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Etrolizumab

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
Manufacturer Roche
Mechanism of action Immunosuppression
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 november 2017: HICKORY trial: well tolerated, clinical improvement

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date May 2022
Expected Registration August 2023
Orphan drug No
Registration phase Clinical trials
Additional remarks Fabrikant: verwachte indiening in het tweede kwartaal van 2022, verwachte registratie in het derde kwartaal van 2023.

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 remarks 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 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 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 remarks 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.

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.