NICE gives green light to Novartis drug in heart failure

In draft guidance published today for consultation, the UK National Institute for Health and Clinical Excellence (NICE) has provisionally recommended novel heart failure drug sacubitril valsartan, trade name Entresto from Swiss pharma giant Novartis (NOVN: VX), as an option for some people with heart failure.

The draft guidance recommends the drug for treating chronic heart failure with reduced ejection fraction in people with New York Heart Association class II to III symptoms who are on a stable dose of ACE inhibitors (or angiotensin II receptor blockers for people who are intolerant of ACE inhibitors) and who have a left ventricular ejection fraction of 35% or less.

Heart failure affects about 900,000 people in the UK, the NICE noted. Heart failure is associated with significant ill-health and mortality. In 2012/13 over 30,000 people were admitted to hospital in England with heart failure with reduced left ventricular ejection fraction. Around 30%-40% of patients diagnosed with heart failure die within a year but thereafter the mortality rate falls to less than 10% per year.

Sacubitril valsartan is an angiotensin receptor neprilysin inhibitor. Sacubitril stops the enzyme neprilysin from working properly. Neprilysin inhibits the actions of other substances called peptides in dilating (widening) the blood vessels. By restricting the action of neprilysin, sacubitril allows the blood vessels to relax, reducing blood pressure and therefore decreasing the heart’s workload. Valsartan belongs to a class of drugs called angiotensin II receptor blockers (ARBs) and also works by lowering blood pressure.

“Drugs to treat heart failure have been available for many years. Despite this, people with this life-threatening and often debilitating condition have a poor prognosis, especially those with reduced ejection fraction. Sacubitril valsartan is an innovative drug that will offer people with this condition a further important treatment option with the potential to prevent deaths and reduce hospital admissions,” commented Meindert Boysen, program director, technology appraisals, at the NICE.

Consultees, including the company, healthcare professionals and members of the public are able to comment on the draft recommendations until January 15, 2016 via the NICE website. Comments received during this consultation will be fully considered by the Committee before the next draft guidance is issued. Until final guidance is published, NHS bodies should make decisions locally on the funding of specific treatments.