Extended indication Darzalex is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the tre
Therapeutic value No estimate possible yet
Total cost 16,091,360.00
Registration phase Positive CHMP opinion

Product

Active substance Daratumumab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Multiple Myeloma
Extended indication Darzalex is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (AL) amyloidosis.
Proprietary name Darzalex
Manufacturer Janssen
Mechanism of action Immunostimulation
Route of administration Subcutaneous
Therapeutical formulation Solution for cutaneous use
Budgetting framework Intermural (MSZ)
Additional comments Antilichaam tegen CD38.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity New therapeutical formulation
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 Bortezomib-cyclofosfamide-dexamethason of lenalidomide-dexamethason.
Therapeutic value No estimate possible yet
Dosage per administration 16mg/kg
References NCT03201965.
Additional comments Daratumumab zal wekelijks worden toegediend in de eerst 8 weken (2 cycli), daarna iedere 2 weken voor 4 cycli (cyclus 3-6) en daarna iedere 4 weken tot progressie of een maximum van 2 jaar. Jaar 1: 23 toedieningen; jaar 2: 13 toedieningen. Maximale behandelduur van 2 jaar.

Expected patient volume per year

Patient volume

< 160

Market share is generally not included unless otherwise stated.

References De behandeling van AL-amyloïdose in Nederland anno 2013, HOVON;
Additional comments De incidentie wordt geschat op 8,9 per miljoen persoonsjaren; dat betekent dat er in Nederland 160 nieuwe patiënten per jaar zijn.

Expected cost per patient per year

Cost < 100,571.00
References Fabrikant, G-standaard
Additional comments Jaar 1: €100.571; Jaar 2: €56.845. Op basis van lijstprijs. Maximale behandelduur van 2 jaar.

Potential total cost per year

Total cost

16,091,360.00

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; Subcutaneous Formulation in patients with relapsed or refractory multiple myeloma; 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.
References Pipeline Janssen.

Other information

There is currently no futher information available.