Ibrutinib

Extended indication	Chronische graft-versus-host disease
Therapeutic value	No judgement
Total cost	22,400,000.00
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)

Registration

Registration route	Centralised (EMA)
Submission date	2021
Expected Registration	November 2021
Orphan drug	Yes
Registration phase	Clinical trials
Additional remarks	Goedgekeurd door de FDA in augustus 2017. Fabrikant verwacht registratie in Q4 2021.

Therapeutic value

Therapeutic value	No judgement
Duration of treatment	continuous
Frequency of administration	1 times a day
Dosage per administration	420 mg

Expected patient volume per year

Patient volume	< 320 Market share is generally not included unless otherwise stated.
Additional remarks	400-500 allogene stamceltransplantaties per jaar. 70-80% kans op chronische GvHD.

Patient volume

< 320

Market share is generally not included unless otherwise stated.

Additional remarks

400-500 allogene stamceltransplantaties per jaar. 70-80% kans op chronische GvHD.

Expected cost per patient per year

Cost	70,000.00
References	G-standaard
Additional remarks	Huidige lijstprijs (€63,78/capsule 140 mg) x maximaal gebruik per jaar (3 capsules/dag x 365 dagen) = €69.839. Voor de indicatie 1e lijns Chronische Lymfatische Leukemie (CLL) wordt onderhandeld over een financieel arrangement en zit het geneesmiddel in de sluis. Voor deze indicatie zit ibrutinib niet in de sluis.

Potential total cost per year

Total cost	22,400,000.00 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

22,400,000.00

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	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 p.p.p.j..

Other information

There is currently no futher information available.