Tisagenlecleucel-T Medicine 07 December 2021 Extended indication Extension of indication for Kymriah, to include adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. Therapeutic value No estimate possible yet Total cost € 112,000,000.00 Registration phase Registered Product Active substance Tisagenlecleucel-T Domain Hematology Reason of inclusion Indication extension IND Main indication Indolent non-Hodgkin’s lymphoma Extended indication Extension of indication for Kymriah, to include adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. Current proprietary name Already available biosimilars / generics Proprietary name Kymriah Manufacturer Novartis Portfolio holder Mechanism of action CAR-T therapy Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks CAR-T therapie is een nieuwe cellulaire therapie waarbij de T-cellen van de patiënt genetisch worden gemodificeerd. De gemodificeerde CAR-T cellen prolifereren, herkennen de kankercellen beter en elimineren de kankercellen vervolgens. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP Yes Submission date October 2021 Expected Registration April 2022 Orphan drug Yes Registration phase Registered Reimbursement Medicine sluice Broadly excluded Additional remarks Registratie Kymriah FL indicatie 29 april 2022. Kymriah is breed uitgesloten van vergoeding en stroomt derhalve automatische de sluis in. Wel opgenomen in verzekerde pakket voor 3L+DLBCL en pALL. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume < 350 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Budget impact analyse van ibrutinib (Imbruvica) bij de behandeling van chronische lymfatische leukemie (patiënten zonder 17p of TP53 mutaties). Additional remarks Er zijn 350 patiënten per jaar met FL of MZL die een tweedelijns behandeling starten. Een gedeelte van deze patiënten zal mogelijk gebruik maken van Tisagenlecleucel-T. Expected cost per patient per year Cost € 320,000.00 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 G-Standaard Additional remarks Eenmalige toediening Potential total cost per year Total cost € 112,000,000.00 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks