Ixekizumab Medicine 12 June 2018 Extended indication Taltz is indicated for the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy and patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs). Therapeutic value Possible added value Total cost € 14,118,000.00 Registration phase Registered and reimbursed Product Active substance Ixekizumab Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Rheumatism Extended indication Taltz is indicated for the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy and patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs). Current proprietary name Already available biosimilars / generics Proprietary name Taltz Manufacturer Eli Lilly Portfolio holder Mechanism of action Immunosuppression Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Door elke reumatoloog in Nederland voor te schrijven. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date September 2019 Expected Registration June 2020 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in april 2020. Therapeutic value Current treatment options Verschillende TNF blokkers na falen NSAID of anti-IL17A; secukinumab. Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Mogelijke meerwaarde ten opzichte van TNFi op effectiviteit. De meerwaarde is vooral zichtbaar bij patiënten die falen op een TNF-blokker. De werkgroep verwacht echter gelijke waarde met secukinumab voor deze indicatie. Onduidelijk wat het effect is op lange termijn. Duration of treatment Frequency of administration 2 times a month Dosage per administration 80 mg References NCT02757352 https://acrabstracts.org/abstract/ixekizumab-significantly-improves-signs-symptoms-and-spinal-inflammation-of-active-ankylosing-spondylitis-radiographic-axial-spondyloarthritis-16-week-results-of-a-phase-3-randomized-active-a/ 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 ReumaNederland; Additional remarks Axiale spondyloartritis komt voor bij ongeveer 1 op de 200 mensen, dit zijn in Nederland ongeveer 95.000 mensen. De inschatting is dat ongeveer 3.000-4.000 patiënten anti-TNF medicatie krijgen. Na het falen op anti-TNF komen patiënten in aanmerking voor ixekizumab, dit zijn er minder dan 1.000. Expected cost per patient per year Cost € 14,118.00 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 G-standaard november 2020 Additional remarks Apotheekinkoopprijs per verpakking van 80 mg: €1.086 Behandelschema (op basis van SmPC en de pivotale registratiestudies): Dosering: 80 mg (voor zowel radiografisch als non-radiografisch) Toedieningsfrequentie: De aanbevolen startdosering is 160mg (door middel van 2 subcutane injecties van 80 mg) in week 0, gevolgd door onderhoudsdosering 80 mg iedere 4 weken. Kosten ixekizumab per onderhoudsjaar = €1.086 x 13 = €14.118. Potential total cost per year Total cost € 14,118,000.00 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