- Sales of Novartis' Entresto (sacubitril/valsartan), which was approved for treatment of severe chronic heart failure (CHF) in July, were only $16 million for its first quarter post-approval. However, Novartis asserts that there are several reasons for this and that it expects an uptick in sales in coming quarters.
- One reason is that cardiologists are slow on the uptake of new drugs and often stick with generic mainstays for treatment of CHF.
- Entresto is not yet on most formularies, including Medicare Part D, which has a mandatory six-month block on new medications.
According to the CDC, roughly 5.1 million people in the U.S. have CHF, with an additional 550,000 diagnoses each year. The mainstay of care is comprised of various generic drugs, including ACE inhibitors, aldosterone antagonists, beta blockers, digoxin, diuretics, and other medications. Cardiologists and primary care physicians have been using these drugs for years since they understand how the drugs work and because they are relatively inexpensive.
Yet, despite an array of treatments, half of people who develop CHF die within five years. The introduction of Entresto to the market hinges on trying to decrease the mortality rate associated with CHF. And there's ample evidence that Entresto has this potential.
For instance, in a large phase 3 study of patients with CHF—PARADIGM-HF—treatment with Entresto decreased mortality by 20% compared with treatment with enalapril, an ACE inhibitor. In fact, the results were so compelling that the trial was stopped early.
All of this goes to say that an uptick in uptake should be expected given the formulary issues and the strength of the data. Still, Novartis will be embarking on a major DTC campaign in January, the point at which the six-month ban on advertising is lifted. The goal is to make Entresto a standard go-to treatment, which is included in consensus guidelines and viewed by physicians as a known drug. It's likely only a matter of time—but Novartis has its work cut out with convincing cardiologists that Entresto is worth the extra money and patient switches.