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Encorafenib

Braftovi

Extended indication Extension of indication to include binimetinib in combination with encorafenib for the treatment of
Therapeutic value No estimate possible yet
Total cost 12,225,000.00
Registration phase Registration application pending

Product

Active substance Encorafenib
Domain Oncology
Reason of inclusion Indication extension
Main indication Lung cancer
Extended indication Extension of indication to include binimetinib in combination with encorafenib for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with a BRAF V600 mutation.
Proprietary name Braftovi
Manufacturer Pierre Fabre
Portfolio holder Pierre Fabre
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)
Additional remarks BRAF remmers

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date October 2023
Expected Registration August 2024
Registration phase Registration application pending
Additional remarks NCT03915951

Therapeutic value

Current treatment options Ametinib
Therapeutic value No estimate possible yet
Substantiation Lopende fase 2 studie in zowel behandelde als onbehandelde patiënten.

Expected patient volume per year

Patient volume

< 75

Market share is generally not included unless otherwise stated.
References NKR 2021 (1) Yan N, Guo S, Zhang H, Zhang Z, Shen S, Li X. BRAF-Mutated Non-Small Cell Lung Cancer: Current Treatment Status and Future Perspective. Front Oncol. 2022 Mar 31;12:863043. doi: 10.3389/fonc.2022.863043. PMID: 35433454; PMCID: PMC9008712 (2)
Additional remarks In 2021 waren er 10.096 diagnoses NSCLC in Nederland. Dit betrof 1.727 patiënten in stadium I, 822 patiënten in stadium II, 2.231 patiënten in stadium III, 5.247 patiënten in stadium IV (1) Ongeveer 2% betreft een BFAF mutatie, waarvan de helft een V600 mutatie betreft (2). Dit betekent dat er ongeveer 75 patiënten in aanmerking zullen komen

Expected cost per patient per year

Cost < 163,000.00
References Medicijnkosten.nl; SmPC
Additional remarks Deze inschatting is gebaseerd op een eerdere indicatie voor melanoom. 450 mg encorafenib (6 capsules 75 mg) 1 maal per dag gedurende een jaar kost in totaal €83.687,03. Daarnaast moeten patiënten ook 1 maal per dag 6 capsules binimetinib innemen (15 mg). Dit kost per jaar €79.140,40. In totaal kost deze behandeling dus €162.827,43.

Potential total cost per year

Total cost

12,225,000.00

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

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.