Ixekizumab Medicine 12 June 2018 Extended indication Axiale Spondyloartritis Therapeutic value Possible equal value Total cost € 22,500,000.00 Registration phase Clinical trials Product Active substance Ixekizumab Domain Chronic immune diseases Reason of inclusion Main indication Rheumatism Extended indication Axiale Spondyloartritis Current proprietary name Already available biosimilars / generics Proprietary name Taltz Manufacturer Eli Lilly Portfolio holder Mechanism of action Unknown Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Door elke reumatoloog in Nederland voor te schrijven. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Indication extension ATMP Unknown Submission date 2019 Expected Registration 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Verschillende TNF blokkers na falen NSAID of anti-IL17A; Secukinumab. Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Werkgroep denkt vooralsnog gelijke waarde ten opzichte van TNFi en Secukinumab, meerwaarde zal nog moeten worden aangetoond. Duration of treatment Frequency of administration 2 times a month Dosage per administration 80 mg References NCT02757352 Additional remarks Toediening Q2W en Q4W worden getest. Expected patient volume per year Patient volume < 1,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Axiale spondyloartritis komt voor bij ongeveer 1 op de 400 mensen, dit zijn in Nederland ongeveer 42.500 mensen. De inschatting van de werkgroep is dat ongeveer de helft van deze patienten in aanmerking komt voor een behandeling met een biological (21.250 patienten). De verwachting is dat ongeveer 5% van deze patienten een bDMARD nodig hebben (m.a.w. ongeveer 1000 patienten). Onduidelijk is hoeveel daarvan in aanmerking komen voor Ixekizumab. Expected cost per patient per year Cost € 15,000.00 - 30,000.00 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 €1151,16 per 80 mg. Berekend volgens behandelschema. Potential total cost per year Total cost € 22,500,000.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks