Valsartan / sacubitril Medicine 09 January 2018 Extended indication Chronic heart failure with preserved ejection fraction. Post-myocardial infarction, to reduce adverse cardiac outcomes in patients with evidence of LV systolic dysfunction and/or pulmonary congestion. Therapeutic value No judgement Total cost Registration phase Unknown Product Active substance Valsartan / sacubitril Domain Cardiovascular diseases Reason of inclusion Main indication Heart failure Extended indication Chronic heart failure with preserved ejection fraction. Post-myocardial infarction, to reduce adverse cardiac outcomes in patients with evidence of LV systolic dysfunction and/or pulmonary congestion. Current proprietary name Already available biosimilars / generics Proprietary name Entresto Manufacturer Novartis Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Fabrikant (nov 2017): Verwachte registratie HFpEF :2020, verwachte registratie MI: 2021 Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration 2020 Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Indicatie-uitbreiding 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 € > 1,900.00 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 € 2,62 per tablet. Voor behandeling op jaarbasis: €1915,02. 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 Unknown Indication extensions References Additional remarks Other information Additional remarks