Casirivimab / imdevimab

Extended indication	Extension of indication to include treatment of paediatric patients from 2 to less than 12 years old, weighing at least 10kg, who do not require supplemental oxygen and who are at increased risk of progression to severe COVID-19 for Ronapreve
Therapeutic value	Possibly no place in the treatment regimen
Registration phase	Registration application pending

Product

Active substance	Casirivimab / imdevimab
Domain	Infectious diseases
Reason of inclusion	Indication extension
Main indication	COVID-19
Extended indication	Extension of indication to include treatment of paediatric patients from 2 to less than 12 years old, weighing at least 10kg, who do not require supplemental oxygen and who are at increased risk of progression to severe COVID-19 for Ronapreve
Proprietary name	Ronapreve
Manufacturer	Roche
Route of administration	Intravenous
Therapeutical formulation	Injection
Budgetting framework	Intermural (MSZ)

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
ATMP	No
Submission date	March 2024
Expected Registration	January 2025
Orphan drug	No
Registration phase	Registration application pending

Therapeutic value	Possibly no place in the treatment regimen
Substantiation	Casirivimab/imdevimab, regdanvimab en tixagevimab/cilgavimab worden bij COVID-19 ontraden, omdat de omikronvariant van het virus minder gevoelig is voor deze monoklonale antilichamen (3). De huidige varianten van SARS-CoV-2 zijn niet gevoelig voor casirivimab/imdevimab. Casirivimab/imdevimab heeft geen therapeutische waarde meer voor behandeling of preventie van COVID-19 (4).
Duration of treatment	one-off
Dosage per administration	600 mg/ 600 mg casirivimab / imdevimab
References	NCT04425629 (1); NCT04452318 (2); Casirivimab/imdevimab. FK. 2024 (3); Expertopinie (4).

Patient volume	< 0 Market share is generally not included unless otherwise stated.
References	Expertopinie (1).
Additional remarks	Geen patiënten omdat de huidige SARS-CoV-2 varianten resistent zijn tegen casirivimab/imdevimab (1).

Patient volume

< 0

Market share is generally not included unless otherwise stated.

References

Expertopinie (1).

Additional remarks

Geen patiënten omdat de huidige SARS-CoV-2 varianten resistent zijn tegen casirivimab/imdevimab (1).

There is currently nothing known about the expected cost.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.