Extended indication Adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by
Therapeutic value Possible equal value
Total cost 4,900,000.00
Registration phase Registered

Product

Active substance Ozanimod
Domain Neurological disorders
Reason of inclusion New medicine (specialité)
Main indication Multiple sclerosis
Extended indication Adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features.
Proprietary name Zeposia
Manufacturer Celgene
Mechanism of action Immunosuppression
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Extramural (GVS)
Additional comments The treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date March 2019
Expected Registration May 2020
Orphan drug No
Registration phase Registered
Additional comments Positieve CHMP-opinie in maart 2020.

Therapeutic value

Current treatment options Omdat het net als fingolimod een sfingosine 1-fosfaatreceptor modulator is en ook oraal wordt toegediend verwachten we eerst vergelijking met fingolimod en daarna met onder andere dimethylfumaraat en teriflunomide.
Therapeutic value Possible equal value
Substantiation Tussen de sfingosine-1-fosfaat receptoragonisten is veel concurrentie en weinig verschil in aangetoonde effectiviteit. Het verschil tussen deze geneesmiddelen ligt met name in de bijwerkingsprofielen.
Duration of treatment Average year / years
Frequency of administration 1 times a day
Dosage per administration 0,92 mg
References RADIANCE: NCT02047734 SUNBEAM: NCT02294058

Expected patient volume per year

Patient volume

200 - 500

Market share is generally not included unless otherwise stated.

References GIP databank, hersenstichting, Nationaal MS fonds.
Additional comments Hersenstichting: In Nederland komt MS voor bij ongeveer 1 op de 1.000 inwoners. Nederland telt dus ongeveer 17.000 mensen met MS. RMS komt bij ongeveer 40% van alle mensen met MS voor (6.800 personen). Door de concurrentie aan middelen zal het verwachte marktaandeel op maximaal een paar honderd patiënten komen te liggen.

Expected cost per patient per year

Cost 9,000.00 - 19,000.00
References GIP-databank
Additional comments Prijs verwacht in lijn met directe concurrenten. Bij substitutie geen toename in kosten.

Potential total cost per year

Total cost

4,900,000.00

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

Off label use No

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.