Extended indication

Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy

Therapeutic value

Possible added value for a subgroup

Registration phase

Clinical trials

Product

Active substance

Deucravacitinib

Domain

Chronic immune diseases

Reason of inclusion

New medicine (specialité)

Main indication

Skin diseases

Extended indication

Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy

Manufacturer

BMS

Mechanism of action

Tyrosine kinase inhibitor

Route of administration

Oral

Therapeutical formulation

Tablet

Budgetting framework

Intermural (MSZ)

Registration

Registration route

Centralised (EMA)

Type of trajectory

Normal trajectory

Particularity

New therapeutical formulation

ATMP

No

Submission date

October 2022

Expected Registration

January 2023

Orphan drug

No

Registration phase

Clinical trials

Additional comments
De fabrikant verwacht indiening in oktober 2022 en registratie in januari 2023.

Therapeutic value

Current treatment options

Bijvoorbeeld TNF-alfaremmers en Il12/23 remmers.

Therapeutic value

Possible added value for a subgroup

Substantiation

De veiligheid wordt als erg goed beschreven, vergelijkbaar met placebo. Deucravacitinib zal minder effectief zijn dan de biologicals, maar een meerwaarde hebben voor patiënten waarbij de biological niet aanslaat. Ook is het effectiever dan apremilast.

Frequency of administration

1 times a day

Dosage per administration

6mg

References
NCT04772079

Expected patient volume per year

Additional comments
Komt in principe beschikbaar voor alle patiënten met matige tot ernstige psoriasis, in Nederland zijn dat er circa 165.000. Als ook milde psoriasis onder de indicatie komt te vallen kan het beschikbaar zijn voor 500.000 patiënten.

Expected cost per patient per year

There is currently nothing known about the expected cost.

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.