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

Registered

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

June 2021

Orphan drug

Yes

Registration phase

Registered

Additional comments
Positieve CHMP-opinie in mei 2021. Dit geneesmiddel is breed uitgesloten, wat betekent dat toekomstige indicaties automatisch in de sluis stromen.

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.