Extended indication Extension of indication to include treatment of adult patients with moderate-to-severe SLE (exact indication text to be confirmed).
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Deucravacitinib
Domain Chronic immune diseases
Reason of inclusion Indication extension IND
Main indication Rheumatism
Extended indication Extension of indication to include treatment of adult patients with moderate-to-severe SLE (exact indication text to be confirmed).
Proprietary name Sotyktu
Manufacturer BMS
Portfolio holder BMS
Mechanism of action JAK tyrosine kinase inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional remarks Orale selectieve tyrosinekinase 2 (TYK2) remmer.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity Indication extension
ATMP No
Submission date January 2027
Expected Registration August 2027
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Corticosteroïden, methotrexaat, azathioprine, mycofenolaat mofetil, cyclofosfamide, belimumab en anifrolumab.
Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.

Substantiation Er zijn nog geen resultaten bekend.
References NCT05617677 (POETYK SLE-1); NCT05620407 (POETYK SLE-2)

Expected patient volume per year

Patient volume 400

Market share is generally not included unless otherwise stated.

References Declaratiedata
Additional remarks Er zijn minder dan 400 gebruikers van belimumab voor SLE. Er zijn echter nog altijd onvoldoende alternatieven voor de behandeling van SLE. Als het heel effectief blijkt zal het patiëntvolume mogelijk hoger uit kunnen komen.

Expected cost per patient per year

References medicijnkosten.nl
Additional remarks De prijs in Nederland is €731,71 (exclusief BTW) per verpakking met 28 tabletten. De totale kosten per jaar zijn afhankelijk van de dosering en behandelduur.

Potential total cost per year

Off label use

Indication extension

Other information