GVS assessment of opicapone (Ongentys®) for the treatment of Parkinson's disease

Zorginstituut Nederland has completed its assessment whether opicapone (Ongentys®) is interchangeable with a product that has been included in the Medication Reimbursement System (GVS). The Zorginstituut's advice is to include opicapone (Ongentys®) in the existing cluster 0N04BXAO V on List 1A of the GVS.

Registered indication

Opicapone (Ongentys®) is indicated as adjunctive therapy for levodopa/DOPA decarboxylase inhibitor (DDCI) in adult patients with Parkinson's disease and end-of-dose motor fluctuations who cannot be stabilized on those combinations.

Assessment

Zorginstituut Nederland has reached the final conclusion that in the treatment of Parkinson's disease and end-of-dose motor fluctuations, opicapone (Ongentys®) as an ‘add on’ for levodopa/dopa decarboxylase inhibitor has an equal value compared to entacapone.

On the basis of the criteria for interchangeability, it can be concluded that opicapone (Ongentys®) is interchangeable with the other COMT inhibitor entacapone in the GVS cluster 0N04BXAO V.

Zorginstituut's advice

Based on the considerations mentioned in the report, the Zorginstituut advises the Minister for Medical Care to include opicapone (Ongentys®) on List 1A of the GVS in cluster 0N04BXAO V. 50 mg/day can be used as the standard dose.

This report is a summary of recommendations by Zorginstituut Nederland. The original text is in Dutch.