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Encorafenib

Braftovi

Extended indication Encorafenib in combination with binimetinib (Mektovi) is indicated for the treatment of adult patien
Therapeutic value No judgement
Total cost 37,816,000.00
Registration phase Registered and reimbursed

Product

Active substance Encorafenib
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Skin cancer
Extended indication Encorafenib in combination with binimetinib (Mektovi) is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
Proprietary name Braftovi
Manufacturer Pierre Fabre
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)
Additional remarks Binimetinib en encorafenib worden in combinatie gegeven. BRAF-remmer.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date September 2017
Expected Registration September 2018
Orphan drug No
Registration phase Registered and reimbursed
Additional remarks Positieve CHMP-opinie juli 2018. Geregistreerd in september 2018.

Therapeutic value

Current treatment options Andere BRAF/MEK-combinaties
Therapeutic value No judgement
Duration of treatment Not found
Frequency of administration 1 times a day
Dosage per administration 450 mg
References EPAR
Additional remarks Toedieningsfrequentie: Binimetinib 45 mg 2 maal per dag; Encorafenib 450 mg 1 maal per dag.

Expected patient volume per year

Patient volume

133 - 331

Market share is generally not included unless otherwise stated.
References NKR; Ascierto et al. J Transl Med. 2012; 10: 85.
Additional remarks 661 stadium 3 en 4 melanoomdiagnoses. 50% van melanoom is BRAF mutated.

Expected cost per patient per year

Cost 163,000.00
References Medicijnkosten.nl; SmPC
Additional remarks 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

37,816,000.00

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

Off label use No

Indication extension

Indication extension Yes
Indication extensions BRAF-mutant colorectal cancer.

Other information

There is currently no futher information available.