Upadacitinib Medicine 10 June 2020 Extended indication Rinvoq is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. Rinvoq may be used as monotherapy or in combination with methotrexate. Therapeutic value Possible added value Total cost € 3,436,800.00 Registration phase Registered and reimbursed Product Active substance Upadacitinib Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Rheumatism Extended indication Rinvoq is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. Rinvoq may be used as monotherapy or in combination with methotrexate. Current proprietary name Already available biosimilars / generics Proprietary name Rinvoq Manufacturer Abbvie Portfolio holder 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 Unknown Submission date June 2020 Expected Registration January 2021 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in december 2020. Therapeutic value Current treatment options adalimumab, golimumab, ixekizumab, secukinumab infliximab, certolizumab pegol, etanercept, tofacitinib, ustekinumab, apremilast, abatacept. Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation De verwachting is dat upadacitinib de concurrentie aan zal gaan met de andere JAK remmers. Upadacitnib is even effectief als tofacitinib en baricitnib, maar heeft mogelijk minder nadelige bijwerkingen zoals het ontstaan van trombose. Hierdoor zal waarschijnlijk eerder upadacitnib voorgeschreven worden. Duration of treatment Frequency of administration 1 times a day Dosage per administration 15 mg References NCT03104374 Additional remarks Expected patient volume per year Patient volume 200 - 400 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 ~26% met een biological behandeld (4.914). Er zijn veel verschillende behandelopties voor deze indicatie. De verwachting is dat er maximaal 400 patiënten in aanmerking zullen komen voor deze behandeling. En dat deze patiënten verdeeld zullen worden over upadacitinib en tofacitinib. Expected cost per patient per year Cost € 11,456.00 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 november: 15mg Additional remarks AIP 15mg: €879 per 28 tabletten, €11.456 per jaar. Potential total cost per year Total cost € 3,436,800.00 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 Ankylosing spondylitis; Atopic dermatitis; Crohn's disease; Giant cell arteritis; Ulcerative colitis; Vasculitis References Adisinsight. Additional remarks Lopende fase 3 studies. Other information Additional remarks