Valsartan / sacubitril Medicine 12 June 2019 Extended indication Post acute Myocardial Infarction Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Valsartan / sacubitril Domain Cardiovascular diseases Reason of inclusion Indication extension IND Main indication Other medication for cardiovascular diseases Extended indication Post acute Myocardial Infarction Current proprietary name Already available biosimilars / generics Proprietary name Entresto Manufacturer Novartis Portfolio holder Mechanism of action Combination therapy Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Entresto vertoont het werkingsmechanisme van een angiotensinereceptor-neprilysine-remmer door tegelijk neprilysine (neutrale endopeptidase, NEP) te remmen via LBQ657, de werkzame metaboliet van de prodrug sacubitril, en door de angiotensine II type 1-receptor (AT1-receptor) te blokkeren via valsartan. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date November 2021 Expected Registration November 2022 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 2 times a day Dosage per administration References Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost € 1,800.00 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 € 2,49 per tablet. Voor behandeling op jaarbasis: €1.815,95. 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 Verwachte registratie HFpEF :2020, verwachte registratie MI: 2021. References Fabrikant (nov 2017) Additional remarks Other information Additional remarks