Extended indication

Smouldering multipel myeloom.

Therapeutic value

No judgement

Total cost

9,488,224.50

Registration phase

Clinical trials

Product

Active substance

Daratumumab

Domain

Oncology and Hematology

Reason of inclusion

Indication extension

Main indication

Multiple Myeloma

Extended indication

Smouldering multipel myeloom.

Proprietary name

Darzalex

Manufacturer

Janssen

Mechanism of action

Other, see general comments

Route of administration

Subcutaneous

Therapeutical formulation

Injection

Budgetting framework

Intermural (MSZ)

Registration

Registration route

Centralised (EMA)

Submission date

2021

Expected Registration

April 2022

Registration phase

Clinical trials

Additional comments
Fabrikant verwacht registratie in het tweede kwartaal van 2022.

Therapeutic value

Therapeutic value

No judgement

Dosage per administration

1800mg

References
NCT03301220.
Additional comments
Jaar 1: 23 toedieningen; jaar 2 en 3: 13 toedieningen. Maximale behandelduur van 36 maanden.

Expected patient volume per year

Patient volume

< 111

Market share is generally not included unless otherwise stated.

References
Pakketadvies daratumumab.
Additional comments
Jaarlijks aantal nieuwe multipel myeloma patiënten bedraagt 1.117, waarvan 10% asymptomatisch: 111.

Expected cost per patient per year

Cost

61,735.00 - 109,224.00

References
Fabrikant.
Additional comments
Jaar 1: €109.224; Jaar 2 & 3: €61.735. Op basis van de lijstprijs.

Potential total cost per year

Total cost

9,488,224.50

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

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.