27 April 2016 - Around 100,000 people in England and Wales could now benefit from treatment with Novartis’ revolutionary heart failure drug Entresto, after cost regulators issued a final green light for its use on the National Health Service.

The guidance recommends the £3-per-day treatment for people with heart failure with reduced ejection fraction - a condition where the heart muscle does not contract effectively and less oxygen-rich blood is pumped out to the body - but restricts its use to patients with moderate-to-severe symptoms.

The Institute has stipulated that only in those with New York Heart Association (NYHA) class II to IV symptoms, a left ventricular ejection fraction of 35% or less, and those who are already taking a stable dose of angiotensin-converting enzyme inhibitors or angiotensin II receptor-blockers should get NHS access.

In Australia, the PBAC did not recommend the listing of sacubitril with valsartan on the basis of uncertain cost-effectiveness and high predicted financial impact.

The PBAC considered that the clinical claim of superior comparative effectiveness compared to enalapril was reasonable, but that the size of this benefit was uncertain due to issues with the design of the key study (a randomised controlled trial), and early stopping of this trial. The uncertainty around the treatment effect size, along with the failure of the model to reflect the progression of patients through heart failure, meant that the incremental cost-effectiveness ratio estimated by the submission was not reliable and the cost-effectiveness of treatment remained unknown.

For more details about the NICE outcome, go to: http://www.pharmatimes.com/Article/16-04-27/NICE_backs_restricted_use_of_heart_drug_Entresto.aspx

For more details about the PBAC outcome, go to: http://www.pbs.gov.au/industry/listing/elements/pbac-meetings/pbac-outcomes/2016-03/first-time-decisions-not-to-recommend-2016-03.pdf