Posaconazol

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.
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 remarks	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 remarks	Positieve CHMP opinie ontvangen oktober 2021.

Therapeutic value

Therapeutic value	No estimate possible yet
Dosage per administration	300 mg
References	EMA/124405/2020
Additional remarks	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 remarks	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.

Patient volume

32 - 127

Market share is generally not included unless otherwise stated.

References

Gipdatabank 2020.

Additional remarks

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 remarks	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.

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.