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Posoleucel

Extended indication Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant.
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Posoleucel
Domain Infectious diseases
Reason of inclusion New medicine (specialité)
Main indication Viral infections other
Extended indication Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant.
Manufacturer AlloVir
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
ATMP Yes
Submission date 2023
Expected Registration 2024
Orphan drug Yes
Registration phase Clinical trials
Additional remarks Estimated primary completion datum fase 3 studie in augustus 2022.

Therapeutic value

Current treatment options letermovir
Therapeutic value No estimate possible yet
Substantiation beperkte meerwaarde verwacht
Dosage per administration 2-4 milliliter.
References NCT04693637

Expected patient volume per year

Patient volume

5 - 10

Market share is generally not included unless otherwise stated.
References Expert opinie(1);
Additional remarks Jaarlijks worden in Nederland circa 600 allogene stamceltransplantaties uitgevoerd. Echter, gezien de beperkte meerwaarde zal slechts een klein deel hiervan in aanmerking komen. Er wordt verwacht dat er ongeveer 5 tot 10 patiënten per jaar behandeld zullen worden (1).

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

Indication extension Yes
Indication extensions Mogelijk in de toekomst ingezet bij niertransplantaties

Other information

There is currently no futher information available.