Pioglitazone Medicine 12 June 2019 Extended indication Sudden Sensorineural Hearing Loss (SSHL) Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Pioglitazone Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Hearing disorders Extended indication Sudden Sensorineural Hearing Loss (SSHL) Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Strekin Portfolio holder Mechanism of action Receptor agonist Route of administration Auricular Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks PPAR (peroxisome proliferator-activated receptor)-gamma agonist. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date 2020 Expected Registration 2021 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks De verwachte Primary Completion Date is february 2019 Therapeutic value Current treatment options Geen Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Average 12 week / weeks Frequency of administration Dosage per administration References NCT03331627 Additional remarks De behandeling bestaat uit een intratympanische gel injectie gevolgd door 12 weeks orale behandling. Expected patient volume per year Patient volume < 1,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Verburg et al. Ned Tijdschr Geneeskd. 2010;154:A2460, inschatting brimapitide Additional remarks De geschatte incidentie is 5-20 gevallen per 100.000 mensen per jaar (850-3.400 in totaal voor Nederland). Er is een duidelijke unmet need. Inschatting experts: 1.000 realistisch maximum aantal patiënten dat in aanmerking zou kunnen komen voor deze behandeling. Expected cost per patient per year Cost References Expertopinie Additional remarks Aangezien de behandeling van acuut gehoorverlies nu weinig effectief is en er sprake is van een unmet need zal bij bewezen effectiviteit van Pioglitazone waarschijnlijk een hoge prijs gehanteerd worden. 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