By Thomas M. Burton And Peter Loftus
The Food and Drug Administration approved a promising new
heart-failure drug from Novartis AG that cardiologists say could
potentially improve the lives of millions of patients with the
condition.
The drug, called Entresto, was studied in a clinical trial of
more than 8,000 adults and--in a rare development--reduced the rate
of cardiovascular death and hospitalization compared to a standard
generic therapy, enalapril.
Clyde Yancy, chief of cardiology at Chicago's Northwestern
Memorial Hospital, said that Entresto is "one of the few times that
we have identified a medication that is better than the standard.
It's clearly superior to what we have."
Dr. Yancy, a heart-failure specialist, doesn't have any
relationship with the drug's maker. He estimated that of the six
million people in the U.S. with heart failure, "at least half may
be candidates" for the medicine. And he said that the drug "may
fundamentally change their lives for the better."
Heart failure is a condition in which the patient's heart has
lost some of its pumping capacity, and it can degenerate into a
situation where patients have difficulty breathing and end up in
the emergency room. Dr. Yancy said the drug is especially useful in
"the comfortable patient who can tolerate full doses of
therapy."
Since most of the existing treatments for heart failure are
lower-cost generics, the test for the new treatment may in part be
an economic one. Insurers increasingly are balking at the high cost
of drugs such as those for cancer and hepatitis C.
Wall Street predicts Entresto will be a blockbuster, with
Leerink Partners estimating that annual global sales could top $6
billion by 2024. That would help Switzerland's Novartis weather
impending generic competition for cancer drug Gleevec.
The U.S. price for the twice-daily tablet will be $12.50 a day
per patient, according to a Novartis spokeswoman. The company is in
early-stage discussions with some U.S. health payers to link the
drug's price to clinical outcomes in patients who take it, such as
the rate of hospitalizations for heart failure, the spokeswoman
said. The company didn't identify the payers, and it said it was
too early to share more specifics.
Drug makers and payers have increasingly explored such
"pay-for-performance" pricing models--rather than paying a fixed
per-pill or per-vial cost--amid complaints about the rising price
of medications.
Steve Miller, chief medical officer of the pharmacy-benefits
manager Express Scripts Inc., said that "outcomes-based pricing
clearly comes with some logistical challenges, but it is worth
considering as a strategy to get this drug to the right
patients."
Write to Thomas M. Burton at tom.burton@wsj.com and Peter Loftus
at peter.loftus@wsj.com
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