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Axicabtagene ciloleucel

Yescarta

Extended indication Non-hodgkin lymfoom
Therapeutic value No judgement
Total cost 309,300,000.00

Product

Active substance Axicabtagene ciloleucel
Domain Oncology and Hematology
Main indication Lymphoma
Extended indication Non-hodgkin lymfoom
Proprietary name Yescarta
Manufacturer Gilead
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Geregistreerd bij de FDA in oktober 2017.

Registration

Registration route Centralised (EMA)
Type of trajectory Accelerated assessment
Submission date September 2017
Expected Registration May 2018
Orphan drug Yes

Therapeutic value

Therapeutic value No judgement
Additional remarks Eenmalige infusie

Expected patient volume per year

Patient volume

< 1,031

Market share is generally not included unless otherwise stated.
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
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

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.