Extended indication Treatment of adult patients with pouchitis, who have undergone proctocolectomy and ileal pouch anal
Therapeutic value No estimate possible yet
Total cost 2,298,800.00
Registration phase Registered and reimbursed

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 January 2022
Orphan drug No
Registration phase Registered and reimbursed
Additional comments Positieve CHMP opinie ontvangen in december 2021.

Therapeutic value

Current treatment options anti-TNF.
Therapeutic value No estimate possible yet
Duration of treatment Maximal 30 week / weeks
Frequency of administration 1 times every 8 weeks
Dosage per administration 300 mg
References NCT02790138 (EARNEST)
Additional comments Toediening is op dag 1, in week 2 en week 6 en vervolgens 1 keer per 8 weken. In de studie werd maximaal 30 weken behandeld, maar trad klinische remissie vaak al op na 14 weken.

Expected patient volume per year

Patient volume

200

Market share is generally not included unless otherwise stated.

References Expert opinie (1)(2);
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 ulceratieve colitis. Er wordt verwacht dat er 200 patiënten in aanmerking zullen komen voor deze behandeling (1). Er worden 100 pouchen per jaar gezet, waarvan 10% niet reageert. Daarom is er een incidentie van 10 patiënten per jaar ingeschat (2).

Expected cost per patient per year

Cost 9,195.20 - 13,792.80
References Medicijnkosten
Additional comments Entyvio, 300mg poeder voor oplossing voor infusie 300mg: €2.298,80. In de studie werden 4-6 injecties gegeven afhankelijk van wanneer klinische remissie optrad.

Potential total cost per year

Total cost

2,298,800.00

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.