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 comments Fabrikant verwacht registratie in het maart 2024. Dit geneesmiddel is breed uitgesloten, wat betekent dat toekomstige indicaties automatisch in de sluis stromen.

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 2018(1); Pakketadvies daratumumab (2);
Additional comments 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 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.