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% x 130 = 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.