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
Manufacturer Sunovion
Mechanism of action Receptor agonist
Route of administration Sublingual
Budgetting framework Extramural (GVS)
Additional comments Dopamine receptor agonist

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity New therapeutical formulation
Submission date 2021
Expected Registration 2022
Orphan drug No
Registration phase Clinical trials
Additional comments Registratieaanvraag ingediend bij de FDA in maart 2018.

Therapeutic value

Current treatment options Levodopa, dopamine-agonisten
Therapeutic value No estimate possible yet
Substantiation Fase 3 CTH-300 studie: met endpoints, well tolerated. Inschatting: mogelijke meerwaarde ten opzichte van bestaande toedieningsvorm van apomorfine beperkt.
Dosage per administration 10-35 mg
References NCT02469090

Expected patient volume per year

Patient volume

< 100

Market share is generally not included unless otherwise stated.

References Parkinson Vereniging
Additional comments 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
References GIPdatabank
Additional comments In 2016 werd er €3.400 per gebruiker vergoed.

Potential total cost per year

Total cost

340,000.00

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.

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.