Extended indication

Grade II to IV acute graft-versus-host disease (aGvHD).

Therapeutic value

No judgement

Total cost

18,500,000.00

Registration phase

Clinical trials

Product

Active substance

Itacitinib

Domain

Oncology and Hematology

Reason of inclusion

New medicine (specialité)

Main indication

Graft versus Host

Extended indication

Grade II to IV acute graft-versus-host disease (aGvHD).

Manufacturer

Incyte

Route of administration

Oral

Therapeutical formulation

Tablet

Budgetting framework

Intermural (MSZ)

Additional remarks
Janus kinase 1 (JAK1)-inhibitor.

Registration

Submission date

2019

Expected Registration

2020

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

Duration of treatment

continuous

Frequency of administration

1 times a day

Expected patient volume per year

Patient volume

< 250

Market share is generally not included unless otherwise stated.

Additional remarks
400-500 allogene stamceltransplantaties per jaar. 50% kans op acute GvHD.

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 p.p.p.j..

Potential total cost per year

Total cost

18,500,000.00

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.