Faecal microbiota transplant Medicine 05 December 2023 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. Therapeutic value No estimate possible yet Total cost 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. Current proprietary name Already available biosimilars / generics Proprietary name Rebyota Manufacturer Ferring Portfolio holder Mechanism of action Unknown Route of administration Rectal Therapeutical formulation Liquid Budgetting framework Extramural (GVS) Centre of expertise 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) Type of trajectory Unknown Particularity Unknown ATMP No Submission date 2024 Expected Registration 2025 Orphan drug Unknown Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Geregistreerd door de FDA in de Verenigde Staten. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Op dit moment wordt er ook al zelf microbiota bereidt welke goedkoper is. Duration of treatment Frequency of administration Dosage per administration References NCT03244644 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice 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 patiënt-dagen 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 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. 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 Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks