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Cytarabine / daunorubicin (liposomaal)

Vyxeos

Extended indication Vyxeos is indicated for the treatment of adults with newly diagnosed, therapy-related acute myeloid
Therapeutic value Possible added value
Total cost 11,760,000.00
Registration phase Registered and reimbursed

Product

Active substance Cytarabine / daunorubicin (liposomaal)
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication AML / MDS
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 Combination therapy
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Accelerated assessment
Submission date December 2017
Expected Registration August 2018
Orphan drug Yes
Registration phase Registered and reimbursed
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
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

< 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

Cost 80,000.00
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

Total cost

11,760,000.00

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 No
References SPS

Other information

There is currently no futher information available.