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

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 2023

Expected Registration

March 2024

Orphan drug

Yes

Registration phase

Clinical trials

Additional remarks
Fabrikant verwacht registratie in het maart 2024. Dit geneesmiddel is niet meer breed uitgesloten: https://zoek.officielebekendmakingen.nl/stcrt-2022-29010.html.

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 2018(1); Pakketadvies daratumumab (2);
Additional remarks
Jaarlijks aantal nieuwe multipel myeloom patiënten bedraagt 1.333 (1). Hiervan is 10% asymptomatisch (2). Dit betekent dat er maximaal 133 patiënten in aanmerking zullen komen voor deze behandeling.

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.