Delafloxacin Medicine 12 June 2019 Extended indication Extension of indication to include treatment of Community Acquired Pneumonia (CAP) for Quofenix 450mg tablets and 300mg powder for concentrate for solution for infusion. Therapeutic value Possible equal value Total cost Registration phase Registered Product Active substance Delafloxacin Domain Infectious diseases Reason of inclusion Indication extension IND Main indication Bacterial infections Extended indication Extension of indication to include treatment of Community Acquired Pneumonia (CAP) for Quofenix 450mg tablets and 300mg powder for concentrate for solution for infusion. Current proprietary name Already available biosimilars / generics Proprietary name Quofenix Manufacturer Menarini Benelux Portfolio holder Mechanism of action Antibiotic Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Ook beschikbaar als tablet. DNA gyrase inhibitor; DNA topoisomerase IV inhibitor; Protein 50S ribosomal subunit inhibitor. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date April 2020 Expected Registration March 2021 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Indiening voor deze indicatie bij de FDA verwacht in de eerste helft van 2019. Positieve CHMP-opinie in februari 2021. Therapeutic value Current treatment options Afhankelijk van de diagnose: amoxicilline, doxycycline, azitromycine, claritromycine, cotrimoxazol, levofloxacine, moxifloxacine. Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Geen meerwaarde ten opzichte van levofloxacin en moxifloxacin. Duration of treatment Frequency of administration 2 times a day Dosage per administration 300 - 450 mg References Farmcotherapeutisch Kompas; NCT02679573 Additional remarks 300mg IV, Q12H for at least 6 doses with potential to switch to 450mg oral tablet, Q12H for up to 20 doses total Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Aleva en Boersma. Ned Tijdschr Geneeskd. 2005;149:2501-7; Verheij en Boudry, Ge-Bu, Nr 7, 2006 (40), Pagina 73-79 Additional remarks De incidentie van CAP in de huisartsenpraktijk is 5-8 per 1.000 patiënten per jaar (in totaal 85.000-136.000). Ongeveer één op de tien patiënten wordt in een ziekenhuis opgenomen (8.500-13.600). Het totaal aantal patiënten dat in aanmerking zal komen voor deze behandeling is verwaarloosbaar in Nederland bij CAP. Expected cost per patient per year Cost € < 1,358.00 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 https://www.sps.nhs.uk/medicines/delafloxacin/ Additional remarks 10 tabletten van Quofenix in het Verenigd Koninkrijk is £615. Dit is omgerekend €678,88. 20 tabletten per behandeling is maximaal €1.358. De definitieve prijs in Nederland is 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 Yes Indication extensions References Additional remarks Other information Additional remarks