Giving Novartis’ Entresto to every eligible patient in the US would prevent or postpone almost 10% of heart failure-related deaths every year, according to a new study.
The analysis – published in the journal JAMA Cardiology – is a boost to Novartis’ efforts to build momentum behind Entresto (sacubitril/valsartan), which is predicted to become a blockbuster but has been growing slowly in the market.
The new study extrapolates the findings of the PARADIGM-HF trial of Entresto and suggests that 28,000 lives could be saved if all patients with heart failure with reduced ejection fraction (HFrEF) were treated with the drug.
All told, heart failure contributes to around 300,000 deaths in the US every year, according to figures from the American Heart Association (AHA).
The analysis also suggests that delaying routine use of Entresto could have a “substantial negative effect” on patients as it could result in failure to prevent tens of thousands of deaths, according to Novartis.
Meanwhile, a separate cost-effectiveness analysis found that Entresto saved money compared to enalapril despite its higher price tag, mainly by averting costly hospital admissions.
In the PARADIHM-HF trial, Entresto was shown to reduce cardiovascular death by 20% compared to standard ACE inhibitor treatment with enalapril, and also cut sudden death by 19%, death from any cause by 16% and hospitalisation rates by 23%.
Given the stellar results, it is no surprise that Novartis has predicted similarly lofty sales expectations for Entresto of around $5bn a year at peak. The product brought in just $17m in sales in the first quarter of the year.
The slow take-up suggests that even with good data it is hard to change cardiovascular practice overnight – particularly as the aim is to get doctors to take patients off established drugs such as ACE inhibitors and switch to the new product.
“Entresto has now independently received a class I recommendation in clinical guidelines and was shown in multiple analysis to be cost effective,” commented Novartis’ chief medical officer Vas Narasimhan.
“Physicians and health care systems should feel confident in ensuring rapid and broad use of this breakthrough medicine,” he added.
New analyses like the JAMA Cardiology paper will boost confidence in Entresto, but Novartis is leaving nothing to chance.
The company recently announced a massive 40 trial programme called FortiHFy to reinforce the drug’s benefits, overcome resistance to prescribing and expand into new indications such as heart failure with preserved ejection fraction (HFpEF).
HFpEF accounts for around half of all HF cases and has very few treatment options.