Expand all sections

Ibrutinib

Imbruvica

Extended indication Chronische graft-versus-host disease
Therapeutic value No judgement
Total cost 7,594,800.00
Registration phase Clinical trials

Product

Active substance Ibrutinib
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Stem cell transplants
Extended indication Chronische graft-versus-host disease
Proprietary name Imbruvica
Manufacturer Janssen
Mechanism of action Tyrosine kinase inhibitor
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)
Additional remarks Brutons tyorinse kinase remmer

Registration

Registration route Centralised (EMA)
Submission date 2021
Expected Registration 2022
Orphan drug Yes
Registration phase Clinical trials
Additional remarks 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 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. 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 25,316.00
References G-standaard; Waller et al.Biol Blood Marrow Transplant. 2019 Oct;25(10):2002-2007.
Additional remarks Op basis van lijstprijs (per mei 2020).

Potential total cost per year

Total cost

7,594,800.00

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 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.