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.

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.

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.

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.

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

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.

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.

Off label use

Off label use No

Indication extension

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

Other information

There is currently no futher information available.