Cipaglucosidase alfa

Extended indication	Extension of indication to include treatment of acute bacterial skin and skin structure infections (ABSSSI) in paediatric patients aged from birth to less than 12 years
Therapeutic value	No estimate possible yet
Total cost	47,250.00
Registration phase	Registration application pending

Product

Active substance	Tedizolid
Domain	Infectious diseases
Reason of inclusion	Indication extension
Main indication	Bacterial infections
Extended indication	Extension of indication to include treatment of acute bacterial skin and skin structure infections (ABSSSI) in paediatric patients aged from birth to less than 12 years
Proprietary name	Sivextro
Manufacturer	MSD
Mechanism of action	Antibiotic
Route of administration	Oral
Therapeutical formulation	Tablet
Additional remarks	Toedieningsvorm: tablet/injectievloeistof. Bekostigingskader: GVS voor tabletten / MSZ voor intraveneus Ribosomal protein inhibitors.

Registration

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
ATMP	No
Submission date	July 2024
Expected Registration	May 2025
Orphan drug	No
Registration phase	Registration application pending
Additional remarks	Primary completion (actual): 6 juli 2023.

Therapeutic value

Current treatment options	Antiobiotica (e.g., linezolid)
Therapeutic value	No estimate possible yet
Substantiation	Tedizolid kan als tablet of injectievloeistof toegediend worden. Er wordt niet veel therapeutische meerwaarde ten opzichte van linezolid verwacht. Een voordeel voor een klein aantal patiënten zal zijn dat er minder beenmerg toxiciteit plaatsvindt. Dit zal een uitkomst bieden voor patiënten die gevoelig zijn voor orthopedische infecties.
Duration of treatment	Average 6 day / days
Frequency of administration	1 times a day
Dosage per administration	200 mg
References	NCT03176134 (MK-1986-018)

Expected patient volume per year

Patient volume	40 - 50 Market share is generally not included unless otherwise stated.
References	Expertopinie (1).
Additional remarks	De inschatting is dat er 40-50 kinderen in aanmerkingen zullen komen voor dit middel (1).

Patient volume

40 - 50

Market share is generally not included unless otherwise stated.

References

Expertopinie (1).

Additional remarks

De inschatting is dat er 40-50 kinderen in aanmerkingen zullen komen voor dit middel (1).

Expected cost per patient per year

Cost	1,000.00 - 1,100.00
References	G-standaard; fabrikant
Additional remarks	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	47,250.00 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.

Total cost

47,250.00

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.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension	Yes
Indication extensions	Nosocomial pneumonia; Ventilator associated pneumonia
References	Adisinsight. 2024.

Other information

There is currently no futher information available.

Tedizolid