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 risky cholesterol levels with statins, or can't tolerate them because of side effects.
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. The study, reported at the conference of the American College of Cardiology, involved 18,000 high-risk patients who had uncontrolled cholesterol despite taking a maximum amount of statins.
These participants, who had high cholesterol despite high-intensity statin therapy, saw their rates of reduced rates of major adverse cardiovascular events, called MACE, reduced by 15 percent compared with a placebo.
"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".
As federal officials struggle to tackle exorbitant pharmaceutical prices, at least one drug's manufacturers have pledged to slash prices of a potentially life-saving drug for its most at-risk patients. 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.
The new study tested the rival drug, Praluent, for a longer time and in patients at higher risk - almost 19,000 people who in the previous year had a heart attack or chest pain serious enough to put them in the hospital.
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Praluent functions by preventing the binding of proprotein convertase subtilisin/kexin type 9 (PCSK9) to the LDL receptor.
The drug, which is injected every two weeks or every four weeks based on strength, allows the liver to remove more LDL from the blood and lowers the concentration of LDL cholesterol in the blood. If the drugs were used more broadly to treat all patients included in the trial, the cost-effective price would be in a range of $2,300 to $3,400 annually, ICER said. "Really, it's not just a shame, it's nearly a crime to deny this drug to these patients who are at such high risk and will derive such a big benefit". Praluent was started at a lower dose and increased if LDL did not drop below 50.
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.
"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. Insurers often balk at their high list prices, some $14,000 apiece per patient, per year.