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Faecal microbiota transplant

Rebyota

Extended indication REBYOTA is indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Faecal microbiota transplant
Domain Infectious diseases
Reason of inclusion New medicine (specialité)
Main indication Bacterial infections
Extended indication REBYOTA is indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older, following antibiotic treatment for recurrent CDI.
Proprietary name Rebyota
Manufacturer Ferring
Route of administration Rectal
Therapeutical formulation Liquid
Budgetting framework Extramural (GVS)
Additional remarks Each 150mL-dose contains between 1x108 and 5x1,010 colony forming units (CFU) per mL of fecal microbes, including >1x105 CFU/mL of Bacteroides Fecal matter suspended in polyethylene glycol (PEG) 3,350 and 0.9% NaCl solution.

Registration

Registration route Centralised (EMA)
ATMP No
Submission date 2025
Expected Registration 2026
Registration phase Clinical trials
Additional remarks Geregistreerd door de FDA in de Verenigde Staten.

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation Op dit moment wordt er ook al zelf microbiota bereid welke goedkoper is.
Duration of treatment one-off
References NCT03244644

Expected patient volume per year

References Bauer 2011; Barbut 2007;
Additional remarks Uit twee grootschalige Europese onderzoeken komt naar voren dat de incidentie van C. difficiele-infecties in Europa gemiddeld 2 tot 4 infecties per 10.000 patiëntdagen per ziekenhuis is. Het zal in Nederland om 2.000 tot 3.000 patiënten per jaar gaan in totaal. Bij enkel patiënten met een recidief om 500 tot 600.

Expected cost per patient per year

Cost 8,400.00
References Thomas Lodise. Cost-Effectiveness Analysis of REBYOTA™ (Fecal Microbiota, Live-jslm [FMBL]) Versus Standard of Care for the Prevention of Recurrent Clostridioides difficile Infection in the USA. 24 April 2023.
Additional remarks In een kosteneffectiviteitsanalyse in de Verenigde Staten wordt er voor een kuur $9.000 gerekend. Dat is omgerekend €8.400. De prijs in Nederland is echter nog niet bekend.

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.