Brentuximab vedotin

Active substance
Brentuximab vedotin
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
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).

1. Product

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).

2. Registration

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

3. 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

4. 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.

5. Expected cost per patient per year

Cost
55,803
References
Z-index, ECHELON-2 trial
Additional comments
Gemiddeld 3 vials van 50mg nodig per toediening x 6 cycli: € 3.100,19x3x6 Cycli = € 55.803,42 (exclusief BTW) (op basis van Nieuwe WGP limiet vanaf oktober 2020).

6. Potential total cost per year

Total cost

5,022,270

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.

7. Off label use

Off label use
No
References
fabrikant

8. Indication extension

Indication extension
No
References
fabrikant

9. Other information

There is currently no futher information available.