Venetoclax

Active substance Venetoclax
Domain Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen Indication extension
Main indication CLL
Extended indication Venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).

Product

Proprietary name Venclyxto
Manufacturer Abbvie
Mechanism of action Bcl-2 inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional comments Bcl-2 remmer

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date July 2019
Expected Registration March 2020
Orphan drug No
Registration phase Registered
Additional comments Positieve CHMP-opinie in januari 2020. Venetoclax zit in de sluis.

Therapeutic value

Current treatment options Chloorambucil+anti-CD20 (bv obinutuzumab) of ibrutinib.
Therapeutic value No judgement
Duration of treatment Average 10.5 month / months
References Fabrikant

Expected patient volume per year

Patient volume

< 600

Market share is generally not included unless otherwise stated.

Additional comments Geschat wordt dat er jaarlijks zo'n 600 patiënten in de eerste lijn behandeld worden. Naar verwachting wordt dit niet de voorkeursbehandeling. Het patiëntvolume zal waarschijnlijk lager liggen dan 600 patiënten.

Expected cost per patient per year

Cost 73,000 - 78,000
References G-standaard, Z-index mei 2020
Additional comments AIP van €51,77 per tablet van 100 mg. Op basis van SmPC en AIP zijn de kosten €73.000-€78.000 per jaar. Venetoclax is in de sluis geplaatst om te komen tot een financieel arrangement.

Potential total cost per year

Total cost

45,300,000

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

Indication extension

Indication extension Yes
Indication extensions Mantle-cell lymphoma; Multiple myeloma (lopende fase III studies)
References AdisInsight

Other information

There is currently no futher information available.