Telotristat etiprate Medicine 09 January 2018 Extended indication Xermelo is geïndiceerd voor de behandeling van diarree veroorzaakt door carcinoïdsyndroom in combinatie met therapie met somatostatine-analogen (SSA) bij volwassenen, in geval van onvoldoende controle van de diarree middels SSA-therapie. Therapeutic value Possible added value Total cost € 1,600,000.00 Registration phase Registered and reimbursed Product Active substance Telotristat etiprate Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Neuroendocrine cancer Extended indication Xermelo is geïndiceerd voor de behandeling van diarree veroorzaakt door carcinoïdsyndroom in combinatie met therapie met somatostatine-analogen (SSA) bij volwassenen, in geval van onvoldoende controle van de diarree middels SSA-therapie. Current proprietary name Already available biosimilars / generics Proprietary name Xermelo Manufacturer Ipsen Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date August 2016 Expected Registration September 2017 Orphan drug Yes Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Geregistreerd in september 2017. Therapeutic value Current treatment options Imodium Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Trial and error bij patiënten. Effect op carcinoïd hartziekte is nog onbekend. Duration of treatment Frequency of administration 3 times a day Dosage per administration 250 mg References SMPC Xermelo Additional remarks Expected patient volume per year Patient volume 100 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks In het Erasmus MC worden 100-150 patiënten behandeld met een carcinomatosa syndroom/diarree. Van deze komen waarschijnlijk 20-30 patiënten in aanmerking voor telotristat. In Nederland is de schatting 100 patiënten. NKR: totaal aantal neuroendocriene tumoren is 1500, exlcusief long zijn dit er 300. Expected cost per patient per year Cost € 16,000.00 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 Medicijnkosten.nl Additional remarks 1 tablet 250 mg Xermelo kost €15,30. Bij gebruik van 365 dagen maal 3 tabletten per dag komt dit neer op €16201,99 pppj. Potential total cost per year Total cost € 1,600,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks