Axicabtagene ciloleucel Medicine 09 January 2018 Extended indication Non-hodgkin lymfoom Therapeutic value No judgement Total cost € 309,300,000.00 Registration phase Unknown Product Active substance Axicabtagene ciloleucel Domain Oncology and Hematology Reason of inclusion Main indication Lymphoma Extended indication Non-hodgkin lymfoom Current proprietary name Already available biosimilars / generics Proprietary name Yescarta Manufacturer Gilead Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Geregistreerd bij de FDA in oktober 2017. Registration Registration route Centralised (EMA) Type of trajectory Accelerated assessment Particularity Unknown ATMP Unknown Submission date September 2017 Expected Registration May 2018 Orphan drug Yes Registration phase Unknown Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References Additional remarks Eenmalige infusie Expected patient volume per year Patient volume < 1,031 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Raut et al. South Asian J Cancer. 2014 Jan-Mar; 3(1): 66–70; Casulo et al. Blood 2015 125:40-47 Additional remarks NKR (2015): 1399 DLBLC en varianten (incl. PMBCL); 474 FL. Ongeveer 50 tot 60% van de patiënten met DLBCL behalen complete remissie na eerstelijnstherapie. 30 tot 40% relapse en 10% refractory. Transformatie van FL in 24-70%. 1399x0,5+474x0,7=1031 patiënten bij deze indicatie. Expected cost per patient per year Cost € < 300,000.00 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 Persbericht Gilead VS Additional remarks Lijstprijs in EU nog niet bekend. Lijstprijs in de VS is $373.000. Schatting op basis van US prijs: 300.000 pppj Potential total cost per year Total cost € 309,300,000.00 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