Regorafenib Medicine 09 January 2018 Extended indication Hepatocellular carcinoma, unresectable, 2L after sorafenib. Therapeutic value No judgement Total cost € 1,300,000.00 Registration phase Unknown Product Active substance Regorafenib Domain Oncology and Hematology Reason of inclusion Main indication Liver cancer Extended indication Hepatocellular carcinoma, unresectable, 2L after sorafenib. Current proprietary name Already available biosimilars / generics Proprietary name Stivarga Manufacturer Bayer Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet 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 November 2016 Expected Registration August 2017 Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Dit is een indicatie-uitbreiding. Geregistreerd in augustus 2017. Niet iedereen na sorafenib komt in aanmerking voor regorafenib. Positief CieBOM advies (okt 2017). Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Average 6 month / months Frequency of administration 1 times a day Dosage per administration 160 mg References Bruix et al. Lancet. 2017 Jan 7;389(10064):56-66 Additional remarks Fabrikant: Patiënten hebben één verpakking regorafenib nodig per cyclus. Een behandelcyclus bestaat uit 28 dagen waarvan de patiënt 3 weken regorafenib gebruikt gevolgd door een stopweek. De gemiddelde behandelduur in de fase III studie (Bruix et al. 2016) bedroeg 5,9 maanden Expected patient volume per year Patient volume 30 - 100 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Fabrikant Additional remarks NKR schatting: 500 (primair gediagnosticeerd). Gezien 2e lijns behandeling, schatting: behandeling van 100 patienten maximaal. Fabrikant geeft aan 30 patienten - realistisch volume. Expected cost per patient per year Cost € < 20,000.00 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; Fabrikant Additional remarks Behandeling kost €3.300 euro per cyclus. Kosten pppj zijn €3.300 maal 5,9 maanden. Bij de berekening is geen rekening gehouden met een eventuele dosisreductie. Potential total cost per year Total cost € 1,300,000.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks