Encorafenib Medicine 09 January 2018 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. 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. Current proprietary name Already available biosimilars / generics Proprietary name Braftovi Manufacturer Pierre Fabre Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Capsule Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Binimetinib en encorafenib worden in combinatie gegeven. BRAF-remmer. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date September 2017 Expected Registration September 2018 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie juli 2018. Geregistreerd in september 2018. Therapeutic value Current treatment options Andere BRAF/MEK-combinaties Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Median 11.7 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. Maximum patient volume for sluice 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 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. 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 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions BRAF-mutant colorectal cancer. References Additional remarks Other information Additional remarks