Pamrevlumab Medicine 07 December 2022 Extended indication Idiopathic Pulmonary Fibrosis (IPF) Therapeutic value No estimate possible yet Total cost Registration phase No registration expected Product Active substance Pamrevlumab Domain Lung diseases Reason of inclusion New medicine (specialité) Main indication Lung diseases other Extended indication Idiopathic Pulmonary Fibrosis (IPF) Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Fibrogen Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Werkingsmechanisme: Anti-CTGF (bindweefselgroeifactor) humaan monoklonaal antilichaam. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date 2025 Expected Registration 2026 Orphan drug No Registration phase No registration expected Reimbursement Medicine sluice Additional remarks Fibrogen heeft in juni 2023 aangekondigd dat de fase 3 ZEPHYRUS-1 trial niet het primaire eindpunt heeft behaald. 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 30 mg/kg References NCT04419558, NCT03955146 Additional remarks Expected patient volume per year Patient volume < 2,040 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Jaarverslag Longfibrosepatiëntenvereniging 2017 (1) Additional remarks Er zijn ongeveer 3.400 longfibrose patiënten in Nederland. 60% daarvan heeft IPF. Dit komt neer op 2.040 IPF patiënten. 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 Yes Indication extensions Fase 3: Ambulante en niet-ambulante Duchenne spierdystrofie, alvleesklierkanker. References Adis Insight Additional remarks Other information Additional remarks