Ongentys®

Drug - Ongentys® (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

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)

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