Lenvatinib Medicine 13 December 2018 Extended indication Lenvima is indicated as monotherapy for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy Therapeutic value Possible equal value Total cost € 5,372,000.00 Registration phase Registered and reimbursed Product Active substance Lenvatinib Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Liver cancer Extended indication Lenvima is indicated as monotherapy for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy Current proprietary name Already available biosimilars / generics Proprietary name Lenvima Manufacturer Eisai Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Capsule Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date July 2017 Expected Registration September 2018 Orphan drug Unknown Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve opinie juni 2018. Geregistreerd in augustus 2018. Therapeutic value Current treatment options Sorafenib Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Non-inferior versus sorafenib Duration of treatment Median 5.7 month / months Frequency of administration 1 times a day Dosage per administration 12 mg References Kudo et al. Lancet. 2018 Mar 24;391(10126):1163-1173. 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. Zal de competitie aan moeten gaan met sorafenib. Expected cost per patient per year Cost € 34,000.00 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 Additional remarks 12 mg (3 maal een tablet van 4 mg) kost €195,08. Bij een behandelduur van 5,7 maanden resulteert dit in €33.359,27 per patiënt per jaar. Potential total cost per year Total cost € 5,372,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks