Cabozantinib Medicine 12 June 2018 Extended indication Advanced Hepatocellular Carcinoma Therapeutic value No judgement Total cost € 7,900,000.00 Registration phase Registration application pending Product Active substance Cabozantinib Domain Oncology and Hematology Reason of inclusion Main indication Liver cancer Extended indication Advanced Hepatocellular Carcinoma Current proprietary name Already available biosimilars / generics Proprietary name Cabometyx / Cometriq Manufacturer Ipsen Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Inhibitor of specific receptor tyrosine kinases. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Indication extension ATMP Unknown Submission date March 2018 Expected Registration November 2018 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Scrip pipeline watch 19 januari 2018: Updated Phase III Results. CELESTIAL; improved overall survival, PFS. Therapeutic value Current treatment options Sorafenib 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 60 mg References NCT01908426 Additional remarks Expected patient volume per year Patient volume < 158 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks Totaal aantal patiënten in 2016 met hepatocellulair carcinoom stadium 4 betreft 158. Expected cost per patient per year Cost € 50,000.00 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; Farmacotherapeutisch Kompas Additional remarks Inschatting op basis van kosten SORAFENIB TABLET 200MG (€ 34,80) en behandelschema FK. Kosten van Cabozantinib 6784 euro voor 30 stuks (20MG / 40 MG / 60 MG). Potential total cost per year Total cost € 7,900,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Prostate Cancer, Carcinoid Tumor References Clinicaltrials.gov Additional remarks Other information Additional remarks