JPM 2022: Novartis rewrites the drug launch playbook with Leqvio, and it doesn't plan to stop there, exec says

When Novartis scooped up The Medicines Company and its promising cholesterol drug inclisiran back in late 2019, the company jumped into a field where some of its pharma rivals had struggled to meet expectations over the years. Now, with approvals on both sides of the Atlantic, Novartis is busy rewriting the drug launch playbook in cardiovascular disease.

While Novartis' Leqvio launch strategy will vary in different countries worldwide, the "philosophy" is "very much the same," Novartis' pharma president Marie-France Tschudin said this week in an interview during the virtual J.P. Morgan Healthcare Conference. About 300 million people worldwide have cardiovascular disease, and 80% of serious cardio events are preventable, Tschudin said. 

"We have everything in our hands to make a real difference in cardiovascular disease," she said. "But there are a number of issues not related to clinical barriers."

Those barriers include challenges for patients reaching the right diagnosis and treatment plus drug affordability, Tschudin said. For Leqvio, Novartis wants to "work with systems of care" to help prevent serious cardiovascular complications. 

That means that in the U.S., the company won't just follow a "traditional marketing" approach in an attempt to change prescribing behaviors, Tschudin said. Instead, the company is also working with about 200 healthcare systems—such as hospital groups—to convince them of the power of its new drug when given to appropriate patients.

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Through the partnerships, Novartis wants to home in on how best to identify patients who could benefit from the treatment, create ways for patients to get on the treatment and, finally, enable drug access, Tschudin said. The company is at "different stages" of dialogue with the various groups, but it believes healthcare systems are increasingly moving toward a "preventative medicine approach," Tschudin said.

As one example, Novartis is working with Jefferson Hospital in Philadelphia on a partnership aimed at improving access to treatment for underserved populations, Tschudin said. In September, the partners unveiled a three-year "Close the Gap" initiative aimed at addressing the reasons cardio health varies so widely between the city's different ZIP codes.

Leqvio won FDA approval late last year as an adjunct treatment to diet and statins to lower the level of bad cholesterol in patients who have failed to control elevated low-density lipoprotein cholesterol with statins. Novartis acquired the drug through its $9.7 billion buyout of The Medicines Company in 2019. Shortly after that deal, the drugmaker unveiled a "population-level agreement" deal with officials in England, offering an early hint that the company would try a new approach with the launch.

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The drug, a PCSK9-targeted RNAi therapy, is hitting the scene in a field where other pharmaceutical products—namely Repatha from Amgen and Praluent from Sanofi and Regeneron—have struggled in part because of payer barriers. Those companies launched their drugs with before-discount prices of about $14,000 per year, but they've since cut their prices in a bid to boost access. Leqvio costs $9,750 for the first year and $6,500 for subsequent years before discounts, according to reports.

As for Novartis, the company thinks the population health strategy could apply beyond cardiovascular disease and Leqvio, Tschudin said. Amid the recent challenges for healthcare systems, such as ballooning costs and the pandemic, the Novartis executive said there's a new opportunity for the pharma industry to “interact and play a different role in the healthcare ecosystem.” Still, Tschudin thinks industry can expect more "accountability" going forward, as health systems and patients want more assurances that its products will provide expected benefits.