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

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)

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.

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

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).

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).

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.

Off label use

Off label use

No

Indication extension

Indication extension

No

Other information

There is currently no futher information available.