Extended indication Osteoarthritis van de knie
Therapeutic value No judgement
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
Proprietary name Zilretta
Manufacturer Flexion
Route of administration Intra-articular
Therapeutical formulation Injection
Budgetting framework Extramural (GVS)
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)
Submission date 2019
Expected Registration 2020
Orphan drug No
Registration phase Clinical trials
Additional remarks Betamethason, methylprednisolon, triamcinolonacetonide

Therapeutic value

Therapeutic value No judgement
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.

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

References GIPdatabank
Additional remarks Vergoeding per gebruiker voor betamethason, methylprednisolon, triamcinolonacetonide in 2016 betreft €24,50

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension No

Other information

There is currently no futher information available.