Extended indication Post acute Myocardial Infarction
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance Valsartan / sacubitril
Domain Cardiovascular diseases
Reason of inclusion Indication extension
Main indication Other medication for cardiovascular diseases
Extended indication Post acute Myocardial Infarction
Proprietary name Entresto
Manufacturer Novartis
Mechanism of action Combination therapy
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)
Additional comments 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)
Submission date November 2021
Expected Registration November 2022
Orphan drug No
Registration phase Clinical trials
Additional comments 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 judgement
Duration of treatment continuous
Frequency of administration 2 times a day
Dosage per administration 97/103mg (doeldosering)

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Cost 1,800.00
References Medicijnkosten.nl
Additional comments € 2,49 per tablet. Voor behandeling op jaarbasis: €1.815,95.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes

Other information

There is currently no futher information available.