Extended indication Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma ki
Therapeutic value Possible equal value
Total cost 5,811,132.00
Registration phase Registered and reimbursed

Product

Active substance Brigatinib
Domain Oncology and Hematology
Reason of inclusion 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.
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 Registered and reimbursed
Additional comments Positieve CHMP-opinie in februari 2020.

Therapeutic value

Current treatment options Alectinib, crizotinib, ceritinib
Therapeutic value Possible equal value
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

33 - 126

Market share is generally not included unless otherwise stated.

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 73,096.00
References G-standaard; fabrikant.
Additional comments Kosten per patiënt per volledig behandeljaar, op basis van lijstprijs en rekening houdend met afwijkende startdosering: €1.059 + €72.037 = €73.096 exclusief btw.

Potential total cost per year

Total cost

5,811,132.00

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.