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Itacitinib

Extended indication Grade II to IV acute graft-versus-host disease (aGvHD).
Therapeutic value No estimate possible yet
Total cost 22,200,000.00
Registration phase Clinical trials

Product

Active substance Itacitinib
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Stem cell transplants
Extended indication Grade II to IV acute graft-versus-host disease (aGvHD).
Manufacturer Incyte
Mechanism of action JAK tyrosine kinase inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional remarks Janus kinase 1 (JAK1)-inhibitor.

Registration

Submission date 2021
Expected Registration 2022
Orphan drug Yes
Registration phase Clinical trials
Additional remarks Fase 3 gestart, GRAVITAS-301, JAK1 inhibitor in combinatie met corticosteroïden.

Therapeutic value

Current treatment options Ciclosporin en corticosteroïden (en zodra geregistreerd ibrutinib).
Therapeutic value No estimate possible yet
Substantiation Nog geen valide uitspraak over te doen daar er nog geen data bekend zijn van de GRAVITAS trial.
Duration of treatment continuous
Frequency of administration 1 times a day

Expected patient volume per year

Patient volume

< 300

Market share is generally not included unless otherwise stated.
References EBMT database.
Additional remarks Jaarlijks worden in Nederland circa 600 allogene stamceltransplantaties uitgevoerd. In naar schatting de helft van de gevallen (=300) treedt enige vorm van Graft-versus-Host-ziekte op. Gezien 2L behandeling zal slechts een deel van deze patiënten in aanmerking komen voor Prochymal.

Expected cost per patient per year

Cost 74,000.00
References Medicijnkosten.nl.
Additional remarks Geschatte maximale kosten op basis van kosten en behandelschema ibrutinib is €74.000 per patiënt per jaar.

Potential total cost per year

Total cost

22,200,000.00

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.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension No
References Clinicaltrials.gov.
Additional remarks Er lopen wel meerdere studies voor andere aandoeningen maar nog niet in Fase 3.

Other information

There is currently no futher information available.