Extended indication

Extension of indication to include treatment of Community Acquired Pneumonia (CAP) for Quofenix 450m

Therapeutic value

Possible equal value

Registration phase

Positive CHMP opinion

Product

Active substance

Delafloxacin

Domain

Infectious diseases

Reason of inclusion

Indication extension

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.

Proprietary name

Quofenix

Manufacturer

Menarini

Mechanism of action

Antibiotic

Route of administration

Intravenous

Therapeutical formulation

Intravenous drip

Budgetting framework

Intermural (MSZ)

Additional comments
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

Submission date

April 2020

Expected Registration

June 2021

Orphan drug

No

Registration phase

Positive CHMP opinion

Additional comments
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

Substantiation

Geen meerwaarde ten opzichte van levofloxacin en moxifloxacin.

Frequency of administration

2 times a day

Dosage per administration

300 - 450 mg

References
Farmcotherapeutisch Kompas; NCT02679573
Additional comments
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

References
Aleva en Boersma. Ned Tijdschr Geneeskd. 2005;149:2501-7; Verheij en Boudry, Ge-Bu, Nr 7, 2006 (40), Pagina 73-79
Additional comments
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

References
https://www.sps.nhs.uk/medicines/delafloxacin/
Additional comments
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

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension

Yes

Other information

There is currently no futher information available.