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Daratumumab

Darzalex

Extended indication

In combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple

Therapeutic value

No estimate possible yet
Total cost

€ 47,771,225.00
Registration phase

Registered

Product

Active substance

Daratumumab
Domain

Oncology and Hematology
Reason of inclusion

Indication extension
Main indication

Multiple Myeloma
Extended indication

In combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide-refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy.
Proprietary name

Darzalex
Manufacturer

Janssen
Mechanism of action

Immunostimulation
Route of administration

Subcutaneous
Therapeutical formulation

Injection
Budgetting framework

Intermural (MSZ)
Additional comments 
Antilichaam tegen CD38.

Registration

Registration route

Centralised (EMA)
Submission date

November 2020
Expected Registration

June 2021
Orphan drug

Yes
Registration phase

Registered
Additional comments 
Positieve CHMP-opinie in mei 2021.

Therapeutic value

Current treatment options

Kd, DVd, Pano-Vd, EVd, KRd, ERd, DRd, daratumumab, PomDex.
Therapeutic value

No estimate possible yet
Substantiation

De data van de gerandomiseerde fase 3 Apollo trial is nog niet beschikbaar. In deze studie wordt Dara-Pom-Dex met Pom-Dex vergeleken. De plaatsbepaling in de richtlijn is hiervan afhankelijk.
Dosage per administration

16 mg/kg
References 
NCT03180736.
Additional comments 
Daratumumab in een dosis van 16mg/kg toegediend als een intraveneuze-infusie of 1.800mg subcutaan met wekelijkse intervallen gedurende 8 weken, daarna elke 2 weken gedurende nog eens 16 weken, daarna daarna om de 4 weken. Pomalidomide 4mg oraal (PO) op dag 1 tot en met 21 van elke 28-daagse cyclus Dexamethason 40mg (20mg voor patiënten ≥75 jaar) oraal, eenmaal daags op dag 1, 8, 15 en 22 van elke 28- dag behandelingscyclus. Jaar 1: 23 toedieningen; jaar 2+: 13 toedieningen.

Expected patient volume per year

Patient volume

300 - 650

Market share is generally not included unless otherwise stated.
References 
NKR. Pakketadvies daratumumab (Darzalex®) bij multipel myeloom (ziekte van Kahler), ZIN 2017.
Additional comments 
In het pakketadvies voor daratumumab wordt het aantal patiënten in de tweede lijn ingeschat op 651 waarvan er 293 patiënten behandeld zullen worden met daratumumab.

Expected cost per patient per year

Cost

< € 100,571.00
References 
G-standaard; fabrikant.
Additional comments 
Jaar 1: 23 toedieningen x €4.372,66 = €100.571,20
Jaar 2+: 13 toedieningen x €4.372,66=€56.844,48

Potential total cost per year

Total cost

€ 47,771,225.00

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

Indication extension

Yes
Indication extensions

In fase 3 klinische studies: Relapsed Refractory MM 1+ prior lines w/PomDex; Relapsed Refractory multiple myeloma w/carfilzomib/dex; Amyloidosis; Smoldering multiple myeloma; Frontline multiple myeloma transplant ineligible in combination w/ bortezomib, lenalidomide and dexamethasone; Frontline multiple myeloma transplant eligible in combination w/ bortezomib, lenalidomide and dexamethasone.

Other information

There is currently no futher information available.