Valsartan / sacubitril Medicine 12 June 2019 Extended indication Post acute Myocardial Infarction Therapeutic value No estimate possible yet 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 No Submission date October 2021 Expected Registration November 2022 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Entresto is momenteel beschikbaar voor de behandeling van volwassen patiënten met symptomatisch chronisch hartfalen met verminderde ejectiefractie. Therapeutic value Current treatment options ACE-inhibitors, AT-II antagonisten. Therapeutic value No estimate possible yet 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 97/103mg (doeldosering) References PARADISE-MI, NCT02924727 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 € 1,560.00 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, z-index Additional remarks €2,14 per tablet. Per dag €4,28. Voor behandeling op jaarbasis zo'n €1.560. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions References Additional remarks Other information Additional remarks