Encorafenib Medicine 09 January 2018 Extended indication Treatment in combination with Binimetinib of patients with BRAF-mutant advanced, unresectable or metastatic melanoma. Therapeutic value No judgement Total cost € 17,400,000.00 Registration phase Registration application pending Product Active substance Encorafenib Domain Oncology and Hematology Reason of inclusion Main indication Skin cancer Extended indication Treatment in combination with Binimetinib of patients with BRAF-mutant advanced, unresectable or metastatic melanoma. Current proprietary name Already available biosimilars / generics Proprietary name 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 New medicine ATMP Unknown Submission date September 2017 Expected Registration October 2018 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks 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 Frequency of administration 1 times a day Dosage per administration 450 mg References 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 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 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 Additional remarks Gelijke kosten verwacht. Verwacht in lijn met huidige MEK/BRAF remmers. Potential total cost per year Total cost € 17,400,000.00 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