Extended indication

Treatment of adult patients with pouchitis, who have undergone proctocolectomy and ileal pouch anal

Therapeutic value

No estimate possible yet

Registration phase

Registration application pending

Product

Active substance

Vedolizumab

Domain

Chronic immune diseases

Reason of inclusion

Indication extension

Main indication

Bowel diseases

Extended indication

Treatment of adult patients with pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with, lost response to, or were intolerant to antibiotic therapy.

Proprietary name

Entyvio

Manufacturer

Takeda

Mechanism of action

Immunosuppression

Route of administration

Intravenous

Therapeutical formulation

Powder for solution for infusion

Budgetting framework

Intermural (MSZ)

Registration

Registration route

Centralised (EMA)

Type of trajectory

Normal trajectory

ATMP

No

Submission date

June 2021

Expected Registration

March 2022

Orphan drug

No

Registration phase

Registration application pending

Therapeutic value

Current treatment options

anti-TNF, vedolizumab, ustekinumab, tofacitinib.

Therapeutic value

No estimate possible yet

Expected patient volume per year

Additional comments
Colitis ulcerosa komt steeds vaker voor met name in de westerse landen. Er zijn momenteel ruim 80.000 mensen in Nederland met een chronische darmontsteking. Dit is ongeveer 1 op de 200 mensen. Hiervan heeft iets meer dan de helft ulcerative colitis.

Expected cost per patient per year

References
https://www.farmacotherapeutischkompas.nl/bladeren/preparaatteksten/kostenoverzicht/modal/vedolizumab
Additional comments
Entyvio, 300 mg poeder voor oplossing voor infusie 300 mg: € 2.298,80. Entyvio, 0,68 ml injectievloeistof 158,8 mg/ml: € 658,80

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.