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).

1. 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

2. 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.

3. 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

4. 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.

5. 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.

6. 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.

7. Off label use

Off label use
No

8. Indication extension

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

9. Other information

There is currently no futher information available.