Novartis' Entresto gets the go-ahead in Europe

Novartis' ($NVS) blockbuster-in-waiting, Entresto, has been handed its second big approval. The new heart failure drug has snagged an OK from the European Commission.

The Swiss drugmaker said today that the EC approved the twice a day pills for the treatment of adults who have symptomatic chronic heart failure with reduced ejection fraction (HFrEF). Novartis sought approval after an 8,442-patient study was stopped early because those given Entresto were more likely to be alive and less likely to have been hospitalized for heart failure than those given the standard therapy, enalapril. The drug won an early approval in the U.S. in July.

"We know that people living with heart failure face a high risk of death and have a worse quality of life than those with almost any other chronic condition, so it is very meaningful for HFrEF patients in Europe that we're able to offer a new first-in-class treatment option," David Epstein, who leads Novartis pharma division, said in a statement.

Novartis' pharma head David Epstein

What Novartis did not say is what the base price would be in Europe for Entresto, a drug it has said could reach $4 billion or more in peak sales. In the U.S., it is $12.50 a day, or about $4,560 a year, for the two-pill-a-day regimen, a cost that payers are complaining about. To dampen some of that concern, Novartis is in discussions with payers about the idea of performance-based pricing, so that the cost depends on the drug's effectiveness.

The value pricing idea is getting a lot of discussion as the approach drugmakers are headed toward but has yet to be seriously tested and some payers see traps in the method. One critic is Steve Miller, the CMO at pharmacy benefits manager Express Scripts ($ESRX), who became a public figure with his moves to fight what he saw as the exorbitant prices of the new hepatitis C cures.

For instance, Miller has asked, who bears the cost when patients don't take their drugs or follow diets and end up in the hospital? He asked the question to Bloomberg when Novartis started talking value pricing for Entresto. "If the patient isn't adherent with taking the drug, is it the drug's fault or the patient's fault?" he asked rhetorically.

In other cases, Miller and Express Scripts have been the advocates of value pricing. They have talked about it for drugs that are approved for a variety of different cancer types, with payments based on how well the treatments work in each indication. Miller has suggested to the Wall Street Journal that in that case the PBM would for example, pay Roche ($RHHBY) more for Tarceva for lung cancer, where the survival advantage might justify it, but less in another form of cancer where the survival advantage is less.

- here's the release

Special Report: The 25 most influential people in biopharma in 2015 - Steve Miller - Express Scripts - David Epstein - Novartis