Ibrutinib

Active substance
Ibrutinib
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
Indication extension
Main indication
Indolent non-Hodgkin's lymphoma
Extended indication
Follicular lymphoma (FL), relapsed / refractory.

1. Product

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.

2. 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 Q2 2022

3. Therapeutic value

Current treatment options
Lenalidomide/rituximab/bendamustine followed by rituximab maintenance therapy
Therapeutic value
No judgement
Duration of treatment
Not found
Frequency of administration
1 times a day
Dosage per administration
560 mg
References
Fabrikant

4. 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.

5. Expected cost per patient per year

Cost
92,059
References
G-standaard
Additional comments
Op basis van lijstprijs (per mei 2020).

6. Potential total cost per year

Total cost

18,411,800

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.

7. Off label use

Off label use
No

8. Indication extension

Indication extension
Yes
Indication extensions
Er lopen meerdere PhIII studies in verschillende indicaties, indicatieuitbreidingen verwacht Q2 2019: Waldenstrom's macroglobulinemia (WM) icm Rituximab; Chronische Lymfatische Leukemie 1L, non-fit icm obinituzumab. Voor beide indicaties prijs verwacht rond de €70.000 per patiënt per jaar..

9. Other information

There is currently no futher information available.