- Patients treated with Novartis' new heart failure drug Entresto saw less of a decline in health-related quality of life scores, compared to enalapril-treated patients, according to a new analysis of data from the PARADIGM-HF study, one of the Swiss drugmaker's many trials aimed at proving Entresto's benefit.
- Clinically meaningful declines in these scores are linked to major adverse events for patients, such as heart failure hospitalization or cardiovascular death.
- Despite evidence of clinical benefit, Entresto sales have struggled to get off the growth. But Novartis has doubled down on its investment in the drug, expanding its clinical trial program and signing a number of pay-for-performance deals with U.S. health insurers to boost coverage.
Sales of Entresto, Novartis' combination of sacubitril and valsartan, haven't been quite what Novartis hoped. When the drug was first approved in the U.S., Novartis predicted peak annual sales could exceed $5 billion. Some analysts pegged peak revenue at even higher sums.
While Entresto's Q2 sales of $32 million were almost double the $17 million in Q1, revenue still lags behind the $200 million pace Novartis expects the drug to hit this year.
In hopes of buoying Entresto's performance, Novartis has pumped more money into marketing the drug and advancing further studies. Novartis has also inked pay-for-performance agreements with Aetna, Cigna, Humana and Harvard Pilgrim, tying the cost of Entresto to its ability to reduced heart failure-related hospitalizations.
The new analysis of the PARADIGM-HF study looked at quality of life and its relation to hospitalization and other patient outcomes. This type of data are increasingly demanded by payers that want to know how a drug performs in everyday life.
According to two recent studies, Entresto could potentially prevent or delay more than 28,000 U.S. deaths each year, and reduce long-term costs when compared with standard of care. It has also been added to practice guidelines for the management of heart failure. So what has stopped sales from taking off?
One factor could be familiarity — physicians tend to stick with what they know. Or the slow sales could be tied to its $4,600-a-year price tag. Novartis has also pointed to extended review times for new drugs in the U.S., as payers slow-walk expensive drugs to analyze potential benefit.
Regardless of reason, its clear Novartis believes in this drug's potential. Future earnings reports will see if that faith is borne out.