People had more cardiovascular events when they could not get their LDL-cholesterol medication

People at high risk of cardiovascular events, including people with familial hypercholesterolemia (FH) or atherosclerotic heart disease (ASCVD), have presented with more heart attacks, strokes, and stroke. Other cardiovascular events when they were unable to obtain the prescribed drug to reduce LDL-cholesterol.

In a new study published today in Circulation: quality and cardiovascular outcomesResearchers at the FH Foundation found that people with ASCVD or FH whose PCSK9 inhibitors (PCSK9is) had been rejected by their insurance plan had an immediate 16% increased cardiovascular event risk. of the 12 months of the study.

High cholesterol is a major risk for heart disease, the leading cause of death in the world. PCSK9is has been shown to lower LDL cholesterol and improve cardiovascular outcomes in many randomized trials, but many individuals were unable to obtain treatment.

"More than eighty thousand people at high risk of cardiovascular events have experienced treatment delays.Unprecedented insurance refusals, high drug costs and the badociated incidental fees have resulted in people have not received treatment and have resulted in a significant increase in cardiovascular events, including heart attacks.In other words, real people have had true heart attacks and strokes because 'they could not get the drugs prescribed by their doctor,' said Kelly Myers, head of technology at the FH Foundation and author of the study.

To determine whether PCSK9i orders that were rejected, not met or paid had an impact on the results, the researchers badyzed data on medical consultations of 139,036 people over the age of 18 between August 2015 and December 2017. A status of 39; "paid order" was awarded to those who received 338 or more days of treatment within 12 months, "rejected" if the final claim status was rejected, and "not performed" if the prescription was approved but not filled.

In addition, the risk of a cardiovascular event was immediately increased by 21% in people who did not perform their prescription during the study period. About 65% of the unresolved claims involved Medicare patients, likely due to higher copayment costs.

Myers added, "The higher the co-pays, the more people who dropped out of treatment, even if approved." Unfortunately, these delays in treatment have a disproportionate impact on the most vulnerable groups, including women. minorities and low-income people for heart disease. "

The study also found that people with FH, a common genetic disease causing high LDL cholesterol at birth, are at an even higher risk than other high-risk groups in the study. . All people in the study had a risk of cardiovascular events seven times higher than the general population. In addition, the risk of a cardiovascular event was three times higher in people with HF than in those who did not have HF or ASCVD. In fact, the risk of cardiovascular event was no different in people with hypothetical hypertension compared with those in which an ASCVD had been diagnosed. The highest risk group of the study was a person with HF who was also suffering from cardiovascular disease. The members of this group were more than five times more likely than the other people in the study who had neither FH nor ASCVD. Yet 63% of their prescriptions were rejected.

Although we know that a person who has had a heart attack or other cardiovascular event is much more likely to have a second event and presents a much higher risk than the general population, this new finding underscores that FH people are at such a high risk. It is imperative that we initiate full treatment early in life and that individuals receive the prescribed medications. "

Daniel J. Rader, M.D., director of the Department of Genetics at the Perelman School of Medicine at the University of Pennsylvania

Rader is also Chief Scientific Advisor to the FH Foundation and lead author of the document.

"This concrete evidence shows how much FH people are at risk for a heart attack or surgery if their LDL-C level is not reduced enough." People like me, who have FH and who have had a heart attack, are at the highest immediate level risk of occurrence of a life-threatening cardiovascular event, yet more than two-thirds of prescriptions in this group are still denied, "said Katherine Wilemon, Founder and Executive Director of the FH Foundation.