Extended indication

Extension of indication for Kymriah, to include treatment of adult patients with follicular lymphom

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

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) .

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

September 2022

Orphan drug

Yes

Registration phase

Registration application pending

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.