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Ibrutinib

Imbruvica

Extended indication Extension of indication to include treatment with Imbruvica in combination with bendamustine and
Therapeutic value No estimate possible yet
Total cost 1,338,064.00
Registration phase Registration application pending

Product

Active substance Ibrutinib
Domain Hematology
Reason of inclusion Indication extension
Main indication Aggressive non-Hodgkin’s lymphoma
Extended indication Extension of indication to include treatment with Imbruvica in combination with bendamustine and rituximab (BR) of adult patients with previously untreated mantle cell lymphoma (MCL) who are unsuitable for autologous stem cell transplantation
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)
Submission date March 2022
Expected Registration January 2023
Orphan drug No
Registration phase Registration application pending
Additional remarks Fabrikant verwacht indiening in 2022 en registratie tegen januari 2023.

Therapeutic value

Current treatment options Rituximab-CHOP
Therapeutic value No estimate possible yet
Substantiation In de klinische studie zijn positieve resultaten behaald op PFS, maar er is geen OS winst behaald. Er wordt niet verwacht dat het een standaardbehandeling zal worden. De dosering is wat hoger dan bij patiënten met CLL.
Frequency of administration 1 times a day
Dosage per administration 560mg
References NCT01776840

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
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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.