Itacitinib

Active substance
Itacitinib
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Stem cell transplants
Extended indication
Grade II to IV acute graft-versus-host disease (aGvHD).

1. Product

Manufacturer
Incyte
Mechanism of action
JAK tyrosine kinase inhibitor
Route of administration
Oral
Therapeutical formulation
Tablet
Budgetting framework
Intermural (MSZ)
Additional comments
Janus kinase 1 (JAK1)-inhibitor.

2. Registration

Submission date
2020
Expected Registration
2021
Orphan drug
Yes
Registration phase
Clinical trials
Additional comments
Phase III gestart, GRAVITAS-301, JAK1 inhibitor icm corticosteroids.

3. 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
Frequency of administration
1 times a day

4. Expected patient volume per year

Patient volume

< 300

Market share is generally not included unless otherwise stated.

References
EBMT database
Additional comments
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.

5. Expected cost per patient per year

Cost
74,000
References
Medicijnkosten.nl
Additional comments
Geschatte maximale kosten op basis van kosten en behandelschema ibrutinib is €74.000 per patiënt per jaar.

6. Potential total cost per year

Total cost

22,200,000

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.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

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

9. Other information

There is currently no futher information available.