Extended indication

Extension of indication to include primary treatment of invasive aspergillosis in paediatric patient

Therapeutic value

No estimate possible yet

Total cost

469,527.00

Registration phase

Positive CHMP opinion

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

Registration phase

Positive CHMP opinion

Additional comments
Positieve CHMP opinie ontvangen oktober 2021.

Therapeutic value

Therapeutic value

No estimate possible yet

Dosage per administration

300 mg

References
EMA/124405/2020
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

32 - 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 5-20% 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

469,527.00

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.