Levodopa Medicine 13 December 2018 Extended indication Indicated for the intermittent treatment of episodic motor fluctuations (off episodes) in adult patients with Parkinson’s disease (PD) treated with a levodopa/dopa-decarboxylase inhibitor. Therapeutic value Possible added value Total cost Registration phase Registered Product Active substance Levodopa Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Parkinson's Extended indication Indicated for the intermittent treatment of episodic motor fluctuations (off episodes) in adult patients with Parkinson’s disease (PD) treated with a levodopa/dopa-decarboxylase inhibitor. 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 Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie juli 2019. Geregistreerd in september 2019. Therapeutic value Current treatment options Andere formuleringen van levodopa Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Gezien de snelle opname via inhalatie is deze vorm van levodopa geschikt als rescue medicatie voor patiënten tijdens off-periodes. 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). Gezien de mogelijke meerwaarde zal deze vorm van levodopa potentieel door veel patiënten gebruikt worden. 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