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

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

The companies will be providing high-risk patients with a reduced net price for Praluent, in alignment with a new value assessment approach developed by the US Institute for Clinical and Economic Review.

"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", added Elias Zerhouni, president, Global R&D, Sanofi. The organization recommended a price range of $4,500 to $8,000 for those high-risk patients likely to gain the most benefit from Praluent therapy.

High-risk patients who were subjected to Praluent injection in combination with maximally-tolerated statins had significantly lesser major adverse cardiovascular events compared to patients treated on only maximally-tolerated statins.

Praluent reduced the overall risk of MACE - which includes heart attack, ischemic stroke, death from coronary heart disease (CHD), or unstable angina requiring hospitalisation - by 15 percent, and was also linked with a lower death risk of death overall, the firms noted.

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Praluent's impact on the actual number of deaths from coronary heart disease was modest, however, failing to reach statistical significance (p=0.38). 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. All patients were randomized to receive alirocumab (n = 9,462) or a placebo (n = 9,462) and were treated for a median of 2.8 years, with some patients being treated for up to five years. The data were presented at the American College of Cardiology Annual Scientific Session & Expo in Orlando, FL.

"It may take years and years to really reap all the benefits that one can achieve", study co-chairman Dr. Gregory Schwartz said. It is unclear if benefits would have been more pronounced had more patients received the higher dose.

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.

The drug was deemed extremely safe with no difference from placebo in incidence of neurocognitive problems or new-onset diabetes.