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Glasdegib

Daurismo

Extended indication Treatment of acute myeloid leukaemia (AML) in adult patients who are not candidates for standard ind
Therapeutic value No judgement
Total cost 45,675,000.00
Registration phase Registration application pending

Product

Active substance Glasdegib
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication AML / MDS
Extended indication Treatment of acute myeloid leukaemia (AML) in adult patients who are not candidates for standard induction chemotherapy.
Proprietary name Daurismo
Manufacturer Pfizer
Mechanism of action Other
Route of administration Oral
Therapeutical formulation Film-coated tablet
Budgetting framework Intermural (MSZ)
Additional remarks Glasdegib inhibits of the Hedgehog (Hh) signal transduction pathway via targeting Smoothened (SMO), a transmembrane receptor. Glasdegib inhibits SMO activitation and blocks Hedgehog signaling.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date May 2019
Expected Registration August 2020
Orphan drug Yes
Registration phase Registration application pending
Additional remarks Registratie wordt verwacht in Q3 2020.

Therapeutic value

Current treatment options Lage dosering cytarabine.
Therapeutic value No judgement
Frequency of administration 1 times a day
Dosage per administration 100 mg
References NCT03416179

Expected patient volume per year

Patient volume

< 261

Market share is generally not included unless otherwise stated.
References NKR
Additional remarks De incidentie van AML bij personen van 75 jaar en ouder bedroeg 261 patiënten. Het aantal is afhankelijk van uiteindelijke indicatie. Een groot gedeelte van de patienten wordt in HOVON studies behandeld.

Expected cost per patient per year

Cost < 175,000.00
References FDA approves new blood cancer treatment from Pfizer, Reuters, November 21, 2018
Additional remarks In de VS is de lijstprijs gesteld op $16.925 per maand. De behandelduur is nog niet bekend maar voor een behandeling van een jaar zou dit neerkomen op $203.100 (ongeveer €175.000). De prijsstelling in de EU zal niet voor Q3 2020 beschikbaar zijn.

Potential total cost per year

Total cost

45,675,000.00

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

There is currently no futher information available.