Posaconazol Medicine 07 December 2021 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 € 472,480.00 Registration phase Positive CHMP opinion Product Active substance Posaconazol Domain Infectious diseases Reason of inclusion Indication extension IND 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. Current proprietary name Already available biosimilars / generics Proprietary name Noxafil Manufacturer MSD Portfolio holder Mechanism of action Antifungals Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Deze indicatie-uitbreiding is voor voor zowel de orale als intraveneuze variant. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date 2021 Expected Registration January 2022 Orphan drug Unknown Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Positieve CHMP opinie ontvangen oktober 2021. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 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. Maximum patient volume for sluice 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 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. 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 € 472,480.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks