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Remestemcel-L

Prochymal

Extended indication Crohn's disease (ook voor GvHD).
Therapeutic value No judgement

Product

Active substance Remestemcel-L
Domain Chronic immune diseases
Main indication Bowel diseases
Extended indication Crohn's disease (ook voor GvHD).
Proprietary name Prochymal
Manufacturer Mesoblast
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Expected Registration 2018
Orphan drug No

Therapeutic value

Current treatment options Zie behandeling Crohn: remissie inductie met prednison/budesonides, anti-TNF. Evt MTX. Onderhoudstherapie met thiopurines, MTX, anti-TNF, vedolizumab en ustekinumab.
Therapeutic value No judgement
Substantiation Zeer beperkte literatuur. Daarentegen wel meerwaarde in ‘stamceltransplantatie’ voor de meest ernstige luminale Crohn.
Duration of treatment Not found
References Dhere et al, Aliment Pharmacol Ther. 2016 Sep;44(5):471-81. doi: 10.1111/apt.13717.; Molendijk et al, Gastroenterology. 2015 Oct;149(4):918-27.e6; Forbes et al, Clin Gastroenterol Hepatol. 2014 Jan;12(1):64-71. doi: 10.1016/j.cgh.2013.06.021; Duijvestein et al, Gut. 2010 Dec;59(12):1662-9. doi: 10.1136/gut.2010.215152.; Panés et al, Lancet. 2016 Sep 24;388(10051):1281-90.
Additional remarks Ook meerwaarde in lokale behandeling met mesenchymale stamcellen voor Crohnse fistels. Maar waarschijnlijk zeer kostbare behandeling en logistiek/infrastructuur lastig (na levering in ZKH snel gebruiken).

Expected patient volume per year

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. https://www.crohn-colitis.nl/ibd/wat-is-ziekte-van-crohn/

Expected cost per patient per year

References Prescribing outlook 2017
Additional remarks Prescribing Outlook 2017: 'As a further treatment option it will be additional to current costs. It will be expensive.' Verwachting: €30.000 per toediening.

Potential total cost per year

There is currently nothing known about the possible total cost.

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.