Extended indication

Moderately to severely active Crohn's disease

Therapeutic value

No estimate possible yet

Total cost

6,000,000.00

Registration phase

Clinical trials

Product

Active substance

Etrolizumab

Domain

Chronic immune diseases

Reason of inclusion

Indication extension

Main indication

Bowel diseases

Extended indication

Moderately to severely active Crohn's disease

Proprietary name

Entyvio

Manufacturer

Roche

Mechanism of action

Immunosuppression

Route of administration

Subcutaneous

Therapeutical formulation

Injection

Budgetting framework

Intermural (MSZ)

Additional comments
Gehumaniseerde monclonale antilichamen gericht tegen de beta7 integrin subunit van de heterodimeren alpha4beta7 (α4β7) en alphaEbeta7 (αEβ7). Scrip pipeline watch 3 november 2017: HICKORY trial: well tolerated, clinical improvement

Registration

Registration route

Centralised (EMA)

Type of trajectory

Normal trajectory

Submission date

2023

Expected Registration

2023

Orphan drug

No

Registration phase

Clinical trials

Therapeutic value

Current treatment options

Aminosalicylaten, corticosteroïden, immunosuppressiva, TNF-α-blokkers, Ustekinumab.

Therapeutic value

No estimate possible yet

Duration of treatment

continuous

Frequency of administration

1 times every 4 weeks

Dosage per administration

105 mg

References
NCT02394028
Additional comments
Toedieningsfrequentie is 1 maal per 4 weken

Expected patient volume per year

Patient volume

400

Market share is generally not included unless otherwise stated.

References
Crohn-colitis.nl; GIPdatabank
Additional comments
Er zijn momenteel in Nederland ruim 80.000 mensen met een chronische darmontsteking. Dit is ongeveer 1 op de 200 mensen. Hiervan heeft iets minder dan de helft de ziekte van Crohn. In 2017 werd vedolizumab voorgeschreven aan 1.658 patiënten met chronische darmontstekingen, hiervan hebben er ongeveer 800 Crohn. Uitgaande van 50% marktaandeel wordt geschat dat etrolizumab zal worden voorgeschreven aan 400 patiënten per jaar

Expected cost per patient per year

Cost

10,000.00 - 20,000.00

Additional comments
De fabrikant geeft aan dat de prijs in Nederland nog onbekend is.

Op basis van het farmacotherapeutisch kompas zou een behandeling met de concurrent edolizumab ongeveer €20.000 per jaar kosten (9 infusies per jaar van 300mg). Volgens de GIP-databank is er in 2015 €9.317 per gebruiker vergoed.

Potential total cost per year

Total cost

6,000,000.00

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.

Additional comments
De fabrikant geeft aan dat de prijs in Nederland nog onbekend is.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension

Yes

Indication extensions

Ulcerative colitis

References
NCT02100696

Other information

There is currently no futher information available.