Baricitinib Medicine 07 December 2022 Extended indication Extension of indication to include treatment, as monotherapy or in combination with conventional synthetic disease modifying antirheumatic drugs (DMARDs), of active juvenile idiopathic arthritis (JIA) in patients 2 years of age and older who have had an inadequate response or intolerance to one or more prior conventional synthetic or biologic DMARDs. Therapeutic value No estimate possible yet Total cost € 213,440.00 Registration phase Registered and reimbursed Product Active substance Baricitinib Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Rheumatism Extended indication Extension of indication to include treatment, as monotherapy or in combination with conventional synthetic disease modifying antirheumatic drugs (DMARDs), of active juvenile idiopathic arthritis (JIA) in patients 2 years of age and older who have had an inadequate response or intolerance to one or more prior conventional synthetic or biologic DMARDs. Current proprietary name Already available biosimilars / generics Proprietary name Olumiant Manufacturer Eli Lilly Portfolio holder Eli Lilly Mechanism of action JAK tyrosine kinase inhibitor Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date September 2022 Expected Registration October 2023 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie juli 2023 Therapeutic value Current treatment options Adalimumab, etanercept, tocilizumab, abatacept, tofacitinib. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De fase 3 studie is gepubliceerd in de Lancet met goede resultaten. Substitutie met tofacitinib. Er is een betere toedieningsfrequentie (1 keer per dag) dan tofacitinib (2 keer per dag). Duration of treatment Frequency of administration 1 times a day Dosage per administration 2-4 mg References NCT03773978; expertopinie Additional remarks Expected patient volume per year Patient volume 10 - 30 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References ReumaNederland(1); Expertopinie(2); Additional remarks JIA komt bij ongeveer 4.000 kinderen in Nederland voor; 30-40 nieuwe JIA diagnoses per jaar (1). Op basis van het gebruik van tofacitinib bij deze indicatie en het aantal patiënten in deze leeftijd dat gemiddeld behandeld wordt een patiëntvolume van maximaal 25-30 patiënten verwacht (2). Expected cost per patient per year Cost € 10,672.00 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 Z-index mei 2023 Additional remarks De prijs voor een verpakking van 28 tabletten Olumiant 4mg bedraagt €820,93. 1 tablet kost €29,32. Bij een behandelduur van een jaar (13 verpakkingen) zou dat €10.672,09 bedragen. Potential total cost per year Total cost € 213,440.00 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 zie overige indicaties op de horizonscan References Additional remarks Other information Additional remarks