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Gocovri™

Drug - Gocovri™ (amantadine extended-release) [Adamas Pharma, LLC.]

July 2018

Therapeutic area - Parkinson’s disease

Approval criteria

  • Patient is ≥ 18 years of age AND
  • Patient must have dyskinesia associated with Parkinson’s disease AND
  • Patient must be on concomitant levodopa-based therapy AND
  • Patient has had an adequate trial of or is intolerant to amantadine immediate-release AND
  • Patient does not have end-stage renal disease (creatinine clearance < 15 mL/min/1.73 m2)

Renewal criteria

  • Patient continues to meet criteria defined for initial approval AND
  • Absence of unacceptable toxicity from the drug (e.g., hallucinations, falls, orthostatic hypotension, dizziness, anticholinergic effects, peripheral edema)

Quantity limits

  • 68.5 mg: 30 capsules / 30 days
  • 137 mg: 60 capsules / 30 days

Questions?

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

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