Version 1

Cytarabine / daunorubicin (liposomaal)

Medicine

Extended indication Extension of indication to add treatment of relapsed/refractory AML in paediatric patients
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Cytarabine / daunorubicin (liposomaal)
Domain Hematology
Reason of inclusion New medicine (specialité)
Main indication AML / MDS
Extended indication Extension of indication to add treatment of relapsed/refractory AML in paediatric patients
Proprietary name Vyxeos
Manufacturer Jazz
Mechanism of action Combination therapy
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Unknown
Particularity Unknown
ATMP Unknown
Submission date December 2021
Expected Registration October 2022
Orphan drug Yes
Registration phase Registration application pending

Therapeutic value

Current treatment options EMA: Treatment for AML is complex and depends on a number of factors including the extent of the disease, whether it has been treated before, and the patient’s age, symptoms and general state of health. At the time of designation, the main treatments for AML were chemotherapy (medicines to treat cancer) and haematopoietic (blood) stem-cell transplantation (a complex procedure where the patient receives stem cells from a matched donor to help restore the bone marrow).
Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.
Substantiation EMA geeft aan dat er mogelijke meerwaarde is. Expertopinie: mogelijkheid tot hoger doseren met minder toxiciteit.
Duration of treatment Average 11 day / days
Frequency of administration 1 times every 2 days
Dosage per administration 100 /44 mg/m2
References SmPC Vyxeos

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.

Expected cost per patient per year

Cost € > 79,352.00

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.
References SmPC Vyxeos; Medicijnkosten.nl
Additional remarks Op basis van de SmPC worden er 14 flacons verwacht per behandeling. Per stuk kosten deze flacons €5.668. In totaal komt dit dus neer op €79.352.

Potential total cost per year

Off label use

Off label use Unknown

Indication extension

Indication extensions Unknown

Other information