Rituximab Medicine 12 June 2018 Extended indication Refractaire (auto)immunologische longfibrose Therapeutic value No judgement Total cost € 1,500,000.00 Registration phase Unknown Product Active substance Rituximab Domain Lung diseases Reason of inclusion Main indication Lung other Extended indication Refractaire (auto)immunologische longfibrose Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Roche Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise St Antonius Ziekenhuis Nieuwegein; Erasmus MC Rotterdam; OLVG Amsterdam Additional remarks Sectie Interstitiele Longziekten (SIL) van de NVALT is van mening dat rituximab geindiceerd is bij therapie resistente (auto)immunologisch gemedieerde interstitiele longziekten c.q. longfibrose. Registration Registration route Unknown Type of trajectory Unknown Particularity Indication extension ATMP Unknown Submission date Expected Registration Orphan drug Unknown Registration phase Unknown Reimbursement Medicine sluice Additional remarks Off-label indicatie status is aangevraagd. Therapeutic value Current treatment options Conventionele immunosuppressiva zoals prednisolon, cyclofosfamide of azathioprine. Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 2 times every 6 months Dosage per administration 1000 mg References Yoo. Rheumat Int 2012;32(3):795-8; ClinicalTrials.gov, NCT01862926; Keir et al. Respirol 2014;19(3):353-9; Lota et al. Thorax 2013;68(8):780-1; Keir et al. Eur Respir J 2012;40(3)641-8 Additional remarks Expected patient volume per year Patient volume < 150 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Het betreft <50 patiënten per jaar per expertisecentrum. Er zijn in Nederland 3 erkende (NFU/VWS) expertisecentra voor longfibrose (St Antonius Ziekenhuis Nieuwegein, Erasmus MC Rotterdam en OLVG Amsterdam). Deze centra werken samen met andere longcentra verspreid door Nederland. Het multidisciplinair expertiseteam in een expertisecentra bepaalt, al dan niet via videoconferentie met een ander longcentrum, of een patiënt met refractaire (auto)immunologische longfibrose in aanmerking komt voor rituximab. Zo nodig wordt de patiënt voor deze therapie doorverwezen. Expected cost per patient per year Cost € 10,000.00 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 medicijnkosten.nl Additional remarks Rituximab concentraat voor oplossing voor infusie 10 ml 10 mg/ml €251,07. Potential total cost per year Total cost € 1,500,000.00 Total cost for sluice Additional remarks Off label use Off label use Yes Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks