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Spesolimab

Spevigo

Extended indication Spevigo is indicated for the prevention of flares in adult patients with generalised pustular psoria
Therapeutic value No estimate possible yet
Total cost 660,000.00
Registration phase Registration application pending

Product

Active substance Spesolimab
Domain Chronic immune diseases
Reason of inclusion Indication extension
Main indication Skin diseases
Extended indication Spevigo is indicated for the prevention of flares in adult patients with generalised pustular psoriasis (GPP) as monotherapy.
Proprietary name Spevigo
Manufacturer Boehringer Ingelheim
Portfolio holder Boehringer Ingelheim
Mechanism of action Antibody-drug conjugate
Route of administration Unspecified or multiple
Therapeutical formulation Solution

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date July 2023
Expected Registration November 2024
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Current treatment options Geen.
Therapeutic value No estimate possible yet
Substantiation Nog in afwachting of het werking heeft bij deze indicatie uitbreiding. In Duitsland is dit middel teruggetrokken vanwege onvoldoende effectiviteit.
References Effisayil 2

Expected patient volume per year

Patient volume

30 - 50

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 remarks 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. De fabrikant schat in dat in Nederland mogelijk 30-50 patiënten hiervoor in aanmerking kan komen maar dat maar 80% van de GPP patiënten kan te maken krijgen met GPP flares waarvoor Spesolimab een uitkomst kan bieden.

Expected cost per patient per year

Cost > 16,500.00
References Fabrikant

Potential total cost per year

Total cost

660,000.00

This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.

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.