July 23 (UPI) -- When insurance companies refuse to cover cholesterol-lowering drugs, it puts patients at risk for stroke and heart ailments, a new study says.
Getting rejected for medications these medications puts patients at a 16 percent higher risk of having a heart attack, unstable angina, cardiac arrest or other cardiac events, according to research published Tuesday Tuesday in the journal Circulation: Cardiovascular Quality and Outcomes. Patients who were approval but didn't fill the prescriptions for some reason were at a 21 percent risk of suffering a cardiac event.
"We heard from individuals with familial hypercholesterolemia and physicians that there were consistent difficulties getting PCSK9 inhibitors approved for coverage, even for the people these drugs are meant to help," Kelly Myers, chief technology officer for the FH Foundation and lead author of the study, told UPI.
The study tracked the medical data and pharmacy claims for roughly 139,000 high-risk patients with familial hypercholesterolemia, or arterial plaque buildup. The researchers found insurers turned down nearly two-thirds of claims to cover the cholesterol-lowering drugs.
"The manufacturers have now taken an important step to address cost as a barrier by cutting the list price of both PCSK9is by 60 percent," Myers said. "This is also an important step towards transparency in drug pricing. Insurance plans must now make it easier for patients and their healthcare providers to get these drugs approved for coverage, and also make sure that the out-of-pocket costs are affordable, especially in Medicare."
Between 2015 and 2017, the annual price for PCSK9 inhibitor medications was $14,000, a higher cost than other cholesterol-lowering drugs, the researchers say. Yet, the drug has proved to drastically lower LDL cholesterol levels, otherwise known as "bad" cholesterol, in high-risk patients when other drugs weren't successful.
To make its drug more affordable, Regeneron Pharmaceuticals cut the annual price for its PCSK9 to $7,000. And Amgen cut the price for it's PCSK9 to $5,850, which the company said is a 60 percent reduction from its initial list price.
Yet, experts say the drug's price should fall between $900 and $2,000 a year before it can be considered affordable.
In 2018, the American Heart Association reported that 97 percent of patients were approved for a PCSK9. But the current study shows 15 percent of prescriptions were never filled by patients. Their monthly co-payments averaged $233.30, compared to $103.17 for patients who filled their prescriptions.
This suggests pricier co-payments make it less likely a patient will fill a prescription for a potentially life-saving drug, the researchers say.
"This study underlines the importance of specifically identifying familial hypercholesterolemia -- approximately 90 percent of individuals with familial hypercholesterolemia remain undiagnosed in the U.S. healthcare system today -- and urgently treating it," Myers said.