Extended indication Ulcerative colitis
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 Ulcerative colitis
Manufacturer Roche
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional remarks Scrip pipeline watch 3 nov 2017: BERGAMOT trial: well tolerated, clinical improvement

Registration

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

Therapeutic value

Current treatment options Aminosalicylaten, corticosteroïden, immunosuppressiva, TNF-α-blokkers, Vedolizumab, Ustekinumab.
Therapeutic value No judgement
Duration of treatment continuous
Frequency of administration 1 times every 4 weeks
Dosage per administration 105 mg
References NCT02100696
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 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 colitis. Een vergelijkbare biological die gericht is tegen integrines is Vedolizumab. In 2015 werd vedolizumab voorgeschreven aan 587 patiënten met chronische darmontstekingen, hiervan hebben er ongeveer 300 UC. 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
References Medicijnkosten.nl; Farmacotherapeutisch Kompas; GIPdatabank
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 Ziekte van Crohn
References NCT02394028

Other information

There is currently no futher information available.