmaceuticals, Inc. December 2022. 

2

Cummings J, Gilbart J, Andersen G. Pseudobulbar affect – a disabling but under-recognized consequence of neurological disease and brain injury. European Neurological Review. 2013;8(2):74. doi:10.17925/enr.2013.08.02.74

3

Simmons Z, Ahmed A. Pseudobulbar affect: prevalence and management. Therapeutics and Clinical Risk Management. Published online November 1, 2013:483. doi:10.2147/tcrm.s53906

4

Hammond FM, Sauve W, Ledon F, Davis C, Formella AE. Safety, tolerability, and effectiveness of Dextromethorphan/Quinidine for pseudobulbar affect among study participants with traumatic brain injury: results from the PRISM‐II Open Label study. PM&R. 2018;10(10):993-1003. doi:10.1016/j.pmrj.2018.02.010

5

Zorowitz RD, Alexander DN, Formella AE, Ledon F, Davis C, Siffert J. Dextromethorphan/Quinidine for pseudobulbar affect following stroke: Safety and effectiveness in the PRISM II trial. PM&R. 2018;11(1):17-24. doi:10.1016/j.pmrj.2018.06.003

6

Doody RS, D’Amico S, Cutler AJ, et al. An open-label study to assess safety, tolerability, and effectiveness of dextromethorphan/quinidine for pseudobulbar affect in dementia: PRISM II results. CNS Spectrums. 2015;21(6):450-459. doi:10.1017/s1092852915000620

POLICY AGENT SUMMARY PRIOR AUTHORIZATION

Target Brand Agent(s)

Target Generic Agent(s)

Strength

Targeted MSC

Available MSC

Final Age Limit

Preferred Status

Nuedexta

dextromethorphan hbr-quinidine sulfate cap

20-10 MG

M ; N ; O ; Y

N

POLICY AGENT SUMMARY QUANTITY LIMIT

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

QL Amount

Dose Form

Day Supply

Duration

Addtl QL Info

Allowed Exceptions

Targeted NDCs When Exclusions Exist

Nuedexta

Dextromethorphan HBr-Quinidine Sulfate Cap 20-10 MG

20-10 MG

60

Capsules

30

DAYS

CLIENT SUMMARY – PRIOR AUTHORIZATION

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Client Formulary

Nuedexta

dextromethorphan hbr-quinidine sulfate cap

20-10 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

CLIENT SUMMARY – QUANTITY LIMITS

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Client Formulary

Nuedexta

Dextromethorphan HBr-Quinidine Sulfate Cap 20-10 MG

20-10 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

PA

Initial Evaluation

Target Agent(s) will be approved when ALL of the following are met:

  1. The patient has a diagnosis of pseudobulbar affect (PBA) AND
  2. The patient has ONE of the following:
    1. Amyotrophic lateral sclerosis (ALS) OR
    2. Multiple sclerosis (MS) OR
    3. Dementia OR
    4. Stroke OR
    5. Traumatic brain injury AND
  3. The prescriber has assessed the patient's PBA episodes (laughing and/or crying episodes) prior to therapy with the requested agent AND
  4. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., neurologist, neuropsychologist, psychiatrist), or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
  5. The patient does NOT have any FDA labeled contraindications to the requested agent

Length of Approval: 3 months

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.


Renewal Evaluation

Target Agent(s) will be approved when ALL of the following are met:

  1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process [Note: patients not previously approved for the requested agent will require initial evaluation review] AND
  2. The patient has had clinical benefit with the requested agent AND
  3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., neurologist, neuropsychologist, psychiatrist), or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
  4. The patient does NOT have any FDA labeled contraindications to the requested agent

Length of Approval: 12 months

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. 

QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:

  1. The requested quantity (dose) does NOT exceed the program quantity limit OR
  2. The requested quantity (dose) exceeds the program quantity limit AND ONE of the following:
    1. BOTH of the following:
      1. The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND
      2. There is support for therapy with a higher dose for the requested indication OR
    2. BOTH of the following:
      1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
      2. There is support for why the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit OR
    3. BOTH of the following:
      1. The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND
      2. There is support for therapy with a higher dose for the requested indication

Length of Approval: up to 12 months

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.

Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

 

 

 

Commercial _ PS _ Pseudobulbar_Affect_PAQL _ProgSum_ 04-01-2025