ARI-0001

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.

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.

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.

Daratumumab