Daratumumab

Active substance

Daratumumab

Domain

Oncology and Hematology

Reason of inclusion

Indication extension

Main indication

Multiple Myeloma

Extended indication
Multipel myeloom frontline behandeling i.c.m. VRd voor patiënten die niet in aanmerking komen voor een ASCT.

Product

Proprietary name

Darzalex

Manufacturer

Janssen

Mechanism of action

Other, see general comments

Route of administration

Subcutaneous

Therapeutical formulation

Injection

Budgetting framework

Intermural (MSZ)

Additional comments
anti-CD38

Registration

Registration route

Centralised (EMA)

Expected Registration

November 2021

Registration phase

Clinical trials

Additional comments
Fabrikant verwacht registratie in Q4 2021.

Therapeutic value

Therapeutic value

No judgement

Duration of treatment

Not found

Dosage per administration

1800mg

References
fabrikant, NCT03652064
Additional comments
Jaar 1: 20 toedieningen; jaar 2+: 13 toedieningen

Expected patient volume per year

Patient volume

< 70

Market share is generally not included unless otherwise stated.

References
Pakketadvies daratumumab, expert opinie.
Additional comments
Jaarlijks aantal nieuwe multipel myeloma patiënten bedraagt 1.117, waarvan 90% symptomatisch: 1.006. Patiënten die non-fit zijn voor ASCT zijn >70 jaar of <70 met comorbiditeiten, 70% behandeld (352 ptn). 80% van deze groep krijgt Dara-Rd dus max 20% van deze groep krijgt een andere behandeling (< 70 ptn).

Expected cost per patient per year

Cost

94,977.00

References
Fabrikant
Additional comments
Jaar 1: €94.977; jaar 2+: €61.735

Potential total cost per year

Total cost

6,648,390

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.