NUEDEXTA (dextromethorphan and quinidine)

NUEDEXTA (dextromethorphan and quinidine)

SELF ADMINISTRATION

Indications for Prior Authorization:

• Treatment of Pseudobulbar Affect (PBA) secondary to ALS (amyotrophic lateral sclerosis) or MS (multiple sclerosis) patients

Patients must meet the following criteria for the indication(s) above:

• Diagnosis of PBA secondary to MS or ALS as supported by chart note documentation, AND
• Prescribed by or in consultation with a neurologist, AND
• Baseline Center for Neurologic Study-Lability Scale (CNS-LS) score >13, AND
• Dose does not exceed 40mg dextromethorphan and 20mg quinidine per day (2 capsules per day), AND
• Does not have a contraindication to therapy:
  • Concomitant use with quinidine, quinine, or mefloquine
  • Patients with a history of quinidine, quinine, or mefloquine-induced thrombocytopenia, hepatitis, or other hypersensitivity reactions
  • Patient with known hypersensitivity to dextromethorphan
  • Use with a monoamine oxidase inhibitor (MAOI) or within 14 days of stopping an MAOI
  • Prolonged QT interval, congenital long QT syndrome, history suggestive or torsades de pointes, or heart failure
  • Complete atrioventricular (AV) block without implanted pacemaker, or patients at high risk of complete AV block
  • Concomitant use with drugs that both prolong QT interval and are metabolized by CYP2D6 (e.g. thioridazine or pimozide)

Dosing:

•  Starting dose: 1 capsule (20mg dextromethorphan and 10 mg quinidine) daily for 7 days
• Day 8: increase to 1 capsule every 12 hours

Approval:

• Initial: 12 weeks
• Renewal: 12 months
• Renewal requires chart note documentation supporting positive response to therapy as evidenced by decrease in CNS-LS score by 3 points or greater from baseline AND if the request if for a dose increase, new dose does not exceed 40mg dextromethorphan and 20mg quinidine per day