Risankizumab Medicine 08 June 2021 Extended indication Skyrizi, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). Therapeutic value No estimate possible yet Total cost Registration phase Registered and reimbursed Product Active substance Risankizumab Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Rheumatism Extended indication Skyrizi, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). Current proprietary name Already available biosimilars / generics Proprietary name Skyrizi Manufacturer Abbvie Portfolio holder Mechanism of action Interleukin inhibitor Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Interleukin-23 subunit p19 inhibitors Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date April 2021 Expected Registration December 2021 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks SPS United Kingdom: "Apr 21 · AbbVie submits applications to EMA and Unites States FDA for treatment of adults with active psoriatic arthritis". Positive CHMP opinie ontvangen oktober 2021 Therapeutic value Current treatment options DMARD-therapie, adalimumab, apremilast, certolizumab pegol, etanercept, golimumab, infliximab, abatacept, ixekizumab, tofacitinib, ustekinumab en secukinumab Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Anti-IL 17 wordt ingezet na falen van anti-TNF therapie en conventionele synthetische DMARDS, daarna een JAK remmer en vervolgens ustekniumab. Risankizumab zal de concurrentie aangaan met ustekinumab en guselkumab. De twee fase 3 studies lieten een vooruitgang zien van huid- en gewrichtssymptomen en bewegingsfunctie. Duration of treatment Frequency of administration Dosage per administration References NCT03675308 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References IQVIA Additional remarks Naar schatting zijn er ongeveer 18.544 mensen in Nederland met psoriatrische artritis die in ziekenhuizen behandeld worden. Hiervan wordt ongeveer 26% met een biological behandeld (4.914). Expected cost per patient per year Cost € 13,136.00 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, Z-index mei 2020; fabrikant. Additional remarks AIP van €3.284 per pak met twee wegwerpspuiten, dus €1.642 per wegwerpspuit; kosten €13.136 per patiënt per jaar. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks