Brigatinib

Active substance
Brigatinib
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
Indication extension
Main indication
Lung cancer
Extended indication
Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor

1. Product

Proprietary name
Alunbrig
Manufacturer
Takeda
Mechanism of action
Tyrosine kinase inhibitor
Route of administration
Oral
Therapeutical formulation
Film-coated tablet
Budgetting framework
Intermural (MSZ)
Additional comments
ALK-inhibitor (proteïne kinase remmer)

2. Registration

Registration route
Centralised (EMA)
Type of trajectory
Normal trajectory
Submission date
June 2019
Expected Registration
April 2020
Orphan drug
No
Registration phase
Positive CHMP opinion
Additional comments
Positieve CHMP-opinie in februari 2020.

3. Therapeutic value

Current treatment options
Alectinib, crizotinib, ceritinib
Therapeutic value
Potential equal value
Duration of treatment
Not found
Frequency of administration
1 times a day
Dosage per administration
180 mg
References
NCT02737501 ALTA-1L studie: N. Engl. J. Med. 2018; 379:2027-2039
Additional comments
90 mg per dag eerste 7 dagen, daarna 180 mg per dag

4. Expected patient volume per year

Patient volume

< 126

Market share is generally not included unless otherwise stated.

Expected market share
33
References
NKR; Pakketadvies Atezolizumab; Korpanty et al. Front Oncol. 2014; 4: 204.; GIPdatabank; Tiseo et al. Lung Cancer. 2011 Feb;71(2):241-3.
Additional comments
Jaarlijks presenteren er ongeveer 4.500 patiënten per jaar met NSCLC stadium IV. Hiervan is 5% ALK+ (225). Aannemende dat 70% getest wordt (158), 20% van de ALK+ patiënten geïncludeerd wordt in studies, en 80% van de resterende patiënten een eerstelijns ALK TKI krijgen (126). De verwachting is dat slechts een klein aantal van deze patiënten in aanmerking komt voor deze behandeling. Aangezien de markt verdeeld zal worden over de vier verschillende behandelopties ( Alectinib, ceritinib, crizotinib en brigatinib).

5. Expected cost per patient per year

Cost
71,768
References
G-standaard; fabrikant
Additional comments
Kosten per patiënt per volledig behandeljaar, op basis van lijstprijs en rekening houdend met afwijkende startdosering: €1.040,22 + €70.728,46 = €71.768,68 (exclusief BTW).

6. Potential total cost per year

Total cost

9,042,768

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

9. Other information

There is currently no futher information available.