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 comments
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 comments
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.