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DrugOngentys® (opicapone capsule) [Neurocrine Biosciences, Inc.]

March 2021

Therapeutic area - Antiparkinson’s Agents

Initial approval criteria

  • Patient is ≥ 18 years of age AND
  • Documented diagnosis of Parkinson’s disease (PD) AND
  • Patient is experiencing “off” episodes of PD at least 1.5 hours/day on average AND
  • Patient does NOT have severe hepatic impairment (Child-Pugh C) AND
  • Patient does NOT have end stage renal disease (estimated creatinine clearance < 15 mL/min) AND
  • Patient will avoid concomitant use with non-selective monoamine oxidase-B (MAO-B) inhibitors AND
  • Patient does NOT have history of pheochromocytoma, paraganglioma, or other catecholamine secreting neoplasms AND
  • Patient must be on a concomitant stable levodopa-based therapy regimen AND
  • Patient has had an adequate trial and subsequent failure of at least 2 preferred adjunctive therapies (e.g., dopamine agonists, MAO-B inhibitors, catechol-O-methyltransferase [COMT] inhibitors) to control “off” symptoms

Renewal criteria

  • Patient continues to meet the above initial criteria AND
  • Absence of unacceptable toxicity or treatment related adverse event from the drug (e.g., dyskinesias, hallucinations/psychotic behavior, impulse control/compulsive behaviors) AND
  • Patient has clinically meaningful response to treatment (e.g., patient shows a reduction in time of “off” episodes)

Quantity limits

  • 34 capsules per 34 days 


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

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