Valsartan / sacubitril

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

Product

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.