Extended indication

Extension of indication to include treatment of COVID-19 in hospitalised patients in adults and

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 comments
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

Registration route

Centralised (EMA)

Submission date

February 2022

Expected Registration

January 2023

Orphan drug

No

Registration phase

Registration application pending

Therapeutic value

Therapeutic value

No estimate possible yet

Expected patient volume per year

References
https://data.rivm.nl/covid-19/
Additional comments
Vanaf 1 november 2020 tot 1 november 2021 waren er in Nederland 51.889 opnames van COVID patiënten in het ziekenhuis. Dit betreft dus zo’n 50.000 opnames per jaar (< 20% betreft IC opnames). Dit is de beste data die voorhanden is maar het aantal ziekenhuisopnames kan komend jaar wel af wijken gezien het verloop van de COVID epidemie (dit is onder andere afhankelijk van het aantal gevaccineerde personen, de verschillende varianten van het virus die in opkomst zijn en hoe snel deze zich verspreiden en de overheidsmaatregelen gedurende het jaar). Van deze patiëntengroep zal slechts een deel in aanmerking komen voor dit geneesmiddel.

Expected cost per patient per year

Cost

1,125.00

References
medicijnkosten.nl; EPAR
Additional comments
Prijs inclusief BTW: Ronapreve 300mg/2,5ml (120mg/ml) €562,71 per stuk. Ronapreve 1.332mg/11,1ml (120mg/ml) €2.250,85 per stuk. Het betreft een eenmalige dosis van 600 mg. Dus twee doses van 300 mg kost €1125,42.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.