Pirfenidone Medicine 08 June 2021 Extended indication Extension of indication to include the treatment of unclassifiable interstitial lung disease (UILD) for Esbrie. Therapeutic value No estimate possible yet Total cost Registration phase No registration expected Product Active substance Pirfenidone Domain Lung diseases Reason of inclusion Indication extension IND Main indication Lung diseases other Extended indication Extension of indication to include the treatment of unclassifiable interstitial lung disease (UILD) for Esbrie. Current proprietary name Already available biosimilars / generics Proprietary name Esbriet Manufacturer Roche Portfolio holder Mechanism of action Other, see general comments Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Collagen inhibitor; Cytokine inhibitor Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date January 2021 Expected Registration Orphan drug Yes Registration phase No registration expected Reimbursement Medicine sluice Additional remarks De registratieaanvraag van deze nieuwe indicatie van Esbriet is door de registratiehouder ingetrokken. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost References Additional remarks 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 Unknown Indication extensions References Additional remarks Other information Additional remarks