Expand all sections

Valsartan / sacubitril

Entresto

Extended indication Extension of indication to include treatment of children and adolescents aged one year or older with
Therapeutic value No estimate possible yet
Registration phase Positive CHMP opinion

Product

Active substance Valsartan / sacubitril
Domain Cardiovascular diseases
Reason of inclusion Indication extension
Main indication Other medication for cardiovascular diseases
Extended indication Extension of indication to include treatment of children and adolescents aged one year or older with chronic heart failure with left ventricular systolic dysfunction.
Proprietary name Entresto
Manufacturer Novartis
Route of administration Oral
Therapeutical formulation Granulate
Budgetting framework Extramural (GVS)
Additional remarks The CHMP adopted the addition of a new pharmaceutical form associated with two new strengths (Entresto 6 mg/6 mg and 15 mg/16 mg granules in capsule for opening) and a new indication to include treatment of children and adolescents with heart failure. The CHMP also adopted an extension to the existing indication for Entresto film coated tablets.

Registration

Registration route Centralised (EMA)
Particularity New therapeutical formulation
ATMP No
Submission date July 2022
Expected Registration June 2023
Orphan drug No
Registration phase Positive CHMP opinion
Additional remarks Positieve CHMP 30 maart .

Therapeutic value

Current treatment options Enalapril
Therapeutic value No estimate possible yet
Substantiation De fase 3 studie loopt nog, de resultaten moeten nog afgewacht worden.
Dosage per administration 6 mg/6 mg - 15 mg/16 mg
References NCT02678312
Additional remarks Nieuwe toedieningsvorm: 6 mg/6 mg granules in capsule for opening and 15 mg/16 mg granules in capsule for opening.

Expected patient volume per year

Patient volume

33

Market share is generally not included unless otherwise stated.
References Hypertrophic Cardiomyopathy With Left Ventricular Systolic Dysfunction Insights From the SHaRe Registry. Peter Marstrand. 2020 (1); Expert opinie (2); CBS (3)
Additional remarks De prevalentie van een linker ventrikel systolische functiestoornis was 3,7% in de algehele populatie (1). Ongeveer één op de 100.000 kinderen heeft de diagnose (2). Er zijn 3,3 miljoen kinderen tot 18 jaar in Nederland. Dit betekent dat er ongeveer 33 kinderen in aanmerking zullen komen.

Expected cost per patient per year

Additional remarks Fabrikant geeft aan dat de prijs nog niet bekend is.

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.