Tisagenlecleucel-T Medicine 07 December 2021 Extended indication Extension of indication for Kymriah, to include treatment of adult patients with follicular lymphoma (FL) after two or more lines of therapy who are refractory, or relapsed during or within 6 months after completion of anti -CD20 antibody maintenance, or relapsed after autologous haematopoietic stem cell transplantation (HSCT) . Therapeutic value No estimate possible yet Total cost € 112,000,000.00 Registration phase Registration application pending Product Active substance Tisagenlecleucel-T Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Stem cell transplants Extended indication Extension of indication for Kymriah, to include treatment of adult patients with follicular lymphoma (FL) after two or more lines of therapy who are refractory, or relapsed during or within 6 months after completion of anti -CD20 antibody maintenance, or relapsed after autologous haematopoietic stem cell transplantation (HSCT) . 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 Unknown Particularity Unknown ATMP Yes Submission date October 2021 Expected Registration September 2022 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks 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 Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks