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Daratumumab

Darzalex

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 remarks 
Fabrikant verwacht registratie in het maart 2023

Therapeutic value

Therapeutic value

No estimate possible yet
Dosage per administration

1800mg
References 
NCT03301220.
Additional remarks 
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 remarks 
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 remarks 
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.