Version 3

Cytarabine / daunorubicin (liposomaal)

Medicine

Extended indication Vyxeos is indicated for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-relat
Therapeutic value Possible added value
Registration phase Registered

Product

Active substance Cytarabine / daunorubicin (liposomaal)
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Leukemia
Extended indication Vyxeos is indicated for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).
Proprietary name Vyxeos
Manufacturer Jazz
Mechanism of action Unknown
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Accelerated assessment
Particularity Unknown
ATMP Unknown
Submission date December 2017
Expected Registration August 2018
Orphan drug Yes
Registration phase Registered
Additional remarks Positieve CHMP-opinie in juli 2018. Geregistreerd in augustus 2018.

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 Possible added value

This assessment does not indicate any potential inclusion in the package.
Substantiation EMA gaaft aan dat er mogelijke meerwaarde is. Expertopinie: mogelijkheid tot hoger doseren met minder toxiciteit.

Expected patient volume per year

Patient volume < 147

Market share is generally not included unless otherwise stated.
References NKR 2015
Additional remarks 110 diagnoses AML met myelodysplasie-gerelateerde veranderingen; 37 diagnoses AML na eerdere cytotoxische chemo- en/of radiotherapie.

Expected cost per patient per year

Additional remarks Hoge kosten verwacht afgaande op de bronnen in Amerika: https://www.blinkhealth.com/vyxeos, http://www.bioworld.com/content/fda-approves-jazz-pharma%E2%80%99s-vyxeos-two-types-high-risk-aml-0.

Potential total cost per year

Off label use

Off label use Unknown

Indication extension

Indication extensions No
References SPS

Other information