Ibrutinib

Active substance
Ibrutinib
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
Indication extension
Main indication
CLL
Extended indication
Extension of indication to the existing chronic lymphocytic leukaemia (CLL) indication to include combination use with obinutuzumab for the treatment of adult patients with previously untreated CLL.

1. Product

Proprietary name
Imbruvica
Manufacturer
Janssen
Mechanism of action
Tyrosine kinase inhibitor
Route of administration
Oral
Therapeutical formulation
Tablet
Budgetting framework
Intermural (MSZ)
Additional comments
Proteïnekinaseremmer. Remt irreversibel Bruton’s tyrosinekinase. Is al geregistreerd voor deze indicatie zonder obinutuzumab.

2. Registration

Registration route
Centralised (EMA)
Type of trajectory
Normal trajectory
Submission date
December 2018
Expected Registration
August 2019
Orphan drug
Yes
Registration phase
Registered
Additional comments
Voor 1e lijns Chronische lymfatische leukemie (CLL) zit ibrutinib in de sluis. Positieve CHMP-opinie in juni 2019.

3. Therapeutic value

Current treatment options
BR or Chloorambucil + Rituximab
Therapeutic value
Potential equal value
Substantiation
De expert ziet mogelijk gelijke waarde voor CLL patiënten met ongemuteerde immuunglobuline genherschikking status van ibrutinib t.o.v chemo-immunotherapie. Dit betreft ongeveer 50% van de CLL patienten
Duration of treatment
Average 14 month / months
Frequency of administration
1 times a day
Dosage per administration
420 mg
References
NCT02264574; EPAR; Moreno et al. Lancet Oncol. 2019 Jan;20(1):43-56.
Additional comments
Obinutuzumab 1.000 mg IV gedurende 6 cycli: Days 1+2 (100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of Cycle 1 followed by Day 1 only on Cycles 2-6. De expert ziet voorlopig geen meerwaarde in combinatiebehandeling ibrutinib-obinutuzumab voor deze indicatie.

4. Expected patient volume per year

Patient volume

100 - 200

Market share is generally not included unless otherwise stated.

Expected market share
25
Additional comments
Aangezien voor CLL patiënten met ongemuteerde immuunglobuline genherschikking status er mogelijk gelijke waarde is van chemo-immunotherapie en ibrutinib, zal uiteindelijk ongeveer 25% van de patiënten hiervoor in aanmerking komen

5. Expected cost per patient per year

Cost
69,044
References
G-standaard; Fabrikant
Additional comments
Op basis van lijstprijs (per mei 2020). Ibrutinib zit in de sluis tot een financieel arrangement overeengekomen is.

6. Potential total cost per year

Total cost

10,356,600

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
No
References
clinicaltrials.gov
Additional comments
Geen nieuwe indicatieuitbreidingen buiten de indicaties in de Horizonscan.

9. Other information

There is currently no futher information available.