The National Institute for Health and Care Excellence (NICE) has issued Technical Appraisal Guidance for sacubitril/valsartan (Entresto™, Novartis Pharmaceuticals). The drug has been approved for use within the NHS for the treatment of adults with symptomatic chronic heart failure with New York Heart Association class II to IV symptoms, a left ventricular ejection fraction of 35% or less, and who are also taking a stable dose of angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers.
Sacubitril/valsartan is the first of a new kind of drug called angiotensin receptor neprilysin inhibitors. NICE recognised sacubitril/valsartan as an innovative treatment, which it says “offers the potential to prevent deaths and reduce the more than 30,000 hospital admissions for this condition each year in England”.
It is the first non-cancer drug to be fast-tracked through the Medicines and Healthcare Products Regulatory Agency’s Early Access to Medicines Scheme. The scheme aims to give patients with life threatening or seriously debilitating conditions access to medicines before they are licensed where there is a clear, unmet medical need.
The guidance is available at http://www.nice.org.uk/guidance/indevelopment/gid-tag516