Lefamulin

Active substance Lefamulin
Domain Infectious diseases
Reason of inclusion in Horizonscan Geneesmiddelen New medicine (specialité)
Main indication Bacterial infections
Extended indication Xenleta is indicated for the treatment of community-acquired pneumonia (CAP) in adults when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of CAP or when these have failed.

Product

Proprietary name Xenleta
Manufacturer Nabriva
Mechanism of action Antibiotic
Route of administration Oral
Budgetting framework Extramural (GVS)
Additional comments pleuromutilin antibiotic, interferes with bacterial protein synthesis via a specific interaction with the 23S rRNA of the 50S bacterial ribosome subunit

Registration

Registration route Centralised (EMA)
Submission date June 2019
Expected Registration August 2020
Orphan drug No
Registration phase Positive CHMP opinion
Additional comments Positieve CHMP-opinie in juni 2020.

Therapeutic value

Current treatment options levofloxacine en moxifloxacine
Therapeutic value Potential equal value
Substantiation Lefamulin is in klinische CAP trials non-inferieur ten opzichte van moxifloxacine. Echter, levofloxacine is in Nederland de eerste keus voor CAP. Er wordt verwacht dat lefamulin alleen bij uitzondering ingezet zal worden. Bijvoorbeeld in het geval van contra-indicaties.
Duration of treatment Not found
Frequency of administration 2 times a day
Dosage per administration 150 mg
References LEAP1/2. Veve M. Rev Therapeutics 2018.
Additional comments Leap2 laat behandelduur van 5 dagen zien

Expected patient volume per year

Patient volume

0 - 5

Market share is generally not included unless otherwise stated.

Additional comments Er wordt verwacht dat lefamulin alleen bij uitzondering ingezet zal worden. Bijvoorbeeld in het geval van contra-indicaties. Hoogstwaarschijnlijk zal het niet gebruikt gaan worden, maximaal 2 tot 5 patiënten per jaar.

Expected cost per patient per year

Cost 1,250.00
References http://www.cidrap.umn.edu/news-perspective/2019/09/lefamulin-trial-shows-non-inferiority-pneumonia
Additional comments De lijstprijs per dag is in de Verenigde Staten gezet op $275 (~€250). Bij een behandeling van 5 dagen zal zullen de totale kosten €1.250 bedragen.

Potential total cost per year

Total cost

3,125

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

There is currently nothing known about off label use.

Indication extension

Indication extension No

Other information

There is currently no futher information available.