December 17, 2018

Cholesterol drug lowers risk of death, heart attack

14 March 2018, 12:57 | Randall Craig

Regeneron and Sanofi Plan to Cut Cholesterol Drug Price in Exchange for Wider Coverage

Regeneron CEO Leonard Schleifer shown in 2016 said the exact discount that insurers receive will depend on how much they relax restrictions on who gets the drug

Regeneron and Sanofi's move to adopt ICER's recommended price range reflects the growing scrutiny of drug costs, and calls for pharmaceutical companies to price their products according to their value to patients, rather than what the market will bear, ICER President Steven D. Pearson said in an interview. "We are prepared to change this by improving access and affordability, eliminating these burdensome barriers for high-risk patients in need".

In the large Odyssey study, Praluent statistically significantly reduced the risk of MACE (the primary endpoint based on a composite of heart attack, ischemic stroke, death from coronary heart disease, or unstable angina requiring hospitalization) by 15% (similar to the benefit seen from Amgen's Repatha in a different outcomes study of slightly less sick patients) with a strong p-value of 0.0003.

Regeneron's (NASDAQ: REGN) alirocumab and Amgen's (NASDAQ: AMGN) evolocumab (Repatha), both approved in 2015, belong to a new class of cholesterol lowering medicines called PCSK9 inhibitors, which has been a key battleground between payers and drugmakers.

The PCSK9 inhibitor, which lowered blood lipids by 40-60% in previous trails, reduced the risk of MACE by 15% and was associated with a 29% lower risk of death overall in a patient population with acute coronary syndrome. They had LDL cholesterol at 70 mg/dL or above and non-HDL cholesterol 100 mg/dL or above. An Amgen-backed study released yesterday, for instance, found 65 percent of commercially insured and Medicare patients trying to get a PCSK9 blocker were denied access by their health plans in 2016. A price of $4,500 to $8,000 per year would be justified for patients at higher risk, with LDL over 100. Cardiologists interviewed by Xconomy say the drugs are nearly always rejected upon first request.

Investigators followed the patients for an average of 33 months.

Dr. Valentin Fuster, who critiqued the trial at the meeting but was not involved in the study, said the data show that what is considered normal LDL today may be too high. "It's so hard, I give up".

The offer has been made just after the presentation of the large-scale ODYSSEY OUTCOMES at the American College of Cardiology (ACC) meeting in Orlando, which showed that adding PCSK9 inhibitor Praluent (alirocumab) to high-dose statins reduced cardiovascular events and all-cause mortality compared to statins alone. 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.

On Saturday, the independent group said Praluent should cost, based on the new results, between $2,300 to $3,400 per year for people like those in the study.

The companies and the researchers who oversaw the trial focused on one subset of the patients, accounting for about 30% of the group, whose bad "LDL" cholesterol levels remained stubbornly high despite aggressive treatment to lower it.

Armed with that data, as well as new cost-effectiveness analysis from the US Institute for Clinical and Economic Review (ICER) which provide new estimates of the price range that would be acceptable for the drug - depending on the patient's level of risk.

Ben Fidler is Xconomy's Deputy Biotechnology Editor.

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