Expand all sections

Decitabine / cedazuridine

Inaqovi

Extended indication Inaqovi is indicated as monotherapy for the treatment of adult patients with newly diagnosed acute m
Therapeutic value Possible benefit in ease of use
Total cost 13,230,000.00
Registration phase Registered and reimbursed

Product

Active substance Decitabine / cedazuridine
Domain Hematology
Reason of inclusion New medicine (specialité)
Main indication AML / MDS
Extended indication Inaqovi is indicated as monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy
Proprietary name Inaqovi
Manufacturer Otsuka
Portfolio holder Otsuka
Route of administration Oral
Budgetting framework Intermural (MSZ)
Additional remarks First oral formulation of a Hypomethylating Agent (HMA)

Registration

Registration route Centralised (EMA)
Particularity New therapeutical formulation
ATMP No
Submission date July 2022
Expected Registration September 2023
Orphan drug Yes
Registration phase Registered and reimbursed
Additional remarks EMA Orphan Drug Designation ontvangen in december 2021. Positieve CHMP- opinie juli 2023. Received marketing authorization in September 2023.

Therapeutic value

Current treatment options Waakzaam wachten; Behandelingen met Epo, transfusies, groeifactoren en/of antibiotica; Behandeling met hypomethylerende geneesmiddelen: azacitidine en decitabine; Milde chemotherapie; Intensieve chemotherapie, al dan niet gevolgd door een allogene stamceltransplantatie ; Doelgerichte therapie.
Therapeutic value Possible benefit in ease of use
Substantiation Naar verwachting zal met name concurrentie met azacitidine plaatsvinden. De positie in de richtlijn is nog niet bekend. Echter, is dit nieuwe product oraal en zal er dus wel een mogelijk voordeel in toedieningsgemak zijn. Ook is een fijne bijkomstigheid dat decitabine over het algemeen minder leidt tot misselijkheid.
Duration of treatment Median 8.2 month / months
Frequency of administration 1 times a day
Dosage per administration oral decitabine (35mg) and cedazuridine (100mg) fixed-dose combination tablet
References NCT02103478 NCT03306264
Additional remarks NCT03306264: Multicenter, randomized, open-label, crossover PK study of ASTX727 versus IV decitabine. Adult subjects who are candidates to receive IV decitabine will be randomized 1:1 to receive the ASTX727 tablet Daily×5 in Cycle 1 followed by IV decitabine 20mg/m^2 Daily×5 in Cycle 2, or the converse order. After completion of PK studies during the first 2 treatment cycles, subjects will continue to receive treatment with ASTX727 from Cycle 3 onward (in 28-day cycles) until disease progression, unacceptable toxicity, or the subject discontinues treatment or withdraws from the study.

Expected patient volume per year

Patient volume

< 378

Market share is generally not included unless otherwise stated.
References NKR
Additional remarks 774 diagnoses AML in 2017. Bij ongeveer de helft van het aantal patiënten komt AML terug (378).

Expected cost per patient per year

Cost < 35,000.00
References drugs.com; FDA prescribing information INQOVI; fabrikant
Additional remarks In de Verenigde Staten kost Inqovi rond de $8.060 voor 5 tabletten (€7.865). Dit is de dosering voor een cyclus van 28 dagen. Bij een gemiddelde behandeling van 9 cycli (gebaseerd op een mediane behandelduur van 8,2 maanden) komt dit neer op €70.785. De fabrikant geeft aan dat de behandeling maximaal €35.000 zal bedragen per patiënt per jaar in Nederland.

Potential total cost per year

Total cost

13,230,000.00

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

There is currently nothing known about indication extensions.

Other information

Additional remarks Currently in development: ASTX-727 in combination with venetoclax for the same indication as ASTX-727 monotherapy (AML). Anticipated submission to EMA in 2024