Mepolizumab Medicine 09 January 2018 Extended indication Eosinofile granulomatueze poly angiitis (EGPA) (voorheen Churg Strauss syndroom). Therapeutic value No judgement Total cost € 3,300,000.00 Registration phase Clinical trials Product Active substance Mepolizumab Domain Lung diseases Reason of inclusion Indication extension IND Main indication Lung other Extended indication Eosinofile granulomatueze poly angiitis (EGPA) (voorheen Churg Strauss syndroom). Current proprietary name Already available biosimilars / generics Proprietary name Nucala Manufacturer GSK Portfolio holder Mechanism of action Unknown Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Al geregistreerd voor astma. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration 2019 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Goedgekeurd door de FDA in december 2017 Therapeutic value Current treatment options Corticosteroiden, cyclofosfamide, azathioprine Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Wordt off-label al voorgeschreven. Duration of treatment Frequency of administration 1 times a month Dosage per administration 300 mg References Wechsler et al. N Engl J Med. 2017 May 18;376(20):1921-1932 Additional remarks Expected patient volume per year Patient volume 50 - 100 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Fabrikant; Martin et al, Drug Saf 1999;8(3):179-89; Cottin, et al. Eur Respir J 2016; 48: 1429–41 Additional remarks De prevalentie van EGPA is geschat op 6,8 per miljoen inwoners. Nucala wordt onderzocht in relapsing/refractory EGPA wat ongeveer de helft van de patiënten betreft, daarom zou op basis van bovenstaande een realistisch patiëntvolume enkele tientallen (rond de 50) zijn en het maximale patiëntvolume ongeveer 100 patiënten. Expected cost per patient per year Cost € 44,000.00 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 G-standaard Additional remarks 39 flacons van 100 mg kosten €43.906,59 Potential total cost per year Total cost € 3,300,000.00 Total cost for sluice Additional remarks Off label use Off label use Yes Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Meerdere fase 3 studies References Additional remarks Other information Additional remarks