Colistimethate Sodium Medicine 04 June 2024 Extended indication Treat pseudomonas aeruginosa infections in non–cystic fibrosis bronchiectasis Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Colistimethate Sodium Domain Lung diseases Reason of inclusion Indication extension IND Main indication Unknown Extended indication Treat pseudomonas aeruginosa infections in non–cystic fibrosis bronchiectasis Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Essential Portfolio holder Mechanism of action Unknown Route of administration Inhalation Therapeutical formulation Unknown Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Werkingsmechanisme: Cell membrane modulators Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date 2024 Expected Registration 2025 Orphan drug Unknown Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Colistine. Indicatie voor onderhoudsbehandeling met inhalatieantibiotica bestaat alleen bij 3 of meer exacerbaties per jaar én pseudomonas in het sputum (Polverino, ERS richtlijn 2017). Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT03093974 Additional remarks Expected patient volume per year Patient volume 800 - 3,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Richtlijn Diagnostiek en behandeling van patiënten met bronchiëctasieën, NVALT 2017 Additional remarks De prevalentie van bronchiëctasieën in Nederland bedraagt 52 tot 67 per 100.000. Dat zijn ongeveer 9.000 tot 12.000 patiënten in totaal. Daarnaast telt Nederland ongeveer 1.600 patiënten met CF. Het aantal niet-CF bronchiëctasieën komt daarmee op 7.300 tot 11.400. Chronische infectie met P. aeruginosa komt voor in 12 tot 27% van de volwassen patiënten met bronchiëctasieën (876-3078). Expected cost per patient per year Cost References Additional remarks 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