Extended indication Extension of indication to include treatment of coronavirus disease 2019 (Covid 19) in hospitalised
Therapeutic value Possibly no place in the treatment regimen
Registration phase Registration application pending

Product

Active substance Baricitinib
Domain Infectious diseases
Reason of inclusion Indication extension
Main indication COVID-19
Extended indication Extension of indication to include treatment of coronavirus disease 2019 (Covid 19) in hospitalised adult and paediatric patients aged 10 years and older who require low-flow oxygen or non invasive ventilation/high flow oxygen for Olumiant.
Proprietary name Olumiant
Manufacturer Eli Lilly
Mechanism of action JAK tyrosine kinase inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
ATMP No
Submission date April 2021
Expected Registration May 2022
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value Possibly no place in the treatment regimen
Substantiation Gezien het bescheiden effect dat baricitinib heeft op de ziekte progressie wordt er meer verwacht van andere immuun modulerende strategieën zoals anakinra en tocilizumab.
References Efficacy and safety of baricitinib for the treatment of hospitalised adults with COVID-19 (COV-BARRIER): a randomised, double-blind, parallel-group, placebo-controlled phase 3 trial. V C Marconi. September 2021.

Expected patient volume per year

References expert opinie.
Additional remarks Dit middel zit naar verwachting op dezelfde as als imatinib en dit heeft een kleine bescheiden plek binnen COVID. De verwachting is dan ook dat slecht een klein aantal patiënten in aanmerking zal komen voor dit middel en anakinra en tocilizumab mogelijk vaker ingezet zullen worden.

Expected cost per patient per year

Cost 445.62
References Medicijnkosten
Additional remarks Pediatrische indicatie, kosten kunnen mogelijk afwijken van kosten aangegeven op medicijnkosten voor andere indicaties

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.