Tedizolid

Active substance Tedizolid
Domain Infectious diseases
Reason of inclusion in Horizonscan Geneesmiddelen Indication extension
Main indication Bacterial infections
Extended indication Hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP), complex bacterial infections, caused by gram positive pathogens

Product

Proprietary name Sivextro
Manufacturer MSD
Mechanism of action Antibiotic
Route of administration Oral
Therapeutical formulation Tablet
Additional comments Toedieningsvorm: tablet/injectievloeistof. Bekostigingskader: GVS voor tabletten / MSZ voor IV. Ribosomal protein inhibitors.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date 2020
Expected Registration 2021
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options linezolid
Therapeutic value Potential equal value
Substantiation Klinische studies laat zien dat tedizolid gelijkwaardig is aan linezolid voor behandeling ABSSSI. Tedizolid heeft mogelijk minder bijwerkingen.
Duration of treatment Average 6 day / days
Frequency of administration 1 times a day
Dosage per administration 200 mg
References NCT02019420, Farmacotherapeutisch Kompas
Additional comments Tedizolid is thought to have less frequent dosing, minimal interaction with serotonergic agents, and less adverse events associated with the impairment of mitochondrial protein synthesis that lead to myelosuppression, peripheral and optic neuropathy compared to linezolid.

Expected patient volume per year

Patient volume

< 473

Market share is generally not included unless otherwise stated.

Additional comments In 2017 waren er voor linezolid 473 gebruikers. Een deel van deze gebruikers kan worden overgezet op tedizolid gezien het hier alleen om de patiënten gaat voor bovenstaande indicatie. Kortom, beperkt aantal patiënten.

Expected cost per patient per year

Cost 1,000 - 1,100
References G-standaard; fabrikant
Additional comments Tedizolid tablet 200mg AIP per april 2019: €173,95 per tablet (exclusief BTW). Bij een behandelduur van 6 dagen komt dit neer op €1.043,70

Potential total cost per year

Total cost

496,650

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

Off label use Yes
Indications off label use Mycobacteriele infecties
References Open Forum Infectious Diseases, Volume 3, Issue suppl_1, 1 December 2016, 577,

Indication extension

Indication extension No
References adisinsight.nl

Other information

There is currently no futher information available.