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Regeneron, Sanofi: New data, price plan on cholesterol med put onus on payers

Sanofi and Regeneron Pharmaceuticals Inc.'s promise of lower costs for cholesterol drug Praluent and the results of a five-year study mean it's now up to the payers to improve access to the medicine, executives from both the companies said.

Praluent, part of a class of cholesterol therapies known as PCSK9 inhibitors, reduced the risk of major cardiovascular events by 15% in the overall trial population, but showed particular effects in the highest-risk set, with 24% risk reduction and 29% lower risk of death, results from the study, dubbed Odyssey, showed.

Alongside presenting the findings at the annual American College of Cardiology meeting on March 10, the companies said they would bring the treatment's more-than-$14,000 annual cost down for payers that were willing to work with them on access, basing their new price projections on an analysis by the U.S. price watchdog the Institute for Clinical and Economic Review, or ICER.

The price group had said in a statement on March 10 that the medicine would be cost-effective at $4,500 to $8,000 a year for the high-risk population, and at $2,300 to $3,400 a year for other patients.

"Now, we need to put the onus on the payers to make sure that if the doctors think it's right, and the price is fair, that the payers will oblige with good, fair, straightforward access," Len Schleifer, Regeneron president, CEO and executive director, said in an investor call the same day.

This does not mean that the companies are committing to ICER-advised cost ranges, Sanofi CEO and Director Olivier Brandicourt said on the call. The updated prices "will be very much dependent on that access we can get with individual payers," he said.

Because of that, it is unlikely that the new prices will be publicly disclosed.

Brandicourt said that they would be confidential and negotiated on a case-by-case basis.

Assigning value

Amgen Inc., maker of the other approved PCSK9 therapy Repatha, has countered calls for price cuts with its own series of studies on cost-effectiveness and payer access barriers. Amgen's large-scale trial for Repatha, called Fourier, was presented at the annual cardiology meeting in 2017.

There are significant differences in Sanofi and Regeneron's study design and findings, Robert Pordy, Regeneron's vice president of cardiovascular and metabolism therapeutics, said in an interview.

"I think it is most important to note that Praluent was the only one that had a mortality benefit actually accentuated in the greater-than-100 subgroup," he added, referring to the set of people with certain lipoprotein levels persistently above 100 milligrams per deciliter.

There could be between 300,000 and 400,000 patients a year that fit into that group if the Odyssey trial's definition of high-risk patients is projected onto the U.S. population, ICER had said in its review.

Some analysts pointed out that within the mortality figures there were some complex results. Namely, the risk of death from a cardiovascular event such as heart attack — as opposed to death from coronary heart disease or other reasons — was not as statistically significant as the overall figure.

It is difficult to parse out the specific causes of deaths and in analysis, overall death rates are a cleaner measurement, executives from both companies said.

"Life or death does matter," Schleifer said.

For Bordy, who has ushered Praluent through development since its phase 1 trial, the weekend's results were particularly meaningful. After his mother's heart attack at age 40, she tried various medicines and eventually a multiple bypass surgery.

"I only wish that Praluent was around when she was around, because she would have been placed on it," he said.