Ibrutinib

Active substance

Ibrutinib

Domain

Oncology and Hematology

Reason of inclusion in Horizonscan Geneesmiddelen

Indication extension

Main indication

Stem cell transplants

Extended indication
Chronische graft-versus-host disease

Product

Proprietary name

Imbruvica

Manufacturer

Janssen

Mechanism of action

Tyrosine kinase inhibitor

Route of administration

Oral

Therapeutical formulation

Capsule

Budgetting framework

Intermural (MSZ)

Additional comments
Brutons tyorinse kinase remmer

Registration

Registration route

Centralised (EMA)

Submission date

2021

Expected Registration

2022

Orphan drug

Yes

Registration phase

Clinical trials

Additional comments
Goedgekeurd door de FDA in augustus 2017.

Therapeutic value

Therapeutic value

No judgement

Duration of treatment

Median 4.4 month / months

Frequency of administration

1 times a day

Dosage per administration

420 mg

References
Waller et al.Biol Blood Marrow Transplant. 2019 Oct;25(10):2002-2007.

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. De verwachting is echter dat minder mensen uiteindelijk in aanmerking komen voor dit middel gezien dit middel moet gaan concurreren met andere middelen.

Expected cost per patient per year

Cost

25,316

References
G-standaard; Waller et al.Biol Blood Marrow Transplant. 2019 Oct;25(10):2002-2007.
Additional comments
Op basis van lijstprijs (per mei 2020).

Potential total cost per year

Total cost

7,594,800

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

Yes

Indication extensions

Er lopen meerdere fase 3 studies in verschillende indicaties, indicatieuitbreidingen verwacht Q2 2019: Waldenstrom's macroglobulinemia (WM) icm Rituximab; Chronische Lymfatische Leukemie 1L, non-fit icm obinituzumab. Voor beide indicaties prijs verwacht rond de €70.000 per patiënt per jaar.

Other information

There is currently no futher information available.