Amantadine

Active substance
Amantadine
Domain
Neurological disorders
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Parkinson's
Extended indication
Extended-Release Capsules for Levodopa-Induced Dyskinesia in Parkinson's Disease

1. Product

Proprietary name
Gocovri
Manufacturer
Adamas
Mechanism of action
Receptor antagonist
Route of administration
Oral
Therapeutical formulation
Capsule
Budgetting framework
Extramural (GVS)

2. Registration

Registration route
Centralised (EMA)
Type of trajectory
Normal trajectory
Particularity
New therapeutical formulation
Submission date
2020
Expected Registration
2021
Orphan drug
No
Registration phase
Clinical trials

3. Therapeutic value

Therapeutic value
No judgement
Frequency of administration
1 times a day
Dosage per administration
137-274 mg
References
Prescribing information Gocovri, FDA

4. Expected patient volume per year

References
Eusebi et al. NPJ Parkinsons Dis. 2018; 4: 33.
Additional comments
In 2016 waren er 35.925 gebruikers van levodopa/carbidopa (Sinemet). Ongeveer een kwart van de patiënten krijgt last van levodopa-induced dyskiesia (8.981 patiënten). Hoeveel patiënten hiervan zullen worden behandeld met Gocovri hangt af van de uiteindelijke indicatie en plek in de behandelrichtlijn.

5. Expected cost per patient per year

References
https://seekingalpha.com/article/4108394-adamas-releases-pricing-gocovri
Additional comments
De lijstprijs in de Verenigde Staten is $28.500 per jaar (~€25.500). In de Europa zal dit waarschijnlijk lager geprijsd worden.

6. Potential total cost per year

There is currently nothing known about the possible total cost.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

Indication extension
Yes
Indication extensions
Multiple Sclerosis Patients With Walking Impairment
References
Clinicaltrials.gov

9. Other information

There is currently no futher information available.