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 Positive CHMP opinion

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 July 2021
Orphan drug Yes
Registration phase Positive CHMP opinion
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 (Dara IV) of 1.800mg subcutaan (Dara SC) met wekelijkse intervallen (QW) gedurende 8 weken, daarna elke 2 weken (Q2W) gedurende nog eens 16 weken, daarna daarna om de 4 weken (Q4W). 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.