Pirfenidone Medicine 12 June 2018 Extended indication Asbestosis Therapeutic value No judgement Total cost € 9,900,000.00 Registration phase Clinical trials Product Active substance Pirfenidone Domain Lung diseases Reason of inclusion Main indication Lung other Extended indication Asbestosis Current proprietary name Already available biosimilars / generics Proprietary name Esbriet Manufacturer Roche Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Indication extension ATMP Unknown Submission date Expected Registration Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Corticosteroiden Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 3 times a day Dosage per administration 801 mg References Additional remarks Financiering en protocol van Nederlandse asbestosis studie naar het effect van pirfenidone bij asbest gerelateerde longfibrose zijn rond; de verwachting is dat deze studie in de loop van 2018 zal starten in 3 centra in Nederland: Erasmus MC Rotterdam, St Antonius Ziekenhuis Nieuwegein en Zuyderland Ziekenhuis Heerlen. Expected patient volume per year Patient volume < 300 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Asbest-gerelateerde longfibrose is een zeldzame vorm van longfibrose (het gaat naar schatting om enkele honderden patiënten in Nederland; een belangrijk deel hiervan vertoond nauwelijks tot geen ziekteprogressie; alleen patiënten met duidelijk progressieve ziekte hebben mogelijk baat bij pirfenidone). Expected cost per patient per year Cost € 33,000.00 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 medicijnkosten.nl Additional remarks Pirfenidon tablet 801 mg € 29,73. Dit komt neer op ongeveer €33.000 voor een jaar lang behandeling. Potential total cost per year Total cost € 9,900,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks