Extended indication Extension of indication for treatment of symptomatic chronic Heart failure with reduced ejection fraction in adults and elderly who have not had a rec
Therapeutic value Possibly no place in the treatment regimen
Registration phase Clinical trials

Product

Active substance Vericiguat
Domain Cardiovascular diseases
Reason of inclusion Indication extension IND
Main indication Other medication for cardiovascular diseases
Extended indication Extension of indication for treatment of symptomatic chronic Heart failure with reduced ejection fraction in adults and elderly who have not had a recent hospitalization for heart failure or need for outpatient intravenous diuretics.
Proprietary name Verquvo
Manufacturer Bayer
Portfolio holder Bayer
Mechanism of action Other
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)
Additional remarks Stimulator van het soluble guanylate cyclase (sGC) enzym.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity Unknown
ATMP No
Submission date 2025
Expected Registration 2026
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Patienten met HFrEF ontvangen veel verschillende soorten medicatie via een Stappenplan hartfalen medicatie.
Therapeutic value Possibly no place in the treatment regimen

This assessment does not indicate any potential inclusion in the package.

Substantiation De VICTOR-trial miste het primaire eindpunt en eerdere grote studies lieten geen significant effect zien. Een meta-analyse suggereert mogelijk voordeel in sommige subgroepen, maar het middel zal waarschijnlijk geen grote rol gaan spelen.
Frequency of administration 1 times a day
Dosage per administration 2,5mg, 5mg of 10mg
References NCT05093933 (VICTOR); Expertopinie

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.

Additional remarks In Nederland zijn er circa 240.000 patiënten met hartfalen. Jaarlijks diagnose in circa 38.000 patiënten. Hiervan is circa twee derde HFrEF. Een klein gedeelte van de patiënten zal mogelijk vericiguat ontvangen.

Expected cost per patient per year

Cost < 1,193.00

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 Z-index

Potential total cost per year

Off label use

Off label use No

Indication extension

Indication extensions Unknown

Other information