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Decitabine / cedazuridine

Inaqovi

Extended indication Extension of indication to include treatment of adult patients with myelodysplastic syndromes (MDS)
Therapeutic value Possibly no place in the treatment regimen
Registration phase No registration expected

Product

Active substance Decitabine / cedazuridine
Domain Hematology
Reason of inclusion Indication extension
Main indication AML / MDS
Extended indication Extension of indication to include treatment of adult patients with myelodysplastic syndromes (MDS) and treatment of adult patients with chronic myelomonocytic leukaemia (CMML).
Proprietary name Inaqovi
Manufacturer Otsuka
Route of administration Oral
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Orphan drug Yes
Registration phase No registration expected

Therapeutic value

Therapeutic value Possibly no place in the treatment regimen
References Expertopinie
Additional remarks Decitibine is niet geregistreerd voor deze indicatie (intraveneus). Een vergelijkende studie ontbreekt.

Expected patient volume per year

Patient volume

< 0

Market share is generally not included unless otherwise stated.
References NKR2021; Hematon; expertopinie
Additional remarks De incidentie van MDS bedraagt ongeveer 800 patiënten in Nederland. In Nederland krijgen elk jaar ongeveer 100 mensen CMML. De werkgroep schat in dat het middel niet wordt ingezet en er geen patiënten met decitabine/cedazuridine worden behandeld.

Expected cost per patient per year

There is currently nothing known about the expected cost.

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.