Vericiguat

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)

Product

Manufacturer

Bayer

Mechanism of action

Other, see general comments

Route of administration

Oral

Therapeutical formulation

Tablet

Budgetting framework

Extramural (GVS)

Additional comments
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 comments
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.