Nuedexta – Enhanced & Essential Formulary

Restricted Product(s)

• Nuedexta (dextromethorphan/quinidine)

FDA Approved Use

• For the treatment of pseudobulbar affect (PBA)

Criteria for Approval of Restricted Product(s)

1. The patient is at least 18 years of age; AND 
2. The patient has been diagnosed with pseudobulbar affect; AND 
3. The patient has an underlying neurological disorder such as amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), traumatic brain injury (TBI), stroke, Alzheimer’s and related diseases, or Parkinsonian syndromes; AND 
4. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 365 days (1 year) 

Quantity Limit Exception Criteria

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND 
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND 
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed). 

Duration of Approval: 365 days (1 year)

References

All information referenced is from FDA package insert unless otherwise noted below.

Ahmed, Aiesha, and Zachary Simmons. “Pseudobulbar affect: prevalence and management.” Therapeutics and clinical risk management vol. 9 (2013): 483-9. doi:10.2147/TCRM.S53906

Minden SL, Feinstein A, Kalb RC, et al. Evidence-based guideline: assessment and management of psychiatric disorders in individuals with MS. Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2014;82(2):174-181.

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q4 annually.

August 2024: Criteria update: Annual Criteria review, formatting changes only.

August 2022: Criteria update: Changed duration of approval from 3 years to 365 days.

April 2020: Original utilization management criteria issued.