Decitabine / cedazuridine Medicine 04 December 2025 Extended indication Inaqovi in combination with venetoclax is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy Therapeutic value Total cost € 8,092,500.00 Registration phase Positive CHMP opinion Product Active substance Decitabine / cedazuridine Domain Hematology Reason of inclusion Indication extension IND Main indication AML / MDS Extended indication Inaqovi in combination with venetoclax is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy Current proprietary name Already available biosimilars / generics Proprietary name Inaqovi Manufacturer Otsuka Portfolio holder Otsuka Mechanism of action Other, see general comments Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date November 2025 Expected Registration June 2026 Orphan drug No Registration phase Positive CHMP opinion Reimbursement Medicine sluice Rejected Additional remarks Positieve CHMP-opinie in april 2026. Therapeutic value Current treatment options Therapeutic value Substantiation Duration of treatment Median 15 month / months Frequency of administration 5 times a month Dosage per administration References NCT04657081 (ASTX727-07) Additional remarks Expected patient volume per year Patient volume 415 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice 0 References (1) NKR 2024; (2) Heuser, M., Fernandez, C., Hauch, O., Klibanov, O. M., Chaudhary, T., & Rives, V. (2023). Therapies for acute myeloid leukemia in patients ineligible for standard induction chemotherapy: a systematic review. Future Oncology, 19(11), 789–810. Additional remarks De incidentie van patiënten met nieuw gediagnosticeerde acute myeloïde leukemie (AML) was 829 (1). Ongeveer de helft (50%) van de patiënten komt niet in aanmerking voor standaard inductietherapie (2). Dat komt uit op een patiëntvolume van 829 x 50% = 415. Aangezien dit een indicatieuitbreiding betreft met toevoeging van venetoclax aan het bestaand label, wordt er geen additioneel patiëntvolume verwacht voor de sluis. Expected cost per patient per year Cost € 19,000.00 - 20,000.00 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. References medicijnkosten.nl; Ascertain studie Additional remarks De prijs per 100mg tablet is €763,57 (exclusief BTW). Een 28-daagse cyclus bestaat uit een dagelijkse tablet op dag één t/m vijf. Met een gemiddelde behandelduur van 5 cycli komen de behandelkosten per patiënt per jaar uit op €19.089,22. Potential total cost per year Total cost € 8,092,500.00 Total cost for sluice € 0.00 Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks