Naldemedine Medicine 13 December 2018 Extended indication Rizmoic is indicated for the treatment of opioid-induced constipation (OIC) in adult patients who have previously been treated with a laxative. Therapeutic value No judgement Total cost € 1,575,000.00 Registration phase Registered Product Active substance Naldemedine Domain Chronic immune diseases Reason of inclusion New medicine (specialité) Main indication Other chronic immune diseases Extended indication Rizmoic is indicated for the treatment of opioid-induced constipation (OIC) in adult patients who have previously been treated with a laxative. Current proprietary name Already available biosimilars / generics Proprietary name Rizmoic Manufacturer Shionogi Portfolio holder Mechanism of action Receptor antagonist Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Peripherally-selective μ-opioid receptor antagonist Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date March 2017 Expected Registration February 2019 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie december 2018. Geregistreerd in februari 2019. Therapeutic value Current treatment options laxantia Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times a day Dosage per administration 0,2 mg References NCT01993940; NCT01965158; NCT01965652 Additional remarks Expected patient volume per year Patient volume 200 - 500 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIPdatabank; De Groot et al. Ned Tijdschr Geneeskd. 2010;154:A2224 Additional remarks In 2016 kregen 970.070 patiënten opioïden. Ongeveer 50%-90% van de patiënten die worden behandeld met opioïden krijgt last van obstipatie. Dit zou 485.035-873.063 patiënten betekenen. Het daadwerkelijke patiëntvolume is sterk afhankelijk van de therapeutische waarde en de plaats in de behandeling. Potentieel is dit een grote groep patiënten. Dit middel zal waarschijnlijk worden ingezet wanneer andere geneesmiddelen niet werken. De inschatting is daarom enkele honderden patiënten. Expected cost per patient per year Cost € < 4,500.00 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 GoodRx.com Additional remarks In de Verenigde Staten kosten 30 tabletten naldemedine 0,2 mg gemiddeld $383,13. Dit is de hoeveelheid voor gebruik van een maand, dus dit zou $4.597,56 per patiënt per jaar bedragen. De prijs in Europa is waarschijnlijk lager. Potential total cost per year Total cost € 1,575,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks