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Brentuximab vedotin

Adcetris

Extended indication CD30 positieve cutane T-cellymfomen (CTCL) na één eerdere systemische therapie of radiotherapie.
Therapeutic value No judgement
Total cost 1,450,000.00

Product

Active substance Brentuximab vedotin
Domain Oncology and Hematology
Main indication Lymphoma
Extended indication CD30 positieve cutane T-cellymfomen (CTCL) na één eerdere systemische therapie of radiotherapie.
Proprietary name Adcetris
Manufacturer Takeda
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date August 2017
Expected Registration January 2018
Orphan drug No
Additional remarks Dit is een indicatie-uitbreiding. Positieve CHMP-opinie november 2017.

Therapeutic value

Current treatment options Systemische chemotherapie
Therapeutic value No judgement
Frequency of administration 2 times a month
Dosage per administration 1,8 mg/kg
References Fabrikant; Kim et al. Blood 2016 128:182; Prince et al. Lancet. 2017 Aug 5;390(10094):555-566.
Additional remarks Toediningsfrequentie: 12 cycli; 1 maal per 3 weken

Expected patient volume per year

Patient volume

11 - 18

Market share is generally not included unless otherwise stated.
References Fabrikant; Willemze. Ned Tijdschr Hematol 2008;5:3-11; Kantar Health 2015
Additional remarks Fabrikant: Max. patiëntvolume: Van 131 patiënten met CTCL (IKNL, 2016) heeft 45% mycosis fungoides en 10% cutaan anaplastich grootcellig lymfoom (totaal 55%, 72 patiënten). Hiervan ontvangt 35% direct een systemische therapie, en 23% na lokale therapie (42 patiënten). In verdere lijnen ontvangt 47% een tweede behandeling, en 48% hierna een derde systemische behandeling (20 + 9 patiënten). Van deze patiënten is 60% CD30 positief (ALCANZA studie). Van max. naar realistisch patiëntvolume: aangenomen aandeel van 60%.

Expected cost per patient per year

Cost 80,000.00 - 120,000.00
References Medicijnkosten.nl
Additional remarks Per cyclus zijn 2-3 vials nodig (1,8 mg/kg; 50 mg vial). Mediane behandelduur studie: 12 cycli. Prijs €3.300 per vial.

Potential total cost per year

Total cost

1,450,000.00

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.