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)
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
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

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Cost > 79,352.00
References SmPC Vyxeos; Medicijnkosten.nl
Additional comments 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

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.