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.