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.