Extended indication Adcetris in combination with cyclophosphamide, doxorubicin and prednisone (CHP) is indicated for adu
Therapeutic value No judgement
Total cost 4,863,330.00
Registration phase Registered and reimbursed

Product

Active substance Brentuximab vedotin
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Aggressive non-Hodgkin's lymphoma
Extended indication Adcetris in combination with cyclophosphamide, doxorubicin and prednisone (CHP) is indicated for adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL).
Proprietary name Adcetris
Manufacturer Takeda
Mechanism of action Antibody-drug conjugate
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Centre of expertise HOVON A centra
Additional comments Antibody-drug conjugate (ADC) bestaande uit een anti-CD30-gericht monoklonaal antilichaam verbonden aan het antineoplastische middel monomethyl auristatin E (MMAE).

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date July 2019
Expected Registration May 2020
Orphan drug Yes
Registration phase Registered and reimbursed
Additional comments Positieve-CHMP opinie in maart 2020.

Therapeutic value

Current treatment options Chemotherapie: CHOP (cyclophosphamide, doxorubicine, vincristine en prednison) of CHOEP (cyclophosphamide, doxorubicine, vincristine, etoposide en prednison), eventueel in combinatie met een stamcel transplantatie.
Therapeutic value No judgement
Substantiation In de dubbelblinde, dubbel-dummy ECHELON-2 studie werden 452 patiënten gerandomiseerd tot Adcetris+CHP (cyclophosphamide, doxorubicine en prednison) of CHOP. Progressievrije overleving was significant verlengd in de A+CHP arm (mediaan 48.2 maanden versus 20.8 maanden; HR 0.71 p=0.0110) Ook totale overleving was significant beter in de A+CHP arm (HR 0.66 p=0.0244). Indien er sprake is van mogelijke meerwaarde ten opzichte van de huidige behandelopties dan zal dit middel de eerste keus worden.
Duration of treatment Median 18 week / weeks
Frequency of administration 1 times every 3 weeks
Dosage per administration 1.8 mg / kg
References ECHELON-2 studie: Lancet. 2019 Jan 19;393(10168):229-240.
Additional comments 6 toedieningen.

Expected patient volume per year

Patient volume

90

Market share is generally not included unless otherwise stated.

References Fabrikant op basis van: cijfersoverkanker.nl, Bossard Blood 2014, PALGA en expert-opinie.
Additional comments Circa 200 patiënten per jaar met T-cel lymfoom, geschat gemiddeld 45% CD30+: zo'n 90 patiënten per jaar.

Expected cost per patient per year

Cost 54,037.00
References Z-index, ECHELON-2 trial.
Additional comments Gemiddeld 3 vials van 50mg nodig per toediening x 6 cycli: € 3.002,07 x3x6 Cycli = € 54.037,26 (exclusief btw) (op basis van Nieuwe WGP limiet vanaf oktober 2020).

Potential total cost per year

Total cost

4,863,330.00

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

Off label use No
References fabrikant

Indication extension

Indication extension No
References Fabrikant.

Other information

There is currently no futher information available.