Olokizumab Medicine 13 December 2018 Extended indication Moderate-to-severe rheumatoid arthritis in adults who previously failed DMARD therapy in combination with methotrexate. Therapeutic value Possible equal value Total cost € 2,000,000.00 Registration phase Clinical trials Product Active substance Olokizumab Domain Chronic immune diseases Reason of inclusion New medicine (specialité) Main indication Rheumatism Extended indication Moderate-to-severe rheumatoid arthritis in adults who previously failed DMARD therapy in combination with methotrexate. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer R-Pharm Portfolio holder Mechanism of action Interleukin inhibitor Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Monoklonaal antilichaam gericht tegen IL-6. Bekostigingskader mogelijk intramuraal conform sarilumab Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2021 Expected Registration 2022 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Meerdere fase 3 studies lopen af in de loop van 2019 Therapeutic value Current treatment options Andere IL-6 inhibitors: tocilizumab en sarilumab Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation De inschatting is dat olokizumab competitief is met tocilizumab en sarilumab. Duration of treatment Frequency of administration 1 times every 4 weeks Dosage per administration 64 mg References NCT02760433; NCT02760368; NCT02760407 Additional remarks Expected patient volume per year Patient volume 100 - 300 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Afhankelijk van de uiteindelijke indicatiestelling, therapeutische meerwaarde en de plaats in de behandelrichtlijn mogelijk enkele honderden patiënten. Zal de concurrentie moeten aangaan met andere IL-6 remmers. Inschatting: 100-300 patiënten. 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 GIPdatabank Additional remarks Afhankelijk van de therapeutische meerwaarde maar naar verwachting vergelijkbaar met andere biological IL-6 remmers zoals tocilizumab. De vergoeding voor tocilizumab bedroeg van 2012-2015 rond de €10.000 per patiënt per jaar. Potential total cost per year Total cost € 2,000,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Ziekte van Crohn (fase 2) References clinicaltrials.gov Additional remarks Other information Additional remarks