March 10, 2018 / 2:00 PM / a year ago

Regeneron/Sanofi heart drug succeeds in major trial; Will insurers pay?

March 10 (Reuters) - A potent, expensive cholesterol drug sold by Regeneron Pharmaceuticals and Sanofi significantly reduced major adverse heart events in a huge study presented on Saturday, but it remains to be seen whether the new data will prompt insurers to pay for increased use of the medicine.

The drug, Praluent, also led to fewer deaths among high-risk patients, which could be the strongest argument for insurers to finally remove barriers that have severely constrained sales and frustrated physicians trying to get the medicine to patients.

Insurers have balked at paying for cholesterol drugs like Praluent with list prices of more than $14,000 a year before discounts over fear they could be used for many years by millions of patients.

The multi-year study, called Odyssey Outcomes, tested the injected biotech drug versus placebo in nearly 19,000 patients who had a recent heart attack or severe chest pain episode and were already on maximum doses of cholesterol-lowering statins, such as Pfizer’s Lipitor.

The trial succeeded on its primary goal, reducing the combined risk of heart attack, stroke, heart disease-related death and chest pain requiring hospitalization by 15 percent.

While the fewer heart-related deaths with Praluent did not reach statistical significance, there was a nominally significant reduction in all-cause deaths - 334 versus 392 for placebo, researchers reported.

In a subgroup analysis of highest-risk patients - those with “bad” LDL cholesterol of 100 or above despite maximum statin therapy - Praluent significantly reduced all-cause death risk by 29 percent and risk of the adverse event composite by 24 percent.

Those are the patients most likely to be prescribed the medicine, researchers said.

“It matters tremendously to patients and physicians when there are fewer deaths in one column than the other,” said Dr. Phillippe Steg, the study’s co-chairman who presented the data at the American College of Cardiology meeting in Orlando.

“I think that will impress the field and people who have to make (reimbursement) decisions,” added Steg.

Data presented on Amgen’s rival drug Repatha, which also has a list price of more than $14,000, showed that some 70 percent of prescriptions are being denied, even for those deemed at highest risk of serious heart problems. Praluent has faced the same issues.

Regeneron and Sanofi shared the Odyssey results with ICER, an independent organization that evaluates clinical and cost effectiveness of new medicines, to seek its view based on the new findings.

ICER’s updated report issued on Saturday found that for higher-risk patients $4,500 to $8,000 was an appropriate annual Praluent price based on the value of the benefits those patients receive. But for the larger at-risk population with LDL below 100 the cost should be $2,300 to $3,400, it said.

A similar Repatha study in a slightly different patient population showed an identical 15 percent overall risk reduction but no death benefit.


That trial, carried out over two years, showed a more pronounced risk reduction in the second year, leading some cardiologists to suggest a longer trial would have spawned better results. Odyssey followed patients on average for 3.3 years and the risk reduction versus placebo was greater over time.

Artery clogging that leads to heart disease problems develops over decades, noted study co-chairman Dr. Gregory Schwartz.

“It may be unrealistic to think it can be modified on the timeframe of a usual clinical trial. It may take years and years to really reap all the benefits that one can achieve,” Schwartz said.

With an LDL target range of 25-50, rather than taking it as low as possible, three-quarters of patients were on a lower dose of Praluent and some were taken off the drug if their LDL remained at 15 or lower. It is unclear if benefits would have been more pronounced had more patients received the higher dose.

The drug was deemed extremely safe with no difference from placebo in incidence of neurocognitive problems or new-onset diabetes. (Reporting by Bill Berkrot; Editing by Cynthia Osterman)

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