Omecamtiv mecarbil Medicine 08 June 2021 Extended indication Treatment of adult patients with symptomatic chronic heart failure and reduced ejection fraction less than 30%. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Omecamtiv mecarbil Domain Cardiovascular diseases Reason of inclusion New medicine (specialité) Main indication Other medication for cardiovascular diseases Extended indication Treatment of adult patients with symptomatic chronic heart failure and reduced ejection fraction less than 30%. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Cytokinetics Portfolio holder Mechanism of action Other, see general comments Route of administration Oral Therapeutical formulation Unknown Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Cardiac myosin stimulant. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date December 2022 Expected Registration October 2023 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks 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 fase 3 studie ten opzichte van placebo is geen verschil in adverse events van beide groepen waargenomen. Ook is er geen verlaging van de bloeddruk gezien, bij andere therapieën is dit vaak een beperkende factor. Indien het geregistreerd wordt is de verwachting dat het gebruik niet groot zal zijn. Er wordt op dit moment meer verwacht van vericiguat bij deze indicatie. In de richtlijn zullen eerst een bètablokker, mrna antagonist, ace remmer of SGLT2-remmer voorgeschreven worden. Duration of treatment Frequency of administration 2 times a day Dosage per administration References NCT02929329 (GALACTIC-HF) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References 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 omecamtiv mecarbil ontvangen. 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 Unknown Indication extensions References Additional remarks Other information Additional remarks