Version 3

Levodopa / carbidopa

Medicine

Extended indication Onerji is indicated for the treatment of motor fluctuations in patients with advanced Parkinsonʼs disease which are not sufficiently controlled by ora
Therapeutic value Possibly no place in the treatment regimen
Registration phase Registered

Product

Active substance Levodopa / carbidopa
Domain Neurological disorders
Reason of inclusion New medicine (specialité)
Main indication Parkinson's
Extended indication Onerji is indicated for the treatment of motor fluctuations in patients with advanced Parkinsonʼs disease which are not sufficiently controlled by oral anti-Parkinson medicinal products.
Proprietary name Onerji
Manufacturer Mitsubishi
Mechanism of action Neurotransmitter
Route of administration Subcutaneous
Therapeutical formulation Intravenous drip
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Particularity New therapeutical formulation
ATMP No
Submission date February 2025
Expected Registration April 2026
Orphan drug No
Registration phase Registered
Additional remarks Positieve CHMP-opinie in februari 2026, EC registratie in april 2026.

Therapeutic value

Current treatment options Levodopa, duodopa, foslevodopa/foscarbidopa (produodopa), dopamine-agonisten.
Therapeutic value Possibly no place in the treatment regimen

This assessment does not indicate any potential inclusion in the package.
Substantiation Er is een andere subcutane variant in Nederland beschikbaar: foslevodopa/foscarbidopa (produodopa). Deze variant lijkt minder infusiereacties te geven. Onerji zou daarom niet de voorkeur krijgen op basis van de bijwerkingen.
References NCT04006210 (BouNDless); Expertopinie

Expected patient volume per year

Patient volume < 880

Market share is generally not included unless otherwise stated.
References GIPdatabank
Additional remarks Het aantal gebruikers van duodopa in 2023 betrof 880 patiënten. Bij een aangetoonde meerwaarde zullen deze patiënten mogelijk overstappen op subcutane levodopa/carbidopa.

Expected cost per patient per year

References GIPdatabank
Additional remarks In 2023 werd er per gebruiker van levodopa met een decarboxylaseremmer €958,90 vergoed. De prijs zal afhangen van de therapeutische meerwaarde.

Potential total cost per year

Off label use

Indication extension

Other information