Istradefylline Medicine 10 December 2019 Extended indication Adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson’s disease experiencing “off” episodes Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Istradefylline Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Parkinson's Extended indication Adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson’s disease experiencing “off” episodes Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Kyowa Portfolio holder Mechanism of action Receptor antagonist Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Adenosine A2 receptor antagonists Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2020 Expected Registration 2021 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks FDA heeft dit geneesmiddel al geregistreerd voor bovenstaande indicatie. Therapeutic value Current treatment options levodopa/carbidopa (en levodopa in combinatie met andere decarboxylaseremmers) Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times a day Dosage per administration 20 mg - 40 mg References NCT01968031 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIP databank Additional remarks Het aantal gebruikers van ATC groep N04BC : Dopamineagonisten betreft ongeveer 50.000 patiënten. Een deel hiervan zal in aanmerking komen voor deze nieuwe formulering. Expected cost per patient per year Cost € 800.00 - 1,000.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References GIP databank Additional remarks Kosten naar verwachting vergelijkbaar met levodopa in combinatie met andere decarboxylaseremmers 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 No Indication extensions References Additional remarks Other information Additional remarks