Apomorphine Medicine 13 December 2018 Extended indication Acute Treatment of OFF Episodes in Patients With Parkinson's Disease Therapeutic value No estimate possible yet Total cost € 340,000.00 Registration phase Clinical trials Product Active substance Apomorphine Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Parkinson's Extended indication Acute Treatment of OFF Episodes in Patients With Parkinson's Disease Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Sunovion Portfolio holder Mechanism of action Receptor agonist Route of administration Sublingual Therapeutical formulation Unknown Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Dopamine receptor agonist Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New therapeutical formulation ATMP Unknown Submission date 2021 Expected Registration 2022 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Registratieaanvraag ingediend bij de FDA in maart 2018. Therapeutic value Current treatment options Levodopa, dopamine-agonisten Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Fase 3 CTH-300 studie: met endpoints, well tolerated. Inschatting: mogelijke meerwaarde ten opzichte van bestaande toedieningsvorm van apomorfine beperkt. Duration of treatment Frequency of administration Dosage per administration 10-35 mg References NCT02469090 Additional remarks Expected patient volume per year Patient volume < 100 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Parkinson Vereniging Additional remarks Er zijn ruim 32.000 patiënten met Parkinson in Nederland. Aantal nieuwe gevallen per jaar is 0,51 per 1.000 inwoners (met andere woorden 8.670 patiënten per jaar). De huidige variant van apomorfine (Apo-go) werd in 2016 voorgeschreven aan 119 gebruikers. Afhankelijk van de studieresultaten en de uiteindelijke indicatiestelling zal deze nieuwe formulering een deel van deze patiënten overnemen. Expected cost per patient per year Cost € < 3,400.00 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 GIPdatabank Additional remarks In 2016 werd er €3.400 per gebruiker vergoed. Potential total cost per year Total cost € 340,000.00 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