Extended indication Extension of indication to include primary treatment of invasive aspergillosis in paediatric patient
Therapeutic value Possible equal value
Total cost 750,062.00
Registration phase Registered and reimbursed

Product

Active substance Posaconazol
Domain Infectious diseases
Reason of inclusion Indication extension
Main indication Fungal infections
Extended indication Extension of indication to include primary treatment of invasive aspergillosis in paediatric patients from 2 years of age weighing more than 40kg and adults for Noxafil gastroresistant tablet and concentrate for solution for infusion. Noxafil gastro-resistant tablets and solution are indicated for use in the treatment of the following fungal infections: Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products.
Proprietary name Noxafil
Manufacturer MSD
Mechanism of action Antifungals
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Extramural (GVS)
Additional comments Deze indicatie-uitbreiding is voor voor zowel de orale als intraveneuze variant.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date 2021
Expected Registration January 2022
Orphan drug No
Registration phase Registered and reimbursed
Additional comments Positieve CHMP opinie ontvangen oktober 2021.

Therapeutic value

Current treatment options Voriconazol en isoconazol.
Therapeutic value Possible equal value
Substantiation In eerdere studies bij volwassenen is aangetoond dat posaconazol non inferieur is ten opzichte van voriconazol. De verwachting is dat posaconazol ook voor deze patiëntpopulatie effectief zal zijn.
Dosage per administration 300 mg
References JA Maertens et al. The Lancet. 2021.; EMA/124405/2020; NCT04218851
Additional comments Waiver. POS IV: Day 1: 300mg BID Day 2-84: 300mg QD POS oral: Day 1: 300mg BID Day 2-84: 300mg QD

Expected patient volume per year

Patient volume

127

Market share is generally not included unless otherwise stated.

References Gipdatabank 2020.
Additional comments Er wordt door deze uitbreiding een toename van zo’n 20% in volume verwacht. In 2020 waren er 637 gebruikers van Posaconazol. Dit betekent dat er waarschijnlijk zo'n 32-127 patiënten in aanmerking zullen komen.

Expected cost per patient per year

Cost 5,906.00
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.; Farmacotherapeutisch kompas;
Additional comments In de kosteneffectiviteitsstudie werd een gemiddelde kostenbeslag per patiënt van €5.906,06 per 100 dagen gevonden. Noxafil, maagsapresistente tablet 100mg 0,3g per dag €93,48. Noxafil, suspensie voor oraal gebruik 40mg/ml 0,3g per dag €49,14.

Potential total cost per year

Total cost

750,062.00

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.