Apomorphine

Active substance
Apomorphine
Domain
Neurological disorders
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Parkinson's
Extended indication
Acute Treatment of OFF Episodes in Patients With Parkinson's Disease

1. Product

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

2. Registration

Registration route
Centralised (EMA)
Particularity
New therapeutical formulation
Submission date
2020
Expected Registration
2021
Orphan drug
No
Registration phase
Clinical trials
Additional comments
Registratieaanvraag ingediend bij de FDA in maart 2018.

3. Therapeutic value

Current treatment options
Levodopa, dopamine-agonisten
Therapeutic value
No judgement
Substantiation
Fase 3 CTH-300 studie: met endpoints, well tolerated. Inschatting: mogelijke meerwaarde ten opzichte van bestaande toedieningsvorm van apomorfine beperkt
Duration of treatment
Not found
Dosage per administration
10-35 mg
References
NCT02469090

4. 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 indicatie-stelling zal deze nieuwe formulering een deel van deze patiënten overnemen.

5. Expected cost per patient per year

Cost
< 3,400
References
GIPdatabank
Additional comments
In 2016 werd er €3.400 per gebruiker vergoed.

6. Potential total cost per year

Total cost

340,000

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.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

There is currently nothing known about indication extensions.

9. Other information

There is currently no futher information available.