Extended indication Extension of indication for Kymriah, to include adult patients with relapsed or refractory follicula
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
Main indication Stem cell transplants
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.
Proprietary name Kymriah
Manufacturer Novartis
Mechanism of action CAR-T therapy
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional comments 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)
ATMP Yes
Submission date October 2021
Expected Registration May 2022
Orphan drug Yes
Registration phase Registered
Additional comments Positieve CHMP-opinie ontvangen in maart 2022. Kymriah is breed uitgesloten van vergoeding en stroomt derhalve automatische de sluis in.

Therapeutic value

Therapeutic value No estimate possible yet

Expected patient volume per year

Patient volume

< 350

Market share is generally not included unless otherwise stated.

References Budget impact analyse van ibrutinib (Imbruvica) bij de behandeling van chronische lymfatische leukemie (patiënten zonder 17p of TP53 mutaties).
Additional comments 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
References G-Standaard
Additional comments Eenmalige toediening

Potential total cost per year

Total cost

112,000,000.00

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.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.