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

Other infectious diseases

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 comments
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 comments
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 comments
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.