Casirivimab / imdevimab

Extended indication	Extension of indication to include treatment of COVID-19 in hospitalised patients in adults and adolescents aged 12 years and older weighing at least 40 kg for Ronapreve
Therapeutic value	No estimate possible yet
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 COVID-19 in hospitalised patients in adults and adolescents aged 12 years and older weighing at least 40 kg for Ronapreve
Proprietary name	Ronapreve
Manufacturer	Roche
Route of administration	Intravenous
Therapeutical formulation	Injection
Budgetting framework	Intermural (MSZ)
Additional remarks	Casirivimab and imdevimab have been designed to attach to the spike protein of SARS-CoV-2 at two different sites. When the active substances are attached to the spike protein, the virus is unable to enter the body’s cells.

Registration route	Centralised (EMA)
Submission date	February 2022
Expected Registration	December 2022
Orphan drug	No
Registration phase	Registration application pending

Therapeutic value	No estimate possible yet

There is currently nothing known about the expected patient volume.

References	medicijnkosten.nl
Additional remarks	Prijs incl. BTW: Ronapreve inj/infv 300mg/2,5ml (120mg/ml) 2 flac € 562,71 per stuk. Ronapreve inj/infv 1332mg/11,1ml (120mg/ml) 2 flac € 2.250,85 per stuk.

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.