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Vericiguat

Extended indication Hartfalen met verminderde ejectiefractie (HFrEF)
Therapeutic value No judgement
Registration phase Registration application pending

Product

Active substance Vericiguat
Domain Cardiovascular diseases
Reason of inclusion New medicine (specialité)
Main indication Other medication for cardiovascular diseases
Extended indication Hartfalen met verminderde ejectiefractie (HFrEF)
Manufacturer Bayer
Mechanism of action Other, see general comments
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
Submission date June 2020
Expected Registration July 2021
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Current treatment options Patiënten met HErEF ontvangen veel verschillende soorten medicatie. Voorbeelden hiervan zijn: ''81% of the patients were treated with loop diuretics, 84% with renin-angiotensin-system (RAS) inhibitors, 86% with β-blockers, 56% with mineralocorticoid-receptor antagonists (MRA), and 5% with If-channel inhibition.'' (Brunner-La Rocca et al. , 2019)
Therapeutic value No judgement
Substantiation Patiënten met HErEF ontvangen al veel medicatie, vericiguat zal naast deze medicatie voorgeschreven worden. Ondanks dat er geen directe vergelijking is lijkt dapagliflozine mogelijk iets beter: HR dapagliflozine 0,74 op CV death + HF opnames, HR vericiguat 0,90 op hetzelfde gecombineerde eindpunt.
Duration of treatment continuous
Frequency of administration 1 times a day
Dosage per administration 2,5, 5 of 10 mg
References NCT02861534 Brunner-La Rocca et al. (2019). Contemporary Drug Treatment of Chronic Heart Failure With Reduced Ejection Fraction. JACC: Heart Failure, 7(1), 13-21. doi: 10.1016/j.jchf.2018.10.010

Expected patient volume per year

Patient volume

< 3,000

Market share is generally not included unless otherwise stated.
Additional remarks Patiënten met HErEF ontvangen veel verschillende soorten medicatie, vericiguat zal hier nog bovenop komen. Het patiëntaantal zal naar verwachting niet hoger liggen dan 3.000 patiënten per jaar (en hierbinnen met entresto de concurrentie aan moeten gaan.

Expected cost per patient per year

There is currently nothing known about the expected cost.

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 No

Other information

There is currently no futher information available.