Amantadine Medicine 10 December 2019 Extended indication Extended-Release Capsules for Levodopa-Induced Dyskinesia in Parkinson's Disease Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Amantadine Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Parkinson's Extended indication Extended-Release Capsules for Levodopa-Induced Dyskinesia in Parkinson's Disease Current proprietary name Already available biosimilars / generics Proprietary name Gocovri Manufacturer Adamas Portfolio holder Mechanism of action Receptor antagonist Route of administration Oral Therapeutical formulation Capsule Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New therapeutical formulation ATMP Unknown Submission date 2022 Expected Registration 2023 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet 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 137-274 mg References Prescribing information Gocovri, FDA Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Eusebi et al. NPJ Parkinsons Dis. 2018; 4: 33. Additional remarks In 2016 waren er 35.925 gebruikers van levodopa/carbidopa (Sinemet). Ongeveer een kwart van de patiënten krijgt last van levodopa-induced dyskiesia (8.981 patiënten). Hoeveel patiënten hiervan zullen worden behandeld met Gocovri hangt af van de uiteindelijke indicatie en de plek in de behandelrichtlijn. Expected cost per patient per year Cost € < 25,500.00 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 https://seekingalpha.com/article/4108394-adamas-releases-pricing-gocovri Additional remarks De lijstprijs in de Verenigde Staten is $28.500 per jaar (~€25.500). In de Europa zal dit waarschijnlijk lager geprijsd worden. 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 Yes Indication extensions Multiple Sclerosis Patients With Walking Impairment References Clinicaltrials.gov Additional remarks Other information Additional remarks