Itacitinib

Extended indication	Grade II to IV acute graft-versus-host disease (aGvHD).
Therapeutic value	No judgement 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	2020
Expected Registration	2021
Orphan drug	Yes
Registration phase	Clinical trials
Additional remarks	Phase III gestart, GRAVITAS-301, JAK1 inhibitor icm corticosteroids.

Therapeutic value

Current treatment options	Ciclosporin en corticosteroiden (en zodra geregistreerd ibrutinib)
Therapeutic value	No judgement yet
Substantiation	Nog geen valide uitspraak over te doen daar 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.

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 €74.000,00 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.

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 phase III.

Other information

There is currently no futher information available.