Novartis hit with DOJ probe into Entresto marketing all while dialing up peak sales estimate

The Department of Justice building
Novartis received a request from the U.S. Department of Justice asking for information about the marketing and pricing of heart failure med Entresto. (robertcicchetti/Getty Images)

Novartis is no stranger to investigations into its marketing practices. The latest? U.S. federal prosecutors are sniffing around the company’s second-best-selling drug.

In September, Novartis received a request from the U.S. Department of Justice (DOJ) asking for information about the marketing and pricing of heart failure med Entresto since 2016, the company disclosed (PDF) Tuesday.

The records the DOJ is seeking through the “civil investigative demand” include remuneration provided to healthcare professionals, Novartis said. The company added that it’s evaluating the subpoena. Such a request doesn’t mean a formal litigation process.

Just last year, Novartis wrapped up doctors’ kickback allegations with a $678 million settlement. As part of its agreement with the federal prosecutors, the Swiss drugmaker conceded that its sales reps had “selected high-prescribing doctors to become speakers and intended the honoraria paid to induce these doctors to continue to write or to write more Novartis products.”

That case targeted Novartis’ marketing activities between 2002 and 2011 and mainly focused on several aging high blood pressure products including Lotrel, Valturna, Tekturna, Diovan and Exforge. As part of the settlement, the company also agreed to scale back on future speaker programs.

RELATED: With new settlement, Novartis has shelled out $1.3B for kickbacks, bribery and price fixing this year

Entresto also belongs to Novartis’ cardiovascular portfolio, approved to treat patients with heart failure. The fixed combo of sacubitril and valsartan is Novartis’ second-ranking product by sales and is still on a strong growth trajectory. Thanks to a major label expansion earlier this year into heart failure with preserved ejection fraction, Entresto saw sales jump 41% at constant currencies to $2.6 billion in the first nine months of 2021.

Based on the strong performance, Novartis has dialed up its peak sales estimate, now expecting Entresto could hit at least $5 billion before potentially losing its market exclusivity in 2025. 

Recent recommendations from EU and U.S. cardiology societies for Entresto for front-line treatment are fueling penetration gains, Novartis Pharmaceuticals President Marie-France Tschudin told investors during a call Tuesday. But still, a large patient pool remains untapped. 

About 4 million patients are on Entresto today across the globe, but roughly 85% of U.S. heart failure patients who are eligible to receive Entresto remain on prior standard of care, Tschudin said.

RELATED: Is Entresto maker Novartis scared of Jardiance's landmark heart failure win? Not really, exec says

Novartis is also getting more bullish about its top-selling med, inflammatory disease therapy Cosentyx, having increased its peak sales estimate to at least $7 billion. The drug’s nine-month haul came in at $3.48 million after an 18% year-over-year growth at unchanged foreign exchange rates.

Cosentyx boasts five indications, all of which still have low biologics penetration, and is under testing to potentially cover more than 10 indications, Tschudin noted. Plus, the drug’s also the only interleukin inhibitor with national reimbursement in China, where Novartis sees strong growth potential, she added. 

Driven by Cosentyx, Entresto and spinal muscular atrophy gene therapy Zolgensma, among others, Novartis recorded $13 billion in third-quarter sales, up 5% at constant currencies over the same period last year.

Editor's note: The story has been updated with additional information from Novartis' earnings call.