Filgotinib Medicine 13 December 2018 Extended indication Jyseleca is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Jyseleca may be used as monotherapy or in combination with methotrexate (MTX). Therapeutic value Possible equal value Total cost € 2,300,000.00 Registration phase Registered and reimbursed Product Active substance Filgotinib Domain Chronic immune diseases Reason of inclusion New medicine (specialité) Main indication Rheumatism Extended indication Jyseleca is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Jyseleca may be used as monotherapy or in combination with methotrexate (MTX). Current proprietary name Already available biosimilars / generics Proprietary name Jyseleca Manufacturer Galapagos Portfolio holder Mechanism of action JAK tyrosine kinase inhibitor Route of administration Oral Therapeutical formulation Film-coated tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Selectieve JAK1 inhibitor. Gilead werkt samen met Galapagos. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date September 2019 Expected Registration September 2020 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in juli 2020. Therapeutic value Current treatment options DMARDs, andere JAK inhibitors zoals tofacitinib. Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Filgotinib werkt specifiek in op de JAK 1 pathway. Hierdoor veroorzaakt het mogelijk minder bijwerkingen dan concurrerende behandelopties. Filgotinib zal de competitie aangaan met tofacitinib. Duration of treatment Frequency of administration 1 times a day Dosage per administration 200 mg References NCT02873936; NCT02886728; NCT02889796 Additional remarks Filgotinib is een specifiekere remmer van JAK1 ten opzichte van tofacitinib en baricitinib. Expected patient volume per year Patient volume 100 - 300 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expertopinie; Tofacitinib voor RA in de horizonscan. Additional remarks De inschatting is dat er ongeveer 1.000 RA-patiënten in aanmerking komen voor een behandeling met JAK-remmers. De huidige en toekomstige JAK-remmers zullen deze markt moeten delen. Voor tofacitinib schat de fabrikant in dat er 130 RA-patiënten voor in aanmerking komen. Uiteindelijk zullen naar verwachting een paar honderd patiënten in aanmerking komen voor filgotinib. Afhankelijk van de therapeutische waarde en de plaats in de richtlijn kan dit aantal variëren. Expected cost per patient per year Cost € 11,000.00 - 12,000.00 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; Farmacotherapeutisch Kompas; fabrikant Additional remarks De prijs is sterk afhankelijk van de therapeutische waarde ten opzichte van huidige JAK-remmers en andere behandelopties. Huidige inschatting is gebaseerd op de kosten per patiënt per jaar van baricitinib (€11.456), upadacitinib (€11.456) en tofacitinib (€11.123) bij de behandeling van RA. Potential total cost per year Total cost € 2,300,000.00 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 Fase III studies lopen voor Crohn en ulcerative colitis (UC). References Clinicaltrials.gov Additional remarks Other information Additional remarks