Sanofi, Regeneron to cut price of Praluent

Kenny Tucker
March 13, 2018

Regeneron Pharmaceuticals and partner Sanofi report new data this morning from a large, highly-anticipated trial suggesting that their drug alirocumab (Praluent) may reduce the risk of death for people with high cholesterol who have recently suffered heart attacks or strokes and are at risk of having another one or dying.

The news comes as the high price of prescription drugs remains a big political flashpoint; both new U.S. Health and Human Services Secretary Alex Azar and FDA Commissioner Scott Gottlieb amped up the pressure on drug companies, hospitals, and insurers this week to change payment schemes and increase drug price transparency to help drive down healthcare costs.

The net price range is based on a cost-effectiveness analysis by an independent nonprofit group called the Institute for Clinical and Economic Review. The trial is the first to show a statistically significant reduction in deaths by a PCSK9 drug, compared to placebo. As heart attack is a common and leading cause of death, hence it is important to find the proper treatment that can slow down the risk for people.

"Not all patients with heart disease are the same". The discount deal would apply only to patients with dangerously high levels of cholesterol who are at especially high risk for heart attack or stroke. "With almost 90 percent of the patients in this trial on high-intensity statins, the data demonstrate that a precision-medicine approach in the field of cardiovascular disease may further advance how we better treat high-risk patients". Regeneron and Amgen have been hoping to make PCSK9 blockers available to more and more of the millions of patients who can't reduce their unsafe cholesterol levels with statins, or can't tolerate them because of side effects.

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Alirocumab inhibits the binding of proprotein convertase subtilisin/kexin type 9 (PCSK9) to the LDL receptor and thus heightens the number of available LDL receptors on the surface of liver cells. The analyses presented included the results from 730 patients (8%) in the Praluent group who continued to be assessed in the Praluent arm despite stopping therapy with the drug, as specified in the protocol for patients with persistent LDL-C readings below 15 mg/dL.

With an LDL target range of 25-50, rather than taking it as low as possible, three-quarters of patients ended up on a lower dose of Praluent and some were taken off the drug if their LDL remained at 15 or lower.

Regeneron president and chief scientific officer George Yancopoulos said: "This trial was consistent with earlier statin trials, showing the greatest benefit in patients with higher cholesterol levels at baseline". The companies are specifically asking that insurers loosen restrictions only for patients at the highest risk of death-those who have had a heart attack or other serious coronary event in the past year, and whose cholesterol levels exceed the threshold recommended by doctors despite taking statins.

The makers of an expensive cholesterol-lowering drug plan to offer discounts of up to 69% in exchange for insurers and pharmacy-benefit managers expanding their coverage of the medicine to more patients.

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