Extended indication Relapsing remitting multiple sclerosis
Therapeutic value No judgement
Total cost 4,750,000.00
Registration phase Clinical trials

Product

Active substance ALKS8700
Domain Neurological disorders
Main indication Multiple sclerosis
Extended indication Relapsing remitting multiple sclerosis
Manufacturer Alkermes
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Extramural (GVS)
Additional remarks EVOLVE-MS trial: well tolerated. Prodrug of monomethyl fumarate (MMF) in a controlled-release formulation that rapidly and efficiently convert to MMF in the body.

Registration

Registration route Centralised (EMA)
Particularity New medicine
Submission date 2021
Expected Registration 2022
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Dimethylfumaraat of andere MS-middelen (zie farmacotherapeutisch kompas).
Therapeutic value No judgement
Frequency of administration 2 times a day
Dosage per administration 462 mg
References clinicaltrials.gov

Expected patient volume per year

Patient volume

< 500

Market share is generally not included unless otherwise stated.

References GIP databank, hersenstichting, Nationaal MS fonds.
Additional remarks Hersenstichting: In Nederland komt MS voor bij ongeveer 1 op de 1.000 inwoners. Nederland telt dus ongeveer 17.000 mensen met MS. Nationaal MS fonds: Relapsing Remitting MS komt bij ongeveer 40% van alle mensen met MS voor (6.800 personen). ALK8700 zal met Dimethylfumaraat moeten gaan concurreren binnen deze patiëntenpopulatie. Aantal gebruikers Dimethylfumaraat bedroeg in 2016: 2.174. De werkgroep schat in dat ALKS8700 hier een klein deel (maximaal 500) van zal over gaan nemen.

Expected cost per patient per year

Cost 9,000.00 - 10,000.00
References GIPdatabank
Additional remarks Dimethylfumaraat kostte in 2016 €9.199 per patiënt per jaar.

Potential total cost per year

Total cost

4,750,000.00

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

Indication extension No

Other information

There is currently no futher information available.