Extended indication Patients with Generalized pustular psoriasis (GPP) who experiencing acute moderate or severe disease
Therapeutic value Possible added value
Registration phase Clinical trials

Product

Active substance Spesolimab
Domain Chronic immune diseases
Reason of inclusion New medicine (specialité)
Main indication Skin diseases
Extended indication Patients with Generalized pustular psoriasis (GPP) who experiencing acute moderate or severe disease flares.
Manufacturer Boehringer Ingelheim
Mechanism of action Antibody-drug conjugate
Route of administration Intravenous
Therapeutical formulation Solution
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date 2021
Expected Registration 2022
Orphan drug No
Registration phase Clinical trials
Additional comments Generalized pustular psoriasis is an extremely rare type of psoriasis that can present in a variety of forms. Unlike the most general and common forms of psoriasis, Generalized pustular psoriasis usually covers the entire body and with pus-filled blisters rather than plaques. Generalized pustular psoriasis can present at any age, but is rarer in young children. It can appear with or without previous psoriasis conditions or history, and can reoccur in periodic episodes.

Therapeutic value

Current treatment options Geen.
Therapeutic value Possible added value
Substantiation Er is op dit moment geen goede behandeling voor deze indicatie. Dit betekent dat spesolimab mogelijk een grote therapeutische meerwaarde voor de patiënt zal hebben. De fase 3 studie loopt op dit moment nog.
References NCT03782792

Expected patient volume per year

Patient volume

< 30

Market share is generally not included unless otherwise stated.

References Mirza HA, Badri T, Kwan E. Generalized Pustular Psoriasis. [Updated 2020 Sep 15]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan-.
Additional comments In Frankrijk wordt de prevalentie van Generalized pustular psoriasis geschat op 1,76 per miljoen inwoners. Voor Nederland zou dit neerkomen op ongeveer 30 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

Indication extension Yes
Indication extensions Ulcerative colitis, Atopic dermatitis, Crohn's disease, Palmoplantar pustulosis
References AdisInsight
Additional comments Een indicatie uitbreiding naar Palmoplantar pustulosis zal mogelijk voor een grote groei in het patiëntvolume zorgen. Prevalentie 0.05% (=max 8.500 patiënten in Nederland) waarvan een deel lokaal of met conventionele systemische middelen kan worden behandeld.

Other information

There is currently no futher information available.