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Ibrutinib

Imbruvica

Extended indication Mantle cell lymphoma (MCL), 1L.
Therapeutic value No judgement
Total cost 1,488,000.00

Product

Active substance Ibrutinib
Domain Oncology and Hematology
Main indication Lymphoma
Extended indication Mantle cell lymphoma (MCL), 1L.
Proprietary name Imbruvica
Manufacturer Janssen
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Expected Registration 2020
Orphan drug Yes
Additional remarks Dit is een indicatie-uitbreiding.

Therapeutic value

Therapeutic value No judgement
Duration of treatment Not found

Expected patient volume per year

Patient volume

< 16

Market share is generally not included unless otherwise stated.
References Budget impact analyse van ibrutinib (Imbruvica) bij de behandeling van chronische lymfatische leukemie (patiënten zonder 17p of TP53 mutaties)

Expected cost per patient per year

Cost < 93,000.00
References Medicijnkosten.nl
Additional remarks Per capsule van 140 mg €67,61.

Potential total cost per year

Total cost

1,488,000.00

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.