Extended indication

Smouldering multipel myeloom.

Therapeutic value

No estimate possible yet

Total cost

13,375,943.00

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

May 2022

Expected Registration

March 2023

Orphan drug

Yes

Registration phase

Clinical trials

Additional comments
Fabrikant verwacht registratie in het maart 2023

Therapeutic value

Therapeutic value

No estimate possible yet

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

< 133

Market share is generally not included unless otherwise stated.

References
NKR, Pakketadvies daratumumab.
Additional comments
Jaarlijks aantal nieuwe multipel myeloma patiënten bedraagt 1.333 (NKR 2018), waarvan 10% asymptomatisch: 133.

Expected cost per patient per year

Cost

< 100,571.00

References
Fabrikant, G-standaard
Additional comments
Jaar 1: €100.571; Jaar 2 en 3: €56.845. Op basis van de lijstprijs.

Potential total cost per year

Total cost

13,375,943.00

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

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.