Extended indication Treatment of relapsing remitting multiple sclerosis.
Therapeutic value Possible equal value
Total cost 4,750,000.00
Registration phase Registration application pending

Product

Active substance Diroximel fumarate
Domain Neurological disorders
Reason of inclusion New medicine (specialité)
Main indication Multiple sclerosis
Extended indication Treatment of relapsing remitting multiple sclerosis.
Manufacturer Alkermes
Mechanism of action Other
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Extramural (GVS)
Additional comments Ook bekend onder de naam ALKS8700. 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)
Submission date January 2021
Expected Registration February 2022
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Current treatment options Dimethylfumaraat of andere MS-middelen (zie farmacotherapeutisch kompas).
Therapeutic value Possible equal value
Substantiation Er wordt vergelijkbare effectiviteit met tecfidera verwacht met mogelijk minder gastrointestinale bijwerkingen.
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 comments Hersenstichting: In Nederland komt multiple sclerose voor bij ongeveer 1 op de 1.000 inwoners. Nederland telt dus ongeveer 17.000 mensen met multiple sclerose. Nationaal MS fonds: Relapsing Remitting Multiple Sclerose komt bij ongeveer 40% van alle mensen met multiple sclerose 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 comments 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.