Abaloparatide Medicine 09 January 2018 Extended indication Osteoporose voor postmenopauzale vrouwen Therapeutic value No judgement Total cost € 22,500,000.00 Registration phase Registration application pending Product Active substance Abaloparatide Domain Metabolism and Endocrinology Reason of inclusion Main indication Hormonal disorders Extended indication Osteoporose voor postmenopauzale vrouwen Current proprietary name Already available biosimilars / generics Proprietary name Eladynos Manufacturer Radius Portfolio holder Mechanism of action Unknown Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New medicine ATMP Unknown Submission date January 2016 Expected Registration Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Negatieve opinie CHMP maart 2018. Herbeoordeling gestart in april 2018. Therapeutic value Current treatment options Teriparatide, Denosumab 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 80 ug References Additional remarks Expected patient volume per year Patient volume < 1,500 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIPdatabank Additional remarks Denosumab zit nu op 20 miljoen met ruim 20000 gebruikers (voor alle indicaties) en Teriparatide op 5 miljoen met 1500 gebruikers. Expected cost per patient per year Cost € 10,000.00 - 20,000.00 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 FiercePharma Additional remarks In de VS wordt Tymlos ingezet op $19.500 pppj. Potential total cost per year Total cost € 22,500,000.00 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 Transdermal patch in ontwikkeling References Additional remarks Other information Additional remarks