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Cholesterol-lowering drugs known as PCSK9 inhibitors can reduce the risk of heart attack and stroke by 20 percent, new research confirms. And if patients and health plans still harbor doubts, at least one manufacturer has a bold offer: a money-back guarantee.

Reduced Risk of Heart Attack, Stroke

Presented at the annual American College of Cardiology meeting, new clinical trials data demonstrate that:

The significant reduction in LDL eclipses gains typically made by patients taking traditional statins alone.  About 80 percent of study participants had suffered heart attacks previously.

Alliance for Patient Access Executive Director Brian Kennedy remarked on what this data could mean for patients.  “Heart disease accounts for one in every four deaths in the United States each year,” Kennedy noted.  “For patients with extremely high cholesterol or a genetic predisposition to heart disease, who live in daily fear of heart attack and stroke, this data offers real hope for medication that can improve and protect their lives.”

Money-Back Guarantee

That hope has been dashed in past months by high rates of health plan rejection for patients whose doctors prescribe PCSK9 inhibitors.  Health plan report cards issued this month by the Institute for Patient Access show rejection rates of about 50 percent, depending upon the state.

If new data doesn’t reduce health plan barriers, perhaps a new offer from one PCSK9 inhibitor manufacturer will.  Amgen announced Friday that it’s willing to strike a deal with health plans: If its PCSK9 inhibitor fails to prevent a stroke or a heart attack, the company will refund the medication’s cost.  The manufacturer also offered to consider risk-sharing arrangements with health plans, as well as annual payment caps. In return, Amgen would ask the health plans to drop excessive barriers to patient access.

About PCSK9 Inhibitors

First approved by the Food and Drug Administration in 2015, PCSK9 inhibitors block the PCSK9 protein from destroying a receptor on the liver that clears bad cholesterol.  By prolonging the life of the receptor, the drugs increase the amount of LDL cholesterol that’s cleared from the body.

For more on PCSK9 inhibitors and the prior authorization barriers that prevent many patients from accessing them, watch “Accessing Breakthrough Cholesterol Treatment” from the Partnership to Advance Cardiovascular Health

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