Vedolizumab

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.
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 remarks	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 remarks	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 remarks	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).

Patient volume

200

Market share is generally not included unless otherwise stated.

References

Expert opinie (1)(2);

Additional remarks

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 remarks	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.

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.