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.