Baricitinib Medicine 08 June 2021 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. Therapeutic value Possibly no place in the treatment regimen Total cost Registration phase No registration expected Product Active substance Baricitinib Domain Infectious diseases Reason of inclusion Indication extension IND 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. Current proprietary name Already available biosimilars / generics Proprietary name Olumiant Manufacturer Eli Lilly Portfolio holder Mechanism of action JAK tyrosine kinase inhibitor Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date April 2021 Expected Registration Orphan drug No Registration phase No registration expected Reimbursement Medicine sluice Additional remarks Registratieaanvraag teruggetrokken (CHMP opinie december 2022). Therapeutic value Current treatment options Therapeutic value Possibly no place in the treatment regimen This assessment does not indicate any potential inclusion in the package. 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. Duration of treatment Frequency of administration Dosage per administration 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. Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice 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 slechts een klein aantal patiënten in aanmerking zal komen voor dit middel en tocilizumab mogelijk vaker ingezet zal worden. Expected cost per patient per year Cost € 10,672.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References G-standaard november 2022 Additional remarks Pediatrische indicatie, kosten kunnen mogelijk afwijken van kosten aangegeven op medicijnkosten voor andere indicaties = niet correct! De prijs voor een verpakking van 28 tabletten Olumiant 4mg bedraagt €820,93. 1 tablet kost €29,32. Bij een behandelduur van een jaar (13 verpakkingen) zou dat €10. 672,09 bedragen. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks