Vericiguat Medicine 10 December 2019 Extended indication Verquvo is indicated for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilised after a recent decompensation event requiring IV therapy Therapeutic value No estimate possible yet Total cost Registration phase Positive CHMP opinion Product Active substance Vericiguat Domain Cardiovascular diseases Reason of inclusion New medicine (specialité) Main indication Other medication for cardiovascular diseases Extended indication Verquvo is indicated for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilised after a recent decompensation event requiring IV therapy Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Bayer Portfolio holder Mechanism of action Other, see general comments Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Stimulator van het soluble guanylate cyclase (sGC) enzym. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date June 2020 Expected Registration July 2021 Orphan drug No Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in mei 2021. 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 estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation In de Victoria Fase III study is aangetoond dat vericiguat de kans op het gecombineerd eindpunt van hartfalen hospitalisatie of cardiovasculaire mortaliteit significant vermindert met een absolute risico reductie (ARR) van 4,2% per jaar. In deze studie werd vericiguat vergeleken met placebo als toevoeging aan standaardbehandeling. Het bijwerkingsprofiel van vericiguat was daarnaast gunstig en vergelijkbaar met placebo. 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 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. Armstrong PW, et al. Vericiguat in patients with heart failure with reduced ejection fraction. N Engl J Med. DOI: 10.1056/NEJMoa1915928.). Additional remarks Expected patient volume per year Patient volume < 3,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References 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 Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks