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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.