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).

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).

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.

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

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).

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.

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.