Extended indication Mantle cell lymphoma (MCL), 1L.
Therapeutic value No estimate possible yet
Total cost 1,472,944.00
Registration phase Clinical trials

Product

Active substance Ibrutinib
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Aggressive non-Hodgkin's lymphoma
Extended indication Mantle cell lymphoma (MCL), 1L.
Proprietary name Imbruvica
Manufacturer Janssen
Mechanism of action Tyrosine kinase inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional comments Proteïnekinaseremmer. Remt irreversibel Bruton’s tyrosinekinase.

Registration

Registration route Centralised (EMA)
Submission date 2022
Expected Registration December 2022
Orphan drug Yes
Registration phase Clinical trials
Additional comments Fabrikant verwacht indiening in 2022 en registratie tegen december 2022.

Therapeutic value

Current treatment options Rituximab-CHOP
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 comments 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% x 130 = 16 patiënten per jaar.

Expected cost per patient per year

Cost 92,059.00
References G-standaard; fabrikant
Additional comments Lijstprijs (€63,05/tablet 140mg) x maximaal gebruik per jaar (4 tabletten/dag x 365 dagen) = €92.058 .

Potential total cost per year

Total cost

1,472,944.00

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 fase 3 studies in verschillende indicaties, indicatieuitbreidingen verwacht in het tweede kwartaal van 2019: Waldenstrom's macroglobulinemia (WM) in combinatie met Rituximab; Chronische Lymfatische Leukemie 1L, non-fit icm obinituzumab. Voor beide indicaties prijs verwacht rond de €70.000 per patiënt per jaar.

Other information

There is currently no futher information available.