Triamcinolone Medicine 12 June 2018 Extended indication Osteoarthritis van de knie Therapeutic value No judgement Total cost 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 Unknown 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 III Interim/Top-line Results. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2019 Expected Registration 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Betamethason, methylprednisolon, triamcinolonacetonide Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation 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 References GIPdatabank Additional remarks Vergoeding per gebruiker voor betamethason, methylprednisolon, triamcinolonacetonide in 2016 betreft €24,50 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 No Indication extensions References Additional remarks Other information Additional remarks