As Novartis approached approval for its heart failure drug Entresto, executives saw a “megablockbuster” that could be the company’s “fastest launch ever.”
Well, megablockbuster remains to be seen. Fastest launch? Not close. But Novartis has reason to believe, according to some new data--and expert commentary at the European Society of Cardiology meeting this week.
First, as if to counter payers that have set limits on Entresto, a cost-effectiveness study published in the Annals of Internal Medicine found that the drug delivered “reasonable value” for patients with class II to IV heart failure and ejection fractions less than 40%. In an accompanying editorial, the journal noted that it was the third analysis to deem Entresto cost-effective.
But the editorial’s authors--who include Dr. Milton Packer, one of the two lead investigators an a pivotal Entresto trial, Paradigm-HF--predicted that little would come of the new numbers. “Will this latest analysis persuade physicians not currently prescribing the drug to start doing so?” they wrote. “We doubt it.”
That’s the Novartis lament. Despite impressive trial data and high expectations, doctors haven’t been prescribing the drug, nor payers covering it, as widely as previously thought. The drug delivered a measly $32 million in second-quarter sales.
The editorial went on to lay out a case for doctors to boost their uptake. It’s a detailed case, and complicated, if one wants to dig into the nitty-gritty of comparing data, assessing patients’ death risks, and so on. Those devilish details are why, one expert said at ESC, that Entresto hasn’t hit the ground running. The slow uptake “is a reasonable path,” Northwestern University Feinberg School of Medicine’s cardiology chief, Clyde Yancy, said at the meeting (as quoted by CardioBrief).“[W]e need to provide a lot of education--you can’t digest all the news in a soundbite.”
Novartis has a newly expanded force of sales reps trying to educate doctors about their drug. The company’s payer reps are on the case as well, aiming to make sure that scripts that are written are scripts that can be filled.
Novartis has scored several pay-for-performance deals on the drug, which was one of the company’s goals before launch; CEO Joe Jimenez has said that such results-oriented payments are likely to pay off for truly innovative drugs, and, of course, he sees Entresto as one of them. Cigna and Aetna, for two, have signed up. Soon enough, Novartis and the payers will have some real-world numbers to show whether the trial success translates. Packer and his fellow authors actually think the drug’s value on the market will exceed their trial-based calculations, because Entresto’s cost is likely to be lower under payer contracts.
Entresto also now boasts a Class 1 recommendation in influential heart failure treatment guidelines--a recommendation that advises doctors to not only try the drug in eligible patients, but to switch them from older therapies. Novartis hopes the backing will give Entresto a jump start. But again, it’s complicated, Yancy told CardioBrief. So many drugs have Class 1 recommendations that “most heart failure patients will need to be seen by a heart failure specialist” to determine the best course.
In Europe, however, Entresto is already catching on more rapidly than in the U.S., and there aren’t heart failure specialists on every corner there. The difference may be with payers--single payers, in most countries on the continent--who expect to reap the long-term savings on hospitalizations that Entresto promises. In the U.S., patients cycle from plan to plan, even Medicare patients, who review their Part D drug coverage annually.
“The savings that Entresto could provide across the system is being recognized,” Jimenez said in announcing first-quarter sales of the med. The company expects $200 million in full-year sales for the drug worldwide.
Prominent cardiologist Steve Nissen of the Cleveland Clinic thinks doctors need to step up. “I’m not a heart failure doctor but when a drug shows a 20% reduction in death in a very mortal disease you have to sit up and take notice,” he said at ESC (as quoted by CardioBrief). “When I see heart failure patients I look to see how they match up with the patients in the Paradigm-HF trial, and if it’s appropriate I will discuss it with them.”
And forget questions about whether Entresto is cost-effective, Nissen said. Payers need to step up, too. “Look at cancer,” Nissen said. “They pay hundreds of thousands of dollars for therapies that add a few weeks. But for a chronic disease like heart failure we have trouble getting reimbursement.”
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