Extended indication Hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP) ,complex bacterial infec
Therapeutic value Possible equal value
Registration phase Clinical trials

Product

Active substance Tedizolid
Domain Infectious diseases
Reason of inclusion Indication extension
Main indication Bacterial infections
Extended indication Hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP) ,complex bacterial infections, caused by gram positive pathogens
Proprietary name Sivextro
Manufacturer MSD
Route of administration Oral
Therapeutical formulation Tablet
Additional remarks 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 2019
Expected Registration 2020
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options linezolid
Therapeutic value Possible 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 06 day / days
Frequency of administration 1 times a day
Dosage per administration 200 mg
References NCT02019420, Farmacotherapeutisch Kompas
Additional remarks 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

Additional remarks 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 1,000.00 - 1,100.00
References G-standaard
Additional remarks Tedizolid tablet 200mg AIP per okt 2018: €174,97 per tablet (excl BTW). Bij een behandelduur van 6 dagen komt dit neer op €1.049,82

Potential total cost per year

There is currently nothing known about the possible total cost.

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.