Lefamulin Medicine 13 December 2018 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. Therapeutic value Possibly no place in the treatment regimen Total cost € 3,750.00 Registration phase Registered Product Active substance Lefamulin Domain Infectious diseases Reason of inclusion 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. Current proprietary name Already available biosimilars / generics Proprietary name Xenleta Manufacturer Nabriva Portfolio holder Mechanism of action Antibiotic Route of administration Oral Therapeutical formulation Unknown Budgetting framework Extramural (GVS) Centre of expertise Additional remarks 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) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date June 2019 Expected Registration July 2020 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in juni 2020. Therapeutic value Current treatment options levofloxacine en moxifloxacine Therapeutic value Possibly no place in the treatment regimen This assessment does not indicate any potential inclusion in the package. 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 Average 5 Not found Frequency of administration 2 times a day Dosage per administration 150 mg References LEAP1/2. Veve M. Rev Therapeutics 2018. Additional remarks 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. Maximum patient volume for sluice References Additional remarks 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 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 http://www.cidrap.umn.edu/news-perspective/2019/09/lefamulin-trial-shows-non-inferiority-pneumonia Additional remarks 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 € 3,750.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks