Triamcinolone Medicine 12 June 2018 Extended indication Osteoarthritis van de knie Therapeutic value Possible equal value Total cost € 62,500.00 Registration phase Clinical trials Product Active substance Triamcinolone Domain Chronic immune diseases Reason of inclusion New medicine (specialité) Main indication Other chronic immune diseases Extended indication Osteoarthritis van de knie Current proprietary name Already available biosimilars / generics Proprietary name Zilretta Manufacturer Flexion Portfolio holder Mechanism of action Corticosteroid Route of administration Intra-articular Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Triamcinolone acetonide extended-release injectable suspension, a corticosteroid with anti-inflammatory and immunomodulating properties. Pipeline watch 12 januari 2018: Clinical benefits after repeat administration. Phase 3 Interim/Top-line Results. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2021 Expected Registration 2022 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Betamethason, methylprednisolon, triamcinolonacetonide Therapeutic value Current treatment options Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation De werkgroep verwacht geen grote impact. De verwachting is dat dit een deel van de huidige behandelingen zal overnemen. Duration of treatment Frequency of administration Dosage per administration 40 mg References NCT02357459 Additional remarks Eenmalige injectie Expected patient volume per year Patient volume < 2,500 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Voklsgezondheidenzorg.nl; NIVEL zorgregistraties eerste lijn; Barten et al.BMC Fam Pract 2015) Additional remarks In 2016 werd naar schatting bij 54.900 mensen knieartrose gediagnostiseerd. De prevalentie in 2016 bedroeg 571.600 patiënten. In 5% van de gevallen wordt door de huisarts een intra-articulaire injectie met corticosteroïden toegediend. De verwachting is dat deze nieuwe formulering van triamcinolon bij een deel van deze gevallen zal worden ingezet. Expected cost per patient per year Cost € 25.00 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 GIPdatabank Additional remarks Vergoeding per gebruiker voor betamethason, methylprednisolon, triamcinolonacetonide in 2016 betreft €24,50 Potential total cost per year Total cost € 62,500.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks