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

1. 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.

2. Registration

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

3. 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.

4. 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.

5. 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

6. 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.

7. 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,

8. Indication extension

Indication extension
No
References
adisinsight.nl

9. Other information

There is currently no futher information available.