Treprostinil Medicine 13 December 2018 Extended indication Treatment of adults with chronic thromboembolic pulmonary hypertension (CTEPH) who cannot have surgery, and in patients whose CTEPH continues or has come back after surgery. Therapeutic value No judgement Total cost € 4,200,000.00 Registration phase Withdrawn Product Active substance Treprostinil Domain Cardiovascular diseases Reason of inclusion New medicine (specialité) Main indication Other medication for cardiovascular diseases Extended indication Treatment of adults with chronic thromboembolic pulmonary hypertension (CTEPH) who cannot have surgery, and in patients whose CTEPH continues or has come back after surgery. Current proprietary name Already available biosimilars / generics Proprietary name Treprostinil SciPharm Sàrl Manufacturer Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Treprostinil diethanolamide is een vasodilator, synthetische analoog van prostacycline. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New therapeutical formulation ATMP Unknown Submission date June 2018 Expected Registration Orphan drug Yes Registration phase Withdrawn Reimbursement Medicine sluice Additional remarks De fabrikant heeft de registratieaanvraag teruggetrokken omdat het niet kon voldoen aan de vraag van de EMA om additionele data aan te leveren. De fabrikant dient mogelijk in een later stadium een nieuwe aanvraag in. Therapeutic value Current treatment options Treprostinil IV (Remodulin) Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References United Therapeutics Additional remarks De FREEDOM-EV trial heeft de primaire eindpunten gehaald. Expected patient volume per year Patient volume < 28 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIPdatabank Additional remarks In 2016 waren er 28 gebruikers van Remodulin. Expected cost per patient per year Cost € 150,000.00 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 GIPdatabank Additional remarks In 2016 werd er €150.720,00 vergoed per gebruiker. Potential total cost per year Total cost € 4,200,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Systemic sclerosis References EMA; Clinicaltrials.gov Additional remarks Orphan designation voor deze indicatie, momenteel bevinden studies zich in fase II. Other information Additional remarks