Posaconazol Medicine 08 December 2020 Extended indication Extension of indication to include primary treatment of invasive aspergillosis in adults and adolescents from 13 years of age for Noxafil gastroresistant tablet and concentrate for solution for infusion. Therapeutic value Possible added value Total cost € 118,120.00 Registration phase Registered and reimbursed 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 adults and adolescents from 13 years of age for Noxafil gastroresistant tablet and concentrate for solution for infusion. 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 zowel de orale als intraveneuze variant. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date December 2020 Expected Registration October 2021 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie (september 2021). Therapeutic value Current treatment options Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Deze indicatie-uitbreiding is voor zowel de orale als intraveneuze variant. Tabletten zullen met name interessant zijn voor deze groep. Het is een relatief veilig product en kan ingezet worden als profylaxe en salvage therapie. Duration of treatment Frequency of administration Dosage per administration 300 mg References NCT01782131 Additional remarks 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 < 20 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NTVG; Additional remarks De toepassing van immunosuppressieve therapieën in de laatste 30 jaar heeft geleid tot een stijging van de incidentie van opportunistische infecties met Aspergillus. Na candidose is invasieve aspergillose de frequentst voorkomende gegeneraliseerde schimmelinfectie bij patiënten met een gestoorde weerstand. Er wordt verwacht dat er jaarlijks mogelijk 20 kinderen in aanmerking zullen komen voor dit geneesmiddel. 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 € 118,120.00 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