Extended indication

Follicular lymphoma (FL), relapsed / refractory.

Therapeutic value

No judgement

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

Capsule

Budgetting framework

Intermural (MSZ)

Additional comments
Proteïnekinaseremmer. Remt irreversibel Bruton’s tyrosinekinase.

Registration

Registration route

Centralised (EMA)

Submission date

August 2021

Expected Registration

April 2022

Orphan drug

Yes

Registration phase

Clinical trials

Additional comments
Fabrikant verwacht registratie in het tweede kwartaal van 2022.

Therapeutic value

Current treatment options

Lenalidomide/rituximab/bendamustine followed by rituximab maintenance therapy.

Therapeutic value

No judgement

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 comments
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 comments
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.