Levodopa / carbidopa Medicine 03 June 2025 Extended indication Levodopa/carbidopa monotherapy for treatment of Parkinson's disease in adults over 30 years of age and elderly who are experiencing motor fluctuations. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Levodopa / carbidopa Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Parkinson's Extended indication Levodopa/carbidopa monotherapy for treatment of Parkinson's disease in adults over 30 years of age and elderly who are experiencing motor fluctuations. Current proprietary name Already available biosimilars / generics Proprietary name ND0612 Manufacturer Mitsubishi Portfolio holder Mechanism of action Neurotransmitter Route of administration Subcutaneous Therapeutical formulation Intravenous drip Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity New therapeutical formulation ATMP No Submission date February 2025 Expected Registration March 2026 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Verwachte registratie op basis van een gemiddelde doorlooptijd van 13 maanden voor een nieuw middel. Therapeutic value Current treatment options Levodopa, duodopa, dopamine-agonisten. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT04006210 (BouNDless) Additional remarks Expected patient volume per year Patient volume < 880 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice 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 Cost References GIPdatabank Additional remarks In 2023 werd er per gebruiker van levodopa met een decarboxylaseremmer €958,90 vergoed. De prijs voor ND0612 zal afhangen van de therapeutische meerwaarde. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks