Levodopa Medicine 13 December 2018 Extended indication Treatment for symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen. Therapeutic value No judgement Total cost Registration phase Registration application pending Product Active substance Levodopa Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Parkinson's Extended indication Treatment for symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen. Current proprietary name Already available biosimilars / generics Proprietary name Inbrija Manufacturer Acorda Portfolio holder Mechanism of action Neurotransmitter Route of administration Inhalation Therapeutical formulation Oral powder Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Precursor van dopamine. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New therapeutical formulation ATMP Unknown Submission date June 2018 Expected Registration September 2019 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Nieuws september 2018: "Acorda Therapeutics, Inc today announced that the U.S. Food and Drug Administration (FDA) has extended its decision date on inhaled levodopa to January 5, 2019. According to a press release, the extension is related to submission of additional information on the drug’s chemistry and manufacturing that will take additional time for the FDA to review. " Therapeutic value Current treatment options Andere formuleringen van levodopa Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 5 times a day Dosage per administration References NCT02240030 Additional remarks SPAN-PD trial met primary endpoint: CVT-301 showed statistically significant improvement of motor function compared to placebo. In deze studie is het effect niet vergeleken met Sinemet. Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIPdatabank Additional remarks In 2016 waren er 35.925 gebruikers van levodopa/carbidopa (Sinemet). Afhankelijk van de meerwaarde zal Inbrija hier een deel van overnemen. Expected cost per patient per year Cost € 800.00 - 900.00 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 €859,70 per gebruiker van Sinemet vergoed. 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