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Ibrutinib

Imbruvica

Extended indication Chronische graft-versus-host disease
Therapeutic value No judgement
Total cost 23,680,000.00

Product

Active substance Ibrutinib
Domain Oncology and Hematology
Main indication Graft versus Host
Extended indication Chronische graft-versus-host disease
Proprietary name Imbruvica
Manufacturer Janssen
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Orphan drug Yes
Additional remarks Dit is een indicatie-uitbreiding. Sluis product. Goedgekeurd door de FDA in augustus 2017. Fabrikant (nov 2017): indicatie is sterk vertraagd.

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

Expected cost per patient per year

Cost < 74,000.00
References Medicijnkosten.nl
Additional remarks Per capsule van 140 mg €67,61.

Potential total cost per year

Total cost

23,680,000.00

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 PhIII studies in verschillende indicaties, indicatieuitbreidingen verwacht Q2 2019: Waldenstrom's macroglobulinemia (WM) icm Rituximab; Chrnosiche Lymfatische Leukemie 1L, non-fit icm obinituzumab. Voor beide indicaties prijs verwacht rond de €70.000 pppj.

Other information

There is currently no futher information available.