Pirfenidone Medicine 07 December 2021 Extended indication Pirfenidone AET is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF). Therapeutic value Possible equal value Total cost Registration phase Positive CHMP opinion Product Active substance Pirfenidone Domain Lung diseases Reason of inclusion Generic G Main indication Unknown Extended indication Pirfenidone AET is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF). Current proprietary name Esbriet (Roche) Already available biosimilars / generics geen Proprietary name Pirfenidone AET Manufacturer Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Unknown Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Collagen inhibitors; Cytokine inhibitors Portfoliohouder en fabrikant is AET. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date May 2021 Expected Registration June 2022 Orphan drug No Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Vele patenten geldig, de komende jaren nog allemaal van kracht. Positieve CHMP-opinie verkregen in april 2022. Therapeutic value Current treatment options Therapeutic value Possible equal value 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