Novartis AG NVS 0.86% bet big on its new cholesterol-busting drug. To overcome the tricky market for new heart medicines, it is pursuing an unconventional strategy that turns the traditional drug launch on its head.
Rather than seeking to grab the attention of patients and winning support from individual physicians, the Swiss pharmaceutical giant is focusing on the people who run large hospital systems. Its pitch: A large-scale rollout of the drug, called Leqvio, could avert thousands of heart attacks and strokes.
Despite heart disease being the No. 1 killer in the U.S., the strategy could prove challenging to pull off. It would count on the endorsement of cardiologists, who are often hesitant to adopt new treatments when they already have a bevy of tried-and-trusted medicines in their arsenal. It would also depend on the support of insurers, who have previously been reluctant to pay for pricey new heart drugs.
But if Novartis succeeds, it could unlock a lucrative market that has proven tough for others to crack. Leqvio was at the center of Novartis’s $9.7 billion acquisition of The Medicines Co. two years ago. The drug would need to hit $3 billion to $4 billion in annual sales to justify the price tag, according to analysts. Novartis says it expects Leqvio to become one of its biggest sellers.
Novartis is pursuing an unconventional strategy in launching Leqvio.
PHOTO: NOVARTIS
Novartis plans to promote Leqvio to doctors through its existing sales force for heart-failure drug Entresto. But, unlike other big drug launches, sales representatives won’t play the starring role. “We’re talking about thousands of reps that we’re not hiring,” said Marie-France Tschudin, president of Novartis Pharmaceuticals.
The company says it plans to approach around 200 hospital systems across the U.S. It wants to help them identify, through electronic health records, heart patients who struggle to control their cholesterol with existing drugs. The hospital would then offer these patients Leqvio to prevent further heart problems, in a process more akin to a vaccine drive than a drug launch. Novartis expects to finalize agreements after the Food and Drug Administration completes its review of Leqvio, which the company expects early next year.
Central to the idea is that hospitals would set criteria for eligible patients and set up systems to identify them “instead of having each physician making a call for that individual patient,” said Ms. Tschudin.
Some health systems already take this so-called population health approach. “That proactive management is not new to us,” said Mike Evans, chief pharmacy officer at Danville, Pa.-based Geisinger, which runs nine hospitals in Pennsylvania. “An ounce of prevention is a pound of cure.”
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Geisinger insures around half of the patients that it treats, creating a financial incentive, on top of the clinical rationale, for cutting emergency admissions. While most hospital systems don’t also provide health insurance, there is a growing focus on preventive care. Mr. Evans didn’t specify whether Geisinger had been approached by Novartis about Leqvio.
The drug targets a type of cholesterol known as low-density lipoprotein, or LDL, the sort that can clog up blood vessels and increase the risk of heart attacks and strokes. It isn’t the first drug to do so: for decades, people have been taking statin pills to do the same thing. Around 20 million people in the U.S. take statins following a heart attack or stroke. In recent years, new injectable LDL-lowering drugs have also hit the market.
Despite the widespread availability of statins, which cost pennies a day, most people struggle to lower their LDL. Less than half of all people using statins cut their cholesterol to the recommended level after two years of treatment, according to a large U.K. study published in 2019.
One reason: it is hard to stick to a daily pill for an invisible ailment. A 2016 study in the Journal of the American College of Cardiology found that just 43% of patients who had been prescribed daily statins and ACE inhibitors—a type of drug that widens blood vessels—after a heart attack took them as advised.
Novartis hopes Leqvio can overcome this problem because it is delivered by an injection twice a year and could be administered during routine heart checkups.
Leqvio is also more powerful than statins. In two major clinical trials on patients with a heart problem related to high cholesterol, it cut LDL levels in half when taken on top of statins. In the placebo group, most of whom were taking statins, cholesterol levels rose slightly.
Even so, some cardiologists may remain reluctant to widely prescribe Leqvio without hard evidence that it reduces heart attacks and strokes. While there is a well-established link between LDL cholesterol and heart risks, a trial to show whether Leqvio prevents those events too won’t produce results until 2024 at the earliest. Cardiologists also want reassurance that the drug doesn’t have any unexpected side effects, said Adrian Hernandez, a cardiologist and executive director of Duke Clinical Research Institute.
Leqvio will compete against two similar drugs that have been on the market for a few years, and have already proven that they reduce the risk of heart attack and stroke.
Those drugs, Repatha from Amgen Inc. and Praluent from Sanofi SA and Regeneron Pharmaceuticals Inc., cut cholesterol by roughly the same amount as Leqvio. All three target a protein called PCSK9 that is implicated in the buildup of LDL. Leqvio stops it being produced, while Repatha and Praluent, known as PCSK9 inhibitors, block its action. Novartis hopes its twice-yearly dosing will give it an edge over the rival drugs, which patients self-inject every two or four weeks.
Amgen cut the price for its cholesterol drug Repatha to win broader coverage.
PHOTO: ROBERT DAWSON/ASSOCIATED PRESS
Clyde Yancy, chief of cardiology at Northwestern University Feinberg School of Medicine in Chicago, Ill., said he would in most cases hold back from prescribing Leqvio until the long-term trial produces results. “With lifestyle [changes] plus statins I can control [the cholesterol levels of] virtually every patient in my practice,” he said. “If I need something else, I have PCSK9 inhibitors.”
Even if hospital bosses and cardiologists embrace Leqvio, insurers could still throw up barriers to curtail its use.
Leqvio’s competitors Repatha and Praluent offer a cautionary tale. Those drugs went on sale in 2015, within months of one another, with similar list prices of around $14,000. But insurers imposed high copays and burdensome paperwork that limited their use. Both companies later cut prices by around 60% and won broader coverage.
Novartis hopes to avoid those pitfalls. It plans to price Leqvio at a similar level to the discounted rate for Repatha and Praluent. And while insurers can steer patients away from pricier drugs at pharmacies by charging higher copays, they have fewer tools for controlling the use of drugs that are administered in hospitals or clinics, as Leqvio will be.
“We don’t know if we’re going to succeed, but what we do know is what’s in place today isn’t working,” said Novartis’s Ms. Tschudin. “We need to take a different approach.”
