Extended indication Behandeling van Clostridium difficile infectie (diarree).
Therapeutic value Possible equal value
Total cost 4,200,000.00

Product

Active substance Cadazolid
Domain Infectious diseases
Main indication Bacterial infections
Extended indication Behandeling van Clostridium difficile infectie (diarree).
Manufacturer Actelion
Route of administration Oral
Therapeutical formulation Granulate
Budgetting framework Extramural (GVS)
Centre of expertise LUMC
Additional remarks Nieuw geneesmiddel, een hybride van een fluorochinolon en een oxazolidinone antibioticum klasse.

Registration

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

Therapeutic value

Current treatment options Substituut voor onder andere metronidazol, glycopeptide, fidaxomicine, etc.
Therapeutic value Possible equal value
Duration of treatment Average 10 day / days
Frequency of administration 2 times a day
Dosage per administration 250 mg
References Pubmed; Google Scholar; ECCMID richtlijn. Clin Microbiol Infect 2016; 22 (Suppl. 4); Ooijevaar et al, Update of treatment algorithms for Clostridium difficile infection; Louie et al. Antimicrob Agents Chemother 59(10) (2015) 6266-73.

Expected patient volume per year

Patient volume

< 2,800

Market share is generally not included unless otherwise stated.

References RIVM
Additional remarks Geschat wordt dat ongeveer 2800 opgenomen patiënten CDI ontwikkelen.

Expected cost per patient per year

Cost 1,000.00 - 2,000.00
References Prescribing outlook 2017. Medicijnkosten.nl.
Additional remarks Prescribing outlook 2017: 'Assuming it is similarly priced to fidaxomicin (£1,350 for a 10-day course) there are unlikely to be significant additional cost implications.' Medicijnkosten.nl: Fidaxomicin is 82,08 voor 200 mg uitgaande van 10 dagen behandeling, 2x per dag: 1.642.

Potential total cost per year

Total cost

4,200,000.00

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

Off label use Yes
Indications off label use Het middel zou overwogen kunnen worden bij patiëntgroepen at risk voor rCDI, maar de fase III RCT is nog niet gepubliceerd.

Indication extension

Indication extension No

Other information

There is currently no futher information available.