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Etrolizumab

Extended indication Ziekte van Crohn
Therapeutic value No judgement
Total cost 2,250,000.00
Registration phase Clinical trials

Product

Active substance Etrolizumab
Domain Chronic immune diseases
Main indication Bowel diseases
Extended indication Ziekte van Crohn
Manufacturer Roche
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional remarks Gehumaniseerde monclonale antilichamen gericht tegen de beta7 integrin subunit van de heterodimeren alpha4beta7 (α4β7) en alphaEbeta7 (αEβ7). Scrip pipeline watch 3 nov 2017: HICKORY trial: well tolerated, clinical improvement

Registration

Registration route Centralised (EMA)
Particularity Indication extension
Submission date 2020
Expected Registration 2021
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Aminosalicylaten, corticosteroïden, immunosuppressiva, TNF-α-blokkers, Ustekinumab.
Therapeutic value No judgement
Duration of treatment continuous
Frequency of administration 1 times every 4 weeks
Dosage per administration 105 mg
References NCT02394028
Additional remarks Toedieningsfrequentie is 1 maal per 4 weken

Expected patient volume per year

Patient volume

150

Market share is generally not included unless otherwise stated.
References Crohn-colitis.nl; GIPdatabank
Additional remarks 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 2015 werd vedolizumab voorgeschreven aan 587 patiënten met chronische darmontstekingen, hiervan hebben er ongeveer 300 Crohn. Uitgaande van 50% marktaandeel wordt geschat dat Etrolizumab zal worden voorgeschreven aan 150 patiënten per jaar

Expected cost per patient per year

Cost 10,000.00 - 20,000.00
Additional remarks Op basis van het FK zou een behandeling met de concurrent Vedolizumab ongeveer €20.000 per jaar kosten (9 infusies per jaar van 300 mg). Volgens de GIPdatabank is er in 2015 €9.317 per gebruiker vergoed.

Potential total cost per year

Total cost

2,250,000.00

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

Indication extension Yes
Indication extensions Ulcerative colitis
References NCT02100696

Other information

There is currently no futher information available.