Version 13

Ibrutinib

Medicine

Extended indication Imbruvica in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (Imbruvica + R-CHOP) alternating with R-DHAP (or
Therapeutic value No estimate possible yet
Total cost € 1,337,600.00
Registration phase Registered

Product

Active substance Ibrutinib
Domain Hematology
Reason of inclusion Indication extension IND
Main indication Aggressive non-Hodgkin’s lymphoma
Extended indication Imbruvica in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (Imbruvica + R-CHOP) alternating with R-DHAP (or R-DHAOx) without Imbruvica, followed by Imbruvica monotherapy, is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who would be 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 January 2025
Expected Registration August 2025
Orphan drug Yes
Registration phase Registered
Medicine sluice Broadly excluded
Additional remarks Positieve CHMP-opinie in juni 2025.

Therapeutic value

Current treatment options Inductie met R-CHOP/R-DHAP gevolgd door ASCT.
Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.
Frequency of administration 1 times a day
Dosage per administration 560 mg
References NCT02858258

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 € 83,600.00

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

Potential total cost per year

Total cost € 1,337,600.00

Off label use

Indication extension

Indication extensions No

Other information