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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.