Extended indication Extension of indication to include treatment of invasive aspergillosis in adults
Therapeutic value No judgement
Registration phase Registration application pending

Product

Active substance Posaconazol
Domain Infectious diseases
Reason of inclusion Indication extension
Main indication Infectious diseases other
Extended indication Extension of indication to include treatment of invasive aspergillosis in adults
Proprietary name Noxafil
Manufacturer MSD
Mechanism of action Antifungals
Budgetting framework Extramural (GVS)
Additional remarks Deze indicatie-uitbreiding is voor voorzowel de orale als intravenueze variant.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date December 2020
Expected Registration October 2021
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value No judgement
Dosage per administration 300 mg
References NCT01782131
Additional remarks POS IV: Day 1: 300 mg BID Day 2-84: 300 mg QD POS oral: Day 1: 300 mg BID Day 2-84: 300 mg QD

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

References Rafael Cámara. Cost-Effectiveness of Posaconazole Tablets for Invasive Fungal Infections Prevention in Acute Myelogenous Leukemia or Myelodysplastic Syndrome Patients in Spain. Adv Ther. 2017.
Additional remarks In de kosteneffectiviteitsstudie werd een gemiddelde kostenbeslag per patiënt van € 5.906,06 per 100 dagen gevonden.

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.