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Levodopa

Inbrija

Extended indication Indicated for the intermittent treatment of episodic motor fluctuations (off episodes) in adult pati
Therapeutic value Possible added value
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.
Proprietary name Inbrija
Manufacturer Acorda
Mechanism of action Neurotransmitter
Route of administration Inhalation
Therapeutical formulation Oral powder
Budgetting framework Extramural (GVS)
Additional remarks Precursor van dopamine.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity New therapeutical formulation
Submission date June 2018
Expected Registration September 2019
Orphan drug No
Registration phase Registered
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
Substantiation Gezien de snelle opname via inhalatie is deze vorm van levodopa geschikt als rescue medicatie voor patiënten tijdens off-periodes.
Frequency of administration 5 times a day
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

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
References GIPdatabank
Additional remarks In 2016 werd er €859,70 per gebruiker van Sinemet vergoed.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.