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Ibrutinib

Imbruvica

Extended indication Follicular lymphoma (FL), relapsed / refractory.
Therapeutic value No estimate possible yet
Total cost 18,411,800.00
Registration phase Clinical trials

Product

Active substance Ibrutinib
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Indolent non-Hodgkin’s lymphoma
Extended indication Follicular lymphoma (FL), relapsed / refractory.
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 2022
Expected Registration 2023
Orphan drug Yes
Registration phase Clinical trials
Additional remarks Fabrikant verwacht registratie in 2023.

Therapeutic value

Current treatment options Lenalidomide/rituximab/bendamustine followed by rituximab maintenance therapy.
Therapeutic value No estimate possible yet
Frequency of administration 1 times a day
Dosage per administration 560 mg
References Fabrikant.

Expected patient volume per year

Patient volume

< 200

Market share is generally not included unless otherwise stated.
References NKR; Budget impact analyse van ibrutinib (Imbruvica) bij de behandeling van chronische lymfatische leukemie (patiënten zonder 17p of TP53 mutaties)
Additional remarks In 2015 kregen in Nederland 436 patiënten de diagnose FL. Behandelopties bij patiënten met FL zijn onder andere radiotherapie en chemotherapie, hiermee wordt bij ongeveer 50% van de patiënten langdurige ziektevrije overleving bereikt. De inschatting is dat er ongeveer 200 patiënten met FL starten met een tweedelijnsbehandeling.

Expected cost per patient per year

Cost 92,059.00
References G-standaard
Additional remarks Op basis van lijstprijs (per mei 2020).

Potential total cost per year

Total cost

18,411,800.00

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

Other information

There is currently no futher information available.