Extended indication

Extension of indication to include the treatment of adult patients with moderately to severely activ

Therapeutic value

No estimate possible yet

Registration phase

Positive CHMP opinion

Product

Active substance

Ozanimod

Domain

Chronic immune diseases

Reason of inclusion

Indication extension

Main indication

Bowel diseases

Extended indication

Extension of indication to include the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.

Proprietary name

Zeposia

Manufacturer

Celgene

Mechanism of action

Immunosuppression

Route of administration

Oral

Therapeutical formulation

Capsule

Budgetting framework

Intermural (MSZ)

Additional comments
Sphingosine 1 phosphate receptor modulator.

Registration

Registration route

Centralised (EMA)

Submission date

October 2020

Expected Registration

December 2021

Orphan drug

Yes

Registration phase

Positive CHMP opinion

Additional comments
Positieve CHMP opinie ontvangen oktober 2021.

Therapeutic value

Current treatment options

Vedolizumab, JAK-remmers, biologicals

Therapeutic value

No estimate possible yet

Substantiation

Nieuw werkingsmechanisme bij UC: functionele antagonist van de S1P1-receptor op lymfocyten, waardoor lymfocyten minder makkelijk migreren uit de lymfeklieren. Potentieel van meerwaarde voor UC-patiënten, die niet goed reageren of bijwerkingen hebben op andere geneesmiddelen daarnaast kan ook de orale toediening een voordeel zijn. Naar verwachting zal het ingezet worden na falen op 1e of 2e lijn biological en de concurrentie aangaan met vedolizumab.

Frequency of administration

1 times a day

Dosage per administration

0,92 mg

References
NCT01647516

Expected patient volume per year

References
Crohn-colitis.nl;
Additional comments
Colitis ulcerosa komt steeds vaker voor, met name in de westerse landen. Er zijn momenteel ruim 80.000 mensen in Nederland met een chronische darmontsteking. Dit is ongeveer 1 op de 200 mensen. Hiervan heeft iets meer dan de helft ulcerative colitis. Er wordt verwacht dat er 200-300 patiënten in aanmerking zullen komen voor ozanimod.

Expected cost per patient per year

Cost

16,461.00

References
medicijnkosten
Additional comments
Gemiddelde prijs per 28 stuks Zeposia, capsule 0,92mg €1.266,24.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.