One big Novartis takeaway from Entresto's slow start? Heart failure doesn't work like oncology

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New clinical guidelines favoring Entresto have helped Novartis cut through payer roadblocks.

Novartis heart failure med Entresto, which got a slow start after launching to multibillion-dollar sales expectations, would have seen faster uptake, company executives figure—if only it had been an oncology treatment.

When the drug rolled out, Novartis had oncology professionals running its primary care business—and when they saw Entresto’s 20% reduction in CV death, “there was a belief that ‘the data will sell the drug’, and the payers will come,” Bernstein’s Tim Anderson wrote in a note to clients, paraphrasing Q&A responses from outgoing CEO Joe Jimenez and incoming chief Vas Narasimhan. “In oncology, it would be like this,” they added.

Instead, Novartis came up against resistance from cardiologists unaccustomed to new drugs in the setting and payers who, fearing a big financial hit from rapid Entresto growth, “put in place every roadblock they could.”

These days, the drug is selling better; clinical guideline decisions from the American College of Cardiology earlier this year went in Novartis’ favor, helping the company knock aside payer restrictions. And, in turn, total U.S. prescriptions have accelerated, Anderson wrote.

But the drugmaker still took away some key lessons that it intends to apply to future launches. “We are reminded to target the population with biomarkers … to pare down to a subgroup enjoying high efficacy that payers will have to grant access. And if not—we don’t launch it,” Anderson paraphrased the execs.

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That strategy is already on display with canakinumab, a compound that in August posted data showing it could reduce the risk for major cardiovascular events by 15% and for cardiovascular death by 10%. As Narasimhan said at the time, those figures likely wouldn’t be “fully compelling to payers.”

So a few months later, the company came back with a subgroup analysis it found more promising: In patients with high-sensitivity C-reactive protein (hsCRP) levels below 2 milligrams per liter three months after receiving the drug, canakinumab recorded a 25% risk reduction in major adverse cardiovascular events, plus a 31% reduction in cardiovascular deaths and all-cause mortality. And now, with those data in hand, the pharma giant is gunning for a CV approval.

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Meanwhile, now that Entresto has broken through payer barriers, Novartis feels good about the road ahead. The product would continue to grow steadily over the next three to five years even if the company did nothing, Jimenez and Narasimhan posited, noting, as Anderson put it, that there’s “a dynamic cycling of patients onto this drug that is not going to stop."

With the current flow of new-to-brand prescriptions, Entresto is on track to become a multibillion-dollar drug, they said, pointing to former heart blockbuster Diovan. Entresto is “a bit ahead” of where that med was at the same time post-launch, they said.