Ciprofloxacin Medicine 13 December 2018 Extended indication Bronchiectasis in non-cystic fibrosis patients with chronic respiratory infections due to Pseudomonas aeruginosa - first-line for prevention of pulmonary exacerbations Therapeutic value No judgement Total cost Registration phase Registration application pending Product Active substance Ciprofloxacin Domain Lung diseases Reason of inclusion New medicine (specialité) Main indication Lung other Extended indication Bronchiectasis in non-cystic fibrosis patients with chronic respiratory infections due to Pseudomonas aeruginosa - first-line for prevention of pulmonary exacerbations Current proprietary name Already available biosimilars / generics Proprietary name Linhaliq Manufacturer Aradigm Portfolio holder Mechanism of action Unknown Route of administration Inhalation Therapeutical formulation Nebulizing fluid Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Once-a-day inhaled formulation consisting of a mixture of unencapsulated ciprofloxacin and ciprofloxacin encapsulated in liposomes, delivering immediate and sustained release of the drug within the lung. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New therapeutical formulation ATMP Unknown Submission date April 2018 Expected Registration February 2019 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options ciprofloxacin Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Liposomale inhalatie is nieuw. Duration of treatment Frequency of administration 1 times a day Dosage per administration References Additional remarks Expected patient volume per year Patient volume < 295,150 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIP-databank Additional remarks Het aantal gebruikers van ciprofloxacin in 2016 betrof 295150 patiënten. Een deel van deze patiënten zal in aanmerking komen voor deze nieuwe formulering. Expected cost per patient per year Cost References Additional remarks De prijs zal naar verwachting competitief zijn aan huidige vormen van ciprofloxacin. 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