Venetoclax

Extended indication	Extension of the indication to include treatment with Venclyxto in combination with an anti‐CD20 antibody (obinutuzumab) for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
Therapeutic value	No judgement
Total cost	45,300,000.00
Registration phase	Registration application pending

Product

Active substance	Venetoclax
Domain	Oncology and Hematology
Reason of inclusion	Indication extension
Main indication	CLL
Extended indication	Extension of the indication to include treatment with Venclyxto in combination with an anti‐CD20 antibody (obinutuzumab) for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
Proprietary name	Venclyxto
Manufacturer	Abbvie
Mechanism of action	Bcl-2 inhibitor
Route of administration	Oral
Therapeutical formulation	Tablet
Budgetting framework	Intermural (MSZ)
Additional remarks	Bcl-2 remmer

Registration

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
Submission date	July 2019
Expected Registration	May 2020
Orphan drug	No
Registration phase	Registration application pending
Additional remarks	Venetoclax is in de sluis geplaatst.

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 remarks	Geschat wordt dat er jaarlijks zo'n 600 patiënten in de 1e lijn behandeld worden. Deze patiënten komen dan in aanmerking voor venetoclax (maximum).

Patient volume

< 600

Market share is generally not included unless otherwise stated.

Additional remarks

Geschat wordt dat er jaarlijks zo'n 600 patiënten in de 1e lijn behandeld worden. Deze patiënten komen dan in aanmerking voor venetoclax (maximum).

Expected cost per patient per year

Cost	73,000.00 - 78,000.00
References	Medicijnkosten.nl; SmPC venetoclax
Additional remarks	Op basis van SmPC en AIP zijn de kosten €73.000,00-€78.000,00 per jaar. Venetoclax is in de sluis geplaatst om te komen tot een financieel arrangement.

Potential total cost per year

Total cost	45,300,000.00 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.

Total cost

45,300,000.00

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

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.