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March 12, 2018 at 07:35 PM
Regeneron Pharmaceuticals Inc. and Sanofi are taking the unprecedented step of cutting the price of their $14,000-a-year heart drug Praluent and narrowing its use to high-risk patients shown to benefit most in an effort to get insurers to ease restrictions on its use.
A highly anticipated study of the injected drug found it reduces complications including heart attacks and strokes by 15 percent, less than the 20% benefit analysts say would be needed to force insurers to loosen their stranglehold.
The companies honed in on a smaller group of patients who responded even better, and said they would cut the cost for that group in exchange for allowing them better access.
(Related: `Rigged’ System Blocks Lower-Cost Drugs, Head of FDA Says)
The new price will be in line with a recommendation from the Institute for Clinical & Economic Review, which found Praluent would offer good value at a cost of $4,500 to $8,000 a year in high-risk patients. The study, presented Saturday at the American College of Cardiology meeting in Orlando, Florida, found those patients got a 24% benefit, including a 29% reduction in death.
Opening Move
“Today, we have made the opening move and we challenge payers to respond by making Praluent readily accessible to high-risk patients,” said Regeneron Chief Executive Officer Leonard Schleifer, in a conference call with analysts.
The 19,000 patient study yielded similar disappointing results to one generated a year ago by Amgen Inc.’s rival treatment, Repatha. Both drugs are in a class of medicines known as PCSK9 inhibitors that were once hoped to slash heart complications as dramatically as they help lower cholesterol. But last year’s findings on Repatha sank Amgen’s stock and failed to spark sales, even after the company offered a money-back guarantee.
The new study included people vulnerable to heart problems after they’d survived a heart attack or severe chest pain caused by reduced blood flow to the organ within the previous year. Praluent slashed bad cholesterol by more than half after four years. Heart attacks, strokes, hospitalizations and deaths from heart disease occurred in 9.5% of Praluent patients, compared with 11.1% of placebo patients.
The companies and the researchers who oversaw the trial focused on one subset of the patients, accounting for about 30% of the group, whose bad “LDL” cholesterol levels remained stubbornly high despite aggressive treatment to lower it. Those patients responded best. Their results:
Complications in the highest-risk group Praluent Patients Placebo Patients Heart attack, stroke, hospitalization, death 11.5% 14.9% Death from any cause 4.1% 5.7%
“The majority of our benefit was accounted for by these people who had the highest LDL and the highest risk,” said George Yancopoulos, chief scientific officer at Tarrytown, New York-based Regeneron. “We have to get the whole world to realize this is cost-effective for society and we have to get this drug to the patients who will benefit the most.”
The findings may sway insurance companies and pharmacy benefit managers, which had urged the drugmakers to identify patients most likely to benefit. Some clinical trial purists, however, may say the mortality results aren’t definitive because the companies decided to analyze those findings after the study was complete, rather than planning it in advance.
