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Ibrutinib

Imbruvica

Extended indication Marginal zone lymphoma (MZL), relapsed / refractory.
Therapeutic value No judgement
Total cost 13,950,000.00
Registration phase Clinical trials

Product

Active substance Ibrutinib
Domain Oncology and Hematology
Main indication Lymphoma
Extended indication Marginal zone lymphoma (MZL), relapsed / refractory.
Proprietary name Imbruvica
Manufacturer Janssen
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)
Additional remarks Proteïnekinaseremmer. Remt irreversibel Bruton’s tyrosinekinase

Registration

Registration route Centralised (EMA)
Particularity Indication extension
Submission date August 2019
Expected Registration May 2020
Orphan drug Yes
Registration phase Clinical trials

Therapeutic value

Current treatment options Lenalidomide/Rituximab/Bendamustine followed by Rituximab maintenance therapy.
Therapeutic value No judgement
Frequency of administration 1 times a day
Dosage per administration 560 mg
References Fabrikant

Expected patient volume per year

Patient volume

< 150

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)
Additional remarks Inschatting dat ongeveer 150 patiënten met MZL starten met een tweedelijns behandeling.

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

13,950,000.00

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

Off label use No

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.