Physician Views preview: Entresto gets expanded approval

After a slow and often scrutinised launch, heart failure treatment Entresto has become one of Novartis' key sales growth drivers in recent years. In 2020, it generated global revenues of $2.5 billion.

The company thinks peak sales could double to around $5 billion, a target that should now be in closer reach thanks to expanded approval in the US to include all patients with left ventricular ejection fraction (LVEF) below normal. Entresto therefore becomes the first approved treatment for heart failure with preserved ejection fraction (HFpEF), which is estimated to account for around half of all HF patients.

Quite how this approval translates into commercial success remains somewhat unclear, however. Novartis' pivotal-stage study in HFpEF fell just short against its primary endpoint, but data indicated that certain patients benefited from treatment with Entresto. Furthermore, in expanding the drug's label, the FDA has kept the definition of 'below normal' LVEF suitably vague, describing it as a "variable measure" that requires clinical judgement to be used.

Although Entresto can now effectively be used to treat 5 million of 6 million US heart failure patients, Novartis cautioned on Wednesday that adoption is likely to be slow and potentially influenced by how and when clinical guidelines are updated. Our prior survey suggests, however, that Novartis need not be conservative.

With approval now expanded, we are running another short survey to US cardiologists, specifically asking them…

Q. To approximately what percentage of all chronic heart failure patients under your care do you currently prescribe Entresto (sacubitril/valsartan)?

___% [Range 0-100]

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Q. On Tuesday (February 16), the FDA expanded approval of Entresto to reduce the risk of cardiovascular death and hospitalisation for heart failure in adults with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal.

The label also states LVEF is a variable measure and clinical judgment should be used in deciding whom to treat.

This extends the approved use of Entresto to include the treatment of patients with heart failure with preserved ejection fraction (HFpEF). What impact will this have on your overall utilisation of Entresto?

0 – No impact on my use             1            2            3            4            5            6            7              8            9            10 It will significantly increase my use

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Q. Entresto's prior indication was for heart failure with reduced ejection fraction (HFrEF), defined as LVEF of less than 40%.

With the new label stating that "LVEF is a variable measure and clinical judgment should be used in deciding whom to treat," what would you consider to be the upper-bound LVEF in patients suitable for treatment with Entresto (the PARAGON-HF study enrolled patients with ejection fraction of 45% or higher and found the most pronounced benefit was in patients with an ejection fraction below 57%)?

___% [Range 41-100]

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Q. If you plan to increase your utilisation of Entresto to include the treatment of patients with HFpEF, will your speed of adoption be influenced by when clinical guidelines are updated?

I don't intend to use Entresto to treat HFpEF

I plan to use Entresto for HFpEF and my utilisation will not be influenced by guideline updates

I plan to use Entresto for HFpEF and my utilisation will be influenced by guideline updates

_____________

Q. You said you currently prescribe Entresto to ___% of heart failure patients under your care.

Taking into account its expanded indication and looking ahead 12 months, to what percentage of all chronic heart failure patients under your care would you anticipate prescribing Entresto to in a years' time?

___% [Range 0-100]

_____________

Results and related analysis will shortly be published for FirstWord Pharma PLUS subscribers to read, with the opportunity for non-FirstWord Pharma PLUS subscribers to purchase these findings. To be notified when poll results and analysis become available, please click here

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