Despite being recommended for many high-risk patients with high cholesterol, a new class of cholesterol-lowering drugs are rarely approved by insurance companies, based on a national analysis of more than 220 million pharmacy claims.
The new class of drugs, called PCSK9 inhibitors (proprotein convertase subtilisin/kexin type 9 inhibitors), significantly reduce risk for life-threatening heart events in patients with uncontrolled cholesterol. They are currently recommended for patients with especially high risk for heart events, including those with existing heart disease or a genetic condition called familial hypercholesterolemia, which causes dangerously high levels of cholesterol starting at birth. PCSK9 inhibitors are considered a second-line of treatment for these patients when lifestyle changes and cholesterol-lowering statins fail to work.
The two types of PCSK9 inhibitors currently on the market include alirocumab and evolocumab, both of which have been approved by the U.S. Food and Drug Administration for high-risk patients with high cholesterol. However, both drugs come with a high price tag—costing an average of $14,300 year—and insurance companies aren’t always willing to pay out.
To see how often insurance companies approve prescriptions, researchers analyzed all U.S. pharmacy claims between July 2015 and August 2016. The database included more than 220 million patients from all 50 states with more than 5,100 different insurance plans.
Overall, researchers counted a total of 51,466 prescriptions for PCSK9 inhibitors—only 47% of which were approved by insurance providers. Among all providers, private insurance companies like Aetna and Anthem had the lowest approval rates, with only 24% of prescriptions approved. Medicare, which is the federal health insurance program for adults 65 and older, had the highest approval rates with 61% of prescriptions approved.
Interestingly, researchers note that patients’ cholesterol levels had no impact on whether their prescription would likely be covered or not. However, patients who were older, had existing heart disease, couldn’t take statins or had taken them for a longer period of time, or received their prescription from a cardiologist or other specialist were more likely to have PCSK9 inhibitors approved.
What this study shows, explain authors, is that insurance poses a major barrier for patients in need of this new type of cholesterol-lowering drug. PCSK9 inhibitors can be life-saving for patients who continue to have dangerously high cholesterol levels despite current treatment. Therefore, it’s concerning that more than half of eligible patients are denied coverage for PCSK9 inhibitors, despite a prescription from their doctor.
Experts hope that policy change, updated treatment guidelines and decreases in cost will help boost approval rates to better ensure that high-risk patients get the cholesterol treatment they so desperately need.