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Encorafenib

Extended indication Treatment in combination with Binimetinib of patients with BRAF-mutant advanced, unresectable or met
Therapeutic value No judgement
Total cost 17,400,000.00

Product

Active substance Encorafenib
Domain Oncology and Hematology
Main indication Skin cancer
Extended indication Treatment in combination with Binimetinib of patients with BRAF-mutant advanced, unresectable or metastatic melanoma.
Manufacturer Pierre Fabre
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)
Additional remarks Binimetinib en encorafenib worden in combinatie gegeven.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date September 2017
Expected Registration July 2018
Orphan drug No

Therapeutic value

Current treatment options Andere BRAF/MEK-combinaties
Therapeutic value No judgement
Frequency of administration 1 times a day
Dosage per administration 450 mg
Additional remarks Toediningsfrequentie: 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 NKR 2015: 661 stadium 3 en 4 melanoomdiagnoses. 50% van melanoom is BRAF mutated.

Expected cost per patient per year

Cost 70,000.00 - 80,000.00
Additional remarks Gelijke kosten verwacht. Verwacht in lijn met huidige MEK/BRAF remmers.

Potential total cost per year

Total cost

17,400,000.00

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.