Binimetinib Medicine 09 January 2018 Extended indication Treatment of unresectable or metastatic melanoma with an NRAS Q61 mutation. Therapeutic value No judgement Total cost € 11,250,000.00 Registration phase Unknown Product Active substance Binimetinib Domain Oncology and Hematology Reason of inclusion Main indication Skin cancer Extended indication Treatment of unresectable or metastatic melanoma with an NRAS Q61 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 Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Binimetinib teruggetrokken bij FDA. Komt een combinatietherapie aan met encorafinib BRAF+MEK, dus in dat geval substitutie met andere MEK/BRAF-combi's. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date October 2016 Expected Registration July 2018 Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Andere MEK-inhibitors Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 2 times a day Dosage per administration 45 mg References Additional remarks Expected patient volume per year Patient volume 120 - 180 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Johnson and Puzanov. Curr Treat Options Oncol. 2015 Apr; 16(4): 15 Additional remarks 15-20% van melanoom betreft een NRAS mutatie. Er zijn 6000 nieuwe patiënten per jaar = 900-1200. uitgezaaid melanoom hiervan zo'n 160-180, maar in aanmerking 100-120. 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 € 11,250,000.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks