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.

1. 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

2. 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.

3. 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

4. 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.

5. Expected cost per patient per year

Cost
1,250
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.

6. 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.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

Indication extension
No

9. Other information

There is currently no futher information available.