What happens when high-risk heart patients can’t get the cholesterol-lowering medicine their doctor prescribes? Heart attacks and strokes, new data confirms.

According to research from the FH Foundation, people at high risk for cardiovascular events, such as those with cardiovascular disease or genetic high cholesterol called “familial hypercholesterolemia,” had more heart attacks and strokes when they couldn’t get prescribed PCSK9 inhibitors. The innovative drugs are proven to lower high LDL cholesterol and reduce the risk of heart attack, stroke and death – especially for at-risk patients who don’t respond adequately to statins.

The FH Foundation’s study found:

High-risk patients had a 16% increased risk for a cardiovascular event when their PCSK9 inhibitor was rejected by their health plan

Individuals who did not fill their approved prescription had a 21% increased risk of a cardiovascular event

Individuals with FH and established cardiovascular disease had more than five-times the risk of others in the study. Insurers rejected two-thirds of their prescriptions.

Earlier this year, data from the Institute for Patient Access revealed that commercial insurance rejections for PCSK9 inhibitors averaged 57% across the country. Even about one in three patients with documented cardiovascular disease, familiar hypercholesterolemia or a history of heart attack or stroke was rejected. Now the FH Foundation study confirms concerns about the real-world implications of access barriers for such patients.

“Real people had real heart attacks and strokes because they could not get the medicine prescribed by their doctors,” emphasized the FH Foundation’s Kelly Myers, an author of the study.

In addition to high rejection rates, high co-pays also play a role in access challenges, the study demonstrated. Nearly 65% of people who left their prescription unfilled were Medicare patients. Advocates have recently expressed concern that, while prices for PCSK9 inhibitors have dropped by 60 percent, Medicare plans are not yet passing those savings to beneficiaries.

Finally, the FH Foundation study confirmed that women, minorities and poor patients had higher rates of prescription rejection and prescription abandonment.

“It is imperative that we initiate comprehensive treatment early in life,” said Daniel J Rader, MD, chief scientific advisor of the FH Foundation and senior author of the paper, “and that individuals receive the medications they have been prescribed.”