Slow Start For New Novartis Heart Failure Drug Entresto

Initial sales of Entresto (the combination of sacubitril and valsartan, formerly known as LCZ696) have been slow. In the first few months after its approval in July the drug only had $16 million in sales, the drug’s manufacturer, Novartis, reported last week during its quarterly earnings report. The novel heart failure drug is widely expected to be a blockbuster, but the company and outside observers agree that the early stages may be challenging.

The slow start has a number of causes, according to the company. First, the drug hasn’t yet found a place on formularies, an absence that will be at least partially remedied after the expiration of the six month Medicare Part D mandatory block on new drugs. Medicare reimbursement is key to the future of the drug, since patients on Medicare account for two-thirds of the drug’s likely population.

Also, as reported on Fierce Pharma Marketing, cardiologists “have been using cheap generics to treat heart failure for years now, and they won’t automatically switch to a new, costly drug; Entresto’s list price is $4,500 per year. That takes some convincing. And even those doctors already aware of–and sold on–Entresto’s benefits aren’t likely to push reluctant payers to cover it.” Unlike doctors in some other specialties, cardiologists are not prepared for the extensive fights that can be required to obtain reimbursement for expensive new drugs, said a Novartis official. “They’re just not used to doing it and psychologically it’s even difficult for them to do it.”

Beyond securing reimbursement, direct-to-consumer (DTC) advertising will be a a key strategy for Novartis. It’s likely we’ll see a blizzard of ads in January once the six month ban on advertising new drugs expires.

The eventual place for Entresto in the guidelines will be another key factor. According to one executive, Novartis expects to see updates in both the European and American heart failure guidelines next year, with the European update likely to appear first. “What they will actually say, we are going to have to await and see,” said one executive, but the company is optimistic, given the highly positive results of the PARADIGM-HF trial last year.

During the conference call an executive said the company had been encouraged by the September report  from ICER which found the drug to be “both clinically effective and cost effective…. As you can imagine, having such third-party analysis is helpful for discussions with payers.” But the executive said he thought the ICER prediction that Entresto would achieve 75% market penetration within five years was “on the bullish side.”