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Ibrutinib

Imbruvica

Extended indication Imbruvica in combination with R-CHOP or R-DHAP for the treatment of adult patients with previously u
Therapeutic value No estimate possible yet
Total cost 1,338,064.00
Registration phase Clinical trials

Product

Active substance Ibrutinib
Domain Hematology
Reason of inclusion Indication extension
Main indication Aggressive non-Hodgkin’s lymphoma
Extended indication Imbruvica in combination with R-CHOP or R-DHAP for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are eligible for autologous stem cell transplantation (ASCT).
Proprietary name Imbruvica
Manufacturer Janssen
Mechanism of action Tyrosine kinase inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional remarks Proteïnekinaseremmer. Remt irreversibel Bruton’s tyrosinekinase.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date July 2024
Expected Registration January 2025
Orphan drug Yes
Registration phase Clinical trials

Therapeutic value

Current treatment options inductie met R-CHOP/R-DHAP gevolgd door ASCT
Therapeutic value No estimate possible yet
Frequency of administration 1 times a day
Dosage per administration 560 mg

Expected patient volume per year

Patient volume

16

Market share is generally not included unless otherwise stated.
References NKR; Fabrikant; Budget impact analyse van ibrutinib (Imbruvica) bij de behandeling van chronische lymfatische leukemie (patiënten zonder 17p of TP53 mutaties)
Additional remarks De incidentie van MCL in Nederland was in 2015, 187 patiënten waarvan 130 patiënten ouder zijn dan 65 jaar. Ongeveer 12% van de patiënten hiervan komt in aanmerking voor deze behandeling. Het geschatte aantal patiënten komt daarmee op 12%x130=16 patiënten per jaar.

Expected cost per patient per year

Cost 83,629.00
References G-standaard; fabrikant
Additional remarks Lijstprijs (€57,28/tablet 140mg) x maximaal gebruik per jaar (4 tabletten/dag x 365 dagen) = €83.629.

Potential total cost per year

Total cost

1,338,064.00

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 No

Other information

There is currently no futher information available.