Sanofi and Regeneron will be meeting with USA health plans to discuss potential net pricing adjustments for those that agree to provide straightforward access for high-risk patients.
Results from the trial were presented during a late-breaker session at the American College of Cardiology's (ACC) 67 Annual Scientific Session in Orlando on Saturday.
Praluent was shown to have cut down the overall risk of major adverse cardiovascular events (MACE) by 15%, which is the primary endpoint of the trial. Management sees population of 300K - 400K high-risk patients in USA, only 38K being treated at present.
In addition to significantly reducing the primary endpoint-a combined rate of heart attack, stroke, hospitalization for unstable angina or death from coronary heart disease-alirocumab was also associated with a 15 percent reduction in death from any cause among the full patient population and a 29 percent reduction in death from any cause among those who started the trial with LDL cholesterol above 100 mg/dL.
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Praluent was also associated with a 15% reduction in all-cause mortality, and numerically fewer deaths from coronary heart disease.
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.
In terms of safety and tolerability, the only significant difference between the two study groups was minor local site reactions (mild itching, redness or swelling) at the injection site, which occurred in 3.1 percent of those receiving alirocumab and 2.1 percent of those receiving placebo.
The intention is to take a precision medicine approach to addressing the burden of cardiovascular disease, by focusing efforts on high-risk patients most vulnerable for future CV events, such as those who have suffered a previous event and are unable to reduce their LDL cholesterol (LDL-C) below 100 mg/dL despite statin therapy.
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For those in the Praluent treatment arm, an estimated 75% of patient time was on the 75 mg dose.
"Many patients who have survived a recent heart attack or other coronary event are unable to reach an LDL cholesterol goal of less than 100 mg/dL, and have an urgent need for new therapeutic options due to their increased risk of another event".
ICER's latest analysis sets a value-based price range of $4,500-8,000 per year, net of rebates and discounts, for this group, and the companies have said they will offer discounts of up to 69% to health insurers that reduce prescribing obstacles and will be meeting with United States health plans to discuss pricing adjustments. "Through this trial, we have been able to identify high-risk patients treated with optimal statins who still have an urgent need for additional treatment options".
"We believe a new paradigm is needed in how all members of the healthcare community collaborate to ensure that patients are able to affordably access the medical treatments they need", said Regeneron chief executive Leonard Schleifer in a statement.
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The ODYSSEY OUTCOMES data, backed with a public commitment to work with payers to reduce prices in patients who stand to benefit the most, is the flawless riposte to Amgen.