Ingrezza™

Drug - Ingrezza™ (valbenazine) [Neurocrine Biosciences]

December 2017

Therapeutic area - Movement disorders

Approval criteria

• Patient must be at least 18 years of age AND
• Patient has been clinically diagnosed with tardive dyskinesia (TD) based on the presence of ALL of the following:
  • Involuntary athetoid or choreiform movements lasting at least a few weeks
  • Documentation or claims history of current or former chronic patient use of a dopamine antagonist (e.g., antipsychotic, metoclopramide, prochlorperazine, droperidol, promethazine, etc.)
  • Symptoms lasting longer than 4-8 weeks AND
• Prescribed by or in consultation with a neurologist or psychiatrist (or other mental health provider) AND
• Documentation of functional impairment due to TD symptoms which may include, but is not limited to, limitation of daily living activities such as frequent falls, or missing school or work AND
• Documentation that the prescriber has conducted a comprehensive review of all of patient’s current medications and TD risk mitigation strategies, which include the following, have been tried and failed (unless contraindicated or inappropriate in order to maintain stable psychiatric function)
  • Switching to a preferred second generation antipsychotic OR
  • Discontinuation or dose modification of the offending medication AND
• Documentation of baseline AIMS (Abnormal Involuntary Movement Scale) Score ≥ 10 AND
• Patient has tried and failed Austedo AND
• Patient must not have any ONE of the following: 
  • Concurrent use of MAO inhibitors (e.g., isocarboxazid, phenelzine, rasagiline, safinamide, selegiline, tranylcypromine, etc.) or strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, phenobarbital, rifampin and related agents, St. John’s wort, etc) OR
  • Dual therapy with other vesicular monoamine transporter 2 (VMAT 2) inhibitors

Renewal criteria

• Patient continues to meet criteria defined for initial approval AND
• Documentation of improvement in TD symptoms defined as a decrease from baseline by at least 2 points in AIMS 

Quantity limit

34 capsules per 34 days

Questions?

MHCP Provider Call Center 651-431-2700 or 800-366-5411